Active Implantable Medical Devices

Active Implantable Medical Devices, Total:124 items.

In the international standard classification, Active Implantable Medical Devices involves: Medical equipment, HEALTH CARE TECHNOLOGY, Dentistry, Construction materials, Occupational safety. Industrial hygiene, Radiation protection.

国家食品药品监督管理局, Active Implantable Medical Devices

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
YY/T 1486-2016 Surgical Implants Active Implantable Medical Devices Part 3: Implantable Neurostimulators
YY 0989.7-2017 Surgical implants Active implantable medical devices Part 7: Specific requirements for cochlear implant systems

IX-EU/EC, Active Implantable Medical Devices

TEST/90/385-1996 List of Bodies Notified under Directive 90/385/EEC Active Implantable Medical Devices
90/385/EEC-1990 COUNCIL DIRECTIVE on the approximation of the laws of the Member States relating to active implantable medical devices

International Organization for Standardization (ISO), Active Implantable Medical Devices

ISO 14708-7:2019 Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear and auditory brainstem implant systems
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/CD 10974 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
ISO/TS 10974:2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
ISO/CD 27186 Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements

RU-GOST R, Active Implantable Medical Devices

GOST R ISO 14708-4-2016 Implants for surgery. Active implantable medical devices. Part 4. Implantable infusion pumps
GOST R ISO 14708-3-2016 Implants for surgery. Active Implantable medical devices. Part 3. Implantable neurostimulators
GOST R ISO 14708-7-2016 Implants for surgery. Active Implantable medical devices. Part 7. Particular requirements for cochlear implant systems
GOST R ISO 14708-1-2012 Implants for surgery. Active implantable medical devices. Part 1. General requirements for safety, marking and information to be provided by the manufacturer
GOST R 59745-2021 Active implantable medical devices. Axial pumps for auxiliary blood circulation. General technical requirements

American National Standards Institute （ANSI), Active Implantable Medical Devices

ANSI/AAMI/ISO 14708-3:2008 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
ANSI/AAMI/ISO 27186:2010 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements

Association Francaise de Normalisation, Active Implantable Medical Devices

NF EN ISO 14708-2:2022 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 2 : Stimulateurs cardiaques
NF EN 45502-2-1:2004 Active implantable medical devices - Part 2-1: special rules for active implantable medical devices intended to treat bradyarrhythmia (pacemakers)
NF EN ISO 14708-5:2022 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 5 : Dispositifs d'assistance circulatoire
NF EN ISO 14708-4:2022 Surgical implants - Active implantable medical devices - Part 4: Implantable infusion pump systems
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)
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 14708-7:2022 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 7 : Exigences particulières pour les systèmes d'implant cochléaire et d'implant auditif du tronc cérébral
NF EN 45502-1:2016 Surgical implants - Active implantable medical devices - Part 1: general safety requirements, marking and information provided by the manufacturer

GSO, Active Implantable Medical Devices

GSO ISO 14708-2:2015 Implants for surgery -- Active implantable medical devices -- Part 2: Cardiac pacemakers
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 14708-2:2017 Implants for surgery -- Active implantable medical devices -- Part 2: Cardiac pacemakers
GSO ISO 14708-4:2015 Implants for surgery -- Active implantable medical devices -- Part 4: Implantable infusion pumps
OS GSO ISO 14708-4:2015 Implants for surgery -- Active implantable medical devices -- Part 4: Implantable infusion pumps
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 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 14708-5:2015 Implants for surgery -- Active implantable medical devices -- Part 5: Circulatory support devices
GSO ISO 14708-5:2015 Implants for surgery -- Active implantable medical devices -- Part 5: Circulatory support devices
BH GSO ISO 14708-5:2017 Implants for surgery -- Active implantable medical devices -- Part 5: Circulatory support devices
OS GSO ISO 14708-3:2015 Implants for surgery -- Active implantable medical devices -- Part 3: Implantable neurostimulators
GSO ISO 14708-7:2021 Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear implant systems
BH GSO ISO 14708-7:2022 Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear implant systems
GSO ISO/TS 10974:2016 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
OS GSO ISO/TS 10974:2016 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
GSO EN 45502-1:2023 Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
BH GSO ISO 14708-1:2017 Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
BH GSO EN 45502-1:2023 Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

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, Active Implantable Medical Devices

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

Korean Agency for Technology and Standards (KATS), Active Implantable Medical Devices

KS P ISO 14708-2:2020 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
KS P ISO 14708-4-2010(2016) Implants for surgery－Active implantable medical devices－Part 4：Implantable infusion pumps
KS P ISO 14708-5-2012(2017) Implants for surgery－Active implantable medical devices－Part 5：Circulatory support devices
KS P ISO 14708-3-2010(2016) Implants for surgery－Active implantable medical devices－Part 3：Implantable neurostimulators
KS P ISO 14708-3:2021 Implants for surgery — Active implantable medical devices —Part 3: Implantable neurostimulators
KS P ISO 14708-1:2018 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
KS P ISO 14708-1-2023 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

KR-KS, Active Implantable Medical Devices

KS P ISO 14708-2-2020 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
KS P ISO 14708-3-2021 Implants for surgery — Active implantable medical devices —Part 3: Implantable neurostimulators
KS P ISO 14708-1-2018 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
KS P ISO 14708-1-2018(2023) Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

ES-UNE, Active Implantable Medical Devices

UNE-EN ISO 14708-2:2023 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)
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 14708-5:2023 Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO 14708-5:2020)
UNE-EN ISO 14708-3:2023 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)
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 14708-4:2023 Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022)
UNE-EN ISO 14708-7:2023 Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems (ISO 14708-7:2019)
UNE-EN 45502-1:2015 Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer (Endorsed by AENOR in July of 2015.)

SCC, Active Implantable Medical Devices

CEI EN 45502-2-1:2005 Active implantable medical devices - Part 2: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
DANSK DS/ISO 14708-4:2015 Implants for surgery – Active implantable medical devices – Part 4: Implantable infusion pumps
NS-EN 45502-2-1:2003 Active implantable medical devices — Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
DANSK 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)
AAMI/ISO 14708-3:2017 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
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...
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)
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)
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)
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)
DIN ISO 14708-4 E:2007 Draft Document - Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps (ISO/DIS 14708-4:2007)
BS PD ISO/TS 10974:2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
DANSK DS/ISO/TS 10974:2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
AAMI/ISO TIR10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
BS PD ISO/TS 10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
DIN EN ISO 14708-5 E:2019 Draft Document - Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO/DIS 14708-5:2019); German and English version prEN ISO 14708-5:2019
DIN EN ISO 14708-3 E:2015 Draft Document - Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO/DIS 14708-3:2015); German version prEN ISO 14708-3:2015
DIN ISO 14708-3 E:2007 Draft Document - Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO/DIS 14708-3:2007)
CEI EN 50103:1996 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry
BS EN 50103:1996 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry
DANSK DS/ISO 14708-1:2015 Implants for surgery - Active implantable medical devices - General requirements for safety, marking and for information to be provided by the manufacturer
UNE-EN 50103:1997 GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR THE ACTIVE (INCLUDING ACTIVE IMPLANTABLE) MEDICAL DEVICE INDUSTRY.
AAMI/ISO 14708-1:2014 Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
DIN EN ISO 14708-7 E:2018 Draft Document - Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear implant systems (ISO/DIS 14708-7:2018); German and English version prEN ISO 14708-7:2018
NS-EN 45502-1:2015 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
DANSK DS/EN 45502-1:2015 Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
CEI UNI EN 45502-1:2018 Implants for surgery - Active implantable medical devices Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
DIN ISO 14708-5 E:2007 Draft Document - Implants for surgery - Active implantable medical devices - Part 5: Particular requirements for circulatory support systems (ISO/CDV2 14708-5:2006)
CEI UNI EN 45502-2-3:2010 Active implantable medical devices Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
DANSK DS/EN 45502-2-3:2010 Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
NS-EN 45502-2-3:2010 Active implantable medical devices — Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

British Standards Institution (BSI), Active Implantable Medical Devices

BS EN ISO 14708-5:2022 Implants for surgery. Active implantable medical devices - Circulatory support 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 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)
PD ISO/TS 10974:2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
BS EN 45502-2-3:2010 Active implantable medical devices - Particular requirements for cochlear and auditory brainstem implant systems
BS EN ISO 14708-7:2022 Implants for surgery. Active implantable medical devices - Particular requirements for cochlear and auditory brainstem implant systems
BS EN 50103:1996(2000) Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry
BS EN 50527-1:2010 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - General

国家药监局, Active Implantable Medical Devices

YY/T 0989.5-2022 Surgical implants Active implantable medical devices Part 5: Circulatory support devices

未注明发布机构, Active Implantable Medical Devices

ANSI/AAMI/ISO 14708-4:2008(2011) Implants for surgery—Active implantable medical devices—Part 4: Implantable infusion pumps
ANSI/AAMI/ISO 14708-5:2010(2015) Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices
ANSI/AAMI/ISO 14708-3:2017 Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators

Danish Standards Foundation, Active Implantable Medical Devices

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/ISO 27186:2021 Active implantable medical devices – Four-pole connector system for implantable cardiac rhythm management devices – Dimensional and test requirements

Lithuanian Standards Office , Active Implantable 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)

AENOR, Active Implantable Medical Devices

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 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 209001:2002 IN Guide for the management and the maintenance of active non implantable medical devices.
UNE-EN 45502-2-3:2010 Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

Professional Standard - Medicine, Active Implantable Medical Devices

YY 0989.3-2023 Surgical Implants Active Implantable Medical Devices Part 3: Implantable Neurostimulators

US-AAMI, Active Implantable Medical Devices

ANSI/AAMI/ISO TIR10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device

International Electrotechnical Commission (IEC), Active Implantable Medical Devices

ISO TS 10974:2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
ISO/TS 10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device

CENELEC - European Committee for Electrotechnical Standardization, Active Implantable Medical Devices

EN 50103:1995 Guidance on the Application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the Active (Including Active Implantable) Medical Device Industry

EU/EC - European Union/Commission Legislative Documents, Active Implantable Medical Devices

90/385/EEC CORR-2009 COUNCIL DIRECTIVE on the approximation of the laws of the Member States relating to active implantable medical devices

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Active Implantable Medical Devices

GB 16174.1-2015 Implants for surgery.Active implantable medical devices.Part 1:General requirements for safety,marking and for information to be provided by the manufacturer

Standard Association of Australia （SAA）, Active Implantable Medical Devices

AS ISO 14708.1:2015 Implants for surgery — Active implantable medical devices, Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
AS EN 45502.1:2002(R2014) General requirements for safety, labeling and information provided by manufacturers of active implantable medical devices