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implantable cardiac defibrillator

implantable cardiac defibrillator, Total:61 items.

In the international standard classification, implantable cardiac defibrillator involves: Medical equipment, Electromagnetic compatibility (EMC), Aircraft and space vehicles in general, Character sets and information coding, Applications of information technology.


Professional Standard - Medicine, implantable cardiac defibrillator

  • YY/T 0946-2014 Cardiac defibrillators.Connector assembly DF-1 for implantable defibrillators.Dimensions and test requirements
  • YY/T 0491-2004 Cardiac pacemakers-Low-profile connectors(IS-1) for implantable pacemakers

International Organization for Standardization (ISO), implantable cardiac defibrillator

  • ISO 11318:2002 Cardiac defibrillators - Connector assembly DF-1 for implantable defibrillators - Dimensional and test requirements
  • ISO 11318:1993 Cardiac defibrillators; connector assembly for implantable defibrillators; dimensional and test requirements
  • ISO 11318:1993/Amd 1:1996 Cardiac defibrillators - Connector assembly for implantable defibrillators - Dimensional and test requirements; Amendment 1
  • ISO 14117:2019 Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization device
  • ISO 14117:2012 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
  • ISO 14708-2:2019 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
  • 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/IEC TR 20017:2011 Information technology - Radio frequency identification for item management - Electromagnetic interference impact of ISO/IEC 18000 interrogator emitters on implantable pacemakers and implantable cardioverter defibrillators
  • ISO 14708-6:2010 Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)

KR-KS, implantable cardiac defibrillator

  • KS P ISO 11318-2012(2022) Cardiac defibrillators-Connector assembly DF-1 for implantable defibrillators-Dimensions and test requirements
  • KS P ISO 14708-2-2020 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
  • KS P ISO 5841-3-2018 Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors(IS-1) for implantable pacemakers

Korean Agency for Technology and Standards (KATS), implantable cardiac defibrillator

  • KS P ISO 11318-2012(2017) Cardiac defibrillators-Connector assembly DF-1 for implantable defibrillators-Dimensions and test requirements
  • KS P ISO 11318:2012 Cardiac defibrillators-Connector assembly DF-1 for implantable defibrillators-Dimensions and test requirements
  • KS P ISO 14708-2:2020 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
  • KS P ISO 5841-3:2018 Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors(IS-1) for implantable pacemakers
  • KS P ISO 15674:2009 Cardiovascular implants and artificial organs-Hard-shell cardiotomy/venous reservoir systems(with/without filter) and soft venous reservoir bags

British Standards Institution (BSI), implantable cardiac defibrillator

  • BS ISO 11318:2002 Cardiac defibrillators - Connector assembly DF-1 for implantable defibrillators - Dimensions and test requirements
  • BS ISO 14117:2019 Tracked Changes. Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
  • BS ISO 14117:2013 Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization 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)
  • BS EN ISO 14708-2:2022 Implants for surgery. Active implantable medical devices - Cardiac pacemakers
  • 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 EN 50077:1993 Specification for low profile connectors (IS-1) for implantable pacemakers

国家药监局, implantable cardiac defibrillator

  • YY/T 1874-2023 Electromagnetic compatibility of active implantable medical devices Electromagnetic compatibility test rules for implantable pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices

German Institute for Standardization, implantable cardiac defibrillator

US-AAMI, implantable cardiac defibrillator

  • AAMI TIR41-2011 Active implantable medical devices.Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators
  • ANSI/AAMI PC69-2007 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, implantable cardiac defibrillator

Military Standards (MIL-STD), implantable cardiac defibrillator

国家食品药品监督管理局, implantable cardiac defibrillator

  • YY/T 0492-2017 Implantable pacemaker leads
  • 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

RU-GOST R, implantable cardiac defibrillator

  • GOST R ISO 11318-2010 Connector assembly DF-1 for implantable defibrillators. Technical requirements and test methods
  • 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 57492-2017 Medical devices. Implantable cardiac pacemakers. Technical requirements for governmental purchases
  • GOST R 53919-2010 Implantable electrodes for pacemakers. Technical requirements end test methods
  • GOST R 51073-1997 Implantable cardiac pacemakers. General specifications and basic test methods

Association Francaise de Normalisation, implantable cardiac defibrillator

  • NF C74-346:1988 Safety of implantable cardiac pacemakers.
  • NF C74-347*NF EN 50077:1993 Low-profile connector implantable cardiac pacemakers.
  • 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 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)

Danish Standards Foundation, implantable cardiac defibrillator

  • DS/EN 50077+Corr.:1996 Low-profile connector for implantable cardiac pacemakers
  • DS/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)
  • DS/ISO/IEC TR 20017:2012 Information technology - Radio frequency identification for item management - Electromagnetic interference impact of ISO/IEC 18000 interrogator emitters on implantable pacemakers and implantable cardioverter defibrillfators

Lithuanian Standards Office , implantable cardiac defibrillator

  • LST EN 50077+AC-2001 Low-profile connector for implantable cardiac pacemakers
  • LST 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)
  • LST EN 45502-2-2-2008/AC-2009 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)

AENOR, implantable cardiac defibrillator

  • UNE-EN 50077:1996 LOW-PROFILE CONNECTOR FOR IMPLANTABLE CARDIAC PACEMAKERS.
  • 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)

ES-UNE, implantable cardiac defibrillator

  • 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 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 14708-2:2023 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)

未注明发布机构, implantable cardiac defibrillator

  • 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)

中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会, implantable cardiac defibrillator

  • GB 16174.2-2015 Implants for surgery—Active implantable medical devices—Part 2: Cardiac pacemakers

European Committee for Electrotechnical Standardization(CENELEC), implantable cardiac defibrillator

  • EN 50061:1988 Safety of Implantable Cardiac Pacemakers [: CENELEC EN 45502-2-2]

SE-SIS, implantable cardiac defibrillator

Canadian Standards Association (CSA), implantable cardiac defibrillator

  • CAN/CSA-ISO/IEC TR 20017:2014 Information technology - Radio frequency identification for item management - Electromagnetic interference impact of ISO/IEC 18000 interrogator emitters on implantable pacemakers and implantable cardioverter defibrillators

European Committee for Standardization (CEN), implantable cardiac defibrillator

  • EN ISO 14708-6:2022 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)




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