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11 Health care technology

ICS Field
11.020 Medical sciences and health care facilities in general
Including quality and environmental management in health care technology
IT application in health care technology, see 35.240.80
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
0IWA 1:2005
Quality management systems -- Guidelines for process improvements in health service organizations 60.60 TMB
ISO/IEC Guide 63:1999
Guide to the development and inclusion of safety aspects in International Standards for medical devices 90.92 TMB
ISO/TR 11991:1995
Guidance on airway management during laser surgery of upper airway 90.93 TC 121/SC 2
ISO/ASTM 51939:2005
Practice for blood irradiation dosimetry 90.60 TC 85


11.040 Medical equipment
ICS Field
11.040.01 Medical equipment in general
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO 13485:2003
Medical devices -- Quality management systems -- Requirements for regulatory purposes 90.93 TC 210
ISO/TR 14969:2004
Medical devices -- Quality management systems -- Guidance on the application of ISO 13485: 2003 90.93 TC 210
ISO 14971:2007
Medical devices -- Application of risk management to medical devices 60.60 TC 210
ISO 15223:2000
Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied 90.92 TC 210
ISO 15223:2000/Amd 1:2002
60.60 TC 210
ISO 15223:2000/Amd 2:2004
60.60 TC 210
ISO 15223-1:2007
Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements 90.92 TC 210
ISO/DIS 15223-1
Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements 40.00 TC 210
ISO 15223-1:2007/Amd 1:2008
60.60 TC 210
ISO/DIS 15223-2.2
Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 2: Symbol development, selection and validation 40.60 TC 210
ISO 15225:2000
Nomenclature -- Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange 90.92 TC 210
ISO/DIS 15225
Medical devices -- Quality management -- Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange 40.99 TC 210
ISO 15225:2000/Amd 1:2004
60.60 TC 210
ISO 15378:2006
Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP) 90.20 TC 76
ISO/TR 16142:2006
Medical devices -- Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices 60.60 TC 210
ISO/TS 19218:2005
Medical devices -- Coding structure for adverse event type and cause 90.92 TC 210
25IEC 62304:2006
Medical device software -- Software life cycle processes 60.60 TC 210
26IEC 62366:2007
Medical devices -- Application of usability engineering to medical devices 60.60 TC 210


11.040.10 Anaesthetic, respiratory and reanimation equipment
Including medical gas installations
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO 32:1977
Gas cylinders for medical use -- Marking for identification of content 90.93 TC 58/SC 4
ISO 407:2004
Small medical gas cylinders -- Pin-index yoke-type valve connections 90.60 TC 58/SC 2
ISO 4135:2001
Anaesthetic and respiratory equipment -- Vocabulary 90.60 TC 121/SC 4
ISO 5356-1:2004
Anaesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones and sockets 90.60 TC 121/SC 1
ISO 5356-2:2006
Anaesthetic and respiratory equipment -- Conical connectors -- Part 2: Screw-threaded weight-bearing connectors 60.60 TC 121/SC 1
ISO 5358:1992
Anaesthetic machines for use with humans 90.93 TC 121/SC 1
ISO 5359:2008
Low-pressure hose assemblies for use with medical gases 60.60 TC 121/SC 1
ISO 5360:2006
Anaesthetic vaporizers -- Agent-specific filling systems 60.60 TC 121/SC 1
ISO 5361:1999
Anaesthetic and respiratory equipment -- Tracheal tubes and connectors 90.93 TC 121/SC 2
ISO 5361-4:1987
Tracheal tubes -- Part 4: Cole type 90.93 TC 121/SC 2
ISO 5362:2006
Anaesthetic reservoir bags 90.20 TC 121/SC 2
ISO 5364:2008
Anaesthetic and respiratory equipment -- Oropharyngeal airways 60.60 TC 121/SC 2
ISO 5366-1:2000
Anaesthetic and respiratory equipment -- Tracheostomy tubes -- Part 1: Tubes and connectors for use in adults 90.93 TC 121/SC 2
ISO 5366-3:2001
Anaesthetic and respiratory equipment -- Tracheostomy tubes -- Part 3: Paediatric tracheostomy tubes 90.60 TC 121/SC 2
ISO 5366-3:2001/Cor 1:2003
60.60 TC 121/SC 2
ISO 5367:2000
Breathing tubes intended for use with anaesthetic apparatus and ventilators 90.60 TC 121/SC 2
ISO/FDIS 7376
Anaesthetic and respiratory equipment -- Laryngoscopes for tracheal intubation 50.20 TC 121/SC 2
ISO 7396-1:2007
Medical gas pipeline systems -- Part 1: Pipeline systems for compressed medical gases and vacuum 60.60 TC 121/SC 6
ISO 7396-1:2007/DAmd 1
40.60 TC 121/SC 6
ISO 7396-1:2007/DAmd 2
40.20 TC 121/SC 6
ISO 7396-2:2007
Medical gas pipeline systems -- Part 2: Anaesthetic gas scavenging disposal systems 60.60 TC 121/SC 6
ISO 8185:2007
Respiratory tract humidifiers for medical use -- Particular requirements for respiratory humidification systems 60.60 TC 121/SC 3
ISO 8359:1996
Oxygen concentrators for medical use -- Safety requirements 90.93 TC 121/SC 3
ISO 8835-2:2007
Inhalational anaesthesia systems -- Part 2: Anaesthetic breathing systems 60.60 TC 121/SC 1
ISO 8835-3:2007
Inhalational anaesthesia systems -- Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems 60.60 TC 121/SC 1
ISO 8835-4:2004
Inhalational anaesthesia systems -- Part 4: Anaesthetic vapour delivery devices 90.93 TC 121/SC 1
ISO 8835-5:2004
Inhalational anaesthesia systems -- Part 5: Anaesthetic ventilators 90.93 TC 121/SC 1
ISO/AWI 8835-7
Inhalational anaesthesia systems -- Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases 20.00 TC 121/SC 1
ISO 8836:2007
Suction catheters for use in the respiratory tract 60.60 TC 121/SC 2
ISO 9170-1:2008
Terminal units for medical gas pipeline systems -- Part 1: Terminal units for use with compressed medical gases and vacuum 60.60 TC 121/SC 6
ISO 9170-2:2008
Terminal units for medical gas pipeline systems -- Part 2: Terminal units for anaesthetic gas scavenging systems 60.60 TC 121/SC 6
ISO 9360-1:2000
Anaesthetic and respiratory equipment -- Heat and moisture exchangers (HMEs) for humidifying respired gases in humans -- Part 1: HMEs for use with minimum tidal volumes of 250 ml 90.93 TC 121/SC 3
ISO 9360-2:2001
Anaesthetic and respiratory equipment -- Heat and moisture exchangers (HMEs) for humidifying respired gases in humans -- Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml 90.93 TC 121/SC 3
ISO 9919:2005
Medical electrical equipment -- Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use 90.92 TC 121/SC 3
ISO 10079-1:1999
Medical suction equipment -- Part 1: Electrically powered suction equipment -- Safety requirements 90.92 TC 121/SC 8
ISO 10079-2:1999
Medical suction equipment -- Part 2: Manually powered suction equipment 90.92 TC 121/SC 8
ISO 10079-3:1999
Medical suction equipment -- Part 3: Suction equipment powered from a vacuum or pressure source 90.92 TC 121/SC 8
ISO 10083:2006
Oxygen concentrator supply systems for use with medical gas pipeline systems 60.60 TC 121/SC 6
ISO 10524-1:2006
Pressure regulators for use with medical gases -- Part 1: Pressure regulators and pressure regulators with flow-metering devices 90.20 TC 121/SC 6
ISO 10524-2:2005
Pressure regulators for use with medical gases -- Part 2: Manifold and line pressure regulators 90.93 TC 121/SC 6
ISO 10524-3:2005
Pressure regulators for use with medical gases -- Part 3: Pressure regulators integrated with cylinder valves 90.93 TC 121/SC 6
ISO 10524-3:2005/CD Amd 1
30.20 TC 121/SC 6
ISO 10524-4:2008
Pressure regulators for use with medical gases -- Part 4: Low-pressure regulators 60.60 TC 121/SC 6
ISO 10651-2:2004
Lung ventilators for medical use -- Particular requirements for basic safety and essential performance -- Part 2: Home care ventilators for ventilator-dependent patients 90.93 TC 121/SC 3
ISO 10651-3:1997
Lung ventilators for medical use -- Part 3: Particular requirements for emergency and transport ventilators 90.93 TC 121/SC 3
ISO 10651-4:2002
Lung ventilators -- Part 4: Particular requirements for operator-powered resuscitators 60.60 TC 121/SC 3
ISO 10651-5:2006
Lung ventilators for medical use -- Particular requirements for basic safety and essential performance -- Part 5: Gas-powered emergency resuscitators 90.20 TC 121/SC 3
ISO 10651-6:2004
Lung ventilators for medical use -- Particular requirements for basic safety and essential performance -- Part 6: Home-care ventilatory support devices 90.93 TC 121/SC 3
ISO 11040-1:1992
Prefilled syringes -- Part 1: Glass cylinders for dental local anaesthetic cartridges 90.93 TC 76
ISO 11040-2:1994
Prefilled syringes -- Part 2: Plungers and discs for dental local anaesthetic cartridges 90.92 TC 76
ISO 11040-3:1993
Prefilled syringes -- Part 3: Aluminium caps for dental local anaesthetic cartridges 90.92 TC 76
ISO 11117:2008
Gas cylinders -- Valve protection caps and valve guards -- Design, construction and tests 60.60 TC 58/SC 2
ISO 11117:2008/Cor 1:2009
60.60 TC 58/SC 2
ISO 11195:1995
Gas mixers for medical use -- Stand-alone gas mixers 90.93 TC 121/SC 1
ISO/NP 11197
Medical supply units 10.99 TC 121/SC 6
ISO 11197:2004
Medical supply units 90.92 TC 121/SC 6
ISO 11499:2007
Dentistry -- Single-use cartridges for local anaesthetics 60.60 TC 106/SC 4
ISO 11712:2009
Anaesthetic and respiratory equipment -- Supralaryngeal airways and connectors 60.60 TC 121/SC 2
ISO 11990:2003
Optics and optical instruments -- Lasers and laser-related equipment -- Determination of laser resistance of tracheal tube shafts 90.92 TC 172/SC 9
ISO/DIS 11990-2
Lasers and laser-related equipment -- Determination of laser resistance of tracheal tubes -- Part 2: Tracheal tube cuffs 40.60 TC 172/SC 9
ISO 14408:2005
Tracheal tubes designed for laser surgery -- Requirements for marking and accompanying information 90.93 TC 121/SC 2
ISO 15001:2003
Anaesthetic and respiratory equipment -- Compatibility with oxygen 90.92 TC 121/SC 6
ISO/DIS 15001
Anaesthetic and respiratory equipment -- Compatibility with oxygen 40.60 TC 121/SC 6
ISO 15002:2008
Flow-metering devices for connection to terminal units of medical gas pipeline systems 60.60 TC 121/SC 6
ISO 16628:2008
Tracheobronchial tubes -- Sizing and marking 60.60 TC 121/SC 2
ISO 17510-1:2007
Sleep apnoea breathing therapy -- Part 1: Sleep apnoea breathing therapy equipment 60.60 TC 121/SC 3
ISO 17510-2:2007
Sleep apnoea breathing therapy -- Part 2: Masks and application accessories 60.60 TC 121/SC 3
ISO 18778:2005
Respiratory equipment -- Infant monitors -- Particular requirements 90.60 TC 121/SC 3
ISO 18779:2005
Medical devices for conserving oxygen and oxygen mixtures -- Particular requirements 90.92 TC 121/SC 3
ISO/TS 18835:2004
Inhalational anaesthesia systems -- Draw-over vaporizers and associated equipment 90.93 TC 121/SC 1
ISO/FDIS 20072
Aerosol drug delivery device design verification -- Requirements and test methods 50.20 TC 84
ISO 21647:2004
Medical electrical equipment -- Particular requirements for the basic safety and essential performance of respiratory gas monitors 90.92 TC 121/SC 1
ISO 21647:2004/Cor 1:2005
60.60 TC 121/SC 1
ISO 21969:2005
High-pressure flexible connections for use with medical gas systems 90.92 TC 121/SC 6
ISO/FDIS 21969
High-pressure flexible connections for use with medical gas systems 50.20 TC 121/SC 6
ISO 23328-1:2003
Breathing system filters for anaesthetic and respiratory use -- Part 1: Salt test method to assess filtration performance 90.93 TC 121/SC 3
ISO 23328-2:2002
Breathing system filters for anaesthetic and respiratory use -- Part 2: Non-filtration aspects 90.93 TC 121/SC 3
ISO 23747:2007
Anaesthetic and respiratory equipment -- Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans 60.60 TC 121/SC 3
ISO/FDIS 26782
Anaesthetic and respiratory equipment -- Spirometers intended for the measurement of time forced expired volumes in humans 50.20 TC 121/SC 3
ISO 26825:2008
Anaesthetic and respiratory equipment -- User-applied labels for syringes containing drugs used during anaesthesia -- Colours, design and performance 60.60 TC 121/SC 1
ISO 27427:2009
Anaesthetic and respiratory equipment -- Nebulizing systems and components 60.60 TC 121/SC 2
173IEC 60601-1-8:2006
Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance -- Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 60.60 TC 121/SC 3
175IEC 60601-1-8:2003/Amd 1:2006
60.60 TC 121/SC 3
176IEC 60601-1-10:2007
Medical electrical equipment -- Part 1-10: General requirements for basic safety and essential performance -- Collateral standard: Requirements for the development of physiologic closed-loop controllers 60.60 TC 121/SC 3
177IEC/DIS 60601-1-11
Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in home care applications 40.20 TC 121/SC 3
178IEC 60601-2-12:2001
Medical electrical equipment -- Part 2-12: Particular requirements for the safety of lung ventilators -- Critical care ventilators 90.60 TC 121/SC 3
180IEC 60601-2-13:2003
Medical electrical equipment -- Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems 60.60 TC 121/SC 1
181IEC 60601-2-13:2003/Amd 1:2006
60.60 TC 121/SC 1
ISO/CD 80369-1
Small bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements 30.99 TC 210
ISO/CD 80601-2-12
Medical electrical equipment -- Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators 30.99 TC 121/SC 3
ISO/CD 80601-2-13
Medical electrical equipment -- Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation 30.60 TC 121/SC 1
185IEC 80601-2-30:2009
Medical electrical equipment -- Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers 60.60 TC 121/SC 3
ISO/CD 80601-2-55
Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors 30.60 TC 121/SC 1
ISO/DIS 80601-2-61
Medical electrical equipment -- Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use 40.20 TC 121/SC 3
ISO 81060-1:2007
Non-invasive sphygmomanometers -- Part 1: Requirements and test methods for non-automated measurement type 60.60 TC 121/SC 3
ISO 81060-2:2009
Non-invasive sphygmomanometers -- Part 2: Clinical validation of automated measurement type 60.60 TC 121/SC 3


11.040.20 Transfusion, infusion and injection equipment
Including blood packs
Syringes, needles and catheters, see 11.040.25
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO 32:1977
Gas cylinders for medical use -- Marking for identification of content 90.93 TC 58/SC 4
ISO 407:2004
Small medical gas cylinders -- Pin-index yoke-type valve connections 90.60 TC 58/SC 2
ISO 4135:2001
Anaesthetic and respiratory equipment -- Vocabulary 90.60 TC 121/SC 4
ISO 5356-1:2004
Anaesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones and sockets 90.60 TC 121/SC 1
ISO 5356-2:2006
Anaesthetic and respiratory equipment -- Conical connectors -- Part 2: Screw-threaded weight-bearing connectors 60.60 TC 121/SC 1
ISO 5358:1992
Anaesthetic machines for use with humans 90.93 TC 121/SC 1
ISO 5359:2008
Low-pressure hose assemblies for use with medical gases 60.60 TC 121/SC 1
ISO 5360:2006
Anaesthetic vaporizers -- Agent-specific filling systems 60.60 TC 121/SC 1
ISO 5361:1999
Anaesthetic and respiratory equipment -- Tracheal tubes and connectors 90.93 TC 121/SC 2
ISO 5361-4:1987
Tracheal tubes -- Part 4: Cole type 90.93 TC 121/SC 2
ISO 5362:2006
Anaesthetic reservoir bags 90.20 TC 121/SC 2
ISO 5364:2008
Anaesthetic and respiratory equipment -- Oropharyngeal airways 60.60 TC 121/SC 2
ISO 5366-1:2000
Anaesthetic and respiratory equipment -- Tracheostomy tubes -- Part 1: Tubes and connectors for use in adults 90.93 TC 121/SC 2
ISO 5366-3:2001
Anaesthetic and respiratory equipment -- Tracheostomy tubes -- Part 3: Paediatric tracheostomy tubes 90.60 TC 121/SC 2
ISO 5366-3:2001/Cor 1:2003
60.60 TC 121/SC 2
ISO 5367:2000
Breathing tubes intended for use with anaesthetic apparatus and ventilators 90.60 TC 121/SC 2
ISO/FDIS 7376
Anaesthetic and respiratory equipment -- Laryngoscopes for tracheal intubation 50.20 TC 121/SC 2
ISO 7396-1:2007
Medical gas pipeline systems -- Part 1: Pipeline systems for compressed medical gases and vacuum 60.60 TC 121/SC 6
ISO 7396-1:2007/DAmd 1
40.60 TC 121/SC 6
ISO 7396-1:2007/DAmd 2
40.20 TC 121/SC 6
ISO 7396-2:2007
Medical gas pipeline systems -- Part 2: Anaesthetic gas scavenging disposal systems 60.60 TC 121/SC 6
ISO 8185:2007
Respiratory tract humidifiers for medical use -- Particular requirements for respiratory humidification systems 60.60 TC 121/SC 3
ISO 8359:1996
Oxygen concentrators for medical use -- Safety requirements 90.93 TC 121/SC 3
ISO 8835-2:2007
Inhalational anaesthesia systems -- Part 2: Anaesthetic breathing systems 60.60 TC 121/SC 1
ISO 8835-3:2007
Inhalational anaesthesia systems -- Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems 60.60 TC 121/SC 1
ISO 8835-4:2004
Inhalational anaesthesia systems -- Part 4: Anaesthetic vapour delivery devices 90.93 TC 121/SC 1
ISO 8835-5:2004
Inhalational anaesthesia systems -- Part 5: Anaesthetic ventilators 90.93 TC 121/SC 1
ISO/AWI 8835-7
Inhalational anaesthesia systems -- Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases 20.00 TC 121/SC 1
ISO 8836:2007
Suction catheters for use in the respiratory tract 60.60 TC 121/SC 2
ISO 9170-1:2008
Terminal units for medical gas pipeline systems -- Part 1: Terminal units for use with compressed medical gases and vacuum 60.60 TC 121/SC 6
ISO 9170-2:2008
Terminal units for medical gas pipeline systems -- Part 2: Terminal units for anaesthetic gas scavenging systems 60.60 TC 121/SC 6
ISO 9360-1:2000
Anaesthetic and respiratory equipment -- Heat and moisture exchangers (HMEs) for humidifying respired gases in humans -- Part 1: HMEs for use with minimum tidal volumes of 250 ml 90.93 TC 121/SC 3
ISO 9360-2:2001
Anaesthetic and respiratory equipment -- Heat and moisture exchangers (HMEs) for humidifying respired gases in humans -- Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml 90.93 TC 121/SC 3
ISO 9919:2005
Medical electrical equipment -- Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use 90.92 TC 121/SC 3
ISO 10079-1:1999
Medical suction equipment -- Part 1: Electrically powered suction equipment -- Safety requirements 90.92 TC 121/SC 8
ISO 10079-2:1999
Medical suction equipment -- Part 2: Manually powered suction equipment 90.92 TC 121/SC 8
ISO 10079-3:1999
Medical suction equipment -- Part 3: Suction equipment powered from a vacuum or pressure source 90.92 TC 121/SC 8
ISO 10083:2006
Oxygen concentrator supply systems for use with medical gas pipeline systems 60.60 TC 121/SC 6
ISO 10524-1:2006
Pressure regulators for use with medical gases -- Part 1: Pressure regulators and pressure regulators with flow-metering devices 90.20 TC 121/SC 6
ISO 10524-2:2005
Pressure regulators for use with medical gases -- Part 2: Manifold and line pressure regulators 90.93 TC 121/SC 6
ISO 10524-3:2005
Pressure regulators for use with medical gases -- Part 3: Pressure regulators integrated with cylinder valves 90.93 TC 121/SC 6
ISO 10524-3:2005/CD Amd 1
30.20 TC 121/SC 6
ISO 10524-4:2008
Pressure regulators for use with medical gases -- Part 4: Low-pressure regulators 60.60 TC 121/SC 6
ISO 10651-2:2004
Lung ventilators for medical use -- Particular requirements for basic safety and essential performance -- Part 2: Home care ventilators for ventilator-dependent patients 90.93 TC 121/SC 3
ISO 10651-3:1997
Lung ventilators for medical use -- Part 3: Particular requirements for emergency and transport ventilators 90.93 TC 121/SC 3
ISO 10651-4:2002
Lung ventilators -- Part 4: Particular requirements for operator-powered resuscitators 60.60 TC 121/SC 3
ISO 10651-5:2006
Lung ventilators for medical use -- Particular requirements for basic safety and essential performance -- Part 5: Gas-powered emergency resuscitators 90.20 TC 121/SC 3
ISO 10651-6:2004
Lung ventilators for medical use -- Particular requirements for basic safety and essential performance -- Part 6: Home-care ventilatory support devices 90.93 TC 121/SC 3
ISO 11040-1:1992
Prefilled syringes -- Part 1: Glass cylinders for dental local anaesthetic cartridges 90.93 TC 76
ISO 11040-2:1994
Prefilled syringes -- Part 2: Plungers and discs for dental local anaesthetic cartridges 90.92 TC 76
ISO 11040-3:1993
Prefilled syringes -- Part 3: Aluminium caps for dental local anaesthetic cartridges 90.92 TC 76
ISO 11117:2008
Gas cylinders -- Valve protection caps and valve guards -- Design, construction and tests 60.60 TC 58/SC 2
ISO 11117:2008/Cor 1:2009
60.60 TC 58/SC 2
ISO 11195:1995
Gas mixers for medical use -- Stand-alone gas mixers 90.93 TC 121/SC 1
ISO/NP 11197
Medical supply units 10.99 TC 121/SC 6
ISO 11197:2004
Medical supply units 90.92 TC 121/SC 6
ISO 11499:2007
Dentistry -- Single-use cartridges for local anaesthetics 60.60 TC 106/SC 4
ISO 11712:2009
Anaesthetic and respiratory equipment -- Supralaryngeal airways and connectors 60.60 TC 121/SC 2
ISO 11990:2003
Optics and optical instruments -- Lasers and laser-related equipment -- Determination of laser resistance of tracheal tube shafts 90.92 TC 172/SC 9
ISO/DIS 11990-2
Lasers and laser-related equipment -- Determination of laser resistance of tracheal tubes -- Part 2: Tracheal tube cuffs 40.60 TC 172/SC 9
ISO 14408:2005
Tracheal tubes designed for laser surgery -- Requirements for marking and accompanying information 90.93 TC 121/SC 2
ISO 15001:2003
Anaesthetic and respiratory equipment -- Compatibility with oxygen 90.92 TC 121/SC 6
ISO/DIS 15001
Anaesthetic and respiratory equipment -- Compatibility with oxygen 40.60 TC 121/SC 6
ISO 15002:2008
Flow-metering devices for connection to terminal units of medical gas pipeline systems 60.60 TC 121/SC 6
ISO 16628:2008
Tracheobronchial tubes -- Sizing and marking 60.60 TC 121/SC 2
ISO 17510-1:2007
Sleep apnoea breathing therapy -- Part 1: Sleep apnoea breathing therapy equipment 60.60 TC 121/SC 3
ISO 17510-2:2007
Sleep apnoea breathing therapy -- Part 2: Masks and application accessories 60.60 TC 121/SC 3
ISO 18778:2005
Respiratory equipment -- Infant monitors -- Particular requirements 90.60 TC 121/SC 3
ISO 18779:2005
Medical devices for conserving oxygen and oxygen mixtures -- Particular requirements 90.92 TC 121/SC 3
ISO/TS 18835:2004
Inhalational anaesthesia systems -- Draw-over vaporizers and associated equipment 90.93 TC 121/SC 1
ISO/FDIS 20072
Aerosol drug delivery device design verification -- Requirements and test methods 50.20 TC 84
ISO 21647:2004
Medical electrical equipment -- Particular requirements for the basic safety and essential performance of respiratory gas monitors 90.92 TC 121/SC 1
ISO 21647:2004/Cor 1:2005
60.60 TC 121/SC 1
ISO 21969:2005
High-pressure flexible connections for use with medical gas systems 90.92 TC 121/SC 6
ISO/FDIS 21969
High-pressure flexible connections for use with medical gas systems 50.20 TC 121/SC 6
ISO 23328-1:2003
Breathing system filters for anaesthetic and respiratory use -- Part 1: Salt test method to assess filtration performance 90.93 TC 121/SC 3
ISO 23328-2:2002
Breathing system filters for anaesthetic and respiratory use -- Part 2: Non-filtration aspects 90.93 TC 121/SC 3
ISO 23747:2007
Anaesthetic and respiratory equipment -- Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans 60.60 TC 121/SC 3
ISO/FDIS 26782
Anaesthetic and respiratory equipment -- Spirometers intended for the measurement of time forced expired volumes in humans 50.20 TC 121/SC 3
ISO 26825:2008
Anaesthetic and respiratory equipment -- User-applied labels for syringes containing drugs used during anaesthesia -- Colours, design and performance 60.60 TC 121/SC 1
ISO 27427:2009
Anaesthetic and respiratory equipment -- Nebulizing systems and components 60.60 TC 121/SC 2
173IEC 60601-1-8:2006
Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance -- Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 60.60 TC 121/SC 3
175IEC 60601-1-8:2003/Amd 1:2006
60.60 TC 121/SC 3
176IEC 60601-1-10:2007
Medical electrical equipment -- Part 1-10: General requirements for basic safety and essential performance -- Collateral standard: Requirements for the development of physiologic closed-loop controllers 60.60 TC 121/SC 3
177IEC/DIS 60601-1-11
Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in home care applications 40.20 TC 121/SC 3
178IEC 60601-2-12:2001
Medical electrical equipment -- Part 2-12: Particular requirements for the safety of lung ventilators -- Critical care ventilators 90.60 TC 121/SC 3
180IEC 60601-2-13:2003
Medical electrical equipment -- Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems 60.60 TC 121/SC 1
181IEC 60601-2-13:2003/Amd 1:2006
60.60 TC 121/SC 1
ISO/CD 80369-1
Small bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements 30.99 TC 210
ISO/CD 80601-2-12
Medical electrical equipment -- Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators 30.99 TC 121/SC 3
ISO/CD 80601-2-13
Medical electrical equipment -- Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation 30.60 TC 121/SC 1
185IEC 80601-2-30:2009
Medical electrical equipment -- Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers 60.60 TC 121/SC 3
ISO/CD 80601-2-55
Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors 30.60 TC 121/SC 1
ISO/DIS 80601-2-61
Medical electrical equipment -- Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use 40.20 TC 121/SC 3
ISO 81060-1:2007
Non-invasive sphygmomanometers -- Part 1: Requirements and test methods for non-automated measurement type 60.60 TC 121/SC 3
ISO 81060-2:2009
Non-invasive sphygmomanometers -- Part 2: Clinical validation of automated measurement type 60.60 TC 121/SC 3


11.040.25 Syringes, needles and catheters
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO 594-1:1986
Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirements 90.93 TC 210
ISO 594-2:1998
Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings 90.60 TC 210
ISO 595-1:1986
Reusable all-glass or metal-and-glass syringes for medical use -- Part 1: Dimensions 90.93 TC 84
ISO 595-2:1987
Reusable all-glass or metal-and-glass syringes for medical use -- Part 2: Design, performance requirements and tests 90.93 TC 84
ISO 6009:1992
Hypodermic needles for single use -- Colour coding for identification 90.93 TC 84
ISO 6009:1992/Cor 1:2008
60.60 TC 84
ISO 7864:1993
Sterile hypodermic needles for single use 90.93 TC 84
ISO/DIS 7885
Dentistry -- Sterile injection needles for single use 40.20 TC 106/SC 4
ISO 7885:2000
Sterile dental injection needles for single use 90.92 TC 106/SC 4
ISO 7886-1:1993
Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use 90.93 TC 84
ISO 7886-1:1993/Cor 1:1995
60.60 TC 84
ISO 7886-2:1996
Sterile hypodermic syringes for single use -- Part 2: Syringes for use with power-driven syringe pumps 90.93 TC 84
ISO 7886-3:2005
Sterile hypodermic syringes for single use -- Part 3: Auto-disable syringes for fixed-dose immunization 90.60 TC 84
ISO 7886-4:2006
Sterile hypodermic syringes for single use -- Part 4: Syringes with re-use prevention feature 60.60 TC 84
ISO 8537:2007
Sterile single-use syringes, with or without needle, for insulin 60.60 TC 84
ISO 8836:2007
Suction catheters for use in the respiratory tract 60.60 TC 121/SC 2
ISO 9626:1991
Stainless steel needle tubing for the manufacture of medical devices 90.93 TC 84
ISO 9626:1991/Amd 1:2001
60.60 TC 84
ISO 9997:1999
Dental cartridge syringes 90.93 TC 106/SC 4
ISO 10555-1:1995
Sterile, single-use intravascular catheters -- Part 1: General requirements 90.93 TC 84
ISO 10555-1:1995/Amd 1:1999
60.60 TC 84
ISO 10555-1:1995/Amd 2:2004
60.60 TC 84
ISO 10555-2:1996
Sterile, single-use intravascular catheters -- Part 2: Angiographic catheters 90.93 TC 84
ISO 10555-2:1996/Cor 1:2002
60.60 TC 84
ISO 10555-3:1996
Sterile, single-use intravascular catheters -- Part 3: Central venous catheters 90.93 TC 84
ISO 10555-3:1996/Cor 1:2002
60.60 TC 84
ISO 10555-4:1996
Sterile, single-use intravascular catheters -- Part 4: Balloon dilatation catheters 90.93 TC 84
ISO 10555-4:1996/Cor 1:2002
60.60 TC 84
ISO 10555-5:1996
Sterile, single-use intravascular catheters -- Part 5: Over-needle peripheral catheters 90.93 TC 84
ISO 10555-5:1996/Amd 1:1999
60.60 TC 84
ISO 10555-5:1996/Cor 1:2002
60.60 TC 84
ISO 11040-1:1992
Prefilled syringes -- Part 1: Glass cylinders for dental local anaesthetic cartridges 90.93 TC 76
ISO 11040-2:1994
Prefilled syringes -- Part 2: Plungers and discs for dental local anaesthetic cartridges 90.92 TC 76
ISO 11040-3:1993
Prefilled syringes -- Part 3: Aluminium caps for dental local anaesthetic cartridges 90.92 TC 76
ISO 11040-4:2007
Prefilled syringes -- Part 4: Glass barrels for injectables 60.60 TC 76
ISO 11040-5:2001
Prefilled syringes -- Part 5: Plungers for injectables 90.92 TC 76
ISO/NP 11040-6
Prefilled syringes -- Part 6: Prefilled single-use plastics syringes for injectables 10.99 TC 76
ISO 11070:1998
Sterile, single-use intravascular catheter introducers 90.93 TC 84
ISO 11608-1:2000
Pen-injectors for medical use -- Part 1: Pen-injectors -- Requirements and test methods 90.92 TC 84
ISO 11608-2:2000
Pen-injectors for medical use -- Part 2: Needles -- Requirements and test methods 90.92 TC 84
ISO 11608-3:2000
Pen-injectors for medical use -- Part 3: Finished cartridges -- Requirements and test methods 90.92 TC 84
ISO 11608-4:2006
Pen-injectors for medical use -- Part 4: Requirements and test methods for electronic and electromechanical pen-injectors 90.20 TC 84
ISO 13926-1:2004
Pen systems -- Part 1: Glass cylinders for pen-injectors for medical use 90.93 TC 76
ISO 13926-2:1999
Pen systems -- Part 2: Plungers and discs for pen-injectors for medical use 90.92 TC 76
ISO 14972:1998
Sterile obturators for single use with over-needle peripheral intravascular catheters 90.93 TC 84
ISO/CD 23908-1
Sharps injury protection -- Requirements and test methods -- Part 1: Sharps protection features for single-used hypodermic needles, catheters, introducers for catheters and lancing devices 30.60 TC 84
ISO/NP 23908-2
Sharps injury protection -- Requirements and test methods -- Part 2: Accessories for handling hypodermic needles after use 10.99 TC 84
ISO 26825:2008
Anaesthetic and respiratory equipment -- User-applied labels for syringes containing drugs used during anaesthesia -- Colours, design and performance 60.60 TC 121/SC 1


11.040.30 Surgical instruments and materials
Including surgical dressings, sutures, etc.
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO 7151:1988
Surgical instruments -- Non-cutting, articulated instruments -- General requirements and test methods 90.60 TC 170
ISO 7153-1:1991
Surgical instruments -- Metallic materials -- Part 1: Stainless steel 90.60 TC 170
ISO 7153-1:1991/Amd 1:1999
60.60 TC 170
ISO 7740:1985
Instruments for surgery -- Scalpels with detachable blades -- Fitting dimensions 90.60 TC 170
ISO 7741:1986
Instruments for surgery -- Scissors and shears -- General requirements and test methods 90.93 TC 170
ISO 10936-1:2000
Optics and optical instruments -- Operation microscopes -- Part 1: Requirements and test methods 90.93 TC 172/SC 5
ISO/DIS 10936-2.2
Optics and photonics -- Operation microscopes -- Part 2: Light hazard from operation microscopes used in ocular surgery 40.20 TC 172/SC 7
ISO 10936-2:2001
Optics and optical instruments -- Operation microscopes -- Part 2: Light hazard from operation microscopes used in ocular surgery 90.92 TC 172/SC 7
ISO 11810-1:2005
Lasers and laser-related equipment -- Test method and classification for the laser resistance of surgical drapes and/or patient protective covers -- Part 1: Primary ignition and penetration 90.93 TC 172/SC 9
ISO 11810-2:2007
Lasers and laser-related equipment -- Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers -- Part 2: Secondary ignition 60.60 TC 172/SC 9
ISO 13402:1995
Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure 90.93 TC 170


11.040.40 Implants for surgery, prosthetics and orthotics
Including pacemakers
Ophthalmic implants, see 11.040.70
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO 5832-1:2007
Implants for surgery -- Metallic materials -- Part 1: Wrought stainless steel 60.60 TC 150/SC 1
ISO 5832-1:2007/Cor 1:2008
60.60 TC 150/SC 1
ISO 5832-2:1999
Implants for surgery -- Metallic materials -- Part 2: Unalloyed titanium 90.20 TC 150/SC 1
ISO 5832-3:1996
Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy 90.93 TC 150/SC 1
ISO 5832-4:1996
Implants for surgery -- Metallic materials -- Part 4: Cobalt-chromium-molybdenum casting alloy 90.93 TC 150/SC 1
ISO 5832-5:2005
Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel alloy 90.93 TC 150/SC 1
ISO 5832-6:1997
Implants for surgery -- Metallic materials -- Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy 90.93 TC 150/SC 1
ISO 5832-7:1994
Implants for surgery -- Metallic materials -- Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy 90.93 TC 150/SC 1
ISO 5832-8:1997
Implants for surgery -- Metallic materials -- Part 8: Wrought cobalt-nickel-chromium-molybdenum- tungsten-iron alloy 90.93 TC 150/SC 1
ISO 5832-9:2007
Implants for surgery -- Metallic materials -- Part 9: Wrought high nitrogen stainless steel 60.60 TC 150/SC 1
ISO 5832-11:1994
Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy 90.93 TC 150/SC 1
ISO 5832-12:2007
Implants for surgery -- Metallic materials -- Part 12: Wrought cobalt-chromium-molybdenum alloy 60.60 TC 150/SC 1
ISO 5832-12:2007/Cor 1:2008
60.60 TC 150/SC 1
ISO 5832-14:2007
Implants for surgery -- Metallic materials -- Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy 60.60 TC 150/SC 1
ISO 5833:2002
Implants for surgery -- Acrylic resin cements 90.93 TC 150/SC 1
ISO 5834-1:2005
Implants for surgery -- Ultra-high-molecular-weight polyethylene -- Part 1: Powder form 90.92 TC 150/SC 1
ISO 5834-1:2005/Cor 1:2007
60.60 TC 150/SC 1
ISO 5834-2:2006
Implants for surgery -- Ultra-high-molecular-weight polyethylene -- Part 2: Moulded forms 90.20 TC 150/SC 1
ISO 5834-2:2006/CD Amd 1
30.20 TC 150/SC 1
ISO 5834-3:2005
Implants for surgery -- Ultra-high-molecular-weight polyethylene -- Part 3: Accelerated ageing methods 90.93 TC 150/SC 1
ISO 5834-4:2005
Implants for surgery -- Ultra-high-molecular-weight polyethylene -- Part 4: Oxidation index measurement method 90.92 TC 150/SC 1
ISO 5834-5:2005
Implants for surgery -- Ultra-high-molecular-weight polyethylene -- Part 5: Morphology assessment method 90.92 TC 150/SC 1
ISO 5835:1991
Implants for surgery -- Metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread -- Dimensions 90.60 TC 150/SC 5
ISO 5836:1988
Implants for surgery -- Metal bone plates -- Holes corresponding to screws with asymmetrical thread and spherical under-surface 90.60 TC 150/SC 5
ISO 5837-1:1985
Implants for surgery -- Intramedullary nailing systems -- Part 1: Intramedullary nails with cloverleaf or V-shaped cross-section 90.60 TC 150/SC 5
ISO 5837-2:1980
Implants for surgery -- Intramedullary nailing systems -- Part 2: Medullary pins 90.60 TC 150/SC 5
ISO 5838-1:1995
Implants for surgery -- Skeletal pins and wires -- Part 1: Material and mechanical requirements 90.60 TC 150/SC 5
ISO 5838-2:1991
Implants for surgery -- Skeletal pins and wires -- Part 2: Steinmann skeletal pins -- Dimensions 90.60 TC 150/SC 5
ISO 5838-3:1993
Implants for surgery -- Skeletal pins and wires -- Part 3: Kirschner skeletal wires 90.60 TC 150/SC 5
ISO 5840:2005
Cardiovascular implants -- Cardiac valve prostheses 90.93 TC 150/SC 2
ISO 5841-2:2000
Implants for surgery -- Cardiac pacemakers -- Part 2: Reporting of clinical performance of populations of pulse generators or leads 90.93 TC 150/SC 6
ISO 5841-3:2000
Implants for surgery -- Cardiac pacemakers -- Part 3: Low-profile connectors (IS-1) for implantable pacemakers 90.93 TC 150/SC 6
ISO 5841-3:2000/Cor 1:2003
60.60 TC 150/SC 6
ISO 6474:1994
Implants for surgery -- Ceramic materials based on high purity alumina 90.92 TC 150/SC 1
ISO/DIS 6474-1.2
Implants for surgery -- Ceramic materials -- Part 1: Ceramic materials based on high purity alumina 40.20 TC 150/SC 1
ISO/CD 6474-2
Implants for surgery -- Ceramic materials -- Part 2: Composite materials based on a high purity alumina matrix with zirconia reinforcement 30.20 TC 150/SC 1
ISO 6475:1989
Implants for surgery -- Metal bone screws with asymmetrical thread and spherical under-surface -- Mechanical requirements and test methods 90.60 TC 150/SC 5
ISO 7197:2006
Neurosurgical implants -- Sterile, single-use hydrocephalus shunts and components 90.20 TC 150/SC 3
ISO 7197:2006/Cor 1:2007
60.60 TC 150/SC 3
ISO 7198:1998
Cardiovascular implants -- Tubular vascular prostheses 90.92 TC 150/SC 2
ISO 7199:2009
Cardiovascular implants and artificial organs -- Blood-gas exchangers (oxygenators) 60.60 TC 150/SC 2
ISO 7206-1:2008
Implants for surgery -- Partial and total hip joint prostheses -- Part 1: Classification and designation of dimensions 60.60 TC 150/SC 4
ISO 7206-2:1996
Implants for surgery -- Partial and total hip joint prostheses -- Part 2: Articulating surfaces made of metallic, ceramic and plastics materials 90.92 TC 150/SC 4
ISO 7206-4:2002
Implants for surgery -- Partial and total hip joint prostheses -- Part 4: Determination of endurance properties of stemmed femoral components 90.92 TC 150/SC 4
ISO/DIS 7206-4.2
Implants for surgery -- Partial and total hip joint prostheses -- Part 4: Determination of endurance properties and performance of stemmed femoral components 40.60 TC 150/SC 4
ISO/CD 7206-6
Implants for surgery -- Partial and total hip joint prostheses -- Part 6: Determination of endurance properties of head and neck region of stemmed femoral components 30.60 TC 150/SC 4
ISO 7206-6:1992
Implants for surgery -- Partial and total hip joint prostheses -- Part 6: Determination of endurance properties of head and neck region of stemmed femoral components 90.92 TC 150/SC 4
ISO 7206-8:1995
Implants for surgery -- Partial and total hip joint prostheses -- Part 8: Endurance performance of stemmed femoral components with application of torsion 90.93 TC 150/SC 4
ISO 7206-10:2003
Implants for surgery -- Partial and total hip-joint prostheses -- Part 10: Determination of resistance to static load of modular femoral heads 90.93 TC 150/SC 4
ISO/NP 7206-12
Implants for surgery -- Partial and total hip joint prostheses -- Part 12: Deformation test for acetabular cups 10.99 TC 150/SC 4
ISO 7207-1:2007
Implants for surgery -- Components for partial and total knee joint prostheses -- Part 1: Classification, definitions and designation of dimensions 60.60 TC 150/SC 4
ISO/AWI 7207-2
Implants for surgery -- Components for partial and total knee joint prostheses -- Part 2: Articulating surfaces made of metal, ceramic and plastics materials 20.00 TC 150/SC 4
ISO 7207-2:1998
Implants for surgery -- Components for partial and total knee joint prostheses -- Part 2: Articulating surfaces made of metal, ceramic and plastics materials 90.92 TC 150/SC 4
ISO 8319-1:1996
Orthopaedic instruments -- Drive connections -- Part 1: Keys for use with screws with hexagon socket heads 90.60 TC 150/SC 5
ISO 8319-2:1986
Orthopaedic instruments -- Drive connections -- Part 2: Screwdrivers for single slot head screws, screws with cruciate slot and cross-recessed head screws 90.60 TC 150/SC 5
ISO 8548-1:1989
Prosthetics and orthotics -- Limb deficiencies -- Part 1: Method of describing limb deficiencies present at birth 90.93 TC 168
ISO 8548-2:1993
Prosthetics and orthotics -- Limb deficiencies -- Part 2: Method of describing lower limb amputation stumps 90.93 TC 168
ISO 8548-3:1993
Prosthetics and orthotics -- Limb deficiencies -- Part 3: Method of describing upper limb amputation stumps 90.93 TC 168
ISO 8548-4:1998
Prosthetics and orthotics -- Limb deficiencies -- Part 4: Description of causal conditions leading to amputation 90.93 TC 168
ISO 8548-5:2003
Prosthetics and orthotics -- Limb deficiencies -- Part 5: Description of the clinical condition of the person who has had an amputation 90.60 TC 168
ISO 8549-1:1989
Prosthetics and orthotics -- Vocabulary -- Part 1: General terms for external limb prostheses and external orthoses 90.60 TC 168
ISO 8549-2:1989
Prosthetics and orthotics -- Vocabulary -- Part 2: Terms relating to external limb prostheses and wearers of these prostheses 90.60 TC 168
ISO 8549-3:1989
Prosthetics and orthotics -- Vocabulary -- Part 3: Terms relating to external orthoses 90.60 TC 168
ISO 8551:2003
Prosthetics and orthotics -- Functional deficiencies -- Description of the person to be treated with an orthosis, clinical objectives of treatment, and functional requirements of the orthosis 90.60 TC 168
ISO 8615:1991
Implants for surgery -- Fixation devices for use in the ends of the femur in adults 90.60 TC 150/SC 5
ISO 8637:2004
Cardiovascular implants and artificial organs -- Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators 90.92 TC 150/SC 2
ISO/DIS 8637
Cardiovascular implants and artificial organs -- Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators 40.20 TC 150/SC 2
ISO/DIS 8638
Cardiovascular implants and artificial organs -- Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters 40.20 TC 150/SC 2
ISO 8638:2004
Cardiovascular implants and artificial organs -- Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters 90.92 TC 150/SC 2
ISO 8827:1988
Implants for surgery -- Staples with parallel legs for orthopaedic use -- General requirements 90.60 TC 150/SC 5
ISO 8828:1988
Implants for surgery -- Guidance on care and handling of orthopaedic implants 90.60 TC 150/SC 5
ISO 9268:1988
Implants for surgery -- Metal bone screws with conical under-surface of head -- Dimensions 90.60 TC 150/SC 5
ISO 9269:1988
Implants for surgery -- Metal bone plates -- Holes and slots corresponding to screws with conical under-surface 90.60 TC 150/SC 5
ISO/TR 9325:1989
Implants for surgery -- Partial and total hip joint prostheses -- Recommendations for simulators for evaluation of hip joint prostheses 90.93 TC 150/SC 4
ISO/TR 9326:1989
Implants for surgery -- Partial and total hip joint prostheses -- Guidance for laboratory evaluation of change of form of bearing surfaces 90.93 TC 150/SC 4
ISO 9583:1993
Implants for surgery -- Non-destructive testing -- Liquid penetrant inspection of metallic surgical implants 90.93 TC 150/SC 1
ISO 9584:1993
Implants for surgery -- Non-destructive testing -- Radiographic examination of cast metallic surgical implants 90.93 TC 150/SC 1
ISO 9585:1990
Implants for surgery -- Determination of bending strength and stiffness of bone plates 90.60 TC 150/SC 5
ISO/TR 9586:1988
Implants for surgery -- Usage of terms "valgus" and "varus" in orthopaedic surgery 60.60 TC 150
ISO 9713:2002
Neurosurgical implants -- Self-closing intracranial aneurysm clips 90.93 TC 150/SC 3
ISO 9714-1:1991
Orthopaedic drilling instruments -- Part 1: Drill bits, taps and countersink cutters 90.60 TC 150/SC 5
ISO 10310:1995
Neurosurgical implants -- Marking and packaging of implantable neural stimulators 90.60 TC 150/SC 6
ISO 10328:2006
Prosthetics -- Structural testing of lower-limb prostheses -- Requirements and test methods 60.60 TC 168
ISO 10334:1994
Implants for surgery -- Malleable wires for use as sutures and other surgical applications 90.60 TC 150/SC 5
ISO/NP TS 10974
Requirements for the safety and compatibility of magnetic resonance imaging for patients with an active implantable medical device 10.99 TC 150/SC 6
ISO 11318:2002
Cardiac defibrillators -- Connector assembly DF-1 for implantable defibrillators -- Dimensions and test requirements 90.93 TC 150/SC 6
ISO 11663:2009
Quality of dialysis fluid for haemodialysis and related therapies 60.60 TC 150/SC 2
ISO 12189:2008
Implants for surgery -- Mechanical testing of implantable spinal devices -- Fatigue test method for spinal implant assemblies using an anterior support 60.60 TC 150/SC 5
ISO 12891-1:1998
Retrieval and analysis of surgical implants -- Part 1: Retrieval and handling 90.92 TC 150
ISO/CD 12891-1
Retrieval and analysis of surgical implants -- Part 1: Retrieval and handling 30.20 TC 150
ISO 12891-2:2000
Retrieval and analysis of surgical implants -- Part 2: Analysis of retrieved metallic surgical implants 90.93 TC 150
ISO 12891-3:2000
Retrieval and analysis of surgical implants -- Part 3: Analysis of retrieved polymeric surgical implants 90.93 TC 150
ISO 12891-4:2000
Retrieval and analysis of surgical implants -- Part 4: Analysis of retrieved ceramic surgical implants 90.93 TC 150
ISO/WD 12962
Implants for surgery -- Active implantable medical devices -- Pacemaker magnet mode response 20.20 TC 150/SC 6
ISO/AWI 13077-1
Implants for surgery -- Flexibility testing of spinal segments -- Part 1: Hybrid protocol 20.00 TC 150/SC 5
ISO/NP 13175-3
Implants for surgery -- Calcium phosphates -- Part 3: Hydroxyapatite and beta-Tricalcium phosphate bone substitutes 10.99 TC 150/SC 1
ISO 13356:2008
Implants for surgery -- Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) 60.60 TC 150/SC 1
ISO 13404:2007
Prosthetics and orthotics -- Categorization and description of external orthoses and orthotic components 60.60 TC 168
ISO 13405-1:1996
Prosthetics and orthotics -- Classification and description of prosthetic components -- Part 1: Classification of prosthetic components 90.92 TC 168
ISO 13405-2:1996
Prosthetics and orthotics -- Classification and description of prosthetic components -- Part 2: Description of lower-limb prosthetic components 90.92 TC 168
ISO 13405-3:1996
Prosthetics and orthotics -- Classification and description of prosthetic components -- Part 3: Description of upper-limb prosthetic components 90.92 TC 168
ISO 13779-1:2008
Implants for surgery -- Hydroxyapatite -- Part 1: Ceramic hydroxyapatite 60.60 TC 150/SC 1
ISO 13779-2:2008
Implants for surgery -- Hydroxyapatite -- Part 2: Coatings of hydroxyapatite 60.60 TC 150/SC 1
ISO 13779-3:2008
Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity and phase purity 60.60 TC 150/SC 1
ISO 13779-4:2002
Implants for surgery -- Hydroxyapatite -- Part 4: Determination of coating adhesion strength 60.60 TC 150/SC 1
ISO 13781:1997
Poly(L-lactide) resins and fabricated forms for surgical implants -- In vitro degradation testing 90.93 TC 150/SC 1
ISO 13782:1996
Implants for surgery -- Metallic materials -- Unalloyed tantalum for surgical implant applications 90.93 TC 150/SC 1
ISO 13958:2009
Concentrates for haemodialysis and related therapies 60.60 TC 150/SC 2
ISO 13959:2009
Water for haemodialysis and related therapies 60.60 TC 150/SC 2
ISO 13960:2003
Cardiovascular implants and artificial organs -- Plasmafilters 90.92 TC 150/SC 2
ISO/DIS 13960
Cardiovascular implants and artificial organs -- Plasmafilters 40.20 TC 150/SC 2
ISO/AWI 14242-1
Implants for surgery -- Wear of total hip-joint prostheses -- Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test 20.00 TC 150/SC 4
ISO 14242-1:2002
Implants for surgery -- Wear of total hip-joint prostheses -- Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test 90.92 TC 150/SC 4
ISO 14242-2:2000
Implants for surgery -- Wear of total hip-joint prostheses -- Part 2: Methods of measurement 90.93 TC 150/SC 4
ISO 14242-3:2009
Implants for surgery -- Wear of total hip-joint prostheses -- Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test 60.60 TC 150/SC 4
ISO 14243-1:2002
Implants for surgery -- Wear of total knee-joint prostheses -- Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test 90.92 TC 150/SC 4
ISO/DIS 14243-1
Implants for surgery -- Wear of total knee-joint prostheses -- Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test 40.60 TC 150/SC 4
ISO/DIS 14243-2
Implants for surgery -- Wear of total knee-joint prostheses -- Part 2: Methods of measurement 40.60 TC 150/SC 4
ISO 14243-2:2000
Implants for surgery -- Wear of total knee-joint prostheses -- Part 2: Methods of measurement 90.92 TC 150/SC 4
ISO 14243-3:2004
Implants for surgery -- Wear of total knee-joint prostheses -- Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test 90.93 TC 150/SC 4
ISO 14243-3:2004/Cor 1:2006
60.60 TC 150/SC 4
ISO/TR 14283:2004
Implants for surgery -- Fundamental principles 60.60 TC 150
ISO/DIS 14602
Non-active surgical implants -- Implants for osteosynthesis -- Particular requirements 40.20 TC 150/SC 5
ISO 14602:1998
Non-active surgical implants -- Implants for osteosynthesis -- Particular requirements 90.92 TC 150/SC 5
ISO 14607:2007
Non-active surgical implants -- Mammary implants -- Particular requirements 60.60 TC 150
ISO 14630:2008
Non-active surgical implants -- General requirements 60.60 TC 150
ISO 14708-1:2000
Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer 90.92 TC 150/SC 6
ISO/NP 14708-1
Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer 10.99 TC 150/SC 6
ISO 14708-2:2005
Implants for surgery -- Active implantable medical devices -- Part 2: Cardiac pacemakers 90.92 TC 150/SC 6
ISO/NP 14708-2
Implants for surgery -- Active implantable medical devices -- Part 2: Cardiac pacemakers 10.99 TC 150/SC 6
ISO 14708-3:2008
Implants for surgery -- Active implantable medical devices -- Part 3: Implantable neurostimulators 60.60 TC 150/SC 6
ISO 14708-4:2008
Implants for surgery -- Active implantable medical devices -- Part 4: Implantable infusion pumps 60.60 TC 150/SC 6
ISO/DIS 14708-5
Implants for surgery -- Active implantable medical devices -- Part 5: Circulatory support devices 40.60 TC 150/SC 6
ISO/DIS 14708-6
Implants for surgery -- Active implantable medical devices -- Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) 40.60 TC 150/SC 6
ISO 14879-1:2000
Implants for surgery -- Total knee-joint prostheses -- Part 1: Determination of endurance properties of knee tibial trays 90.93 TC 150/SC 4
ISO 14949:2001
Implants for surgery -- Two-part addition-cure silicone elastomers 90.93 TC 150/SC 1
ISO 15032:2000
Prostheses -- Structural testing of hip units 90.93 TC 168
ISO 15142-1:2003
Implants for surgery -- Metal intramedullary nailing systems -- Part 1: Intramedullary nails 90.93 TC 150/SC 5
ISO 15142-2:2003
Implants for surgery -- Metal intramedullary nailing systems -- Part 2: Locking components 90.93 TC 150/SC 5
ISO 15142-3:2003
Implants for surgery -- Metal intramedullary nailing systems -- Part 3: Connection devices and reamer diameter measurements 90.93 TC 150/SC 5
ISO 15374:1998
Implants for surgery -- Requirements for production of forgings 90.93 TC 150/SC 1
ISO/TS 15539:2000
Cardiovascular implants -- Endovascular prostheses 90.93 TC 150/SC 2
ISO 15674:2009
Cardiovascular implants and artificial organs -- Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags 60.60 TC 150/SC 2
ISO 15675:2009
Cardiovascular implants and artificial organs -- Cardiopulmonary bypass systems -- Arterial blood line filters 60.60 TC 150/SC 2
ISO 15676:2005
Cardiovascular implants and artificial organs -- Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO) 90.93 TC 150/SC 2
ISO 15814:1999
Implants for surgery -- Copolymers and blends based on polylactide -- In vitro degradation testing 90.20 TC 150/SC 1
ISO 16054:2000
Implants for surgery -- Minimum data sets for surgical implants 90.93 TC 150
ISO 16061:2008
Instrumentation for use in association with non-active surgical implants -- General requirements 60.60 TC 150
ISO 16402:2008
Implants for surgery -- Acrylic resin cement -- Flexural fatigue testing of acrylic resin cements used in orthopaedics 60.60 TC 150/SC 1
ISO 16428:2005
Implants for surgery -- Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices 90.93 TC 150/SC 1
ISO 16429:2004
Implants for surgery -- Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods 90.93 TC 150/SC 1
ISO/DIS 17853
Wear of implant materials -- Polymer and metal wear particles -- Isolation, characterization and quantification 40.60 TC 150/SC 4
ISO 17853:2003
Wear of implant materials -- Polymer and metal wear particles -- Isolation, characterization and quantification 90.92 TC 150/SC 4
ISO 17853:2003/Cor 1:2004
60.60 TC 150/SC 4
ISO 18192-1:2008
Implants for surgery -- Wear of total intervertebral spinal disc prostheses -- Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test 90.92 TC 150/SC 5
ISO/CD 18192-2
Implants for surgery -- Wear of total intervertebral spinal disc prostheses -- Part 2: Nucleus replacements 30.20 TC 150/SC 5
ISO 20160:2006
Implants for surgery -- Metallic materials -- Classification of microstructures for alpha+beta titanium alloy bars 90.20 TC 150/SC 1
ISO 21534:2007
Non-active surgical implants -- Joint replacement implants -- Particular requirements 60.60 TC 150/SC 4
ISO 21535:2007
Non-active surgical implants -- Joint replacement implants -- Specific requirements for hip-joint replacement implants 60.60 TC 150/SC 4
ISO 21536:2007
Non-active surgical implants -- Joint replacement implants -- Specific requirements for knee-joint replacement implants 60.60 TC 150/SC 4
ISO 22523:2006
External limb prostheses and external orthoses -- Requirements and test methods 60.60 TC 168
ISO 22675:2006
Prosthetics -- Testing of ankle-foot devices and foot units -- Requirements and test methods 60.60 TC 168
ISO/TR 22676:2006
Prosthetics -- Testing of ankle-foot devices and foot units -- Guidance on the application of the test loading conditions of ISO 22675 and on the design of appropriate test equipment 60.60 TC 168
ISO 23317:2007
Implants for surgery -- In vitro evaluation for apatite-forming ability of implant materials 90.92 TC 150/SC 1
ISO/NP 23317
Implants for surgery - Titanium plasma sprayed coatings - Part 1: General requirements 10.99 TC 150/SC 1
ISO/CD 23500
Fluids for haemodialysis and related therapies 30.20 TC 150/SC 2
ISO/TS 23810:2006
Cardiovascular implants and artificial organs -- Checklist for preoperative extracorporeal circulation equipment setup 90.93 TC 150/SC 2
ISO 25539-1:2003
Cardiovascular implants -- Endovascular devices -- Part 1: Endovascular prostheses 90.92 TC 150/SC 2
ISO 25539-1:2003/Amd 1:2005
Test methods 60.60 TC 150/SC 2
ISO 25539-2:2008
Cardiovascular implants -- Endovascular devices -- Part 2: Vascular stents 60.60 TC 150/SC 2
ISO/CD 25539-3
Cardiovascular implants -- Endovascular devices -- Part 3: Vena cava filters 30.20 TC 150/SC 2
ISO/WD 25832-1
Implants for surgery -- Seamless tubes for surgical implants -- Part 1: Materials based on iron 20.20 TC 150/SC 1
ISO 26722:2009
Water treatment equipment for haemodialysis applications and related therapies 60.60 TC 150/SC 2
ISO/CD 27185
Cardiac rhythm management devices -- Symbols to be used with cardiac rhythm management device labels, and information to be supplied -- General information 30.99 TC 150/SC 6
ISO/DIS 27186
Active implantable medical devices -- Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements 40.99 TC 150/SC 6
ISO 29781:2008
Prostheses and orthoses -- Factors to be included when describing physical activity of a person who has had a lower limb amputation(s) or who has a deficiency of a lower limb segment(s) present at birth 60.60 TC 168
ISO 29782:2008
Prostheses and orthoses -- Factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation 60.60 TC 168
ISO 29783-1:2008
Prosthetics and orthotics -- Vocabulary -- Part 1: Normal gait 60.60 TC 168


11.040.50 Radiographic equipment
Including radiographic diagnostic and therapy equipment
Dental, medical and industrial radiographic films, see 37.040.25
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO 21439:2009
Clinical dosimetry -- Beta radiation sources for brachytherapy 60.60 TC 85/SC 2


11.040.55 Diagnostic equipment
Including medical monitoring equipment, medical thermometers and related materials
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO 7376:2003
Anaesthetic and respiratory equipment -- Laryngoscopes for tracheal intubation 90.92 TC 121/SC 2
ISO 8600-1:2005
Optics and photonics -- Medical endoscopes and endotherapy devices -- Part 1: General requirements 90.92 TC 172/SC 5
ISO 8600-2:2002
Optics and optical instruments -- Medical endoscopes and endoscopic accessories -- Part 2: Particular requirements for rigid bronchoscopes 90.93 TC 172/SC 5
ISO 8600-3:1997
Optics and optical instruments -- Medical endoscopes and endoscopic accessories -- Part 3: Determination of field of view and direction of view of endoscopes with optics 90.93 TC 172/SC 5
ISO 8600-3:1997/Amd 1:2003
60.60 TC 172/SC 5
ISO 8600-4:1997
Optics and optical instruments -- Medical endoscopes and certain accessories -- Part 4: Determination of maximum width of insertion portion 90.93 TC 172/SC 5
ISO 8600-5:2005
Optics and photonics -- Medical endoscopes and endotherapy devices -- Part 5: Determination of optical resolution of rigid endoscopes with optics 90.93 TC 172/SC 5
ISO 8600-6:2005
Optics and photonics -- Medical endoscopes and endotherapy devices -- Part 6: Vocabulary 90.93 TC 172/SC 5
ISO/TR 13154:2009
Medical electrical equipment -- Deployment, implementation and operational guidelines for indentifying febrile humans using a screening thermograph 60.60 TC 121/SC 3
ISO 19001:2002
In vitro diagnostic medical devices -- Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology 90.92 TC 212
ISO/FDIS 80601-2-56
Medical electrical equipment -- Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement 50.00 TC 121/SC 3
14IEC 80601-2-59:2008
Medical electrical equipment -- Part 2-59: Particular requirements for basic safety and essential performance of screening thermographs for human febrile temperature screening 60.60 TC 121/SC 3


11.040.60 Therapy equipment


11.040.70 Ophthalmic equipment
Including ophthalmic implants, glasses, contact lenses and their cleaning products
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO 7998:2005
Ophthalmic optics -- Spectacle frames -- Lists of equivalent terms and vocabulary 90.93 TC 172/SC 7
ISO 8429:1986
Optics and optical instruments -- Ophthalmology -- Graduated dial scale 90.93 TC 172/SC 7
ISO 8596:1994
Ophthalmic optics -- Visual acuity testing -- Standard optotype and its presentation 90.92 TC 172/SC 7
ISO/FDIS 8596
Ophthalmic optics -- Visual acuity testing -- Standard optotype and its presentation 50.60 TC 172/SC 7
ISO 8598:1996
Optics and optical instruments -- Focimeters 90.92 TC 172/SC 7
ISO 8598:1996/Cor 1:1998
60.60 TC 172/SC 7
ISO/CD 8598-1
Optics and optical instruments -- Focimeters -- Part 1: General purpose instruments 30.60 TC 172/SC 7
ISO 8612:2001
Ophthalmic instruments -- Tonometers 90.92 TC 172/SC 7
ISO/FDIS 8612
Ophthalmic instruments -- Tonometers 50.00 TC 172/SC 7
ISO 8624:2002
Ophthalmic optics -- Spectacle frames -- Measuring system and terminology 90.93 TC 172/SC 7
ISO/CD 8624
Ophthalmic optics -- Spectacle frames -- Measuring system and terminology 30.60 TC 172/SC 7
ISO 8980-1:2004
Ophthalmic optics -- Uncut finished spectacle lenses -- Part 1: Specifications for single-vision and multifocal lenses 90.93 TC 172/SC 7
ISO 8980-1:2004/Cor 1:2006
60.60 TC 172/SC 7
ISO 8980-2:2004
Ophthalmic optics -- Uncut finished spectacle lenses -- Part 2: Specifications for progressive power lenses 90.93 TC 172/SC 7
ISO 8980-2:2004/Cor 1:2006
60.60 TC 172/SC 7
ISO 8980-3:2003
Ophthalmic optics -- Uncut finished spectacle lenses -- Part 3: Transmittance specifications and test methods 90.92 TC 172/SC 7
ISO 8980-4:2006
Ophthalmic optics -- Uncut finished spectacle lenses -- Part 4: Specifications and test methods for anti-reflective coatings 60.60 TC 172/SC 7
ISO 8980-5:2005
Ophthalmic optics -- Uncut finished spectacle lenses -- Part 5: Minimum requirements for spectacle lens surfaces claimed to be abrasion-resistant 90.92 TC 172/SC 7
ISO 9342-1:2005
Optics and optical instruments -- Test lenses for calibration of focimeters -- Part 1: Test lenses for focimeters used for measuring spectacle lenses 90.93 TC 172/SC 7
ISO 9342-2:2005
Optics and optical instruments -- Test lenses for calibration of focimeters -- Part 2: Test lenses for focimeters used for measuring contact lenses 90.60 TC 172/SC 7
ISO 9394:1998
Ophthalmic optics -- Contact lenses and contact lens care products -- Determination of biocompatibility by ocular study using rabbit eyes 90.60 TC 172/SC 7
ISO 9801:1997
Ophthalmic instruments -- Trial case lenses 90.92 TC 172/SC 7
ISO/FDIS 9801
Ophthalmic instruments -- Trial case lenses 50.60 TC 172/SC 7
ISO 10322-1:2006
Ophthalmic optics -- Semi-finished spectacle lens blanks -- Part 1: Specifications for single-vision and multifocal lens blanks 60.60 TC 172/SC 7
ISO 10322-2:2006
Ophthalmic optics -- Semi-finished spectacle lens blanks -- Part 2: Specifications for progressive power lens blanks 60.60 TC 172/SC 7
ISO 10341:1997
Ophthalmic instruments -- Refractor heads 90.92 TC 172/SC 7
ISO/FDIS 10341
Ophthalmic instruments -- Refractor heads 50.60 TC 172/SC 7
ISO 10342:2003
Ophthalmic instruments -- Eye refractometers 90.60 TC 172/SC 7
ISO/FDIS 10343
Ophthalmic instruments -- Ophthalmometers 50.60 TC 172/SC 7
ISO 10343:1997
Ophthalmic instruments -- Ophthalmometers 90.92 TC 172/SC 7
ISO/CD 10685-1
Ophthalmic optics -- Spectacle frames electronic catalogue and identification -- Part 1: Definition of keywords 30.60 TC 172/SC 7
ISO/NP 10685-2
Ophthalmic optics -- Spectacle frames electronic catalogue and identification -- Part 2: Data specification 10.99 TC 172/SC 7
ISO 10938:1998
Ophthalmic instruments -- Chart projectors 90.60 TC 172/SC 7
ISO 10939:2007
Ophthalmic instruments -- Slit-lamp microscopes 60.60 TC 172/SC 7
ISO/FDIS 10940
Ophthalmic instruments -- Fundus cameras 50.20 TC 172/SC 7
ISO 10940:1998
Ophthalmic instruments -- Fundus cameras 90.92 TC 172/SC 7
ISO 10942:2006
Ophthalmic instruments -- Direct ophthalmoscopes 60.60 TC 172/SC 7
ISO 10943:2006
Ophthalmic instruments -- Indirect ophthalmoscopes 60.60 TC 172/SC 7
ISO 10944:1998
Ophthalmic instruments -- Synoptophores 90.92 TC 172/SC 7
ISO/FDIS 10944
Ophthalmic instruments -- Synoptophores 50.20 TC 172/SC 7
ISO 11380:1994
Optics and optical instruments -- Ophthalmic optics -- Formers 90.93 TC 172/SC 7
ISO 11381:1994
Optics and optical instruments -- Ophthalmic optics -- Screw threads 90.93 TC 172/SC 7
ISO 11978:2000
Ophthalmic optics -- Contact lenses and contact lens care products -- Information supplied by the manufacturer 90.93 TC 172/SC 7
ISO 11979-1:2006
Ophthalmic implants -- Intraocular lenses -- Part 1: Vocabulary 60.60 TC 172/SC 7
ISO 11979-2:1999
Ophthalmic implants -- Intraocular lenses -- Part 2: Optical properties and test methods 90.92 TC 172/SC 7
ISO 11979-2:1999/Cor 1:2003
60.60 TC 172/SC 7
ISO 11979-3:2006
Ophthalmic implants -- Intraocular lenses -- Part 3: Mechanical properties and test methods 60.60 TC 172/SC 7
ISO 11979-4:2008
Ophthalmic implants -- Intraocular lenses -- Part 4: Labelling and information 60.60 TC 172/SC 7
ISO 11979-5:2006
Ophthalmic implants -- Intraocular lenses -- Part 5: Biocompatibility 60.60 TC 172/SC 7
ISO 11979-6:2007
Ophthalmic implants -- Intraocular lenses -- Part 6: Shelf-life and transport stability 60.60 TC 172/SC 7
ISO 11979-7:2006
Ophthalmic implants -- Intraocular lenses -- Part 7: Clinical investigations 60.60 TC 172/SC 7
ISO 11979-8:2006
Ophthalmic implants -- Intraocular lenses -- Part 8: Fundamental requirements 60.60 TC 172/SC 7
ISO 11979-8:2006/NP Amd 1
10.99 TC 172/SC 7
ISO 11979-9:2006
Ophthalmic implants -- Intraocular lenses -- Part 9: Multifocal intraocular lenses 60.60 TC 172/SC 7
ISO 11979-10:2006
Ophthalmic implants -- Intraocular lenses -- Part 10: Phakic intraocular lenses 60.60 TC 172/SC 7
ISO 11980:1997
Ophthalmic optics -- Contact lenses and contact lens care products -- Guidance for clinical investigations 90.92 TC 172/SC 7
ISO/FDIS 11980
Ophthalmic optics -- Contact lenses and contact lens care products -- Guidance for clinical investigations 50.00 TC 172/SC 7
ISO 11980:1997/Cor 1:1998
60.60 TC 172/SC 7
ISO/FDIS 11981
Ophthalmic optics -- Contact lenses and contact lens care products -- Determination of physical compatibility of contact lens care products with contact lenses 50.60 TC 172/SC 7
ISO 11981:1999
Ophthalmic optics -- Contact lenses and contact lens care products -- Determination of physical compatibility of contact lens care products with contact lenses 90.92 TC 172/SC 7
ISO 11981:1999/Cor 1:2005
60.60 TC 172/SC 7
ISO 11985:1997
Ophthalmic optics -- Contact lenses -- Ageing by exposure to UV and visible radiation (in vitro method) 90.93 TC 172/SC 7
ISO 11986:1999
Ophthalmic optics -- Contact lenses and contact lens care products -- Guidelines for determination of preservative uptake and release 90.92 TC 172/SC 7
ISO/CD 11986
Ophthalmic optics -- Contact lenses and contact lens care products -- Guidelines for determination of preservative uptake and release 30.60 TC 172/SC 7
ISO/CD 11987
Ophtalmic optics -- Contact lenses -- Determination of shelf-life 30.00 TC 172/SC 7
ISO 11987:1997
Ophtalmic optics -- Contact lenses -- Determination of shelf-life 90.92 TC 172/SC 7
ISO 11987:1997/Cor 1:1998
60.60 TC 172/SC 7
ISO 12864:1997
Ophthalmic optics -- Contact lenses -- Determination of scattered light 90.93 TC 172/SC 7
ISO 12865:2006
Ophthalmic instruments -- Retinoscopes 60.60 TC 172/SC 7
ISO 12866:1999
Ophthalmic instruments -- Perimeters 90.93 TC 172/SC 7
ISO 12866:1999/Amd 1:2008
. 60.60 TC 172/SC 7
ISO 12867:1998
Ophthalmic instruments -- Trial frames 90.60 TC 172/SC 7
ISO 12870:2004
Ophthalmic optics -- Spectacle frames -- Requirements and test methods 90.93 TC 172/SC 7
ISO/WD 12870
Ophthalmic optics -- Spectacle frames -- Requirements and test methods 20.20 TC 172/SC 7
ISO 13212:1999
Ophthalmic optics -- Contact lens care products -- Guidelines for determination of shelf-life 90.93 TC 172/SC 7
ISO 13666:1998
Ophthalmic optics -- Spectacle lenses -- Vocabulary 90.92 TC 172/SC 7
ISO 13666:1998/DAmd 1
40.60 TC 172/SC 7
ISO/CD 14534
Ophthalmic optics -- Contact lenses and contact lens care products -- Fundamental requirements 30.60 TC 172/SC 7
ISO 14534:2002
Ophthalmic optics -- Contact lenses and contact lens care products -- Fundamental requirements 90.92 TC 172/SC 7
ISO 14729:2001
Ophthalmic optics -- Contact lens care products -- Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses 90.93 TC 172/SC 7
ISO 14729:2001/CD Amd 1
30.60 TC 172/SC 7
ISO 14730:2000
Ophthalmic optics -- Contact lens care products -- Antimicrobial preservative efficacy testing and guidance on determining discard date 90.93 TC 172/SC 7
ISO 14889:2003
Ophthalmic optics -- Spectacle lenses -- Fundamental requirements for uncut finished lenses 90.93 TC 172/SC 7
ISO 15004-1:2006
Ophthalmic instruments -- Fundamental requirements and test methods -- Part 1: General requirements applicable to all ophthalmic instruments 60.60 TC 172/SC 7
ISO 15004-2:2007
Ophthalmic instruments -- Fundamental requirements and test methods -- Part 2: Light hazard protection 60.60 TC 172/SC 7
ISO 15253:2000
Ophthalmic optics and instruments -- Optical devices for enhancing low vision 90.93 TC 172/SC 7
ISO 15254:2002
Ophthalmic optics and instruments -- Electro-optical devices for enhancing low vision 90.92 TC 172/SC 7
ISO/FDIS 15254
Ophthalmic optics and instruments -- Electro-optical devices for enhancing low vision 50.60 TC 172/SC 7
ISO 15752:2000
Ophthalmic instruments -- Endoilluminators -- Fundamental requirements and test methods for optical radiation safety 90.92 TC 172/SC 7
ISO/DIS 15752.2
Ophthalmic instruments -- Endoilluminators -- Fundamental requirements and test methods for optical radiation safety 40.60 TC 172/SC 7
ISO 15798:2001
Ophthalmic implants -- Ophthalmic viscosurgical devices 90.92 TC 172/SC 7
ISO/DIS 15798
Ophthalmic implants -- Ophthalmic viscosurgical devices 40.60 TC 172/SC 7
ISO 15798:2001/Cor 1:2003
60.60 TC 172/SC 7
ISO 16034:2002
Ophthalmic optics -- Specifications for single-vision ready-to-wear near- vision spectacles 90.93 TC 172/SC 7
ISO 16034:2002/Cor 1:2006
60.60 TC 172/SC 7
ISO 16284:2006
Ophthalmic optics -- Information interchange for ophthalmic optical equipment 60.60 TC 172/SC 7
ISO 16671:2003
Ophthalmic implants -- Irrigating solutions for ophthalmic surgery 90.93 TC 172/SC 7
ISO 16672:2003
Ophthalmic implants -- Ocular endotamponades 90.93 TC 172/SC 7
ISO 18369-1:2006
Ophthalmic optics -- Contact lenses -- Part 1: Vocabulary, classification system and recommendations for labelling specifications 60.60 TC 172/SC 7
ISO 18369-1:2006/Amd 1:2009
60.60 TC 172/SC 7
ISO 18369-2:2006
Ophthalmic optics -- Contact lenses -- Part 2: Tolerances 60.60 TC 172/SC 7
ISO 18369-2:2006/DAmd 1
40.60 TC 172/SC 7
ISO 18369-3:2006
Ophthalmic optics -- Contact lenses -- Part 3: Measurement methods 60.60 TC 172/SC 7
ISO 18369-4:2006
Ophthalmic optics -- Contact lenses -- Part 4: Physicochemical properties of contact lens materials 60.60 TC 172/SC 7
ISO/TS 19979:2004
Ophthalmic optics -- Contact lenses -- Hygienic management of multipatient use trial contact lenses 90.93 TC 172/SC 7
ISO 19980:2005
Ophthalmic instruments -- Corneal topographers 90.60 TC 172/SC 7
ISO/TR 20824:2007
Ophthalmic instruments -- Background for light hazard specification in ophthalmic instrument standards 60.60 TC 172/SC 7
ISO/FDIS 21987
Ophthalmic optics -- Mounted spectacle lenses 50.20 TC 172/SC 7
ISO/TR 22979:2006
Ophthalmic implants -- Intraocular lenses -- Guidance on assessment of the need for clinical investigation of intraocular lens design modifications 60.60 TC 172/SC 7
ISO 24157:2008
Ophthalmic optics and instruments -- Reporting aberrations of the human eye 60.60 TC 172/SC 7
ISO/TS 24348:2007
Ophthalmic optics -- Spectacle frames -- Method for the simulation of wear and detection of nickel release from metal and combination spectacle frames 60.60 TC 172/SC 7
ISO/TR 28980:2007
Ophthalmic optics -- Spectacle lenses -- Parameters affecting lens power measurement 60.60 TC 172/SC 7
179IEC 80601-2-58:2008
Medical electrical equipment -- Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery 60.60 TC 172/SC 7


11.040.99 Other medical equipment
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO 16061:2008
Instrumentation for use in association with non-active surgical implants -- General requirements 60.60 TC 150
ISO 18777:2005
Transportable liquid oxygen systems for medical use -- Particular requirements 90.60 TC 121/SC 3
ISO 19054:2005
Rail systems for supporting medical equipment 90.93 TC 121/SC 6
ISO/NP 23907
Sharps injury protection -- Requirements and test methods -- Sharps containers 10.99 TC 84
ISO/CD 23908-1
Sharps injury protection -- Requirements and test methods -- Part 1: Sharps protection features for single-used hypodermic needles, catheters, introducers for catheters and lancing devices 30.60 TC 84
ISO/NP 23908-2
Sharps injury protection -- Requirements and test methods -- Part 2: Accessories for handling hypodermic needles after use 10.99 TC 84


11.060 Dentistry
ICS Field
11.060.01 Dentistry in general
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO/FDIS 1942
Dentistry -- Vocabulary 50.00 TC 106/SC 3
ISO 1942-1:1989
Dental vocabulary -- Part 1: General and clinical terms 90.92 TC 106/SC 3
ISO 1942-1:1989/Amd 1:1992
60.60 TC 106/SC 3
ISO 1942-1:1989/Amd 2:1992
60.60 TC 106/SC 3
ISO 1942-1:1989/Amd 3:1993
60.60 TC 106/SC 3
ISO 1942-1:1989/Amd 5:1993
60.60 TC 106/SC 3
ISO 1942-5:1989
Dental vocabulary -- Part 5: Terms associated with testing 90.92 TC 106/SC 3
ISO 3950:2009
Dentistry -- Designation system for teeth and areas of the oral cavity 60.60 TC 106/SC 3
ISO/AWI TS 11942
Dentistry -- Terminology -- Terminological entries useful to dentistry and not included in ISO 1942 20.00 TC 106/SC 3
ISO/TR 13668:1998
Digital coding of oral health and care 90.92 TC 106/SC 3
ISO/NP TR 13668
Digital coding of oral health and care 10.99 TC 106/SC 3
ISO/TR 15300:2001
Dentistry -- Application of OSI clinical codification to the classification and coding of dental products 60.60 TC 106/SC 3
ISO/TR 15599:2002
Digital codification of dental laboratory procedures 60.60 TC 106/SC 3
ISO/TR 15599:2002/Cor 1:2003
60.60 TC 106/SC 3
ISO 16059:2007
Dentistry -- Required elements for codification used in data exchange 60.60 TC 106/SC 3
ISO 21531:2009
Dentistry -- Graphical symbols for dental instruments 60.60 TC 106/SC 4

11.060.10 Dental materials
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO 1563:1990
Dental alginate impression material 90.93 TC 106/SC 2
ISO 1564:1995
Dental aqueous impression materials based on agar 90.93 TC 106/SC 2
ISO 1567:1999/Amd 1:2003
60.60 TC 106/SC 2
ISO 1942-2:1989
Dental vocabulary -- Part 2: Dental materials 90.92 TC 106/SC 3
ISO 1942-2:1989/Amd 1:1992
60.60 TC 106/SC 3
ISO 1942-2:1989/Amd 2:1992
60.60 TC 106/SC 3
ISO 3107:2004
Dentistry -- Zinc oxide/eugenol and zinc oxide/non-eugenol cements 90.92 TC 106/SC 1
ISO/CD 3107
Dentistry -- Zinc oxide/eugenol and zinc oxide/non-eugenol cements 30.20 TC 106/SC 1
ISO 3107:2004/Cor 1:2006
60.60 TC 106/SC 1
ISO 4049:2000
Dentistry -- Polymer-based filling, restorative and luting materials 90.92 TC 106/SC 1
ISO/FDIS 4049
Dentistry -- Polymer-based restorative materials 50.20 TC 106/SC 1
ISO 4823:2000
Dentistry -- Elastomeric impression materials 90.93 TC 106/SC 2
ISO 4823:2000/Cor 1:2004
60.60 TC 106/SC 2
ISO 4823:2000/Amd 1:2007
60.60 TC 106/SC 2
ISO 6872:2008
Dentistry -- Ceramic materials 60.60 TC 106/SC 2
ISO 6873:1998
Dental gypsum products 90.92 TC 106/SC 2
ISO 6874:2005
Dentistry -- Polymer-based pit and fissure sealants 90.93 TC 106/SC 1
ISO 6876:2001
Dental root canal sealing materials 90.92 TC 106/SC 1
ISO 6877:2006
Dentistry -- Root-canal obturating points 90.20 TC 106/SC 1
ISO 7405:2008
Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry 60.60 TC 106
ISO 7491:2000
Dental materials -- Determination of colour stability 90.93 TC 106/SC 2
ISO 7551:1996
Dental absorbent points 90.60 TC 106/SC 1
ISO 9333:2006
Dentistry -- Brazing materials 60.60 TC 106/SC 2
ISO 9693:1999
Metal-ceramic dental restorative systems 90.93 TC 106/SC 2
ISO 9693:1999/Amd 1:2005
60.60 TC 106/SC 2
ISO 9693:1999/NP Amd 2
10.99 TC 106/SC 2
ISO 9917-1:2007
Dentistry -- Water-based cements -- Part 1: Powder/liquid acid-base cements 60.60 TC 106/SC 1
ISO 9917-2:1998
Dental water-based cements -- Part 2: Light-activated cements 90.92 TC 106/SC 1
ISO/DIS 9917-2
Dentistry -- Water-based cements -- Part 2: Resin-modified cements 40.99 TC 106/SC 1
ISO 10139-1:2005
Dentistry -- Soft lining materials for removable dentures -- Part 1: Materials for short-term use 90.93 TC 106/SC 2
ISO 10139-1:2005/Cor 1:2006
60.60 TC 106/SC 2
ISO/FDIS 10139-2
Dentistry -- Soft lining materials for removable dentures -- Part 2: Materials for long-term use 50.20 TC 106/SC 2
ISO 10139-2:1999
Dentistry -- Soft lining materials for removable dentures -- Part 2: Materials for long-term use 90.92 TC 106/SC 2
ISO 10271:2001
Dental metallic materials -- Corrosion test methods 90.93 TC 106/SC 2
ISO/DIS 10271
Dental metallic materials -- Corrosion test methods 40.20 TC 106/SC 2
ISO 10271:2001/Cor 1:2005
60.60 TC 106/SC 2
ISO 10477:2004
Dentistry -- Polymer-based crown and bridge materials 90.93 TC 106/SC 2
ISO/TS 11405:2003
Dental materials -- Testing of adhesion to tooth structure 90.93 TC 106/SC 1
ISO/AWI 13017
Dentistry -- Magnetic attachments 20.00 TC 106/SC 2
ISO/NP 13116
Dentistry - Radio-opacity - Method for determination of radio-opacity of materials used in dentistry 10.99 TC 106/SC 1
ISO 13716:1999
Dentistry -- Reversible-irreversible hydrocolloid impression material systems 90.93 TC 106/SC 2
ISO 13897:2003
Dentistry -- Amalgam capsules 90.93 TC 106/SC 6
ISO 13897:2003/Cor 1:2003
60.60 TC 106/SC 6
ISO 14233:2003
Dentistry -- Polymer-based die materials 90.93 TC 106/SC 2
ISO 14356:2003
Dentistry -- Duplicating material 90.93 TC 106/SC 2
ISO/TR 14569-1:2007
Dental materials -- Guidance on testing of wear -- Part 1: Wear by toothbrushing 60.60 TC 106/SC 2
ISO/TS 14569-2:2001
Dental materials -- Guidance on testing of wear -- Part 2: Wear by two- and/or three body contact 90.93 TC 106/SC 2
ISO 15841:2006
Dentistry -- Wires for use in orthodontics 60.60 TC 106/SC 1
ISO 15854:2005
Dentistry -- Casting and baseplate waxes 90.93 TC 106/SC 2
ISO 15912:2006
Dentistry -- Casting investments and refractory die materials 60.60 TC 106/SC 2
ISO 15912:2006/CD Amd 1
30.60 TC 106/SC 2
ISO 20795-1:2008
Dentistry -- Base polymers -- Part 1: Denture base polymers 60.60 TC 106/SC 2
ISO 20795-1:2008/Cor 1:2009
60.60 TC 106/SC 2
ISO/DIS 20795-2
Dentistry -- Base polymers -- Part 2: Orthodontic base polymers 40.60 TC 106/SC 2
ISO/CD 21563
Dentistry -- Hydrocolloid Impression Materials 30.60 TC 106/SC 2
ISO 21606:2007
Dentistry -- Elastomeric auxiliaries for use in orthodontics 60.60 TC 106/SC 1
ISO 22112:2005
Dentistry -- Artificial teeth for dental prostheses 90.60 TC 106/SC 2
ISO 22674:2006
Dentistry -- Metallic materials for fixed and removable restorations and appliances 60.60 TC 106/SC 2
ISO 24234:2004
Dentistry -- Mercury and alloys for dental amalgam 90.60 TC 106/SC 1
ISO 24234:2004/CD Amd 1
Requirements for marking and manufacturer's instructions concerning mercury 30.99 TC 106/SC 1
ISO/DIS 27020
Dentistry -- Brackets and tubes for use in orthodontics 40.20 TC 106/SC 1
ISO/DIS 28319
Dentistry -- Laser welding 40.20 TC 106/SC 2
ISO/CD TR 28642
Dentistry -- Dental shade conformity and shade interconvertability 30.20 TC 106/SC 2

11.060.15 Dental implants
Including dentures
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO 10451:2002
Dental implant systems -- Contents of technical file 90.92 TC 106/SC 8
ISO/DIS 10451
Dentistry -- Contents of technical file for dental implant systems 40.20 TC 106/SC 8
ISO/TR 11175:1993
Dental implants -- Guidelines for developing dental implants 60.60 TC 106/SC 8
ISO/DIS 11953
Dentistry -- The performance of hand torque instruments for the clinical tightening of screw-retained joints in endosseous dental implant systems 40.20 TC 106/SC 8
ISO 14801:2007
Dentistry -- Implants -- Dynamic fatigue test for endosseous dental implants 60.60 TC 106/SC 8
ISO 22794:2007
Dentistry -- Implantable materials for bone filling and augmentation in oral and maxillofacial surgery -- Contents of a technical file 60.60 TC 106/SC 8
ISO 22803:2004
Dentistry -- Membrane materials for guided tissue regeneration in oral and maxillofacial surgery -- Contents of a technical file 90.93 TC 106/SC 8
ISO/TS 22911:2005
Dentistry -- Preclinical evaluation of dental implant systems -- Animal test methods 90.93 TC 106/SC 8

11.060.20 Dental equipment
Dental radiographic films, see 37.040.25
Toothbrushes and dental floss, see 97.170
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO/CD 1797-1
Dental rotary instruments -- Shanks -- Part 1: Shanks made of metals 30.99 TC 106/SC 4
ISO 1797-1:1992
Dental rotary instruments -- Shanks -- Part 1: Shanks made of metals 90.93 TC 106/SC 4
ISO 1797-1:1992/Amd 1:1997
60.60 TC 106/SC 4
ISO 1797-2:1992
Dental rotary instruments -- Shanks -- Part 2: Shanks made of plastics 90.93 TC 106/SC 4
ISO 1942-3:1989
Dental vocabulary -- Part 3: Dental instruments 90.92 TC 106/SC 3
ISO 1942-3:1989/Amd 1:1992
60.60 TC 106/SC 3
ISO 1942-3:1989/Amd 2:1992
60.60 TC 106/SC 3
ISO 1942-4:1989
Dental vocabulary -- Part 4: Dental equipment 90.92 TC 106/SC 3
ISO 1942-4:1989/Amd 1:1992
60.60 TC 106/SC 3
ISO 2157:1992
Dental rotary instruments -- Nominal diameters and designation code number 90.93 TC 106/SC 4
ISO 3630-1:2008
Dentistry -- Root-canal instruments -- Part 1: General requirements and test methods 60.60 TC 106/SC 4
ISO/CD 3630-2
Dental root-canal instruments -- Part 2: Enlargers 30.60 TC 106/SC 4
ISO 3630-2:2000
Dental root-canal instruments -- Part 2: Enlargers 90.92 TC 106/SC 4
ISO 3630-3:1994
Dental root-canal instruments -- Part 3: Condensers, pluggers and spreaders 90.93 TC 106/SC 4
ISO 3630-4
Dentistry -- Root canal instruments -- Part 4: Auxiliary instruments 60.00 TC 106/SC 4
ISO/CD 3630-5
Dentistry - Root-canal instruments -- Part 5: Shaping and cleaning instruments 30.99 TC 106/SC 4
ISO 3823-1:1997
Dental rotary instruments -- Burs -- Part 1: Steel and carbide burs 90.93 TC 106/SC 4
ISO 3823-2:2003
Dentistry -- Rotary bur instruments -- Part 2: Finishing burs 90.93 TC 106/SC 4
ISO 3823-2:2003/Amd 1:2008
60.60 TC 106/SC 4
ISO 3964:1982
Dental handpieces -- Coupling dimensions 90.93 TC 106/SC 4
ISO/FDIS 4073
Dentistry -- Information system on the location of dental equipment in the working area of the oral health care provider 50.20 TC 106/SC 6
ISO 4073:1980
Dental equipment -- Items of dental equipment at the working place -- Identification system 90.92 TC 106/SC 6
ISO 6875:1995
Dental patient chair 90.92 TC 106/SC 6
ISO 7488:1991
Dental amalgamators 90.60 TC 106/SC 6
ISO 7492:1997
Dental explorers 90.93 TC 106/SC 4
ISO 7493:2006
Dentistry -- Operator's stool 90.20 TC 106/SC 6
ISO 7494-1:2004
Dentistry -- Dental units -- Part 1: General requirements and test methods 90.92 TC 106/SC 6
ISO 7494-2:2003
Dentistry -- Dental units -- Part 2: Water and air supply 90.93 TC 106/SC 6
ISO 7711-1:1997
Dental rotary instruments -- Diamond instruments -- Part 1: Dimensions, requirements, marking and packaging 90.93 TC 106/SC 4
ISO 7711-1:1997/Amd 1:2009
60.60 TC 106/SC 4
ISO/CD 7711-2
Dentistry -- Rotary diamond instruments -- Part 2: Discs 30.99 TC 106/SC 4
ISO 7711-2:1992
Dental rotary instruments -- Diamond instruments -- Part 2: Discs 90.92 TC 106/SC 4
ISO 7711-3:2004
Dentistry -- Diamond rotary instruments -- Part 3: Grit sizes, designation and colour code 90.93 TC 106/SC 4
ISO 7785-1:1997
Dental handpieces -- Part 1: High-speed air turbine handpieces 90.93 TC 106/SC 4
ISO 7785-2:1995
Dental handpieces -- Part 2: Straight and geared angle handpieces 90.93 TC 106/SC 4
ISO 7786:2001
Dental rotary instruments -- Laboratory abrasive instruments 90.93 TC 106/SC 4
ISO 7787-1:1984
Dental rotary instruments -- Cutters -- Part 1: Steel laboratory cutters 90.60 TC 106/SC 4
ISO 7787-2:2000
Dental rotary instruments -- Cutters -- Part 2: Carbide laboratory cutters 90.93 TC 106/SC 4
ISO 7787-3:1991
Dental rotary instruments -- Cutters -- Part 3: Carbide laboratory cutters for milling machines 90.93 TC 106/SC 4
ISO 7787-4:2002
Dental rotary instruments -- Cutters -- Part 4: Miniature carbide laboratory cutters 90.93 TC 106/SC 4
ISO/DIS 7885
Dentistry -- Sterile injection needles for single use 40.20 TC 106/SC 4
ISO 7885:2000
Sterile dental injection needles for single use 90.92 TC 106/SC 4
ISO 8282:1994
Dental equipment -- Mercury and alloy mixers and dispensers 90.60 TC 106/SC 6
ISO 8325:2004
Dentistry -- Test methods for rotary instruments 90.93 TC 106/SC 4
ISO 9168:1991
Dental handpieces -- Hose connectors 90.92 TC 106/SC 4
ISO/FDIS 9168
Dentistry -- Hose connectors for air driven dental handpieces 50.20 TC 106/SC 4
ISO 9173-1:2006
Dentistry -- Extraction forceps -- Part 1: General requirements and test methods 90.20 TC 106/SC 4
ISO/DIS 9173-2
Dentistry -- Extraction forceps -- Part 2: Functional designation 40.20 TC 106/SC 4
ISO 9680:2007
Dentistry -- Operating lights 60.60 TC 106/SC 6
ISO 9687:1993
Dental equipment -- Graphical symbols 90.60 TC 106/SC 6
ISO 9873:1998
Dental hand instruments -- Reusable mirrors and handles 90.60 TC 106/SC 4
ISO 9873:1998/Cor 1:2000
60.60 TC 106/SC 4
ISO 9997:1999
Dental cartridge syringes 90.93 TC 106/SC 4
ISO 10323:1991
Dental rotary instruments -- Bore diameters for discs and wheels 90.93 TC 106/SC 4
ISO 10637:1999
Dental equipment -- High- and medium-volume suction systems 90.93 TC 106/SC 6
ISO 10650-1:2004
Dentistry -- Powered polymerization activators -- Part 1: Quartz tungsten halogen lamps 90.93 TC 106/SC 6
ISO 10650-2:2007
Dentistry -- Powered polymerization activators -- Part 2: Light-emitting diode (LED) lamps 60.60 TC 106/SC 6
ISO 11040-1:1992
Prefilled syringes -- Part 1: Glass cylinders for dental local anaesthetic cartridges 90.93 TC 76
ISO 11040-2:1994
Prefilled syringes -- Part 2: Plungers and discs for dental local anaesthetic cartridges 90.92 TC 76
ISO 11040-3:1993
Prefilled syringes -- Part 3: Aluminium caps for dental local anaesthetic cartridges 90.92 TC 76
ISO/TS 11080:2009
Dentistry -- Essential characteristics of test methods for the evaluation of treatment methods intended to improve or maintain the microbiological quality of dental unit procedural water 60.60 TC 106/SC 6
ISO 11143:2008
Dentistry -- Amalgam separators 60.60 TC 106/SC 6
ISO 11144:1995
Dental equipment -- Connections for supply and waste lines 90.93 TC 106/SC 6
ISO 11498:1997
Dental handpieces -- Dental low-voltage electrical motors 90.93 TC 106/SC 4
ISO 11499:2007
Dentistry -- Single-use cartridges for local anaesthetics 60.60 TC 106/SC 4
ISO/NP 13078
Dentistry - Dental furnace - Dynamic test method for temperature measurements with separate thermocouple 10.99 TC 106/SC 2
ISO 13294:1997
Dental handpieces -- Dental air-motors 90.93 TC 106/SC 4
ISO 13295:2007
Dentistry -- Mandrels for rotary instruments 60.60 TC 106/SC 4
ISO 13397-1:1995
Periodontal curettes, dental scalers and excavators -- Part 1: General requirements 90.93 TC 106/SC 4
ISO 13397-2:2005
Dentistry -- Periodontal curettes, dental scalers and excavators -- Part 2: Periodontal curettes of Gr-type 90.93 TC 106/SC 4
ISO 13397-3:1996
Periodontal curettes, dental scalers and excavators -- Part 3: Dental scalers -- H-type 90.93 TC 106/SC 4
ISO 13397-4:1997
Periodontal curettes, dental scalers and excavators -- Part 4: Dental excavators -- Discoid-type 90.93 TC 106/SC 4
ISO 13402:1995
Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure 90.93 TC 170
ISO 15087-1:1999
Dental elevators -- Part 1: General requirements 90.93 TC 106/SC 4
ISO 15087-2:2000
Dental elevators -- Part 2: Warwick James elevators 90.93 TC 106/SC 4
ISO 15087-3:2000
Dental elevators -- Part 3: Cryer elevators 90.93 TC 106/SC 4
ISO 15087-4:2000
Dental elevators -- Part 4: Coupland elevators 90.93 TC 106/SC 4
ISO 15087-5:2000
Dental elevators -- Part 5: Bein elevators 90.93 TC 106/SC 4
ISO 15087-6:2000
Dental elevators -- Part 6: Flohr elevators 90.93 TC 106/SC 4
ISO 15098-1:1999
Dental tweezers -- Part 1: General requirements 90.93 TC 106/SC 4
ISO 15098-2:2000
Dental tweezers -- Part 2: Meriam types 90.93 TC 106/SC 4
ISO 15098-3:2000
Dental tweezers -- Part 3: College types 90.93 TC 106/SC 4
ISO 15606:1999
Dental handpieces -- Air-powered scalers and scaler tips 90.93 TC 106/SC 4
ISO 21530:2004
Dentistry -- Materials used for dental equipment surfaces -- Determination of resistance to chemical disinfectants 90.93 TC 106/SC 6
ISO 21533:2003
Dentistry -- Reusable cartridge syringes intended for intraligamentary injections 90.93 TC 106/SC 4
ISO 21671:2006
Dentistry -- Rotary polishers 60.60 TC 106/SC 4
ISO 21671:2006/CD Amd 1
30.99 TC 106/SC 4
ISO/TS 22595-1:2006
Dentistry -- Plant area equipment -- Part 1: Suction systems 60.60 TC 106/SC 6
ISO/TS 22595-2:2008
Dentistry -- Plant area equipment -- Part 2: Compressor systems 60.60 TC 106/SC 6
135IEC/CD 80601-2-60
Medical electrical equipment -- Part 2-60: Particular requirements for basic safety and essential performance of dental equipment 30.60 TC 106/SC 6

11.060.25 Dental instruments
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO 6360-1:2004
Dentistry -- Number coding system for rotary instruments -- Part 1: General characteristics 90.93 TC 106/SC 4
ISO 6360-1:2004/Cor 1:2007
60.60 TC 106/SC 4
ISO 6360-2:2004
Dentistry -- Number coding system for rotary instruments -- Part 2: Shapes 90.93 TC 106/SC 4
ISO 6360-2:2004/CD Amd 1
30.60 TC 106/SC 4
ISO 6360-3:2005
Dentistry -- Number coding system for rotary instruments -- Part 3: Specific characteristics of burs and cutters 90.93 TC 106/SC 4
ISO 6360-4:2004
Dentistry -- Number coding system for rotary instruments -- Part 4: Specific characteristics of diamond instruments 90.93 TC 106/SC 4
ISO 6360-5:2007
Dentistry -- Number coding system for rotary instruments -- Part 5: Specific characteristics of root-canal instruments 60.60 TC 106/SC 4
ISO 6360-6:2004
Dentistry -- Number coding system for rotary instruments -- Part 6: Specific characteristics of abrasive instruments 90.93 TC 106/SC 4
ISO 6360-7:2006
Dentistry -- Number coding system for rotary instruments -- Part 7: Specific characteristics of mandrels and special instruments 90.20 TC 106/SC 4
ISO 22374:2005
Dentistry -- Dental handpieces -- Electrical-powered scalers and scaler tips 90.60 TC 106/SC 4


11.080 Sterilization and disinfection
ICS Field
11.080.01 Sterilization and disinfection in general
Including sterilization methods, air quality of surgery rooms, etc.
11.080.10 Sterilizing equipment
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO 15883-1:2006
Washer-disinfectors -- Part 1: General requirements, terms and definitions and tests 90.20 TC 198
ISO 15883-2:2006
Washer-disinfectors -- Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. 90.20 TC 198
ISO 15883-3:2006
Washer-disinfectors -- Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers 90.20 TC 198
ISO 15883-4:2008
Washer-disinfectors -- Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes 60.60 TC 198
ISO/TS 15883-5:2005
Washer-disinfectors -- Part 5: Test soils and methods for demonstrating cleaning efficacy 90.60 TC 198
ISO/DIS 15883-6
Washer-disinfectors -- Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment 40.20

11.080.20 Disinfectants and antiseptics
Chemicals for industrial and domestic disinfection purposes, see 71.100.35
11.080.30 Sterilized packaging
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO 11607-1:2006
Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems 90.20 TC 198
ISO 11607-2:2006
Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes 90.20 TC 198
ISO/NP 11607-3
Packaging for terminally sterilized medical devices -- Part 3: Guidance on the application of ISO 11607-1 and ISO 11607-2 10.99 TC 198

11.080.99 Other standards related to sterilization and disinfection

11.100 Laboratory medicine
ICS Field
11.100.01 Laboratory medicine in general
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO 7713:1985
Laboratory glassware -- Disposable serological pipettes 90.93 TC 48/SC 6
ISO 12771:1997
Plastics laboratory ware -- Disposable serological pipettes 90.93 TC 48/SC 6
ISO 12772:1997
Laboratory glassware -- Disposable microhaematocrit capillary tubes 90.93 TC 48/SC 6
ISO 15189:2007
Medical laboratories -- Particular requirements for quality and competence 60.60 TC 212
ISO/CD 15189
Medical laboratories -- Particular requirements for quality and competence 30.20 TC 212
ISO 15190:2003
Medical laboratories -- Requirements for safety 90.92 TC 212
ISO/TS 22367:2008
Medical laboratories -- Reduction of error through risk management and continual improvement 60.60 TC 212
ISO/TS 22367:2008/Cor 1:2009
60.60 TC 212
ISO/TR 22869:2005
Medical laboratories -- Guidance on laboratory implementation of ISO 15189: 2003 60.60 TC 212
ISO 22870:2006
Point-of-care testing (POCT) -- Requirements for quality and competence 90.20 TC 212
ISO 24998:2008
Plastics laboratory ware -- Single-use Petri dishes for microbiological procedures 60.60 TC 48/SC 6

11.100.10 In vitro diagnostic test systems
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO 15193:2009
In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Requirements for content and presentation of reference measurement procedures 60.60 TC 212
ISO 15194:2009
In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Requirements for certified reference materials and the content of supporting documentation 60.60 TC 212
ISO 15197:2003
In vitro diagnostic test systems -- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus 90.92 TC 212
ISO 15198:2004
Clinical laboratory medicine -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer 90.93 TC 212
ISO 17511:2003
In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrological traceability of values assigned to calibrators and control materials 60.60 TC 212
ISO/TR 18112:2006
Clinical laboratory testing and in vitro diagnostic test systems -- In vitro diagnostic medical devices for professional use -- Summary of regulatory requirements for information supplied by the manufacturer 60.60 TC 212
ISO/FDIS 18113-1
In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 1: Terms, definitions and general requirements 50.00 TC 212
ISO/FDIS 18113-2
In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use 50.00 TC 212
ISO/FDIS 18113-3
In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 3: In vitro diagnostic instruments for professional use 50.00 TC 212
ISO/FDIS 18113-4
In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 4: In vitro diagnostic reagents for self-testing 50.00 TC 212
ISO/FDIS 18113-5
In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 5: In vitro diagnostic instruments for self-testing 50.00 TC 212
ISO 18153:2003
In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials 90.60 TC 212
ISO 19001:2002
In vitro diagnostic medical devices -- Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology 90.92 TC 212
ISO/DIS 29701
Nanotechnologies -- Endotoxin test on nanomaterial samples for in vitro systems -- Limulus amebocyte lysate (LAL) test 40.20 TC 229

11.100.20 Biological evaluation of medical devices
Medical microbiology, see 07.100.10
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO 10993-1:2003
Biological evaluation of medical devices -- Part 1: Evaluation and testing 90.92 TC 194
ISO/FDIS 10993-1
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process 50.00 TC 194
ISO 10993-2:2006
Biological evaluation of medical devices -- Part 2: Animal welfare requirements 60.60 TC 194
ISO/CD 10993-3
Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity 30.92 TC 194
ISO 10993-3:2003
Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity 90.92 TC 194
ISO 10993-4:2002
Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood 90.93 TC 194
ISO 10993-4:2002/Amd 1:2006
60.60 TC 194
ISO 10993-5:2009
Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity 60.60 TC 194
ISO 10993-6:2007
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation 60.60 TC 194
ISO 10993-7:2008
Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals 60.60 TC 194
ISO 10993-9:1999
Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products 90.92 TC 194
ISO/FDIS 10993-9
Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products 50.00 TC 194
ISO 10993-10:2002
Biological evaluation of medical devices -- Part 10: Tests for irritation and delayed-type hypersensitivity 90.92 TC 194
ISO/DIS 10993-10
Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization 40.60 TC 194
ISO 10993-10:2002/Amd 1:2006
60.60 TC 194
ISO 10993-11:2006
Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity 60.60 TC 194
ISO 10993-12:2007
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials 90.92 TC 194
ISO/CD 10993-12
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials 30.60 TC 194
ISO/DIS 10993-13
Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices 40.60 TC 194
ISO 10993-13:1998
Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices 90.92 TC 194
ISO 10993-14:2001
Biological evaluation of medical devices -- Part 14: Identification and quantification of degradation products from ceramics 90.93 TC 194
ISO 10993-15:2000
Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys 90.93 TC 194
ISO/DIS 10993-16
Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables 40.60 TC 194
ISO 10993-16:1997
Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables 90.92 TC 194
ISO 10993-17:2002
Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances 90.60 TC 194
ISO 10993-18:2005
Biological evaluation of medical devices -- Part 18: Chemical characterization of materials 90.60 TC 194
ISO/TS 10993-19:2006
Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials 90.20 TC 194
ISO/TS 10993-20:2006
Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices 60.60 TC 194
ISO/CD 13022
Tissue product safety -- Application of risk management to viable materials of human origin used for the production of medical products 30.20 TC 194/SC 1
ISO/DIS 14155
Clinical investigation of medical devices for human subjects -- Good clinical practice 40.60 TC 194
ISO 14155-1:2003
Clinical investigation of medical devices for human subjects -- Part 1: General requirements 90.92 TC 194
ISO 14155-2:2003
Clinical investigation of medical devices for human subjects -- Part 2: Clinical investigation plans 90.92 TC 194
ISO 17593:2007
Clinical laboratory testing and in vitro medical devices -- Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy 60.60 TC 212
ISO 20776-1:2006
Clinical laboratory testing and in vitro diagnostic test systems -- Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices -- Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases 60.60 TC 212
ISO 20776-2:2007
Clinical laboratory testing and in vitro diagnostic test systems -- Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices -- Part 2: Evaluation of performance of antimicrobial susceptibility test devices 60.60 TC 212
ISO/TS 20993:2006
Biological evaluation of medical devices -- Guidance on a risk-management process 60.60 TC 194
ISO 22442-1:2007
Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk management 60.60 TC 194/SC 1
ISO 22442-2:2007
Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing, collection and handling 60.60 TC 194/SC 1
ISO 22442-3:2007
Medical devices utilizing animal tissues and their derivatives -- Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents 60.60 TC 194/SC 1
ISO/NP TR 22442-4
Medical devices utilizing animal tissues and their derivatives -- Part 4: Guidance on inactivation or removal of transmissible spongiform encephalopathy agents (TSE agents/prions) potentially contaminating bovine tissue-derived devices and similar or related devices and the associated processing equipment 10.99 TC 194/SC 1
ISO/AWI TS 29741
Biological evaluation of medical devices -- Development of tolerable intake values for Di(2-ethylhexyl)phthalate (DEHP) 20.00 TC 194

11.100.30 Analysis of blood and urine
Including doping control
11.100.99 Other standards related to laboratory medicine
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO 7405:2008
Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry 60.60 TC 106
ISO 15195:2003
Laboratory medicine -- Requirements for reference measurement laboratories 90.60 TC 212
ISO/AWI 25680
Medical laboratories - Calculation and expression of measurement uncertainty 20.00 TC 212



11.120 Pharmaceutics
ICS Field
11.120.01 Pharmaceutics in general
11.120.10 Medicaments
Including medical prescriptions and medicinal herbs
11.120.20 Wound dressings and compresses
11.120.99 Other standards related to pharmaceutics
Including equipment for pharmaceutical industry
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO 11418-1:2005
Containers and accessories for pharmaceutical preparations -- Part 1: Drop-dispensing glass bottles 90.93 TC 76
ISO 11418-2:2005
Containers and accessories for pharmaceutical preparations -- Part 2: Screw-neck glass bottles for syrups 90.93 TC 76
ISO 11418-3:2005
Containers and accessories for pharmaceutical preparations -- Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms 90.93 TC 76
ISO 11418-4:2005
Containers and accessories for pharmaceutical preparations -- Part 4: Tablet glass bottles 90.93 TC 76
ISO 11418-5:1997
Containers and accessories for pharmaceutical preparations -- Part 5: Dropper assemblies 90.60 TC 76
ISO 11418-7:1998
Containers and accessories for pharmaceutical preparations -- Part 7: Screw-neck vials made of glass tubing for liquid dosage forms 90.60 TC 76

11.140 Hospital equipment
Including hospital beds, surgical tables, medical garments, medical gloves, containers for sharp disposal, etc.
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO 10282:2002
Single-use sterile rubber surgical gloves -- Specification 90.93 TC 45/SC 4
ISO 10282:2002/Cor 1:2005
60.60 TC 45/SC 4
ISO 11193-1:2008
Single-use medical examination gloves -- Part 1: Specification for gloves made from rubber latex or rubber solution 60.60 TC 45/SC 4
ISO 11193-2:2006
Single-use medical examination gloves -- Part 2: Specification for gloves made from poly(vinyl chloride) 90.20 TC 45/SC 4
ISO 21171:2006
Medical gloves -- Determination of removable surface powder 90.20 TC 45/SC 3
ISO 22609:2004
Clothing for protection against infectious agents -- Medical face masks -- Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected) 90.93 TC 94/SC 13
ISO 22882:2004
Castors and wheels -- Requirements for castors for hospital beds 90.60 TC 110/SC 3
12IEC/DIS 60601-2-52
Medical electrical equipment -- Part 2-52: Particular requirements for basic safety and essential performance of medical beds 40.60 TC 173
13IEC/DIS 80601-2-35
Medical electrical equipment -- Part 2-35: Particular requirements for basic safety and essential performance of blankets, pads and mattresses intended for heating in medical use 40.60 TC 121/SC 1

11.160 First aid
Including kits, equipment, facilities and medical transport for first aid
11.180 Aids for disabled or handicapped persons
Including aids for elderly people
ICS Field
11.180.01 Aids for disabled and handicapped persons in general
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO/IEC Guide 71:2001
Guidelines for standards developers to address the needs of older persons and persons with disabilities 90.93 TMB
ISO/NP 9999
Assistive products for persons with disability -- Classification and terminology 10.99 TC 173/SC 2
ISO 9999:2007
Assistive products for persons with disability -- Classification and terminology 90.92 TC 173/SC 2
ISO 9999:2007/Cor 1:2007
60.60 TC 173/SC 2
ISO 16201:2006
Technical aids for persons with disability -- Environmental control systems for daily living 60.60 TC 173
ISO/TR 22411:2008
Ergonomics data and guidelines for the application of ISO/IEC Guide 71 to products and services to address the needs of older persons and persons with disabilities 60.60 TC 159

11.180.10 Aids and adaptation for moving
Including wheelchairs, walking sticks and lifting platforms
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO 7176-1:1999
Wheelchairs -- Part 1: Determination of static stability 90.93 TC 173/SC 1
ISO 7176-2:2001
Wheelchairs -- Part 2: Determination of dynamic stability of electric wheelchairs 90.60 TC 173/SC 1
ISO 7176-3:2003
Wheelchairs -- Part 3: Determination of effectiveness of brakes 90.92 TC 173/SC 1
ISO/NP 7176-3
Wheelchairs -- Part 3: Determination of effectiveness of brakes 10.99 TC 173/SC 1
ISO 7176-4:2008
Wheelchairs -- Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range 60.60 TC 173/SC 1
ISO 7176-5:2008
Wheelchairs -- Part 5: Determination of dimensions, mass and manoeuvring space 60.60 TC 173/SC 1
ISO 7176-6:2001
Wheelchairs -- Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs 90.60 TC 173/SC 1
ISO 7176-7:1998
Wheelchairs -- Part 7: Measurement of seating and wheel dimensions 90.92 TC 173/SC 1
ISO 7176-8:1998
Wheelchairs -- Part 8: Requirements and test methods for static, impact and fatigue strengths 90.93 TC 173/SC 1
ISO/DIS 7176-9
Wheelchairs -- Part 9: Climatic tests for electric wheelchairs 40.60 TC 173/SC 1
ISO 7176-9:2001
Wheelchairs -- Part 9: Climatic tests for electric wheelchairs 90.92 TC 173/SC 1
ISO 7176-10:2008
Wheelchairs -- Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs 60.60 TC 173/SC 1
ISO 7176-11:1992
Wheelchairs -- Part 11: Test dummies 90.92 TC 173/SC 1
ISO/NP 7176-11
Wheelchairs -- Part 11: Test dummies 10.99 TC 173/SC 1
ISO 7176-13:1989
Wheelchairs -- Part 13: Determination of coefficient of friction of test surfaces 90.60 TC 173/SC 1
ISO 7176-14:2008
Wheelchairs -- Part 14: Power and control systems for electrically powered wheelchairs and scooters -- Requirements and test methods 90.92 TC 173/SC 1
ISO/NP 7176-14
Wheelchairs -- Part 14: Power and control systems for electrically powered wheelchairs and scooters -- Requirements and test methods 10.99 TC 173/SC 1
ISO 7176-15:1996
Wheelchairs -- Part 15: Requirements for information disclosure, documentation and labelling 90.92 TC 173/SC 1
ISO/CD 7176-16
Wheelchairs -- Part 16: Resistance to ignition of upholstered parts -- Requirements and test methods 30.99 TC 173/SC 1
ISO 7176-16:1997
Wheelchairs -- Part 16: Resistance to ignition of upholstered parts -- Requirements and test methods 90.92 TC 173/SC 1
ISO 7176-19:2008
Wheelchairs -- Part 19: Wheeled mobility devices for use as seats in motor vehicles 60.60 TC 173/SC 1
ISO 7176-21:2009
Wheelchairs -- Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers 60.60 TC 173/SC 1
ISO 7176-22:2000
Wheelchairs -- Part 22: Set-up procedures 90.93 TC 173/SC 1
ISO 7176-23:2002
Wheelchairs -- Part 23: Requirements and test methods for attendant-operated stair-climbing devices 90.60 TC 173/SC 1
ISO 7176-24:2004
Wheelchairs -- Part 24: Requirements and test methods for user-operated stair-climbing devices 90.60 TC 173/SC 1
ISO 7176-26:2007
Wheelchairs -- Part 26: Vocabulary 60.60 TC 173/SC 1
ISO/CD 7176-28
Wheelchairs -- Part 28: Requirements and test methods for stair-climbing devices 30.99 TC 173/SC 1
ISO 7193:1985
Wheelchairs -- Maximum overall dimensions 90.93 TC 173/SC 1
ISO 9386-1:2000
Power-operated lifting platforms for persons with impaired mobility -- Rules for safety, dimensions and functional operation -- Part 1: Vertical lifting platforms 90.93 TC 178
ISO 9386-2:2000
Power-operated lifting platforms for persons with impaired mobility -- Rules for safety, dimensions and functional operation -- Part 2: Powered stairlifts for seated, standing and wheelchair users moving in an inclined plane 90.93 TC 178
ISO/TR 9527:1994
Building construction -- Needs of disabled people in buildings -- Design guidelines 90.60 TC 59
ISO 10535:2006
Hoists for the transfer of disabled persons -- Requirements and test methods 60.60 TC 173/SC 6
ISO/DIS 10542-1
Technical systems and aids for disabled or handicapped persons -- Wheelchair tiedown and occupant-restraint systems -- Part 1: Requirements and test methods for all systems 40.20 TC 173/SC 1
ISO 10542-1:2001
Technical systems and aids for disabled or handicapped persons -- Wheelchair tiedown and occupant-restraint systems -- Part 1: Requirements and test methods for all systems 90.92 TC 173/SC 1
ISO 10542-2:2001
Technical systems and aids for disabled or handicapped persons -- Wheelchair tiedown and occupant-restraint systems -- Part 2: Four-point strap-type tiedown systems 90.92 TC 173/SC 1
ISO 10542-3:2005
Technical systems and aids for disabled or handicapped persons -- Wheelchair tiedown and occupant-restraint systems -- Part 3: Docking-type tiedown systems 90.92 TC 173/SC 1
ISO 10542-4:2004
Technical systems and aids for disabled or handicapped persons -- Wheelchair tiedown and occupant-restraint systems -- Part 4: Clamp-type tiedown systems 90.92 TC 173/SC 1
ISO 10542-5:2004
Technical systems and aids for disabled or handicapped persons -- Wheelchair tiedown and occupant-restraint systems -- Part 5: Systems for specific wheelchairs 90.92 TC 173/SC 1
ISO/CD 10865-1
Assistive products for persons with disability -- Wheelchair containment and occupant retention systems for rearward-facing wheelchair-seated passengers -- Part 1: Systems for accessible transport vehicles designed for use by both sitting and standing passengers 30.99 TC 173/SC 1
ISO 11199-1:1999
Walking aids manipulated by both arms -- Requirements and test methods -- Part 1: Walking frames 90.93 TC 173
ISO 11199-2:2005
Walking aids manipulated by both arms -- Requirements and test methods -- Part 2: Rollators 90.60 TC 173
ISO 11199-3:2005
Walking aids manipulated by both arms -- Requirements and test methods -- Part 3: Walking tables 90.60 TC 173
ISO 11334-1:2007
Assistive products for walking manipulated by one arm -- Requirements and test methods -- Part 1: Elbow crutches 60.60 TC 173
ISO 11334-4:1999
Walking aids manipulated by one arm -- Requirements and test methods -- Part 4: Walking sticks with three or more legs 90.93 TC 173
ISO/TR 13570-1:2005
Wheelchairs -- Part 1: Guidelines for the application of the ISO 7176 series on wheelchairs 60.60 TC 173/SC 1
ISO/CD TR 13570-2
Wheelchairs -- Part 2: Typical values and recommended limits or dimensions, mass and manoeuvring space as determined in ISO 7176-5 30.60 TC 173/SC 1
ISO 16840-1:2006
Wheelchair seating -- Part 1: Vocabulary, reference axis convention and measures for body segments, posture and postural support surfaces 90.20 TC 173/SC 1
ISO 16840-2:2007
Wheelchair seating -- Part 2: Determination of physical and mechanical characteristics of devices intended to manage tissue integrity -- Seat cushions 60.60 TC 173/SC 1
ISO/NP 16840-3
Wheelchair seating -- Part 3: Determination of static impact and repetitive load strengths for postural support devices 10.99 TC 173/SC 1
ISO 16840-3:2006
Wheelchair seating -- Part 3: Determination of static, impact and repetitive load strengths for postural support devices 90.92 TC 173/SC 1
ISO 16840-4:2009
Wheelchair seating -- Part 4: Seating systems for use in motor vehicles 60.60 TC 173/SC 1
ISO/NP 16840-7
Wheelchair seating -- Part 7: Test methods for determining the heat and vapour dissipation characteristics of seat cushions intended to manage tissue integrity 10.99 TC 173/SC 1
ISO 24415-1:2009
Tips for assistive products for walking -- Requirements and test methods -- Part 1: Friction of tips 60.60 TC 173
ISO/DIS 24415-2
Tips for assistive products for walking -- Requirements and test methods -- Part 2: Durability of tips for crutches 40.20 TC 173

11.180.15 Aids for deaf and hearing impaired people
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO 12124:2001
Acoustics -- Procedures for the measurement of real-ear acoustical characteristics of hearing aids 90.93 TC 43
ISO 23600:2007
Assistive products for persons with vision impairments and persons with vision and hearing impairments -- Acoustic and tactile signals for pedestrian traffic lights 60.60 TC 173
ISO/DIS 24500
Ergonomics -- Accessible design -- Auditory signals for consumer products 40.20 TC 159/SC 5
ISO/DIS 24501
Ergonomics -- Accessible design -- Sound pressure levels of auditory signals for consumer products 40.20 TC 159/SC 5

11.180.20 Aids for incontinence and ostomy
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO 8669-1:1988
Urine collection bags -- Part 1: Vocabulary 90.60 TC 173/SC 3
ISO 8669-2:1996
Urine collection bags -- Part 2: Requirements and test methods 90.60 TC 173/SC 3
ISO 8670-1:1988
Ostomy collection bags -- Part 1: Vocabulary 90.60 TC 173/SC 3
ISO 8670-2:1996
Ostomy collection bags -- Part 2: Requirements and test methods 90.60 TC 173/SC 3
ISO 8670-3:2000
Ostomy collection bags -- Part 3: Determination of odour transmission of colostomy and ileostomy bags 90.60 TC 173/SC 3
ISO 9949-1:1993
Urine absorbing aids -- Vocabulary -- Part 1: Conditions of urinary incontinence 90.60 TC 173/SC 3
ISO 9949-2:1993
Urine absorbing aids -- Vocabulary -- Part 2: Products 90.60 TC 173/SC 3
ISO 9949-3:1993
Urine absorbing aids -- Vocabulary -- Part 3: Identification of product types 90.60 TC 173/SC 3
ISO 11948-1:1996
Urine-absorbing aids -- Part 1: Whole-product testing 90.93 TC 173/SC 3
ISO/AWI 12505
Skin barrier -- Test methods 20.00 TC 173/SC 3
ISO 15621:1999
Urine-absorbing aids -- General guidance on evaluation 90.92 TC 173/SC 3
ISO/CD 15621
Urine-absorbing aids -- General guidance on evaluation 30.60 TC 173/SC 3
ISO 16021:2000
Urine-absorbing aids -- Basic principles for evaluation of single-use adult-incontinence-absorbing aids from the perspective of users and caregivers 90.60 TC 173/SC 3
ISO 16391:2002
Aids for ostomy and incontinence -- Irrigation sets -- Requirements and test methods 90.60 TC 173/SC 3
ISO 17190-1:2001
Urine-absorbing aids for incontinence -- Test methods for characterizing polymer-based absorbent materials -- Part 1: Determination of pH 90.60 TC 173/SC 3
ISO 17190-2:2001
Urine-absorbing aids for incontinence -- Test methods for characterizing polymer-based absorbent materials -- Part 2: Determination of amount of residual monomers 90.60 TC 173/SC 3
ISO 17190-3:2001
Urine-absorbing aids for incontinence -- Test methods for characterizing polymer-based absorbent materials -- Part 3: Determination of particle size distribution by sieve fractionation 90.60 TC 173/SC 3
ISO 17190-4:2001
Urine-absorbing aids for incontinence -- Test methods for characterizing polymer-based absorbent materials -- Part 4: Determination of moisture content by mass loss upon heating 90.60 TC 173/SC 3
ISO 17190-5:2001
Urine-absorbing aids for incontinence -- Test methods for characterizing polymer-based absorbent materials -- Part 5: Gravimetric determination of free swell capacity in saline solution 90.60 TC 173/SC 3
ISO 17190-6:2001
Urine-absorbing aids for incontinence -- Test methods for characterizing polymer-based absorbent materials -- Part 6: Gravimetric determination of fluid retention capacity in saline solution after centrifugation 90.60 TC 173/SC 3
ISO 17190-7:2001
Urine-absorbing aids for incontinence -- Test methods for characterizing polymer-based absorbent materials -- Part 7: Gravimetric determination of absorption under pressure 90.60 TC 173/SC 3
ISO 17190-8:2001
Urine-absorbing aids for incontinence -- Test methods for characterizing polymer-based absorbent materials -- Part 8: Gravimetric determination of flowrate 90.60 TC 173/SC 3
ISO 17190-9:2001
Urine-absorbing aids for incontinence -- Test methods for characterizing polymer-based absorbent materials -- Part 9: Gravimetric determination of density 90.60 TC 173/SC 3
ISO 17190-9:2001/Cor 1:2002
60.60 TC 173/SC 3
ISO 17190-10:2001
Urine-absorbing aids for incontinence -- Test methods for characterizing polymer-based absorbent materials -- Part 10: Determination of extractable polymer content by potentiometric titration 90.60 TC 173/SC 3
ISO 17190-11:2001
Urine-absorbing aids for incontinence -- Test methods for characterizing polymer-based absorbent materials -- Part 11: Determination of content of respirable particles 90.60 TC 173/SC 3
ISO 17191:2004
Urine-absorbing aids for incontinence -- Measurement of airborne respirable polyacrylate superabsorbent materials -- Determination of dust in collection cassettes by sodium atomic absorption spectrometry 90.60 TC 173/SC 3
ISO 24214:2006
Skin barrier for ostomy aids -- Vocabulary 60.60 TC 173/SC 3

11.180.30 Aids for blind or partially sighted people
Including Braille
Glasses, contact lenses and their cleaning products, see 11.040.70
11.180.40 Aids for drinking and eating
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO/TR 11548-1:2001
Communication aids for blind persons -- Identifiers, names and assignation to coded character sets for 8-dot Braille characters -- Part 1: General guidelines for Braille identifiers and shift marks 60.60 TC 173
ISO/TR 11548-2:2001
Communication aids for blind persons -- Identifiers, names and assignation to coded character sets for 8-dot Braille characters -- Part 2: Latin alphabet based character sets 60.60 TC 173
ISO 11683:1997
Packaging -- Tactile warnings of danger -- Requirements 90.60 TC 122
ISO 23600:2007
Assistive products for persons with vision impairments and persons with vision and hearing impairments -- Acoustic and tactile signals for pedestrian traffic lights 60.60 TC 173
ISO/CD 24502
Ergonomics -- Accessible design -- Specification of age-related relative luminance in visual signs and displays 30.99 TC 159/SC 5
ISO/CD 24503
Ergonomics -- Accessible design -- Using tactile dots and bars on consumer products 30.99 TC 159/SC 4

11.180.99 Other standards related to aids for disabled and handicapped people
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO/IEC 10779:2008
Information technology -- Office equipment accessibility guidelines for elderly persons and persons with disabilities 60.60 JTC 1/SC 28
ISO/WD 11156
Packaging - Accessible design - General guidelines 20.60 TC 122
ISO/IEC CD 13066-1
Information Technology - Interoperability with Assistive Technology (AT) -- Part 1: Requirements and recommendations for interoperability 30.20 JTC 1/SC 35
ISO/IEC TR 19765:2007
Information technology -- Survey of icons and symbols that provide access to functions and facilities to improve the use of information technology products by the elderly and persons with disabilities 60.60 JTC 1/SC 35
ISO/IEC TR 19766:2007
Information technology -- Guidelines for the design of icons and symbols accessible to all users, including the elderly and persons with disabilities 60.60 JTC 1/SC 35
ISO/IEC CD 29136
Information Technology - User Interfaces - Accessibility functions for personal computers 30.20 JTC 1/SC 35
ISO/IEC TR 29138-1
Information technology -- Accessibility considerations for people with disabilities -- Part 1: User needs summary 60.00 JTC 1
ISO/IEC TR 29138-2
Information technology -- Accessibility considerations for people with disabilities -- Part 2: Standards inventory 60.00 JTC 1
ISO/IEC TR 29138-3
Information technology -- Accessibility considerations for people with disabilities -- Part 3: Guidance on user needs mapping 60.00 JTC 1


11.200 Birth control. Mechanical contraceptives
Standards and projects under the direct responsibility of Secretariat
Standard and/or project TC
ISO/DIS 4074
Natural rubber latex condoms -- Requirements and test methods 40.00 TC 157
ISO 4074:2002
Natural latex rubber condoms -- Requirements and test methods 90.92 TC 157
ISO 4074:2002/Cor 1:2003
60.60 TC 157
ISO 4074:2002/Cor 2:2008
60.60 TC 157
ISO 7439:2002
Copper-bearing intra-uterine contraceptive devices -- Requirements, tests 90.92 TC 157
ISO 7439:2002/FDAmd 1
50.60 TC 157
ISO 8009:2004
Mechanical contraceptives -- Reusable natural and silicone rubber contraceptive diaphragms -- Requirements and tests 90.93 TC 157
ISO 8009:2004/CD Amd 1
30.99 TC 157
ISO/NP 11249
Mechanical contraceptives -- Guidance for clinical evaluation of intra-uterine contraceptive devices (IUDs) 10.99 TC 157
ISO/WD 11250
Mechanical female contraceptive devices -- Tubal ligation/Fallopian rings 20.20 TC 157
ISO 16037:2002
Rubber condoms for clinical trials -- Measurement of physical properties 90.93 TC 157
ISO 16037:2002/CD Amd 1
30.99 TC 157
ISO 16038:2005
Rubber condoms -- Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms 90.92 TC 157
ISO/DIS 16038
Male condoms -- Guidance on the use of ISO 4074 and ISO 23409 in the quality management of natural rubber latex condoms and synthetic condoms 40.20 TC 157
ISO/DIS 23409.2
Male condoms -- Requirements and test methods for condoms made from synthetic materials 40.20 TC 157
ISO/DIS 25841
Female condoms -- Requirements and test methods 40.93 TC 157
ISO/DIS 29941
Condoms -- Determination of nitrosamines migrating from natural rubber latex condoms into various media 40.20 TC 157
ISO/DIS 29942
Prophylactic dams -- Requirements and test methods 40.20 TC 157
ISO/NP 29943-1
Condoms -- Guidance on clinical studies -- Part 1: General consideration for studies based on self-reports 10.99 TC 157
ISO/NP 29943-2
Condoms -- Guidance on clinical studies -- Part 2: Male condoms -- In-use studies of slippage and breakage 10.99 TC 157
ISO/NP 29943-3
Condoms -- Guidance on clinical studies -- Part 3: Female condoms 10.99 TC 157

11.220 Veterinary medicine
Including equipment specific to veterinary medicine


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