Lastest & Cheapest ISO Standards In PDF (4)

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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

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