implanted defibrillator

implanted defibrillator, Total:71 items.

The international standard classification for "implanted defibrillator" includes: Implants for surgery, prosthetics and orthotics .

The Chinese standard classification for "implanted defibrillator" includes: General and microsurgical devices , Orthopedic devices , Radio Measurement .

Professional Standard - Medicine

YY/T 1874-2023 Active implantable medical devices―Electromagnetic compatibility―EMC test protocols for implantable cardiac pacemakers,implantable cardioverter defibrillators and cardiac resynchronization devices
YY/T 0946-2014 Cardiac defibrillators―Connector assembly DF-1 for implantable defibrillators―Dimensions and test requirements

国家食品药品监督管理局

YY 0989.6-2016 Implants for surgery―Active implantable medical devices―Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia(including implantable defibrillators)

未注明发布机构

ANSI/AAMI/ISO 14117:2019 Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices

National Metrological Technical Specifications of the People's Republic of China

JJF 1149-2006 Calibration Specification for Cardiac Defibrillators & Cardiac Defibrillators-monitors

RU-GOST R

GOST R ISO 11318-2010 Connector assembly DF-1 for implantable defibrillators. Technical requirements and test methods
GOST R 50267.4-1992 Medical electrical equipment. Part 2. Particular requirements for the safety of defibrillators and defibrillators-monitors
GOST R 57506-2017 Medical devices. Implantable defibrillators and other active implantable medical devices intended to treat tachyarrhythmia. Technical requirements for governmental purchases

SCC

DANSK DS/ISO 11318:2014 Cardiac defibrillators - Connector assembly DF-1 for implantable defibrillators - Dimensions and test requirements
BS 7778:1994 Specification for connector assembly DF-1 for implantable cardiac defibrillators
DANSK DS/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)
CEI UNI 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)
AENOR 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)
AENOR UNE-EN 45502-2-2 CORR:2008 Active implantable medical devices — Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
NS-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)
CEI UNI EN 45502-2-2:2019 Active implantable medical devices Part 2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
NS-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)
DIN 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); German version EN ISO 14708-...
AAMI/ISO 14117:2012 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices
08/30191609 DC BS 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)
DANSK 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)
BS ISO 14117:2012 Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
DIN EN ISO 14708-6 E:2018 Draft Document - Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators); German and English version prE...
DANSK DS/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)
AAMI 14117:2019 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
CEI UNI EN 45502-2-2/AB:2019 Active implantable medical devices Part 2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
AAMI PC69:2007 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators (Includes Errata)
CAN/CSA-CEI/IEC 1288-1-1998(C2012) Cardiac defibrillators - Cardiac defibrillator monitors - Part 1: Operation
CAN/CSA-CEI/IEC 1288-2-1998(R2012) Cardiac defibrillators - Cardiac defibrillators-monitors - Part 2: Maintenance
CAN/CSA-CEI/IEC 1288-2-1998(C2012) Cardiac defibrillators - Cardiac defibrillator monitors - Part 2: Maintenance
CAN/CSA-CEI/IEC 1288-1-1998(R2012) Cardiac defibrillators - Cardiac defibrillators-monitors - Part 1: Operation
DANSK DS/ISO 14117:2019 Active implantable medical devices – Electromagnetic compatibility – EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices

GSO

BH GSO ISO 11318:2017 Cardiac defibrillators -- Connector assembly DF-1 for implantable defibrillators -- Dimensions and test requirements
GSO ISO 14117:2015 Active implantable medical devices -- Electromagnetic compatibility -- EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
GSO ISO 11318:2015 Cardiac defibrillators -- Connector assembly DF-1 for implantable defibrillators -- Dimensions and test requirements
GSO ISO 14708-6:2024 Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
BH GSO ISO 14708-6:2017 Implants for surgery -- Active implantable medical devices -- Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
OS GSO ISO 14708-6:2015 Implants for surgery -- Active implantable medical devices -- Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
BH GSO ISO 14117:2017 Active implantable medical devices -- Electromagnetic compatibility -- EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
GSO ISO 14708-6:2015 Implants for surgery -- Active implantable medical devices -- Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
GSO ISO 14117:2024 Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices

KR-KS

KS P ISO 11318-2012(2022) Cardiac defibrillators－Connector assembly DF-1 for implantable defibrillators－Dimensions and test requirements

International Organization for Standardization (ISO)

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 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 14117:2019 Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization device
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)

Korean Agency for Technology and Standards (KATS)

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

US-AAMI

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

British Standards Institution (BSI)

BS ISO 11318:2002 Cardiac defibrillators - Connector assembly DF-1 for implantable defibrillators - Dimensions and test requirements
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 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)
BS ISO 14117:2019 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
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)

VDE - VDE Verlag GmbH@ Berlin@ Germany

VDE-AR-E 2750-10-2010 Rules for the technically optimized application of implantable cardia pacemakers@ defibrillators and CRT devices

ES-UNE

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)

International Electrotechnical Commission (IEC)

IEC TR3 61288-2:1993 Cardiac defibrillators; cardiac defibrillators-monitors; part 2: maintenance
IEC TR3 61288-1:1993 Cardiac defibrillators; cardiac defibrillators-monitors; part 1: operation

German Institute for Standardization

DIN VDE 0753-3:1983 Rules of application for cardiac defibrillators [VDE Guide]

Japanese Industrial Standards Committee (JISC)

JIS T 1355:1987 Cardiac defibrillators and cardiac defibrillator-monitors

AENOR

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)

IEC - International Electrotechnical Commission

IEC TR 61288-2:1993 Défibrillateurs cardiaques - Moniteurs-défibrillateurs cardiaques - Partie 2: Maintenance (Edition 1.0)

Association Francaise de Normalisation

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 Surgical implants - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices designed to treat tachyarrhythmia (including implantable defibrillators)

Canadian Standards Association (CSA)

CAN/CSA-CEI/IEC-1288-1:1998 Cardiac Defibrillators - Cardiac Defibrillators-Monitors - Part 1: Operation (First Edition)

European Committee for Standardization (CEN)

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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