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Core medical

Core medical, Total:330 items.

In the international standard classification, Core medical involves: Medical equipment, Medical sciences and health care facilities in general, Vocabularies, Applications of information technology, Pharmaceutics, Electrical accessories, Finances. Banking. Monetary systems. Insurance, Information sciences. Publishing, Radiation protection, Services, Lamps and related equipment, Networking, Hospital equipment, Radiation measurements, Sterilization and disinfection, Laboratory medicine, Electromagnetic compatibility (EMC), Law. Administration, Microbiology, Dentistry, Quality.

未注明发布机构, Core medical

DIN EN ISO 21549-3:2004 Medical informatics – patient data on cards in healthcare – Part 3: Clinical data – core data set
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)

Korean Agency for Technology and Standards (KATS), Core medical

KS P 3106-2006(2016) Centrifuge for medical use
KS C 2623-1981(2011) Hospital Grade Earth Centerbody and Terminals
KS C IEC 61948-1:2007 Nuclear medicine instrumentation－Routine tests－Part 1：Radiation counting systems
KS C IEC 60598-2-25:2015 Luminaires — Part 2-25: Particular requirements — Luminaires for use in clinical areas of hospitals and health care buildings
KS C IEC 60598-2-25:2003 Luminaires-Part 2-25:Particular requirements-Luminaires for use in clinical areas of hospitals and health care buildings
KS P ISO TR 37137:2019 Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
KS C IEC 61303:2018 Medical electrical equipment — Radionuclide calibrators — Particular methods for describing performance
KS P ISO 14708-2:2008 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 14708-2:2020 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
KS X ISO/IEEE 11073-10103-2016(2021) Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac
KS X 3201-2008 Health informatics-Personal health device communication-Interface protocol for 2-lead electrocardiogram signal
KS X ISO/IEEE 11073-10103:2016 Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac
KS C IEC 60601-2-25:2017 Medical electrical equipment — Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
KS C IEC 60601-2-4:2017 Medical electrical equipment — Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
KS C IEC 61948-2:2007 Nuclear medicine instrumentation－Routine tests－Part 2：Scintillation cameras and single photon emission computed tomography imaging

Group Standards of the People's Republic of China, Core medical

T/NAHIEM 56-2022 Construction Standards for Radiotherapy Centers of Medical Institutions
T/CACM 1325-2019 Diagnosis and treatment guidelines of traditional Chinese medicine for stable angina pectoris of coronary heart disease
T/CACM 1199-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM fibroadenoma of breast
T/CHATA 023-2022 Specifications for prevention and control of tuberculosis infection in designated tuberculosis medical institutions
T/CHATA 017-2022 Guidelines for tuberculosis health education in designated medical institutions
T/GDWJ 012-2022 Specification for construction of medical data center Part 2:Operational data reepository
T/GZBC 16.3-2020 Specification for construction of medical data center—Part 3:Scientific research data center
T/GZBC 16.1-2019 Pecification for construction of medical data center Part 1 Clinical data center
T/GDWJ 012.2-2022 Medical Data Center Construction Specification Part 2: Operational Data Center
T/CACM 1139-2018 Traditional Chinese medicine guidelines for the diagnosis and treatment of mental diseases- Dysthymia
T/NAHIEM 83-2023 Construction standards for proton and heavy ion centers in medical institutions
T/JCCIA 004-2022 Specification for debugging network equipment in data centers in the medical industry
T/CACM 1224-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Ischemic Cardiomyopathy
T/CACM 1273-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Acute myocardial infarction
T/CACM 1232-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Acute Myocardial Infarction with PCI
T/GDMDMA 0012.2-2021 Medical equipment standardized management in hospital - Part 2：Operation and management of allocation center
T/CHATA 006-2020 Quality evaluation on tuberculosis prevention and control in designated medical institutions
T/CHATA 018-2022 Guidelines for the Prevention and Control of Tuberculosis Infection in Primary Medical and Health Institutions
T/CACM 1167-2016 Guideline for Clinical Diagnosis and Treatment of TCM Diabetes mellitus complicated with heart disease
T/CACM 1231-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Xinzhang Disease (Hypertensive Left Ventricular Hypertrophy)
T/WSJD 39-2023 Requirements for the item information traceability system of the disinfection supply center of medical institutions
T/CNMIA 0037-2022 Evaluation of medical quality service ability of independent hemodialysis center run by society
T/CACM 1169-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM gasp syndrome(Chronic obstructive pulmonary disease and right heart failure)
T/CHAS 20-2-2-2021 Pharmacy administration and Pharmacy practice in Healthcare institutions—— Part 2-2: Pharmacy Practice—Prescription Review

RU-GOST R, Core medical

GOST R ISO 16142-2008 Medical devices. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
GOST R IEC 60601-2-51-2008 Medical electrical equipment. Part 2-51. Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
GOST 34244-2017 Telemedicine systems. General requirements for basic safety and essential performance of stationary telemedicine consultative and diagnostic centers
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 IEC/TO 61948-1-2009 Nuclear medicine instrumentation. Routine tests. Part 1. Radiation counting systems
GOST R 57492-2017 Medical devices. Implantable cardiac pacemakers. Technical requirements for governmental purchases
GOST R 55952-2014 Medical electrical equipment. Electrocardiographic monitoring equipment. Technical requirements for public procurement
GOST IEC 61303-2011 Medical electrical equipment. Radionuclide calibrators. Particular methods for describing performance
GOST R IEC 61303-1999 Medical electrical equipment. Radionuclide calibrators. Particular methods for describing performance
GOST R 50267.25-1994 Medical electrical equipment. Part 2. Particular requirements for safety of electrocardiographs
GOST R 55747-2013 Guidelines for regulatory auditing of quality management systems of medical device manufacturers. Part 5. Audits of manufacturer control of suppliers
GOST R 56323-2014 Medical electrical equipment. System of Holter monitoring. Technical requirements for governmental purchases
GOST R 50267.27-1995 Medical electrical equipment. Part 2. Particular requirements for safety of electrocardiographic monitoring equipment
GOST R 54421-2011 Guidelines for regulatory auditing of quality management systems of medical device manufacturers. Part 1. General requirements
GOST R IEC 60601-2-25-2016 Medical electrical equipment. Part 2-25. Particular requirements for the basic safety and essential performance of electrocardiographs
GOST R 55748-2013 Guidelines for regulatory auditing of quality management systems of medical device manufacturers. Part 4. Multiple site auditing
GOST 30324.31-2002 Medical electrical equipment. Part 2. Particular requirements for the safety of external cardiac pacemakers with internal power source
GOST R 57299-2016 Health informatics. Point-of-care medical device communication. Part 10406. Device specialization. Basic electrocardiograph (ECG) (1- to 3- lead ECG)
GOST R 56313-2014 Medical electrical equipment. Generators of radionuclides for production radiopharmpreparations. Technical requirements for governmental purchases
GOST R IEC 60601-2-27-2013 Medical electrical equipment. Part 2-27. Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
GOST R 50267.31-1999 Medical electrical equipment. Part 2. Particular requirement for the safety of external cardiac pacemakers with internal power source
GOST R IEC 60601-2-4-2013 Medical electrical equipment. Part 2-4. Particular requirements for the basic safety and essential performance of cardiac defibrillators
GOST R IEC/TO 61948-2-2008 Nuclear medicine instrumentation. Routine tests. Part 2. Scintillation cameras and single photon emission computed tomography imaging
GOST R IEC 60601-2-47-2017 Medical electrical equipment. Part 2-47. Particular requirements for basic safety and essential performance of ambulatory electrocardiographic systems
GOST R 50267.47-2004 Medical electrical equipment. Part 2. Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
GOST 30324.2.47-2012 Medical electrical equipment. Part 2-47. Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
GOST R IEC 60601-2-47-2015 Medical electrical equipment. Part 2-47. Particular requirements for basic safety and essential performance of ambulatory electrocardiographic systems

Jilin Provincial Standard of the People's Republic of China, Core medical

DB22/T 3024-2019 TCM diagnosis and treatment norms for newly diagnosed pulmonary tuberculosis
DB22/T 3247-2021 Standardization of traditional Chinese medicine treatment for children with myocarditis

Institute of Electrical and Electronics Engineers (IEEE), Core medical

IEEE P1073.1.3.10/D3.0:1999 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Cardiac Output
IEEE Std P1073.1.3.10/D3.0-1999 IEEE Draft Standard for Medical Device Communications -- Medical Device Data Language (MDDL) Virtual Medical Device, Specialized -- Cardiac Output
IEEE Std P1073.1.3.5/D0.04 Unapproved IEEE Draft Standard for Medical Device Communications -Medical Device Data Language (MDDL) Virtual Medical Device, Specialized -Cardiac Output (Withdrawn PAR)
IEEE P11073-10103/D1.05.04, March 2012 Standard for Health informatics - Point-of-care medical device communication - Nomenclature - Implantable device, cardiac
IEEE P11073-10103/D1.05.02, Sept 2011 Standard for Health informatics - Point-of-care medical device communication - Nomenclature - Implantable device, cardiac
IEEE P11073-10103 IEEE Draft Standard for Health informatics - Point-of-care medical device communication - Nomenclature - Implantable device, cardiac
IEEE Std 11073-10103-2012 Health informatics--Point-of-care medical device communication Part 10103: Nomenclature--Implantable device, cardiac
IEEE P11073-10103/D0.3, June 2023 IEEE Draft Standard for Health informatics - Point-of-care medical device communication - Nomenclature - Implantable device, cardiac
IEEE P11073-10103/D0.2, November 2022 IEEE Draft Standard for Health informatics - Point-of-care medical device communication - Nomenclature - Implantable device, cardiac

American National Standards Institute （ANSI), Core medical

ANSI P1073.1.3.6/D6.0-1999 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - ECG
ANSI P1073.1.3.10/D3.0-1999 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized – Cardiac Output
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 EC13-2002 Medical electrical equipment - Part 2-27: Particular requirements for basic safety and essential performance of electrocardiographic monitoring equipment
ANSI/AAMI/ISO 27186:2010 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements

British Standards Institution (BSI), Core medical

BS ISO 21426:2018 Tourism and related services. Medical spas. Service requirements
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 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)
PD ISO/TS 22077-2:2015 Health informatics. Medical waveform format. Electrocardiography
BS EN 60598-2-25:1995 Luminaires - Particular requirements - Luminaires for use in clinical areas of hospitals and health care buildings
PD ISO/TS 22077-3:2015 Health informatics. Medical waveform format. Long term electrocardiography
BS EN 60601-2-25:1996 Medical electrical equipment - Particular requirements for safety - Specification for electrocardiographs
BS EN 60601-2-25:1993 Medical electrical equipment. Particular requirements for safety. Specification for electrocardiographs
PD ISO/TS 22077-4:2019 Health informatics. Medical waveform format. Stress test electrocardiography
BS PD IEC/TR 61948-1:2016 Nuclear medicine instrumentation. Routine tests. Gamma radiation counting system
BS ISO 21474-2:2022 In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids - Validation and verification
BS ISO 22956:2021 Healthcare organization management. Requirements for patient-centred staffing
PD ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants
BS ISO 21474-1:2020 In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids - Terminology and general requirements for nucleic acid quality evaluation
BS PD ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants
BS EN ISO 14708-2:2022 Implants for surgery. Active implantable medical devices - Cardiac pacemakers
22/30452589 DC BS ISO 22077-2. Health informatics. Medical waveform format - Part 2. Electrocardiography
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 11073-10102:2014 Health informatics. Point-of-care medical device communication. Nomenclature. Annotated ECG
BS EN ISO 11073-10103:2013 Health informatics. Point-of-care medical device communication. Nomenclature. Implantable device, cardiac
23/30452592 DC BS ISO 22077-3. Health informatics. Medical waveform format - Part 3. Long term electrocardiography
19/30396746 DC BS ISO 22956. Healthcare organization management. Guidelines for patient centered staffing
BS EN 60601-2-25:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of electrocardiographs
BS EN ISO 11073-10103:2014 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 60601-2-4:2003 Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety of cardiac defibrillators
BS EN 60601-2-27:2014 Medical electrical equipment. Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
PD ISO/TR 14872:2019 Health informatics. Identification of medicinal products. Core principles for maintenance of identifiers and terms
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)
19/30361173 DC BS ISO 21474. In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids. Part 1. Terminology and general requirements for nucleic acid quality evaluation
21/30415510 DC BS ISO 21474-2. In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids. Part 2. Validation and verification
BS ISO 16637:2016 Radiological protection. Monitoring and internal dosimetry for staff members exposed to medical radionuclides as unsealed sources
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 EN 60601-2-27:2006 Medical electrical equipment — Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment
18/30343603 DC BS EN ISO 14708-2. Implants for surgery. Active implantable medical devices. Part 2. Cardiac pacemakers
BS EN 60601-2-47:2015 Tracked Changes. Medical electrical equipment. Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
BS EN 60601-2-31:2008+A1:2011 Medical electrical equipment. Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
BS EN 60601-2-31+A1:2009 Medical electrical equipment. Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
BS EN 60601-2-31:2009 Medical electrical equipment. Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
BS EN 60601-2-68:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equi
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 60601-2-51:2003 Medical electrical equipment - Particular requirements for safety - Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

ES-UNE, Core medical

UNE-ISO 21426:2019 Tourism and related services. Medical spas. Service requirements.
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)
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 11073-10103:2013 Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac (ISO/IEEE 11073-10103:2014) (Endorsed by AENOR in February of 2014.)
UNE-EN ISO 11073-10102:2014 Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG (ISO/IEEE 11073-10102:2014) (Endorsed by AENOR in April of 2014.)

NZ-SNZ, Core medical

SNZ HB 8171.1-2005 Allied Health Services Sector Standard - Physiotherapy Services Audit Workbook
SNZ HB 8171.2-2005 Allied Health Services Sector Standards - Chiropractic Services Audit Workbook

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, Core medical

GB/T 34411-2017 Specification for audit of basic medical insurance benefits
GB 16174.2-2015 Implants for surgery—Active implantable medical devices—Part 2: Cardiac pacemakers

Anhui Provincial Standard of the People's Republic of China, Core medical

DB34/T 4351-2022 General Hospital Rehabilitation Treatment Center Construction Specifications

Danish Standards Foundation, Core medical

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/ENV 1064:1993 Medical informatics. Standard communication protocol. Computer-assisted electrocardiography
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 27186:2021 Active implantable medical devices – Four-pole connector system for implantable cardiac rhythm management devices – Dimensional and test requirements

Lithuanian Standards Office , Core medical

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 45502-2-2-2008 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)
LST EN 61303-2002 Medical electrical equipment. Radionuclide calibrators. Particular methods for describing performance (IEC 61303:1994)
LST EN 60789-2006 Medical electrical equipment. Characteristics and test conditions of radionuclide imaging devices. Anger type gamma cameras (IEC 60789:2005)

AENOR, Core medical

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 60601-2-25:1997 MEDICAL ELECTRICAL EQUIPMENT. PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROCARDIOGRAPHS.
UNE-EN 61303:1997 MEDICAL ELECTRICAL EQUIPMENT. RADIONUCLEIDE CALIBATORS. PARTICULAR METHODS FOR DESCRIBING PERFORMANCE.
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 73703:1995 IN MINIMUM EQUIPMENT OF A FIRST STAGE MEDICAL CENTRE FOR THE TREATMENT OF THOSE INJURED OR CONTAMINED BY RADIOACTIVE ELEMENTS OR IONIZING RADIATION.

CU-NC, Core medical

NC 57-91-1985 Clinical Methods and Aids Tuberculin PPD RT-23 Quality Specifications

North Atlantic Treaty Organization Standards Agency, Core medical

STANAG 2478-2006 MEDICAL SUPPORT PLANNING FOR NUCLEAR, BIOLOGICAL AND CHEMICAL ENVIRONMENTS
STANAG 2873-2007 CONCEPT OF OPERATIONS OF MEDICAL SUPPORT IN CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR ENVIRONMENTS - AMedP-7(D)

German Institute for Standardization, Core medical

DIN 6844-3:2006 Nuclear medicine departments - Part 3: Radiation protection calculations
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 VDE 0753-2:1983 Rules relating to intracardiac applications of medical electrical equipment VDE Guide
DIN 57753-2:1983 Rules relating to intracardiac applications of medical electrical equipment [VDE Guide]
DIN 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); German version EN 45502-2-2:2008
DIN 6848-2:2003 Characterization of examination results in radiology - Part 2: Nuclear medicine measurements for human specimens
DIN 6844-2:2005 Nuclear medicine departments - Part 2: Rules for the installation and equipment for therapeutic applications of unsealed radioactive sources
DIN EN 60598-2-25:2005 Luminaires - Part 2-25: Particular requirements - Luminaires for use in clinical areas of hospitals and health care buildings (IEC 60598-2-25:1994 + Corrigendum 1994 + A1:2004); German version EN 60598-2-25:1994 + A1:2004
DIN EN 60601-2-25:2001 Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs (IEC 60601-2-25:1993 + A1:1999); German version EN 60601-2-25:1995 + A1:1999
DIN 6850:2006 Radiation protection containers, tables and safes for use in nuclear medicine - Requirements and classification
DIN EN 61303:1996 Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance (IEC 61303:1994); German version EN 61303:1995
DIN 6855-11:2001 Quality control of nuclear medicine instruments - Part 11: Constancy testing of activity meter
DIN 6855-11:2009 Constancy testing of nuclear medicine instruments - Part 11: Radionuclide calibrators (IEC/TR 61948-4:2006, modified)
DIN 6855-11:2016 Constancy testing of nuclear medicine instruments - Part 11: Radionuclide calibrators (IEC/TR 61948-4:2006, modified)
DIN 58943-8:1996 Medical microbiology - Diagnosis of tuberculosis - Part 8: Methods for the determination of susceptibility of tubercle bacilli to chemotherapeutic agents
DIN 58943-8:2009 Medical microbiology - Diagnosis of tuberculosis - Part 8: Methods for the determination of susceptibility of tubercle bacilli to chemotherapeutic agents; Text in German and English
DIN 6855-1:1992 Quality control of nuclear medicine instruments; radiation counting systems for measurements in vivo and in vitro
DIN 6855-4:2016 Constancy testing of nuclear medicine instruments - Part 4: Positron emission tomographs (PET)
DIN EN ISO 11073-10103:2014-06 Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac (ISO/IEEE 11073-10103:2014); English version EN ISO 11073-10103:2013
DIN 6844-2:2020-05 Nuclear medicine departments - Part 2: Rules for the construction and equipment of departments for the therapeutic use of unsealed radioactive substances
DIN 6844-1:2005 Nuclear medicine departments - Part 1: Rules for the installation and equipment for diagnostic applications of unsealed radioactive sources
DIN EN ISO 11073-10102:2014-06 Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG (ISO/IEEE 11073-10102:2014); English version EN ISO 11073-10102:2014
DIN 6855-1:2021 Constancy testing of nuclear medical measuring systems - Part 1: Radiation counting systems for measurements in vivo and in vitro
DIN 6855-4:2004 Quality control of nuclear medicine instruments - Part 4: Constancy testing of positron emission tomographs (PET)
DIN EN 45502-2-2 Berichtigung 1:2009 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators); German version EN 45502-2-2:2008, Corrigendum to DIN EN 45502-2-2 (VDE 0
DIN 6844-1:2020-05 Nuclear medicine departments - Part 1: Rules for the construction and equipping of facilities for ambulatory use of unsealed radioactive materials for diagnosis and treatment

Sichuan Provincial Standard of the People's Republic of China, Core medical

DB5104/T 51.8-2021 Specifications for the Construction of Safe and Comfortable Consumption Environment Part 8: Medical Institutions
DB51/T 2553-2018 Administrative norms for the administration of drug rehabilitation medical centers in compulsory isolated drug rehabilitation facilities in the judicial administration

International Electrotechnical Commission (IEC), Core medical

IEC TR 61948-4:2006 Nuclear medicine instrumentation - Routine tests - Part 4: Radionuclide calibrators
IEC TR 61948-3:2018 Nuclear medicine instrumentation - Routine tests - Part 3: Positron emission tomographs
ISO/TS 10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
IEC 60601-2-4:1983 Medical electrical equipment. Part 2: Particular requirements for the safety of cardiac defibrillators and cardiac defibrillator-monitors
IEC 60601-2-26:1994 Medical electrical equipment; part 2: particular requirements for the safety of electroencephalographs
IEC 62570:2014 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
IEC 60601-2-33:2010/COR1:2012 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis; Corrigendum 1
IEC 60601-2-25:2011 Medical electrical equipment - Part 2-25: Particular requirements for basic safety and essential performance of electrocardiographs

European Committee for Standardization (CEN), Core medical

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)
prEN 60601-2-27-1992 Medical electrical equipment; part 2: particular requirements for the safety of electrocardiographic monitoring equipment
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)
EN ISO 16637:2019 Radiological protection - Monitoring and internal dosimetry for staff members exposed to medical radionuclides as unsealed sources (ISO 16637:2016)
EN ISO 11073-10102:2014 Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG

Association Francaise de Normalisation, Core medical

NF S90-480:1987 MEDICO-SURGICAL EQUIPMENT. IMPLANTS FOR SURGERY. CARDIOVASCULAR IMPLANTS. CARDIAC VALVE PROSTHESES.
NF C74-502-2-1*NF 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)
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 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 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)
FD S99-516*FD ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
FD ISO/TR 37137:2014 Évaluation biologique cardiovasculaire des dispositifs médicaux - Directives pour les implants absorbables
NF C74-340:2006 Medical electrical equipment - Part 2-4 : particular requirements for the safety of cardiac defibrillators.
NF EN 61303:1995 Appareils électromédicaux calibrateurs de radionucleides - Méthodes particulières pour décrire les performances
NF C74-349:1994 Medical electrical equipment. Part 2 : particular requirements for the safety of electrocardiographic monitoring equipment.
NF C74-305:1996 Medical electrical equipment. Part 2 : particular requirements for the safety of electrocardiographs.
NF C74-214*NF EN 61303:1995 Medical electrical equipment. Radionuclide calibrators. Particular methods for describing performance.
NF ISO 21474-2:2022 Dispositifs médicaux de diagnostic in vitro - Tests moléculaires multiplex pour les acides nucléiques - Partie 2 : validation et vérification
NF C74-502-2-2*NF 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)
NF C74-206:2006 Medical electrical equipment - Characteristics and test conditions of radionuclide imaging devices - Anger type gamma cameras.
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 S97-518-10102*NF EN ISO 11073-10102:2014 Health informatics - Point-of-care medical device communication - Part :10102 : nomenclature - Annotated ECG
NF C74-305*NF EN 60601-2-25:2016 Medical electrical equipment - Part 2-25 : particular requirements for the basic safety and essential performance of electrocardiographs
NF C74-340*NF EN 60601-2-4:2012 Medical electrical equipment - Part 2-4 : particular requirements for basic safety and essential performance of cardiac defibrillators
NF C74-308:1995 Medical electrical equipment. Part 2 : particular requirements for the safety of external cardiac pacemakers with internal power source.
NF EN ISO 11073-10103:2014 Informatique de santé - Communication entre dispositifs médicaux sur le site des soins - Partie 10103 : nomenclature - Dispositif implantable, cardiaque
NF C74-349:2006 Medical electrical equipment - Part 2-27 : particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment.
NF C74-349*NF EN 60601-2-27:2014 Medical electrical equipment - Part 2-27 : particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
NF S90-307:1990 Medico-surgical equipment. Centrifuge-type blood cell and plasma separators (monitors and single-use kits) suitability for use.
NF ISO 19461-2:2022 Radioprotection - Mesurage pour la libération des déchets contaminés par des radioisotopes lors des applications médicales - Partie 2 : Gestion des déchets radioactifs solides dans les installations de médecine nucléaire
NF C74-329:1990 Medical electrical equipment. Part 2 : particular safety requirements for separation of cells and plasma monitors by centrifugation.
NF S90-481:1987 MEDICO-SURGICAL EQUIPMENT. IMPLANTS FOR SURGERY. CARDIAC PACEMAKERS. PART 2 : REPORTING OF THE CLINICAL PERFORMANCE OF POPULATIONS OF PULSE GENERATORS.

American Nuclear Society (ANS), Core medical

ANS 3.7.1-1995 Facilities and Medical Care for On-Site Nuclear Power Plant Radiological Emergencies

ANS - American Nuclear Society, Core medical

3.7.1-1995 Facilities and Medical Care for On-Site Nuclear Power Plant Radiological Emergencies
3.4-1996 Medical Certification and Monitoring of Personnel Requiring Operator Licenses for Nuclear Power Plants
3.7.1-1979 FACILITIES AND MEDICAL CARE FOR ON-SITE NUCLEAR POWER PLANT RADIOLOGICAL EMERGENCIES (R 1986)
3.4-1983 MEDICAL CERTIFICATION AND MONITORING OF PERSONNEL REQUIRING OPERATOR LICENSES FOR NUCLEAR POWER PLANTS (R 1988)

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Core medical

GB/T 17857-1999 Medical radiology--Terminology(Equipment for radiotherapy,nuclear medicine and radiation dosimetry)

Professional Standard - Environmental Protection, Core medical

HJ 1105-2020 Pollutant Discharge Permit Application and Issuance of Technical Specifications for Medical Institutions

NATO - North Atlantic Treaty Organization, Core medical

AMEDP-7(D)-2007 CONCEPT OF OPERATIONSOF MEDICAL SUPPORT INCHEMICAL BIOLOGICAL RADIOLOGICAL AND NUCLEAR ENVIRONMENTS
STANAG 2873-1982 Concept of Operations of Medical Support in Nuclear@ Biological and Chemical Environments - AMedP-7(A) (ED 2 AMD 0; To obtain please contact your national Defense Standardization Office or the NATO Standardization Office website: http:/ so.nato.int so@ Ph
STANAG 2873-1996 Concept of Operations of Medical Support in Nuclear@ Biological and Chemical Environments - AMedP-7(C) (ED 3 AMD 0; To obtain please contact your national Defense Standardization Office or the NATO Standardization Office website: http:/ so.nato.int so@ Ph
AJMEDP-7-2015 ALLIED JOINT MEDICAL DOCTRINE FOR SUPPORT TO CHEMICAL@ BIOLOGICAL@ RADIOLOGICAL@ AND NUCLEAR (CBRN) DEFENSIVE OPERATIONS (ED A@ Ver. 1)
AMEDP-7.6-2018 COMMANDER'S GUIDE ON MEDICAL SUPPORT TO CHEMICAL@ BIOLOGICAL@ RADIOLOGICAL@ AND NUCLEAR (CBRN) DEFENSIVE OPERATIONS (ED A; Ver. 1)
AMEDP-6-1973 NATO Handbook on the Medical Aspects of NBC Defensive Operations; Part I - Nuclear@ Part II - Biological@ Part III - Chemical (To obtain please contact your national Defense Standardization Office or the NATO Standardization Office website: http:/ so.nato

CENELEC - European Committee for Electrotechnical Standardization, Core medical

PREN 50447-2004 Active implantable medical devices - Particular requirements for Heart-Lung Machines (HLM)
EN 60601-2-4:2003 Medical electrical equipment Part 2-4: Particular requirements for the safety of cardiac defibrillators

American Society for Testing and Materials (ASTM), Core medical

ASTM F2761-09(2013) Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
ASTM F3211-17 Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
ASTM F2761-09 Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
ASTM F2052-14 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ASTM E2063-05(2011) Standard Practice for Calibration and Functionality Checks Used in Forensic Psychophysiological Detection of Deception (Polygraph) Examinations
ASTM E2063-12 Standard Practice for Calibration and Functionality Checks Used in Forensic Psychophysiological Detection of Deception (Polygraph) Examinations

Jiangsu Provincial Standard of the People's Republic of China, Core medical

DB32/T 4383-2022 Service Specifications for Chronic Disease Management Centers of Primary Medical and Health Institutions

SE-SIS, Core medical

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

US-CFR-file, Core medical

CFR 38-17.2000-2013 Pensions, bonuses, and veterans'relief. Part17:Medical. Section17.2000:Vet Center services.
CFR 42-414.1270-2013 Public Health. Part414:Payment for Part B medical and other health services. Section414.1270:Determination and calculation of Value-Based Payment Modifier adjustments.
CFR 42-410.71-2013 Public Health. Part410:Supplementary medical insurance (SMI) benefits. Section410.71:Clinical psychologist services and services and supplies incident to clinical psychologist services.

ZA-SANS, Core medical

SANS 60598-2-25:1994 Luminaires Part 2-25: Particular requirements - Luminaires for use in clinical areas of hospitals and health care buildings
SANS 11137-1:2007 Sterilization of health care products - Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

European Committee for Electrotechnical Standardization（CENELEC）, Core medical

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)
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) (Incorporating corrigendum April 2009)
EN 60601-2-4:2011 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
EN 60598-2-25:1994 Luminaires - Part 2-25: Particular requirements - Luminaires for use in clinical areas of hospitals and health care buildings (Incorporates Amendment A1: 2004)

CN-CNCA, Core medical

CNCA 08C-032-2001 Implementation Rules for Compulsory Certification of Medical Device Products ECG Machine
CNCA 08C-035-2001 Implementation Rules for Compulsory Certification of Medical Device Products Hollow Fiber Dialyzer
CNCA 08C-041-2001 Implementation Rules for Compulsory Certification of Medical Devices Artificial Heart-Lung Machine Heat Exchanger
CNCA 08C-038-2001 Implementation Rules for Compulsory Certification of Medical Devices Artificial Heart-Lung Machine Roller Type Blood Pump
CNCA 08C-042-2001 Implementation Rules for Compulsory Certification of Medical Devices Heat Exchange Water Tank for Artificial Heart-Lung Machine
CNCA 08C-043-2001 Implementation Rules for Compulsory Certification of Medical Devices Silicone Rubber Pump Tubes for Artificial Heart-Lung Machines
CNCA 08C-036-2001 Implementation Rules for Compulsory Certification of Medical Device Products Implantable Cardiac Pacemakers
CNCA 08C-040-2001 Implementation Rules for Compulsory Certification of Medical Devices Artificial Heart-Lung Machine Bubble Oxygenator
CNCA 08C-039-2001 Implementation Rules for Compulsory Certification of Medical Devices Artificial Heart-Lung Machine Rolling Type Pulsating Blood Pump

International Organization for Standardization (ISO), Core medical

ISO/CD TS 9321:2023 Health informatics — General requirements of multi-center medical data collaborative analysis
ISO 22956:2021 Healthcare organization management - Requirements for patient-centred staffing
ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
ISO/TS 22077-4:2019 Health informatics — Medical waveform format — Part 4: Stress test electrocardiography
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 14708-2:2019 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
ISO 19461-2:2022 Radiological protection — Measurement for the clearance of waste contaminated with radioisotopes for medical application — Part 2: Management of solid radioactive waste in nuclear medicine facilities
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)
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 14117:2012 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
ISO/TS 10974:2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
ISO 21474-2:2022 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification
ISO/IEEE 11073-10103:2014 Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac
ISO 14117:2019 Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization device
ISO 16637:2016 Radiological protection - Monitoring and internal dosimetry for staff members exposed to medical radionuclides as unsealed sources
ISO/TS 15843:2000 Sterilization of health care products - Radiation sterilization - Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits
ISO/IEC TS 17021-15:2023 Conformity assessment requirements for bodies providing audit and certification of management systems — Part 15: Competence requirements for auditing and certification of management systems for quality in healthcare organizations
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

AT-ON, Core medical

ONORM S 5275-1-2001 Nuclear medical therapy - Criterias for the discharge - Simplified calculation method for the discharge activity
ONORM S 5225-1994 Radiation protection Containers, tables and safes for use in nuclear medicine - Requirements and Classification - Marking of conformity
ONORM S 5224-1997 Installations for nuclear medicine - Rules for construction and equipment
ONORM S 5226-1998 Radiation protection tests for installations for nuclear medicine - Rules for testing the radiation protection for handling with unsealed radioactive material

国家食品药品监督管理局, Core medical

YY/T 1500-2016 Medical device pyrogen test Monocyte activation test Human whole blood ELISA method
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 1608-2018 Sampling methods for radiation sterilization verification dose experiments and sterilization dose audits of medical devices
YY/T 0972-2016 Dimensions and test requirements for four-pole connector systems for active implantable medical devices and implantable cardiac rhythm regulation devices

KR-KS, Core medical

KS C 1929-2-2017(2022) U-healthcare ─ electrocardiograph ─ Particular requirements for the basic safety and performance
KS P ISO TR 37137-2019 Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
KS C IEC 61303-2018 Medical electrical equipment — Radionuclide calibrators — Particular methods for describing performance
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 C IEC 60601-2-47-2017 Medical electrical equipment－Part 2-47：Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
KS C IEC 60601-2-25-2017 Medical electrical equipment — Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
KS C IEC 60601-2-4-2017 Medical electrical equipment — Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators

GB-REG, Core medical

REG AC 120-96-2008 Integration of Operations Control Centers into Helicopter Emergency Medical Services Operations

Japanese Industrial Standards Committee (JISC), Core medical

JIS T 0601-2-25:2006 Medical electrical equipment -- Part 2: Particular requirements for the safety of electrocardiographs

Standard Association of Australia （SAA）, Core medical

AS/NZS 4354:1995 Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance

Canadian Standards Association (CSA), Core medical

CSA C22.2 No.601.2.25-94-CAN/CSA AMD 1-2002 Medical electrical equipment ?Part 2-25: Particular requirements for the safety of electrocardiographs
CSA C22.2 No.60601-2-22-01-2001 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Diagnostic and Therapeutic Laser Equipment Second Edition; IEC 601-2-22:1995
CSA C22.2 No.60601-2-4-04-2004 Medical electrical equipment ?Part 2-4: Particular requirements for the safety of cardiac defibrillators Second Edition
CSA C22.2 No.60601-2-27-06-2006 Appareils 閘ectrom閐icaux ?Partie 2-27: Exigences particuli鑢es de s閏urit? incluant les performances essentielles, des appareils de surveillance d'閘ectrocardiographie la deuxi鑝e 閐ition
CSA C22.2 No.601.2.25-94-CAN/CSA-1994 Medical Electrical Equipment - Part 2-25: Particular Requirements for the Safety of Electrocardiographs First Edition; General Instruction No 1
CSA Z305.6-92-CAN/CSA-1992 Medical Oxygen Concentrator Central Supply System: for Use with Nonflammable Medical Gas Piping Systems First Edition; General Instruction No 1

工业和信息化部, Core medical

YD/T 4043-2022 Reference architecture of multi-center medical data collaborative analysis platform based on artificial intelligence

Indonesia Standards, Core medical

SNI 04-6191.2.4-1999 Medical electrical equipment. Part 2.4: Particular requirements for the safety of cardiac defibrillators and cardiac defibrillator - Monitors
SNI IEC 60601-2-27:2016 Perangkat elektromedik - Bagian 2-27: Persyaratan khusus untuk keselamatan dasar dan kinerja esensial peralatan monitor elektrokardiografik

IT-UNI, Core medical

UNI ISO 21474-1:2021 In vitro diagnostic medical devices - Multiplex molecular testing for nucleic acids - Part 1: Terminology and general requirements for nucleic acid quality evaluation

Professional Standard - Medicine, Core medical

YY/T 0127.12-2008 Dentistry.Biological evaluation of medical devices used in dentistry Part 2:Test method.Micronucleus test
YY/T 0870.4-2014 Test for genotoxicity of medical devices.Part 4:Mammalian bone marrow erythocyte micronucleus test
YY/T 1897-2023 Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test
YY 9706.268-2022 Medical electrical equipment Part 2-68: X-ray image guides for electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment

国家药监局, Core medical

YY/T 0870.6-2019 Medical device genotoxicity testing Part 6: In vitro mammalian cell micronucleus test
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

US-HHS, Core medical

HHS 21 CFR PART 26-2011 MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY

US-FCR, Core medical

FCR 21 CFR PART 26-2015 MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY
FCR 21 CFR PART 26-2013 MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY
FCR 21 CFR PART 26-2014 MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY

IEEE - The Institute of Electrical and Electronics Engineers@ Inc., Core medical

IEEE 11073-10103-2012 Health informatics-Point-of-care medical device communication Part 10103: Nomenclature-Implantable device@ cardiac

GOSTR, Core medical

GOST R 54881-2011 Guidelines for auditing of quality management systems of medical device manufacturers to conform to requlating requirements. Part 3. Audit report

US-AAMI, Core medical

ANSI/AAMI PC69-2007 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators