Cardiac Medical Devices

Cardiac Medical Devices, Total:134 items.

The international standard classification for "Cardiac Medical Devices" includes: Implants for surgery, prosthetics and orthotics , Medical equipment in general , Therapy equipment , Medical Sciences and health care facilities in general , Medical equipment .

The Chinese standard classification for "Cardiac Medical Devices" includes: Orthopedic devices , Medical apparatus and devices in general , Extracorporeal circulation, artificial organ and prosthesis device , Physiotherapy and TCM instrument and equipment , Medical science .

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

GB/T 42062-2022 Medical devices—Application of risk management to medical devices
GB/T 12279.2-2024 Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes
GB 16174.2-2024 Implants for surgery—Active implantable medical devices—Part 2: Cardiac pacemakers

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

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

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 0316-2003 Medical devices -- Application of risk management to medical devices
YY/T 0316-2008 Medical devices - Application of risk management to medical devices
YY/T 0860-2011 Radio frequency ablation instrument for cardiac application
YY 0860-2011 Radio frequency ablation instrument for cardiac application
YY/T 0860-2024 Cardiac radiofrequency ablation equipment
YY/T 0316-2016 Medical devices-Application of risk management to medical devices

卫生健康委员会

WS/T 603-2018 Safety Management for cardiac defibrillator
WS/T 654-2019 Safety management for medical devices

Group Standards of the People's Republic of China

T/CACM 1167-2016 Guideline for Clinical Diagnosis and Treatment of TCM Diabetes mellitus complicated with heart disease

国家食品药品监督管理局

YY/T 1474-2016 Medical devices－Application of risk management to medical devices

RU-GOST R

GOST R 57492-2017 Medical devices. Implantable cardiac pacemakers. Technical requirements for governmental purchases
GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices

Association Francaise de Normalisation

NF S90-480:1987 MEDICO-SURGICAL EQUIPMENT. IMPLANTS FOR SURGERY. CARDIOVASCULAR IMPLANTS. CARDIAC VALVE PROSTHESES.
NF S97-518-10103*NF EN ISO 11073-10103:2014 Health informatics - Point-of-care medical device communication - Part 10103 : nomenclature - Implantable device, cardiac
NF C74-340:2006 Medical electrical equipment - Part 2-4 : particular requirements for the safety of cardiac defibrillators.
NF S90-481:1987 MEDICO-SURGICAL EQUIPMENT. IMPLANTS FOR SURGERY. CARDIAC PACEMAKERS. PART 2 : REPORTING OF THE CLINICAL PERFORMANCE OF POPULATIONS OF PULSE GENERATORS.
NF S99-211:2013 Medical devices - Application of risk management to medical devices
NF EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
NF S99-211/A11*NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices

Lithuanian Standards Office

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)

Danish Standards Foundation

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 14971:2013 Medical devices - Application of risk management to medical devices

SCC

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)
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)
AENOR 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)
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 14708-2:2022 Implants for surgery – Active implantable medical devices – Part 2: Cardiac pacemakers
CEI UNI EN ISO 14708-2:2023 Implants for surgery - Active implantable medical devices Part 2: Cardiac pacemakers
DIN EN ISO 14708-2:2022 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019); German version EN ISO 14708-2:2022
DIN 58289:2017 Medical instruments - Abdominal and liver retractor type Mikulicz, blade curred
DANSK DS/EN ISO 14708-2:2022 Implants for surgery – Active implantable medical devices – Part 2: Cardiac pacemakers (ISO 14708-2:2019)
NS-EN ISO 14708-2:2022 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)
BS ISO 14117:2012 Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
AAMI/ISO 14117:2012 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices
DIN 58289 E:2017 Draft Document - Medical instruments - Abdominal and liver retractor type Mikulicz, blade curred
CAN/CSA C22.2 No.60601-2-4-2004 Medical Electrical Equipment - Part 2-4: Particular Requirements for the Safety of Cardiac Defibrillators
CAN/CSA C22.2 No.60601-2-4-2012(R2021) Medical Electrical Equipment - Part 2-4: Particular Requirements for the Safety of Cardiac Defibrillators
CAN/CSA-C22.2 No.60601-2-4-2004(R2009) Medical Electrical Equipment - Part 2-4: Particular Requirements for the Safety of Cardiac Defibrillators
CAN/CSA-C22.2 No.60601-2-4-2004(C2009) Electrical medical devices - Part 2-4: Special safety rules for cardiac defibrillators
BS 6902-1:1990 Cardiac pacemakers-Specification for implantable cardiac pacemakers
AAMI 14117:2019 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
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
CAN/CSA-ISO 14971:2007(C2012) Medical devices - Application of risk management to medical devices
CEI UNI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
AAMI/ISO 14971:2019 Medical devices - Application of risk management to medical devices
CAN/CSA-ISO 14971:2001(R2006) Medical Devices - Application of Risk Management to Medical Devices
DANSK DS/ISO 14971:2020 Medical devices – Application of risk management to medical devices
DANSK DS/EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
CAN/CSA-ISO 14971:2007(R2012) Medical Devices - Application of Risk Management to Medical Devices
ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices
BS 5724-2.4:1985 Medical electrical equipment. Particular requirements for safety-Specification for cardiac defibrillators and cardiac defibrillator-monitors
CAN/CSA-ISO 14971:2001(C2006) Medical devices - Application of risk management to medical devices
BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices

Spanish Association for Standardization (UNE)

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 14708-2:2023 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)
UNE-EN ISO 14971:2020/A11:2022 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)

SE-SIS

SIS SS IEC 601-2-4:1986 Medical electrical equipment -Particular requirements for the safety of cardiac defibrillators and cardiac defibrillator-monitors
SIS SS IEC 601-2-5:1986 Medical electrical equipment - Particular requirements for the safety of cardiac defibrillators and cardiac defibrillator-monitors

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 14117:2012 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
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
ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management to medical devices

GSO

GSO ISO 14708-2:2024 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
BH GSO ISO 14708-2:2017 Implants for surgery -- Active implantable medical devices -- Part 2: Cardiac pacemakers
GSO ISO 14117:2024 Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
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 14971:2015 Medical devices -- Application of risk management to medical devices
BH GSO ISO 14971:2017 Medical devices -- Application of risk management to medical devices
OS GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices

KR-KS

KS P ISO 14708-2-2020 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
KS X ISO/IEEE 11073-10103-2016 Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac
KS P ISO 14971-2018 Medical devices — Application of risk management to medical devices
KS P ISO 14971-2021 Medical devices — Application of risk management to medical devices

Korean Agency for Technology and Standards (KATS)

KS P ISO 14708-2:2020 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
KS P ISO 14708-2:2014 Implants for surgery－Active implantable medical devices－Part 2：Cardiac pacemakers
KS P ISO 14708-2:2008 Implants for surgery-Active implantable medical devices-Part 2:Cardiac pacemakers
KS P ISO 14971:2021 Medical devices — Application of risk management to medical devices
KS P ISO 14971:2018 Medical devices — Application of risk management to medical devices

International Organization for Standardization (ISO)

ISO 14708-2:2019 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
ISO 14117:2019 Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization device
ISO/IEEE 11073-10103:2014 Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac
ISO 14708-2:2005 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
ISO 14708-2:2012 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
ISO 14117:2012 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
ISO 14971:2019 Medical devices — Application of risk management to medical devices
ISO 14971:2000 Medical devices - Application of risk management to medical devices

CN-CNCA

CNCA 08C-036-2001 Implementation Rules for Compulsory Certification of Medical Device Products Implantable Cardiac Pacemakers

British Standards Institution (BSI)

BS EN ISO 11073-10103:2013 Health informatics. Point-of-care medical device communication. Nomenclature. Implantable device, cardiac
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 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 14117:2019 Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
BS EN 45502-2-1:2004 Active implantable medical devices - Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
BS EN ISO 14708-2:2022 Implants for surgery. Active implantable medical devices - Cardiac pacemakers
BS EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices
BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices
BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to medical devices
BS EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
BS EN ISO 14971:2019+A11:2021 Medical devices - Application of risk management to medical devices
BS EN 60601-2-4:2003 Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety of cardiac defibrillators

German Institute for Standardization

DIN 58289:2010 Medical instruments - Abdominal and liver retractor type Mikulicz, blade curred
DIN 58289 E:2017-03 Medical instruments - Abdominal and liver retractor type Mikulicz, blade curred
DIN 58289:2017-08 Medical instruments - Abdominal and liver retractor type Mikulicz, blade curred
DIN EN ISO 11073-10103 E:2013-07 Health Informatics Point-of-care Testing Medical Device Communication Part 10103: Naming Cardiac Implantable Devices (Draft)
DIN 57753-2:1983 Rules relating to intracardiac applications of medical electrical equipment [VDE Guide]
DIN VDE 0753-2:1983 Rules relating to intracardiac applications of medical electrical equipment VDE Guide
DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices
DIN 58846:2017-11 Medical instruments - Raspatories
DIN 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); German version EN 45502-2-1:2003
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices

Indonesia Standards

SNI 04-6191.2.4-1999 Medical electrical equipment. Part 2.4: Particular requirements for the safety of cardiac defibrillators and cardiac defibrillator - Monitors

VDE - VDE Verlag GmbH@ Berlin@ Germany

VDE 0750-20-2-2018 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO/DIS 14708-2:2018); German and English version prEN ISO 14708-2:2018

International Electrotechnical Commission (IEC)

IEC 60601-2-4:1983 Medical electrical equipment. Part 2: Particular requirements for the safety of cardiac defibrillators and cardiac defibrillator-monitors
IEC 62366:2014 Medical devices - Application of usability engineering to medical devices

European Committee for Standardization (CEN)

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)
EN ISO 14708-2:2022 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

Japanese Industrial Standards Committee (JISC)

JIS T 14971:2003 Medical devices -- Application of risk management to medical devices
JIS T 14971:2012 Medical devices -- Application of risk management to medical devices

CEN - European Committee for Standardization

EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
EN ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
EN ISO 14971:2019 Medical devices - Application of risk management to medical devices

South African Bureau of Standard

SANS 14971:2008 Medical devices - Application of risk management to medical devices

TH-TISI

TIS 14971-2013 Medical devices.application of risk management to medical devices

Standard Association of Australia （SAA）

AS ISO 14971:2020 Medical devices — Application of risk management to medical devices