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Class II medical device requirements

Class II medical device requirements, Total:500 items.

In the international standard classification, Class II medical device requirements involves: Graphical symbols, Medical equipment, Pharmaceutics, Sterilization and disinfection, Laboratory medicine, Character sets and information coding, Quality, Applications of information technology, Company organization and management, Medical sciences and health care facilities in general, Sociology. Demography, First aid, Microbiology, Dentistry, Hospital equipment, Standardization. General rules, Optical equipment, Packaging materials and accessories, Sacks. Bags, Character symbols, Electromagnetic compatibility (EMC).


Association Francaise de Normalisation, Class II medical device requirements

  • NF S99-015*NF EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates.
  • NF EN 556-1:2002 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage STERILE - Partie 1 : exigences relatives aux dispositifs médicaux stérilisés au stade terminal
  • NF S98-107-2*NF EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2 : requirements for aseptically processed medical devices
  • NF EN 15986:2011 Symbole à utiliser pour l'étiquetage des dispositifs médicaux - Exigences relatives à l'étiquetage des dispositifs médicaux contenant des phtalates
  • NF EN 556-2:2015 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage "STÉRILE" - Partie 2 : exigences pour les dispositifs médicaux soumis à un traitement aseptique
  • NF S98-107-1*NF EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1 : requirements for terminally sterilized medical devices
  • NF S98-107-2:2004 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2 : requirements for aseptically processed medical devices".
  • NF S90-445:1985 MEDICO-SURGICAL EQUIPMENT. IMPLANTS FOR SURGERY. ORTHOPAEDIC JOINT PROSTHESES. BASIC REQUIREMENTS.
  • NF S99-101/A11*NF EN ISO 13485/A11:2021 Medical devices - Quality management systems - Requirements for regulatory purposes
  • NF S99-101*NF EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
  • NF EN ISO 13485:2016 Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires
  • NF EN ISO 13485/A11:2021 Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires
  • NF EN 13532:2002 Exigences générales relatives aux dispositifs médicaux de diagnostic in vitro pour auto-test
  • XP S98-224*XP ISO/TS 22421:2021 Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
  • XP ISO/TS 22421:2021 Stérilisation des produits de santé - Exigences communes applicables aux stérilisateurs utilisés pour la stérilisation terminale des dispositifs médicaux dans les établissements de santé
  • FD S99-212*FD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
  • NF EN 50637:2017 Appareils électromédicaux - Exigences particulières de sécurité de base et de performances essentielles des lits médicaux pour enfants
  • NF S99-014-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1 : general requirements.
  • NF S99-101:2012 Medical devices - Quality management systems - Requirements for regulatory purposes
  • NF S93-004*NF EN ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
  • NF S98-104*NF EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
  • NF EN ISO 20857:2013 Stérilisation des produits de santé - Chaleur sèche - Exigences pour l'élaboration, la validation et le contrôle de routine d'un processus de stérilisation pour dispositifs médicaux
  • NF S97-165/IN1:2013 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
  • NF EN ISO 10993-2:2022 Évaluation biologique des dispositifs médicaux - Partie 2 : Exigences relatives à la protection des animaux
  • NF S90-449:1985 Medico-surgical equipment. Implants for surgery. Partial and total hip joint prostheses. Part 1 : classification, designation of dimensions and requirements.
  • NF EN ISO 11135:2014 Stérilisation des produits de santé - Oxyde d'éthylène - Exigences de développement, de validation et de contrôle de routine d'un processus de stérilisation pour des dispositifs médicaux
  • FD CEN/TR 17223:2018 Document d'orientation sur la relation entre l'EN ISO 13485:2016 (Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires) et le Règlement européen relatif aux dispositifs médicaux ainsi que le Règle...
  • NF EN 45502-2-2:2008 Dispositifs médicaux implantables actifs - Partie 2-2 : exigences particulières pour les dispositifs médicaux implantables actifs destinés au traitement des tachyarythmies (y compris les défibrillateurs implantables)
  • NF S98-103-1*NF EN ISO 11137-1:2016 Sterilization of health care products - Radiation - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices
  • NF EN 868-4:2017 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 4 : sacs en papier - Exigences et méthodes d'essai
  • AFNOR SPEC S93-250:2022 Néonatalogie - Exigences relatives aux dispositifs médicaux destinés à l'administration de l'alimentation et des médicaments par voie entérale
  • NF S98-051-4*NF EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4 : paper bags - Requirements and test methods
  • NF S98-101:1994 Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization.
  • NF S98-103:1994 Sterilization of medical devices. Validation and routine control of sterilization by irradiation.
  • NF EN 868-2:2017 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2 : enveloppe de stérilisation - Exigences et méthodes d'essai
  • NF EN ISO 14708-6:2022 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 6 : Exigences particulières pour les dispositifs médicaux implantables actifs conçus pour traiter la tachyarythmie (y compris les défibrillateurs implantables)
  • NF S98-051-2*NF EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2 : sterilization wrap - Requirements and test methods
  • NF EN ISO 25424/A1:2022 Stérilisation des produits de santé - Formaldéhyde et vapeur à faible température - Exigences pour le développement, la validation et le contrôle de routine d'un procédé de stérilisation pour dispositifs médicaux - Amendement 1
  • NF EN ISO 14937:2009 Stérilisation des produits de santé - Exigences générales pour la caractérisation d'un agent stérilisant et pour la mise au point, la validation et la vérification de routine d'un processus de stérilisation pour dispositifs médicaux
  • NF S99-014-1*NF EN ISO 15223-1:2021 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1 : general requirements
  • NF EN ISO 15223-1:2021 Dispositifs médicaux - Symboles à utiliser avec les informations à fournir par le fabricant - Partie 1 : exigences générales
  • NF S98-052-2*NF EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices - Part 2 : validation requirements for forming, sealing and assembly processes
  • NF S98-101*NF EN ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
  • NF EN 14079:2004 Dispositifs médicaux non actifs - Exigences de performance et méthodes d'essais pour la gaze de coton absorbante et la gaze de coton et viscose absorbante
  • NF EN 868-6:2017 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 6 : papier pour des procédés de stérilisation à basse température - Exigences et méthodes d'essai
  • NF EN ISO 11607-2:2020 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2 : exigences de validation pour les procédés de formage, scellage et assemblage
  • NF S98-051-6*NF EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6 : paper for low temperature sterilization processes - Requirements and test methods
  • XP ISO/TS 21387:2020 Stérilisation des dispositifs médicaux - Lignes directrices concernant les exigences de validation et de traitement de routine des procédés de stérilisation à l'oxyde d'éthylène par libération paramétrique
  • NF S92-010-1:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1 : terms, definitions and general requirements.
  • NF S92-010-1*NF EN ISO 18113-1:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1 : terms, definitions and general requirements

US-FCR, Class II medical device requirements

Lithuanian Standards Office , Class II medical device requirements

  • LST EN 556-1-2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • LST EN 556-2-2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
  • LST EN 15986-2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
  • LST EN 556-1-2002/AC-2006 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
  • LST EN 45502-2-1-2004 Active implantable medical devices -- Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
  • LST EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
  • LST EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)
  • LST EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003+Cor.1:2009)
  • LST EN 868-4-2009 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
  • LST EN 868-2-2009 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
  • LST EN ISO 13485:2012/AC:2012 Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor.1:2009)
  • LST EN ISO 14937:2010 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
  • LST EN 14079-2004 Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
  • LST EN 868-6-2009 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
  • LST EN 45502-1-2000 Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer

AENOR, Class II medical device requirements

  • UNE-EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • UNE-EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
  • UNE-EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing.
  • UNE-EN 45502-2-1:2005 Active implantable medical devices -- Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
  • UNE-EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
  • UNE-EN 45502-2-2:2008 Active implantable medical devices -- Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
  • UNE-EN ISO 9626:2017 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)
  • UNE-EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
  • UNE-EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
  • UNE-EN ISO 15223-1:2017 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
  • UNE-EN ISO 10993-2:2007 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
  • UNE-EN ISO 13485:2013 Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009)
  • UNE-EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
  • UNE-EN ISO 14937:2010 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
  • UNE-EN 14079:2004 Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
  • UNE-EN 45502-2-3:2010 Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
  • UNE-EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods

未注明发布机构, Class II medical device requirements

  • BS EN 556-1:2001(2006) Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1 : Requirements for terminally sterilized medical devices
  • BS EN ISO 13488:2001 Quality systems - Medical devices - Particular requirements for the application
  • DIN EN ISO 13485:2003 Medical devices quality management systems requirements for regulatory purposes
  • YY 0288-1996 Quality system. Medical devices. GB/T 19002—Special requirements for ISO 9002 applications
  • BS EN 45502-2-2:2008(2009) Active implantable medical devices — Part 2 - 2 : Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
  • DIN EN 868-1:1997 Packaging materials and systems for medical devices which are to be sterilized — Part 1: General requirements and test methods
  • BS EN ISO 11135:2014+A1:2019(2020) Sterilization of health - care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
  • DIN EN ISO 15223-1:2022 Medical devices – Symbols for use within the information to be provided by the manufacturer – Part 1: General requirements (ISO 15223-1:2021)

German Institute for Standardization, Class II medical device requirements

  • DIN EN 556-1:2002-03 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001 / Note: To be replaced by DIN EN 556-1 (2023-02).
  • DIN EN 556-1 Berichtigung 1:2006-12 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001, Corrigenda to DIN EN 556-1:2002-03; German version EN 556-1...
  • DIN EN 556-2:2023-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: requirements for aseptically processed medical devices; German and English version prEN 556-2:2023 / Note: Date of issue 2023-01-06*Intended as r...
  • DIN EN 556-2:2015-11 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015 / Note: To be replaced by DIN EN 556-2 (2023-02).
  • DIN EN 556-1:2023-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German and English version prEN 556-1:2023 / Note: Date of issue 2023-01-06*Intended as r...
  • DIN EN 15986:2011-05 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version EN 15986:2011, with CD-ROM
  • DIN EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2003
  • DIN EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015
  • DIN EN 13532:2002-08 General requirements for in vitro diagnostic medical devices for self-testing; German version EN 13532:2002, German and English texts
  • DIN EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version EN 15986:2011, with CD-ROM
  • DIN EN ISO 13485/A1:2019 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019
  • DIN EN ISO 13485:2021-12 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021
  • DIN EN ISO 10993-2:2023-02 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022); German version EN ISO 10993-2:2022
  • DIN EN ISO 9626:2016-12 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016); German version EN ISO 9626:2016
  • DIN EN ISO 15223-1/A1:2019 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016); German and English version EN ISO 15223-1:2016/prA1:2019
  • DIN EN ISO 15223-1:2020 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2020); German and English version prEN ISO 15223-1:2020
  • DIN EN ISO 11137-1:2020-04 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018); German version EN ISO 11137-1...
  • DIN EN 868-4:2017-05 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods; German version EN 868-4:2017
  • DIN EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009); German version EN ISO 25424:2011
  • DIN EN ISO 10993-2:2023 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
  • DIN EN ISO 11135:2023-05 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2023); German and English version prEN ISO 11135:2023 / Note: Date o...
  • DIN EN ISO 15223-1:2013 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012); German version EN ISO 15223-1:2012, with CD-ROM
  • DIN EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012); German version EN ISO 15223-1:2012, with CD-ROM
  • DIN EN ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006); English version of DIN EN ISO 10993-2:2006-10
  • DIN EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016
  • DIN EN 868-2:2017-05 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; German version EN 868-2:2017
  • DIN EN 13795:2013 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels; German version
  • DIN EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing; German version EN 13532:2002, German and English texts
  • DIN EN ISO 20857:2013-08 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010); German version EN ISO 20857:2013
  • DIN EN ISO 17665:2022-11 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 17665:2022); German and English version prEN ISO 17665:2022 / Note: Date of is...
  • DIN EN ISO 15223-1:2017 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03); German version EN ISO 15223-1:2016, with CD-ROM
  • DIN EN ISO 13485:2021 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021
  • DIN EN ISO 14937:2010-03 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009); German version EN ISO 14937:2009
  • DIN EN 868-6:2017-05 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-6:2017
  • DIN EN ISO 11607-2:2020-05 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); German version EN ISO 11607-2:2020 / Note: To be amended by DIN EN ISO 11607-2/A1 (2022-08).
  • DIN EN ISO 11607-2/A11:2022-08 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); German version EN ISO 11607-2:2020/A11:2022
  • DIN EN ISO 11135:2020-04 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018); German version EN ISO 11135:2014 + A1:2019
  • DIN EN 14079:2003-08 Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze; German version EN 14079:2003 / Note: To be replaced by DIN EN 14079 (2004-07), DIN EN 14079-1 (2006-11), DIN EN 14...
  • DIN EN ISO 15883-6:2016-04 Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011); German version EN ISO 15883-6:2015
  • DIN EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2012 + AC:2012

ES-UNE, Class II medical device requirements

  • UNE-EN 556-1:2002/AC:2007 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
  • UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
  • UNE-EN ISO 13485:2018/A11:2022 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
  • UNE-EN ISO 13485:2018 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016). (Consolidated version)
  • UNE-EN 45502-2-2:2008 CORR:2009 Active implantable medical devices -- Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
  • UNE-EN ISO 14708-6:2023 Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2019)
  • UNE-EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
  • UNE-EN ISO 10993-2:2023 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
  • UNE-EN ISO 15223-1:2022 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
  • UNE-EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
  • UNE-EN ISO 11607-2:2020/A11:2022 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
  • UNE-EN ISO 15883-6:2015 Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)

Danish Standards Foundation, Class II medical device requirements

  • DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
  • DS/EN 556-1/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
  • DS/EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
  • DS/EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices
  • DS/EN 556:1995 Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile"
  • DS/ISO/TS 22421:2021 Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
  • DS/EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes
  • DS/EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
  • DS/EN 46002:1993 Quality systems. Medical devices. Particular requirements for the application of EN 29002
  • DS/EN 46001:1993 Quality systems. Medical devices. Particular requirements for the application of EN 29001
  • DS/EN ISO 13485:2021 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
  • DS/EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
  • DS/EN 45502-2-1:2004 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (Cardiac pacemakers)
  • DS/EN ISO 13485/AC:2012 Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1
  • DS/ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices – Part 1: General requirements
  • DS/EN ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • DS/EN ISO 11137-1/A1:2013 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • DS/EN 868-4:2009 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
  • DS/EN ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
  • DS/EN ISO 15223-1 Bil. 1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements - Fact Sheet 1: Graphical symbols in electronic format
  • DS/EN ISO 15223-1 Bil. 1:2021 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements – Fact Sheet 1: Graphical symbols in electronic format
  • DS/EN 868-2:2009 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
  • DS/EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
  • DS/ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
  • DS/EN 20594-1:1994 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment. Part 1: General requirements
  • DS/EN 14079:2003 Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
  • DS/EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
  • DS/ISO 27186:2021 Active implantable medical devices – Four-pole connector system for implantable cardiac rhythm management devices – Dimensional and test requirements
  • DS/EN 868-6:2009 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
  • DS/EN 45502-1:1998 Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
  • DS/EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
  • DS/EN 868-7:2009 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods

European Committee for Standardization (CEN), Class II medical device requirements

  • EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
  • EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
  • EN 556-2:2003 Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2: Requirements for aseptically processed medical devices
  • prEN 556-1991 Sterilization of medical devices; sterility assurance level for medical devices labelled "Sterile"; requirements
  • prEN 46001-1992 Quality systems; medical devices; particular requirements for the application of EN 29001
  • prEN 46002-1991 Particular requirements for the application of EN 29002 for medical devices
  • EN ISO 13485:2000 Quality Systems - Medical Devices - Particular Requirements for the Application of EN ISO 9001 Revision of EN 46001:1996; Identical to ISO 13485:1996
  • EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (Incorporating corrigendum July 2012)
  • EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
  • EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
  • EN ISO 15223-1:2021 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
  • EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (Remains Current)
  • EN ISO 13488:2000 Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002 Revision of EN 46002: 1996; Identical to ISO 13488: 1996; Superseded by EN ISO 13485:2003
  • EN 46001:1993 Quality Systems - Medical Devices - Particular Requirements for the Application of EN 29001
  • EN ISO 25424:2019 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
  • EN 46002:1996 Quality Systems - Medical Devices - Particular Requirements for the Application of EN ISO 9002
  • EN 46003:1999 Quality Systems - Medical Devices - Particular Requirements for the Application of EN ISO 9003
  • CEN EN 13532-2002 General Requirements for in Vitro Diagnostic Medical Devices for Self-Testing
  • EN 556:1998 Sterilization of Medical Devices - Requirements for Terminally - Sterilized Medical Devices to Be Labelled "Sterile" Ratified European Text; Includes Amendment 1: 1994
  • EN ISO 10993-2:1998 Biological Evaluation of Medical Devices - Part 2: Animal Welfare Requirements ISO 10993-2:1992
  • EN ISO 10993-2:2022 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
  • EN ISO 13485:2016/A11:2021 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
  • EN ISO 25424:2019/prA1:2021 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/DAM 1:2021)
  • EN ISO 25424:2019/A1:2022 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)
  • EN ISO 13485:2016/AC:2018 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
  • EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
  • EN 1174-1:1996 Sterilization of Medical Devices - Estimation of the Population of Micro- Organisms on Product - Part 1: Requirements
  • prEN 552-1991 Sterilization of medical devices; method for validation and routine control of sterilization by irradiation; requirements
  • prEN 554-1991 Sterilization of medical devices; method for validation and routine control of steam sterilization; requirements
  • EN ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
  • EN 15354:2022 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
  • EN 12929-2:2015+A1:2022 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
  • EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
  • prEN 550-1991 Sterilization of medical devices; method for validation and routine control of ethylene oxide sterilization; requirements
  • prEN ISO 11137-1 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023)
  • EN ISO 11137-1:2006/A1:2013 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006/Amd 1:2013)
  • EN ISO 11137-1:2015/A2:2019 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
  • EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
  • EN 868-1:1997 Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 1: General Requirements and Test Methods
  • EN 868-4:1999 Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 4: Paper Bags - Requirements and Test Methods
  • EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
  • EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
  • EN ISO 18113-1:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements

CEN - European Committee for Standardization, Class II medical device requirements

  • EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
  • EN 556-2:2015 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices"
  • PD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
  • EN 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development@ validation and routine control of a sterilization process for medical devices
  • EN 46002:1993 Quality Systems - Medical Devices - Particular Requirements for the Application of EN 29002
  • EN 46001:1996 Quality Systems - Medical Devices - Particular Requirements for the Application of EN ISO 9001
  • EN ISO 18113-1:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms@ definitions and general requirements

RU-GOST R, Class II medical device requirements

  • GOST EN 556-1-2011 Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized medical devices
  • GOST R 57501-2017 Maintenance of medical devices. Requirements for governmental purchases
  • GOST R 57504-2017 Medical devices. Syringe pumps. Technical requirements for governmental purchases
  • GOST R ISO 20857-2016 Sterilization of medical devices. Dry heat. Requirements for development, validation and routine control of a sterilization process for medical devices
  • GOST R ISO 15223-1-2014 Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 1. General requirements
  • GOST ISO 13485-2017 Medical devices. Quality management systems. Requirements for regulatory purposes
  • GOST R 57506-2017 Medical devices. Implantable defibrillators and other active implantable medical devices intended to treat tachyarrhythmia. Technical requirements for governmental purchases
  • GOST R ISO 25424-2013 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
  • GOST R 57497-2017 Medical devices. Implantable active devices intended to circulatory support. Technical requirements for governmental purchases
  • GOST R 57495-2017 Medical devices. Implantable neurostimulators. Technical requirements for governmental purchases
  • GOST R 57492-2017 Medical devices. Implantable cardiac pacemakers. Technical requirements for governmental purchases
  • GOST R 57505-2017 Medical devices. Cochlear implant system. Technical requirements for governmental purchases
  • GOST R 57500-2017 Medical devices. Implantable infusion pumps. Technical requirements for governmental purchases
  • GOST ISO 13485-2011 Medical devices. Quality management systems. System requirements for regulatory purposes
  • GOST R EN 13718-1-2015 Medical vehicles and their equipment. Air Ambulances. Part 1. Requirements for medical devices used in air ambulances
  • GOST R 52770-2016 Medical devices. Safety requirements. Methods of sanitation-chemical and toxicological tests
  • GOST R 57493-2017 Medical devices. Protective garments for radiology department stuff. Technical requirements for governmental purchases
  • GOST R 57503-2017 Medical devices. Protective garments for radiology department patients. Technical requirements for governmental purchases
  • GOST R 57451-2017 Medical devices. Quality Management System. Requirements for competence and maintaining competence for audit organizations that audit medical device manufacturers for regulatory purposes
  • GOST R IEC 62359-2011 Medical equipment. General requirements for methods of determination of mechanical and thermal fields safe indices for medical ultrasonic diagnostic equipment
  • GOST R 55037-2012 Optics and optical instruments. Medical endoscopes and endotherapy devices. Particular requirements. Test methods
  • GOST R 57498-2017 Medical devices. X-Ray therapy apparatus with anode voltage from 10 to 300 kV. Technical requirements for governmental purchases
  • GOST R ISO 17665-1-2016 Sterilization of health care products. Moist heat. Part 1. Requirements for development, validation and routine control of a sterilization process for medical device
  • GOST R 56837-2015 Health informatics. Information security management for remote maintenance of medical devices and medical information systems. Part 1. Requirements and risk analysis
  • GOST R 59745-2021 Active implantable medical devices. Axial pumps for auxiliary blood circulation. General technical requirements
  • GOST 24263-1980 Medical apparatus. Information symbols on the endoscopes and their functional elements. Forms and dimensions. Technical requirements
  • GOST R IEC 61326-2-6-2014 Electrical equipment for measurement, control and laboratory use. EMC requirements. Part 2-6. Particular requirements. In vitro diagnostic (IVD) medical equipment
  • GOST R ISO 14708-7-2016 Implants for surgery. Active Implantable medical devices. Part 7. Particular requirements for cochlear implant systems
  • GOST ISO 11135-2017 Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
  • GOST R 56330-2016 Medical equipment. Technical means of placement and transfer of patients in the prehospital. General technical requirements and test methods
  • GOST R 55991.1-2014 In vitro diagnostics medical devices. Part 1. Automatic analyzers for biochemical assays. Technical requirements for public procurement
  • GOST R 55991.2-2014 In vitro diagnostics medical devices. Part 2. Automatic analyzer for immunoassays. Technical requirements for public procurement
  • GOST R 55991.4-2014 In vitro diagnostics medical devices. Part 4. Automatic analyzers for coagulation tests. Technical requirements for public procurement

British Standards Institution (BSI), Class II medical device requirements

  • BS EN 556-2:2015 Tracked Changes. Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices
  • 23/30457240 DC BS EN 556-2. Sterilization of medical devices. Requirements for medical devices to be designated ''STERILE" - Part 2. requirements for aseptically processed medical devices
  • 23/30457243 DC BS EN 556-1. Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Part 1. Requirements for terminally sterilized medical devices
  • BS EN 556-2:2004 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices
  • BS EN ISO 15223-1:2017 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
  • BS EN ISO 15223-1:2012 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
  • PD ISO/TS 22421:2021 Sterilization of health care products. Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
  • BS EN ISO 10993-2:2006 Biological evaluation of medical devices - Animal welfare requirements
  • BS EN ISO 10993-2:2022 Biological evaluation of medical devices - Animal welfare requirements
  • BS PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices. General requirements
  • PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices. General requirements
  • BS EN 868-4:2009 Packaging for terminally sterilized medical devices - Paper bags - Requirements and test methods
  • BS EN ISO 11137-1:2015 Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices
  • BS EN ISO 11137-1:2006+A1:2013 Sterilization of health care products - Radiation - Requirements for development, validation and routine control of a sterilization process for medical devices
  • BS EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
  • BS EN 13795-3:2006+A1:2009 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment — Part 3: Performance requirements and performance levels
  • BS EN 13795:2011 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment. General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
  • BS EN 868-2:2009 Packaging for terminally sterilized medical devices - Sterilization wrap - Requirements and test methods
  • BS EN ISO 11135:2014 Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
  • BS EN ISO 14708-6:2022 Implants for surgery. Active implantable medical devices - Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
  • 18/30371211 DC BS EN 13718-1. Medical vehicles and their equipment. Air ambulances. Part 1. Requirements for medical devices used in air ambulances
  • BS EN 13795-1:2002+A1:2009 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Part 1: General requirements for manufacturers, processors and products
  • BS EN 868-4:2017 Tracked Changes. Packaging for terminally sterilized medical devices. Paper bags. Requirements and test methods
  • 20/30387822 DC BS EN ISO 15223-1. Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 1. General requirements
  • PD ISO/TS 11796:2023 Biological evaluation of medical devices. Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
  • BS EN 45502-2-3:2010 Active implantable medical devices - Particular requirements for cochlear and auditory brainstem implant systems
  • BS EN ISO 11607-2:2020+A11:2022 Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes
  • BS EN ISO 9626:2016 Tracked Changes. Stainless steel needle tubing for the manufacture of medical devices. Requirements and test methods
  • 20/30398724 DC BS EN ISO 10993-2. Biological evaluation of medical devices. Part 2. Animal welfare requirements
  • BS ISO 17593:2022 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • BS EN ISO 14160:2011 Sterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a sterilization proc
  • BS EN 868-6:2009 Packaging for terminally sterilized medical devices - Paper for low temperature sterilization processes - Requirements and test methods
  • BS EN 868-2:2017 Tracked Changes. Packaging for terminally sterilized medical devices. Sterilization wrap. Requirements and test methods
  • 19/30401046 DC BS EN ISO 15223-1 AMD1. Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied - Part 1. General requirements
  • BS EN ISO 18113-1:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Terms, definitions and general requirements
  • BS EN ISO 18113-1:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Terms, definitions and general requirements
  • 21/30402425 DC BS ISO 17593. Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for selftesting of oral anticoagulant therapy
  • BS 5724-2.6:1985 Medical electrical equipment - Particular requirements for safety - Specification for microwave therapy equipment
  • BS EN ISO 20857:2013 Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
  • BS EN 1174-1:1996 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Requirements
  • BS EN 868-9:2009 Packaging for terminally sterilized medical devices - Uncoated nonwoven materials of polyolefines - Requirements and test methods
  • BS PD ISO/TS 22421:2021 Sterilization of health care products. Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
  • BS EN 13718-1:2002 Air, water and difficult terrain ambulances - Medical devices interface requirements for the continuity of patient care
  • BS EN 868-7:2009 Packaging for terminally sterilized medical devices - Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
  • BS EN 868-10:2009 Packaging for terminally sterilized medical devices - Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
  • 18/30343606 DC BS EN ISO 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)
  • BS ISO 27186:2013 Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements
  • BS ISO 27186:2020 Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements

Shanghai Provincial Standard of the People's Republic of China, Class II medical device requirements

  • DB31/T 1378-2022 Service Specifications for Class II Medical Device Registration

Canadian Standards Association (CSA), Class II medical device requirements

  • CAN/CSA-ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes (Second Edition)
  • CAN/CSA-ISO 14937:2011 Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (Second Edition)
  • CSA ISO-10993.2-97-CAN/CSA:1997 Evaluation Biologique Des Dispositifs Medicaux - Partie 2: Exigences Concernant La Protection Des Animaux
  • CSA PLUS 14971-2007 The ISO 14971:2007 essentials — A practical handbook for implementing the ISO 14971 Standard for medical devices (Second Edition)
  • CSA ISO 13485-03-CAN/CSA:2003 Dispositifs m閐icaux ?Syst鑝es de management de la qualit??Exigences ?des fins r間lementaires Deuxi鑝e Edition
  • CSA ISO 13485-98-CAN/CSA:1998 Quality Systems - Medical Devices - Particular Requirements for the Application of ISO 9001 First Edition; ISO 13485: 1996
  • CSA ISO 13488-98-CAN/CSA:1998 Systemes Qualite - Dispositifs Medicaux - Exigences Particulieres Relatives A L'Application De L'ISO 9002 Premiere Edition; ISO 13488: 1996
  • CSA Z314.0-2013 Medical device reprocessing - General requirements (First Edition; Incorporated Errata: March 2014)
  • CSA ISO 11135-98-CAN/CSA:1998 Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization First Edition; ISO 11135: 1994; Supersedes CAN/CSA-Z214.5: 1988
  • CSA ISO 14937-01-CAN/CSA:2001-b Sterilization of Health Care Products - General Requirements for Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices First Edition; ISO 14937:2000
  • CSA ISO 11607-1:2021 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (Adopted ISO 11607-1:2019, second edition, 2019-02)

Professional Standard - Medicine, Class II medical device requirements

  • YY/T 0615.1-2007 Requirements for medical devices to be designated“STERILE”.part 1:Requirements for terminally sterilized medical devices
  • YY/T 0615.2-2007 Requirements for medical devices to be dwsignated“SIERILE”.Part 2:Requirements for aseptically processed medical devices
  • YY/T 1914-2023 General requirements for medical devices and appliances used in human assisted reproductive technology
  • YY/T 0048-1991 Basic requirements for working drawings of medical device products
  • YY/T 0466.1-2009 Medical devices.Symbols to be used with medical device labels,labelling and information to be supplied.Part 1:General requirements
  • YY/T 0466.1-2016 Medical devices.Symbols to be used with medical device labels,labelling and information to be supplied.Part 1:General requirements
  • YY/T 1441-2016 General requirements of performance evaluation of in vitro diagnostic medical devices
  • YY 91056-1999 Evaluating requirements for corrosion test of electroplated metallic coatings of medical instruments
  • YY/T 1454-2016 General requirements for in vitro diagnostic medical devices for self-testing
  • YY/T 0287-2017 Medical devices.Quality management systems.Requirements for regulatory purposes
  • YY/T 0287-2003 Medical devices-Quality management systems-Requirements for regulatory purposes
  • YY/T 0288-1996 Quality system.Medical devices.Particular requirements for the application of GB/T 19002.ISO 9002
  • YY/T 1833.3-2022 Artificial Intelligence Medical Device Quality Requirements and Evaluation Part 3: General Requirements for Data Labeling
  • YY/T 1473-2016 Guide to the development and inclusion of safety aspects in Standards for medical devices
  • YY/T 1276-2016 Requirements for the development, validation and routine control of dry heat sterilization process for medical devices
  • YY 1276-2016 Requirements for development, validation and routine control of dry heat sterilization process for medical devices
  • YY/T 1833.4-2023 Artificial Intelligence Medical Device Quality Requirements and Evaluation Part 4: Traceability
  • YY/T 0466.1-2023 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements
  • YY/T 1842.1-2022
  • YY/T 0698.4-2009 Packaging materials for terminally sterilized medical devices - Part 4: Requirements and test methods for paper bags
  • YY/T 0690-2008 Clinical laboratory testing and in vitro medical devices -- Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • YY/T 1464-2016 Sterilization of medical devices.Requirements for the development, validation and routine control of a low temperature steam and formaldehyde sterilization process for medical devices
  • YY/T 0698.2-2009 Packaging materials for terminal sterilized medical devices.Part 2:Sterilization wrap.Requirements and test methods
  • YY/T 0734.4-2016 Washer-disinfectors.Part 4:Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive medical devices, etc.

Standard Association of Australia （SAA）, Class II medical device requirements

PL-PKN, Class II medical device requirements

  • PN Z54058-1990 Medical instruments Needle holders Re?uirements and tests
  • PN Z54032-1989 Medical instruments Haemostatic forceps Re?uirements and tests
  • PN Z58022-1973 Medical instruments ynaecological curettes echnical requirements and tests
  • PN Z54094-1972 Medical and surgical instruments Forceps Technical requirements and tes?s
  • PN Z55102-1988 Medical instruments Reusable needles with brazen nozzles Common requirements and tests

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Class II medical device requirements

  • GB/T 27949-2011 Hygienic requirements for medical items disinfection
  • GB 27949-2011 General Requirements for Disinfectants for Medical Devices
  • GB/T 42061-2022 Medical devices—Quality management systems—Requirements for regulatory purposes
  • GB/T 16886.2-2000 Biological evaluation of medical devices--Part 2: Animal welfare requirements
  • GB/T 16886.2-2011 Biological evaluation of medical devices.Part 2: Animal welfare requirements
  • GB 18279-2023 Development, validation and routine control requirements for ethylene oxide medical device sterilization processes for healthcare product sterilization
  • GB 18280.1-2015 Sterilization of health care products.Radiation.Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices
  • GB 18278.1-2015 Damp heat for sterilization of healthcare products - Part 1: Requirements for development, validation and routine control of sterilization processes for medical devices
  • GB 18279.1-2015 Sterilization of health care products.Ethylene oxide.Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
  • GB/T 1962.1-2015 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment.Part 1:General requirement
  • GB/T 1962.1-2001 The conical fittings with a6%(Luer)taper for syringes,needles and certain other medical equipment Part 1:General requirement
  • GB/T 19974-2005 Sterilization of health care products.General requirement for characterization of a sterilization agent and the development,validation and routine control of a sterilization process for medical devices
  • GB/T 19974-2018 Sterilization of health care products.General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices
  • GB/T 19633.2-2015 Packaging for terminally sterilized medical devices.Part 2:Validation requirements for forming, sealing and assembly processes
  • GB/T 19633.1-2015 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

国家市场监督管理总局、中国国家标准化管理委员会, Class II medical device requirements

  • GB 27949-2020 General requirements of disinfectant of medical instruments

American Society of Quality Control （ASQC), Class II medical device requirements

国家药监局, Class II medical device requirements

  • YY/T 1630-2018 Basic requirements for unique identification of medical devices
  • YY/T 1754.1-2020 Preclinical Animal Studies for Medical Devices Part 1: General Requirements
  • YY/T 1833.2-2022 Artificial Intelligence Medical Device Quality Requirements and Evaluation Part 2: General Requirements for Data Sets
  • YY/T 1833.1-2022 Artificial Intelligence Medical Device Quality Requirements and Evaluation Part 1: Terminology
  • YY 0970-2023 Sterilization of healthcare products Liquid chemical sterilants for single-use medical devices of animal origin Characterization, development, validation and routine control requirements for medical device sterilization processes
  • YY/T 1464-2022 Development, validation and routine control requirements for low-temperature steam formaldehyde medical device sterilization process for sterilization of healthcare products
  • YY/T 0698.2-2022 Packaging materials for terminally sterilized medical devices Part 2: Requirements and test methods for sterilization packaging materials

RO-ASRO, Class II medical device requirements

  • STAS 12902-1990 Human being medical instruments. Dental extracting forceps. General technical requirements for quality
  • STAS 12916-1991 Human use medical instruments. Retractors. General technical requirements for quality
  • STAS 12670-1988 Medical instruments SURGICAL SCISSORS General technical requirements for quality

International Organization for Standardization (ISO), Class II medical device requirements

  • ISO 14971:2000/Amd 1:2003 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements
  • ISO 14971:2019 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements
  • ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
  • ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
  • ISO 15223-1:2007 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
  • ISO 15223-1:2021 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
  • ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
  • ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
  • ISO 13485:1996 Quality systems - Medical devices - Particular requirements for the application of ISO 9001
  • ISO 13488:1996 Quality systems - Medical devices - Particular requirements for the application of ISO 9002
  • ISO 15223-1:2007/Amd 1:2008 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements; Amendment 1
  • ISO 25424:2018 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
  • ISO 25424:2009 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
  • ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements
  • ISO 10993-2:1992 Biological evaluation of medical devices; part 2: animal welfare requirements
  • ISO 10993-2:2022 Biological evaluation of medical devices — Part 2: Animal welfare requirements
  • ISO/DIS 11135 Sterilization of health care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
  • ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
  • ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices — Part 1: General requirements
  • ISO 18250-1:2018 Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 1: General requirements and common test methods
  • ISO 21474-1:2020 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation
  • ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
  • ISO 13485:2003/Cor 1:2009 Medical devices - Quality management systems - Requirements for regulatory purposes; Technical Corrigendum 1
  • ISO 14708-6:2019 Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillato
  • ISO/TS 11796:2023 Biological evaluation of medical devices — Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
  • ISO/DIS 17665 Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
  • ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment; Part 1 : General requirements
  • ISO 25424:2018/Amd 1:2022 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment
  • ISO/FDIS 17665:2023 Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
  • ISO/DIS 15883-2 Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices
  • ISO 14937:2000/Cor 1:2003 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices; Technical Corrigendum 1
  • ISO 17593:2022 Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • ISO/TS 22421:2021 Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
  • ISO/CD 27186 Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements
  • ISO 27186:2010 Space systems - Programme management - Quality assurance requirements
  • ISO 27186:2020 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
  • ISO 18113-1:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements

Korean Agency for Technology and Standards (KATS), Class II medical device requirements

  • KS P ISO 15223-1:2019 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
  • KS P ISO 13485:2018 Medical devices — Quality management systems — Requirements for regulatory purposes
  • KS P ISO 13485:2007 Medical devices－Quality management systems－Requirements for regulatory purposes
  • KS P ISO 13488:2002 Quality systems－Medical devices－Particular requirements for the application of ISO 9002
  • KS P ISO 14155-1-2007(2012) Clinical investigation of medical devices for human subjects－Part 1：General requirements
  • KS P ISO 10993-2-2010(2021) Biological evaluation of medical devices－Part 2：Animal welfare requirements
  • KS P ISO 10993-2-2010(2016) Biological evaluation of medical devices－Part 2：Animal welfare requirements
  • KS P ISO 10993-2:2010 Biological evaluation of medical devices-Part 2:Animal welfare requirements
  • KS P ISO 9626:2020 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
  • KS P ISO 25424:2020 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
  • KS P ISO 17593-2009(2019) Clinical laboratory testing and in vitro medical devices－Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • KS P ISO 11607-2:2021 Packaging for terminally sterilized medical devices —Part 2: Validation requirements for forming, sealing and assembly processes
  • KS P ISO 11607-2:2018 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes

KR-KS, Class II medical device requirements

  • KS P ISO 15223-1-2019 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
  • KS P ISO 13485-2018 Medical devices — Quality management systems — Requirements for regulatory purposes
  • KS P ISO 13488-2002 Quality systems－Medical devices－Particular requirements for the application of ISO 9002
  • KS P ISO 9626-2020 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
  • KS P ISO 25424-2020 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
  • KS P 2201-2022 In vitro diagnostic medical devices: Lateral flow immunoassay for infectious disease — General requirements for test performance
  • KS P ISO 11607-2-2021 Packaging for terminally sterilized medical devices —Part 2: Validation requirements for forming, sealing and assembly processes
  • KS P ISO 11607-2-2018 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
  • KS P ISO 11135-2022 Sterilization of health-care products ─ Ethylene oxide ─ Requirements for the development, validation and routine control of a sterilization process for medical devices

GOSTR, Class II medical device requirements

  • GOST R EN 13532-2010 General requirements for in vitro diagnostic medical devices for self-testing
  • GOST R ISO 15223-1-2020 Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 1. General requirements
  • GOST R ISO 10993-2-2009 Standardization in the Russian Federation. Medical devices. Biological evaluation of medical devices. Part 2. Animal welfare requirements
  • GOST ISO 11607-2-2018 Packaging for terminally sterilized medical devices. Part 2. Validation requirements for forming, sealing and assembly processes

Jiangsu Provincial Standard of the People's Republic of China, Class II medical device requirements

  • DB32/T 3769-2020 Basic requirements for medical device network information security

VN-TCVN, Class II medical device requirements

  • TCVN 6916-1-2008 Medical devices.Symbols to be used with medical device labels, labelling and information to be supplied.Part 1: General requirements
  • TCVN 7391-2-2005 Biological evaluation of medical devices.Part 2: Animal welfare requirements
  • TCVN 7740-1-2007 Clinical investigation of medical devices for human subjects.Part 1: General requirements
  • TCVN 7393-1-2009 Sterilization of health care products.Radiation.Part 1: Requirements for developement, validation and routine control of a sterilization process for medical devices.
  • TCVN 7392-1-2009 Sterilization of health care products.Ethylene oxide.Part 1: Requirements for developement validation and routine control of a sterilization process for medical devices.
  • TCVN 7394-2-2008 Packaging for terminally sterilized medical devices.Part 2: Validation requirements for forming, sealing and assembly processes
  • TCVN 7394-1-2008 Packaging for terminally sterilized medical devices.Part 1: Requirements for materials, sterile barrier systems and packaging systems

Shanxi Provincial Standard of the People's Republic of China, Class II medical device requirements

  • DB14/T 2253-2020 Basic requirements for entrusted storage and distribution services of medical devices

TH-TISI, Class II medical device requirements

  • TIS 13485-2004 Medical devices.quality management systems.requirements for regulatory purposes
  • TIS 2395.2-2008 Biological evaluation of medical devices.part 2: animal welfare requirements

Japanese Industrial Standards Committee (JISC), Class II medical device requirements

  • JIS Q 13485:2005 Medical devices -- Quality management systems -- Requirements for regulatory purposes
  • JIS T 0806-1:2022 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

ZA-SANS, Class II medical device requirements

  • SANS 13485:2004 Medical devices - Quality management systems - Requirements for regulatory purposes

Tianjin Provincial Standard of the People's Republic of China, Class II medical device requirements

  • DB12/T 1016-2020 General requirements for design and implementation of medical device traceability system

国家食品药品监督管理局, Class II medical device requirements

  • YY/T 1613-2018 Characteristics and control requirements of medical device irradiation sterilization process
  • YY 0989.6-2016 Surgical implants Active implantable medical devices Part 6: Specific requirements for active implantable medical devices (including implantable defibrillators) for the treatment of tachyarrhythmias
  • YY/T 0972-2016 Dimensions and test requirements for four-pole connector systems for active implantable medical devices and implantable cardiac rhythm regulation devices

US-AAMI, Class II medical device requirements

  • ANSI/AAMI/ISO 15223-1:2012 Medical devices.Symbols to be used with medical device labels, labeling, and information to be supplied.Part 1: General requirements

国家质量监督检验检疫总局, Class II medical device requirements

  • SN/T 4445.1-2016 Technical requirements for inspection of imported medical devices Part 1: Medical electrical equipment
  • SN/T 4445.2-2016 Technical requirements for inspection of imported medical devices Part 2: Patient monitors
  • SN/T 4508.2-2016 Technical requirements for export medical device inspection Part 2: Disposable syringes (with needle)

Group Standards of the People's Republic of China, Class II medical device requirements

  • T/CAMDI 039-2020 Special requirements for the production quality system of bioprinted medical devices
  • T/CAMDI 026-2019 Group standard for special requirements for customized medical device quality system
  • T/CAMDI 062-2021 Special requirements for 3D modeling software for additive manufacturing of personalized medical devices
  • T/CAMDI 040-2020 Special requirements for the quality management system of metal additive manufacturing medical device production
  • T/CSBME 050-2022 Artificial intelligence medical devices for cervical liquid-based cytology— Quality requirements and evaluation— Part 1: requirements for datasets
  • T/CSBME 064-2022
  • T/CAMDI 028-2019 General Requirements for Internet Implementation Conditions of Custom Additive Manufactured (3D Printing) Medical Devices

CZ-CSN, Class II medical device requirements

  • CSN 36 4721-1983 X-ray primary collimators of medical apparatus Basic sizes Technical requirements

American National Standards Institute （ANSI), Class II medical device requirements

  • ANSI/AAMI/ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements
  • ISO/DIS 11135:2023 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
  • ANSI/AAMI/ISO 27186:2010 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
  • ANSI/AAMI/ISO 14160:2011 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr

海关总署, Class II medical device requirements

  • SN/T 5473.1-2022 Technical Requirements for Inspection of Export Medical Devices Part 1: Ventilators
  • SN/T 5473.2-2022 Technical requirements for inspection of exported medical devices Part 2: Patient monitors
  • SN/T 5473.3-2022 Technical Requirements for Inspection of Export Medical Devices Part 3: Infrared Thermometer

Professional Standard - Agriculture, Class II medical device requirements

American Society for Testing and Materials (ASTM), Class II medical device requirements

  • ASTM F2761-09(2013) Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
  • ASTM F2761-09 Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model

PH-BPS, Class II medical device requirements

IT-UNI, Class II medical device requirements

  • UNI ISO 18250-1:2021 Medical devices -- Connectors for reservoir delivery systems for healthcare applications - Part 1: General requirements and common test methods
  • UNI ISO 21151:2021 In vitro diagnostic medical devices -- Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples

US-CFR-file, Class II medical device requirements

  • CFR 21-821.3-2013 Food and Drugs. Part821:Medical device tracking requirements. Section821.3:Medical device tracking requirements.
  • CFR 21-821.25-2013 Food and Drugs. Part821:Medical device tracking requirements. Section821.25:Device tracking system and content requirements: manufacturer requirements.
  • CFR 21-821.30-2013 Food and Drugs. Part821:Medical device tracking requirements. Section821.30:Tracking obligations of persons other than device manufacturers: distributor requirements.

Professional Standard - Commodity Inspection, Class II medical device requirements

  • SN/T 3062.2-2011 Pachaking materials for terminally sterilized medical devices for import.Part 2:Paper bags.Requirements and test methods
  • SN/T 3062.1-2011 Packing materials for terminally sterilized medical devices for import. Part 1:Validation requirements for forming,sealing and assembly processes
  • SN/T 3062.4-2011 Pachaking materials for terminally sterilized medical devices for import.Part 4:Requirements for materials and sterile barrier systems of importing medical device sterilization packaging

IX-EU/EC, Class II medical device requirements

  • NO 722/2012-2012 COMMISSION REGULATION concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal o

中国国家认证认可监督管理委员会, Class II medical device requirements

  • RB/T 217-2017 Inspection and testing agency qualification accreditation capability evaluation medical device inspection agency requirements

UNKNOWN, Class II medical device requirements

  • GB/T 18279.1-2015 Ethylene oxide for sterilization of healthcare products Part 1: Requirements for the development, validation and routine control of sterilization processes for medical devices

Indonesia Standards, Class II medical device requirements

  • SNI ISO 13485:2003 Medical devices - Quality management sistems - Requrements for regulatory purposes dan ISO 13485: 2003/Cor.1: 2009, TECHNICAL CORRIGENDUM 1

AT-ON, Class II medical device requirements

  • ONORM S 5225-1994 Radiation protection Containers, tables and safes for use in nuclear medicine - Requirements and Classification - Marking of conformity
  • ONORM S 5224-1997 Installations for nuclear medicine - Rules for construction and equipment

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