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Active Medical Device Aging

Active Medical Device Aging, Total:118 items.

In the international standard classification, Active Medical Device Aging involves: Medical equipment, Sterilization and disinfection, HEALTH CARE TECHNOLOGY, Dentistry, Occupational safety. Industrial hygiene, Radiation protection, Radiation measurements, Electromagnetic compatibility (EMC), Laboratory medicine, Microbiology.

Danish Standards Foundation, Active Medical Device Aging

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
DS/EN 45502-1:1998 Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer

Lithuanian Standards Office , Active Medical Device Aging

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 45502-1-2000 Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
LST EN 50527-1-2010 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices -- Part 1: General
LST EN ISO 18153:2004 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)

AENOR, Active Medical Device Aging

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
UNE-EN 50527-1:2011 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices -- Part 1: General
UNE-EN ISO 18153:2004 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)

Association Francaise de Normalisation, Active Medical Device Aging

NF EN 45502-2-1:2004 Dispositifs médicaux implantables actifs - Partie 2-1 : règles particulières pour les dispositifs médicaux implantables actifs destinés à traiter la bradyarythmie (stimulateurs cardiaques)
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 14708-2:2022 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 2 : Stimulateurs cardiaques
NF EN 50103:2003 Guide pour l'application des EN 29001 et EN 46001 et des EN 29002 et EN 46002 à l'industrie des dispositifs médicaux actifs (comprenant les dispositifs actifs 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)
NF EN ISO 14708-5:2022 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 5 : Dispositifs d'assistance circulatoire
NF EN ISO 14708-4:2022 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 4 : Systèmes de pompe à perfusion implantables
NF C99-130-1:2010 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1 : general.
NF EN 45502-1:2016 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 1 : exigences générales de sécurité, marquage et informations fournies par le fabricant
NF EN 45502-2-3:2010 Dispositifs médicaux implantables actifs - Partie 2-3 : exigences particulières pour les systèmes d'implant cochléaire et les systèmes d'implant auditif du tronc cérébral
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 ISO 15193:2009 Dispositifs médicaux de diagnostic in vitro - Mesurage des grandeurs dans des échantillons d'origine biologique - Exigences relatives au contenu et à la présentation des procédures de mesure de référence
NF EN ISO 15194:2009 Dispositifs médicaux de diagnostic in vitro - Mesurage des grandeurs dans les échantillons d'origine biologique - Exigences relatives aux matériaux de référence certifiés et au contenu de la documentation associée
NF EN ISO 18153:2004 Dispositifs médicaux de diagnostic in vitro - Mesurage des grandeurs dans des échantillons d'origine biologique - Traçabilité métrologique des valeurs de concentration catalytique des enzymes attribuées aux agents d'étalonnage et aux matériau...

American Society for Testing and Materials (ASTM), Active Medical Device Aging

ASTM F1980-99e1 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
ASTM F1980-07(2011) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

未注明发布机构, Active Medical Device Aging

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 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 ISO 15194:2009(2016) In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation

ES-UNE, Active Medical Device Aging

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 14708-2:2023 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)
UNE-EN ISO 14708-3:2023 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)
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 14708-4:2023 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.)

国家食品药品监督管理局, Active Medical Device Aging

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

RU-GOST R, Active Medical Device Aging

GOST R 57497-2017 Medical devices. Implantable active devices intended to circulatory support. Technical requirements for governmental purchases
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 14708-3-2016 Implants for surgery. Active Implantable medical devices. Part 3. Implantable neurostimulators
GOST R ISO 14708-4-2016 Implants for surgery. Active implantable medical devices. Part 4. Implantable infusion pumps
GOST R 59745-2021 Active implantable medical devices. Axial pumps for auxiliary blood circulation. General technical requirements
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

British Standards Institution (BSI), Active Medical Device Aging

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 14708-5:2022 Implants for surgery. Active implantable medical devices - Circulatory support devices
BS EN 45502-2-3:2010 Active implantable medical devices - Particular requirements for cochlear and auditory brainstem implant systems
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)
PD ISO/TS 10974:2018 Tracked Changes. Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
BS EN 50527-1:2010 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - General
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
BS EN ISO 14708-7:2022 Implants for surgery. Active implantable medical devices - Particular requirements for cochlear and auditory brainstem implant systems
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 50527-2-1:2011 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices. Specific assessment for workers with cardiac pacemakers

国家药监局, Active Medical Device Aging

YY/T 0989.5-2022 Surgical implants Active implantable medical devices Part 5: Circulatory support devices
YY/T 0681.1-2018 Sterile Medical Device Packaging Test Methods Part 1: Guidelines for Accelerated Aging Tests
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 1874-2023 Electromagnetic compatibility of active implantable medical devices Electromagnetic compatibility test rules for implantable pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices

International Organization for Standardization (ISO), Active Medical Device Aging

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 14708-2:2019 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
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
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 14708-7:2019 Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear and auditory brainstem implant systems

IX-EU/EC, Active Medical Device Aging

MEDDEV 2.1/1-1994 GUIDELINES RELATING TO THE APPLICATION OF: THE COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES
TEST/90/385-1996 List of Bodies Notified under Directive 90/385/EEC Active Implantable Medical Devices
MEDDEV 2.2/3-1998 GUIDELINES RELATING TO THE APPLICATION OF: THE COUNCIL DIRECTIVE 90/385 EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES "USE-BY DATE" (Rev. 3)
MEDDEV 2.1/3-2009 GUIDELINES RELATING TO THE APPLICATION OF: THE COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES (Rev 3)
90/385/EEC-1990 COUNCIL DIRECTIVE on the approximation of the laws of the Member States relating to active implantable medical devices
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
95/C 307/09-1995 Commission Communication in the Framework of the Implementation of Council Directive 90/ 385/EEC of 20 June 1990 Concerning Active Implantable Medical Devices and Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices
97/C 149/04-1997 Commission Communication in the Framework of the Implementation of Council Directive 90/385/EEC of 20 June 1990 in Relation to Active Implantable Medical Devices and Council Directive 93/42/EEC of 14 June 1993 in Relation to Medical Devices

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 Medical Device Aging

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

Korean Agency for Technology and Standards (KATS), Active Medical Device Aging

KS P ISO 14708-2:2020 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
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 14708-4-2010(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 14708-1:2018 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 18153-2010(2016) In vitro diagnostic medical devices－Measurement of quantities in biological samples－Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control mater
KS P ISO 18153-2010(2021) In vitro diagnostic medical devices－Measurement of quantities in biological samples－Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control mater

KR-KS, Active Medical Device Aging

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

US-AAMI, Active Medical Device Aging

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

European Committee for Standardization (CEN), Active Medical Device Aging

prEN 50103-1992 Guidance on the application of ISO 9001/EN 46001 and ISO 9002/EN 46002 for the active (including active implantable) medical device industry
EN ISO 14160:1998 Sterilization of Single-Use Medical Devices Incorporating Materials of Animal Origin - Validation and Routine Control of Sterilization by Liquid Chemical Sterilants ISO 14160: 1998

Professional Standard - Medicine, Active Medical Device Aging

YY/T 0681.1-2009 Test methods for sterile medical device package.Part 1:Test guide for accelerated aging
YY 0989.3-2023 Surgical Implants Active Implantable Medical Devices Part 3: Implantable Neurostimulators
YY/T 0638-2008 In vitro diagnostic medical devices.Measurement of quantities in biological samples.Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials

International Electrotechnical Commission (IEC), Active Medical Device Aging

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

EU/EC - European Union/Commission Legislative Documents, Active Medical Device Aging

90/385/EEC CORR-2009 COUNCIL DIRECTIVE on the approximation of the laws of the Member States relating to active implantable medical devices
MEDDEV 2.1/3-1998 GUIDELINES RELATING TO THE DEMARCATION BETWEEN - DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES - DIRECTIVE 93/42/EEC ON MEDICAL DEVICES AND -DIRECTIVE 65/65/EEC RELATING TO MEDICINAL PRODUCTS AND RELATED DIRECTIVES (Rev 5.1)

American National Standards Institute （ANSI), Active Medical Device Aging

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

CENELEC - European Committee for Electrotechnical Standardization, Active Medical Device Aging

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

Standard Association of Australia （SAA）, Active Medical Device Aging

AS EN 45502.1:2002(R2014)
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

European Committee for Electrotechnical Standardization（CENELEC）, Active Medical Device Aging

EN 50527-1:2010 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General
EN 50527-1:2016 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General

国家市场监督管理总局、中国国家标准化管理委员会, Active Medical Device Aging

GB/T 19703-2020 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for certified reference materials and the content of supporting documentation

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

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

German Institute for Standardization, Active Medical Device Aging

DIN EN 50527-1:2011 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General; German version EN 50527-1:2010
DIN EN ISO 18153:2003-11 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003); German version EN ISO 181...
DIN EN ISO 18153:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)