Medical Electrical Equipment

Medical Electrical Equipment, Total:152 items.

The international standard classification for "Medical Electrical Equipment" includes: .

The Chinese standard classification for "Medical Electrical Equipment" includes: .

International Organization for Standardization (ISO)

ISO/FDIS 80601-2-79:2024 Medical electrical equipment
ISO/FDIS 80601-2-80:2024 Medical electrical equipment
ISO 80601-2-55:2018/Amd 1:2023 Medical electrical equipment
ISO 80601-2-13:2022/AWI Amd 1:2024 Medical electrical equipment
IEC 80601-2-26:2019/AMD1:2024 Medical electrical equipment
IEC 80601-2-77:2019/AMD1:2023 Medical electrical equipment
ISO/CD 80601-2-74.2:2024 Medical electrical equipment
ISO/CD 80601-2-90.2:2024 Medical electrical equipment
IEC 80601-2-58:2024 Medical electrical equipment
IEC TR 60601-4-1:2017 Medical electrical equipment — Part 4-1: Guidance and interpretation — Medical electrical equipment and medical electrical systems employing a degree of autonomy
IEC/TR 60601-4-1:2017 Medical electrical equipment — Part 4-1: Guidance and interpretation — Medical electrical equipment and medical electrical systems employing a degree of autonomy
IEC TR 60601-4-1:2017 Medical electrical equipment — Part 4-1: Guidance and interpretation — Medical electrical equipment and medical electrical systems employing a degree of autonomy

International Electrotechnical Commission (IEC)

IEC 80601-2-77:2023 Medical electrical equipment
IEC 62353:2007 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
IEC 62353:2014 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
IEC 60601-1:2024 SER Medical electrical equipment - ALL PARTS
IEC TR 62354:2009 General testing procedures for medical electrical equipment
IEC TR 62354:2014 General testing procedures for medical electrical equipment
IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
IEC TR 62354:2005 General testing procedures for medical electrical equipment
IEC 60580:2019 Medical electrical equipment - Dose area product meters
IEC TR 61258:2008 Guidelines for the development and use of medical electrical equipment educational materials

British Standards Institution (BSI)

PD ISO/TR 25555:2024 Ageing societies. Accessibility and usability considerations for home healthcare products, related services and environments
BS ISO 24163-2:2024 Clamp-in tyre valves for tyre pressure monitoring systems - Test methods and performance
BS EN 62353:2008 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
BS EN 62353:2014 Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment
BS PD IEC/TR 60601-4-1:2017 Medical electrical equipment. Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy
PD IEC/TR 60601-4-2:2016 Medical electrical equipment. Guidance and interpretation. Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
BS EN 60601-2-64:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
BS EN IEC 60580:2020 Medical electrical equipment. Dose area product meters
BS PD IEC/TR 62354:2014 General testing procedures for medical electrical equipment
PD IEC/TR 62266:2002 Medical electrical equipment. Guidelines for implementation of DICOM in radiotherapy
BS EN IEC 62667:2018 Medical electrical equipment. Medical light ion beam equipment. Performance characteristics
PD 6573:1994 Fundamental aspects of safety standards for medical electrical equipment
18/30356778 DC BS EN 60580. Medical electrical equipment. Dose area product meters
BS EN 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
BS EN 60601-1-8:2004 Medical electrical equipment. General requirements for safety. Collateral standard. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
BS EN 60976:2008 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
BS EN 60601-1-12:2015+A1:2020 Medical electrical equipment - General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services…
BS EN 60601-2-3:1993 Medical electrical equipment. Particular requirements for safety. Specification for short-wave therapy equipment
BS EN 60601-2-3:1992 Medical electrical equipment. Particular requirements for safety. Specification for short-wave therapy equipment
BS EN 62563-1:2010 Medical electrical equipment - Medical image display systems - Evaluation methods
BS EN 62563-1:2010+A2:2021 Medical electrical equipment. Medical image display systems - Evaluation methods
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
BS EN 60601-1-11:2015+A1:2021 Medical electrical equipment - General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
BS EN 60601-1-12:2015 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

German Institute for Standardization

DIN EN 62353:2008 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (IEC 62353:2007); German version EN 62353:2008
DIN EN IEC 60580:2021-07 Medical electrical equipment - Dose area product meters (IEC 60580:2019); German version EN IEC 60580:2020
DIN EN 62353:2015 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (IEC 62353:2014); German version EN 62353:2014

Association Francaise de Normalisation

NF C74-053:2008 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment.
NF C74-053*NF EN 62353:2015 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
NF EN IEC 62667:2018 Medical electrical devices - Light ion beam medical devices - Performance characteristics
NF EN 60601-2-64:2015 Medical electrical devices - Part 2-64: particular requirements for the basic safety and essential performance of light ion beam medical electrical devices
NF C74-064*NF EN 60601-2-64:2015 Medical electrical equipment - Part 2-64 : particular requirements for the basic safety and essential performance of light ion beam medical eletrical equipment
NF EN IEC 60580:2020 Electromedical devices - Exposure-surface product radiation meters
NF EN 60601-1-12/A1:2020 Medical electrical devices - Part 1-12: general requirements for basic safety and essential performance - Collateral standard: requirements for medical electrical devices and medical electrical systems intended for use...
NF EN 60601-1-12:2015 Medical electrical devices - Part 1-12: general requirements for basic safety and essential performance - Collateral standard: requirements for medical electrical devices and medical electrical systems intended for use...

RU-GOST R

GOST R IEC/TR 60788-2009 Medical electrical equipment. Glossary
GOST R IEC/TR 62266-2009 Medical electrical equipment. Guidelines for implementation of DICOM in radiotherapy
GOST R 56331-2014 Medical electrical equipment. Medical diagnostic ultrasonic equipment. Technical requirements for governmental purchases
GOST R 56279-2014 Medical electrical equipment. Endoscopic racks. Specifications for governmental purchase
GOST R 56316-2014 Medical electrical equipment. Medical electron accelerators. Technical requirements for governmental purchases
GOST R IEC 60976-2013 Medical electrical equipment. Medical electron accelerators. Functional performance characteristics
GOST R IEC 60731-2001 Medical electrical equipment. Dosimeters with ionization chambers in radiotherapy
GOST R IEC 62353-2013 Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment
GOST R IEC 62083-2013 Medical electrical equipment. Requirements for the safety of radiotherapy treatment planning systems
GOST R 56168-2014 Medical electrical equipment. Operation microscope. Specifications for governmental purchase
GOST R 56107-2014 Medical electrical equipment. Operating tables. Technical requirements for governmental purchases
GOST R 57185-2016 Medical electrical equipment. Infusion pumps. Technical requirements for governmental purchases
GOST R 57092-2016 Medical electrical equipment. Equipment for telemedicine videoconferencing. Technical requirements for governmental purchases

Lithuanian Standards Office

LST EN 62353-2008 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (IEC 62353:2007)
LST EN 60580-2002 Medical electrical equipment. Dose area product meters (IEC 60580:2000)

SCC

BS PD IEC/TR 60601-4-2:2016 Medical electrical equipment-Guidance and interpretation. Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
DANSK DS/EN 60580:2001 Medical electrical equipment – Dose area product meters
BS 7139:1989 Guide to graphical symbols for use on medical electrical equipment
DANSK DS/IEC TR 60601-4-2:2016 Medical electrical equipment – Part 4-2: Guidance and interpretation – Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
DANSK DS/EN IEC 60580:2020 Medical electrical equipment – Dose area product meters
CEI EN IEC 60580:2020 Medical electrical equipment - Dose area product meters
DANSK DS/IEC/TR 60788:2004 Medical electrical equipment - Glossary of defined terms
IEC 60601-1:1977 Medical electrical equipment. Part 1: General requirements.
BS PD 6573:1994 Fundamental aspects of safety standards for medical electrical equipment
BS 5724-2-2.3:1983 Medical electrical equipment. Particular requirements for safety-Specification for short wave therapy equipment
BS 5724-2.14:1989 Medical electrical equipment. Particular requirements for safety-Specification for electroconvulsive therapy equipment
BS EN 62563-1:2010+A1:2016 Medical electrical equipment. Medical image display systems-Evaluation methods
BS EN 60601-2.38:1997 Medical electrical equipment. Particular requirements for the safety of electrically operated hospital beds
DIN EN 60601-2-64:2018 Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment (IEC 60601-2-64:2014); German version EN 60601-2-64:2015
BS EN 60601-2-33:1996 Medical electrical equipment. Particular requirements for safety-Specification for magnetic resonance equipment for medical diagnosis
BS EN 60601-2.18:1997 Medical electrical equipment. Particular requirements for safety - Specification for endoscopic equipment
CAN/CSA C22.2 No.60601-1-11-2011 Medical electrical equipment - General requirements for basic safety and essential performance - Collateral standard: Requirements for Medical electrical equipment and medical electrical systems used in the home healthcare environment (Adopted IEC 6060...
BS 5724-2-2.13:1990 Medical electrical equipment. Particular requirements for safety-Specification for anaesthetic machines
DIN EN 60601-1-11/A1 E:2018 Draft Document - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare e...
DIN IEC 60601-1-11 E:2008 Draft Document - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare e...
DIN EN 60601-1-11 E:2014 Draft Document - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare e...
BS 5724-2-2.11:1989 Medical electrical equipment. Particular requirements for safety-Specification for gamma beam therapy equipment

Spanish Association for Standardization (UNE)

IEC 60601-1:2023 SER Medical electrical equipment - ALL PARTS
UNE-EN IEC 60580:2020 Medical electrical equipment - Dose area product meters (Endorsed by Asociación Española de Normalización in May of 2020.)
UNE-EN 60601-1:1993 MEDICAL ELECTRICAL EQUIPMENT. GENERAL REQUIEREMENTS FOR SAFETY.
UNE-EN 60601-2-64:2015 Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment (Endorsed by AENOR in July of 2015.)
UNE 20613-2-14:1993 MEDICAL ELECTRICAL EQUIPMENT. PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROCONSULSIVE THERAPY EQUIPMENT.
UNE 20613-2-6:1988 MEDICAL ELECTRICAL EQUIPMENT. PARTICULAR REQUIREMENTS FOR THE SAFETY OF MICROWAVE THERAPY EQUIPMENT
UNE 20613-1/1M:1993 MEDICAL ELECTRICAL EQUIPMENT. PART 1: GENERAL REQUIREMENTS FOR SAFETY.
UNE-EN 60601-1/A1:1996 MEDICAL ELECTRICAL EQUIPMENT. PART 1: GENERAL REQUIREMENTS FOR SAFETY.
UNE-EN 60601-1/A2:1996 MEDICAL ELECTRICAL EQUIPMENT. PART 1: GENERAL REQUIREMENTS FOR SAFETY.
UNE-EN 60601-1/A13:1997 MEDICAL ELECTRICAL EQUIPMENT. PART 1: GENERAL REQUIREMENTS FOR SAFETY.
UNE-EN 60336:2006 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots

KR-KS

KS C 3598-2018(2023) Medical electrical equipment ─ Glossary of defined terms
KS C IEC 60580-2018 Medical electrical equipment — Dose area product meters
KS C IEC 62667-2019 Medical electrical equipment — Medical light ion beam equipment — Performance characteristics
KS C IEC 62083-2017 Medical electrical equipment — Requirements for the safety of radiotherapy treatment planning systems

Australian/New Zealand Standard (AU-AS/NZS)

AS/NZS 4334:1995 Graphic symbols for use on medical electrical equipment
AS/NZS 4334:1995/AMD 1:1996 Graphic symbols for use on medical electrical equipment
AS/NZS 2500:2020 Safe use of medical electrical equipment in health care
AS/NZS 4957:2002 Medical electrical equipment - Dose area product meters
AS/NZS 4434.1:1996 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
AS/NZS 4537:1999 Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
AS/NZS 4434.2:1996 Medical electrical equipment - Medical electron accelerators - Periodic function performance testing
AS/NZS 3200.1.8:2005 Medical electrical equipment Part 1.8: General requirements for safetyCollateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

GSO

GSO IEC 60580:2014 Medical electrical equipment - Dose area product meters
OS GSO IEC 60580:2014 Medical electrical equipment - Dose area product meters
GSO IEC TR 60601-4-2:2021 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
BH GSO IEC TR 60601-4-2:2022 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
BH GSO IEC 60580:2016 Medical electrical equipment - Dose area product meters
OS GSO IEC/TR 60788:2014 Medical electrical equipment - Glossary of defined terms
GSO IEC/TR 60788:2014 Medical electrical equipment - Glossary of defined terms
BH GSO IEC/TR 60788:2016 Medical electrical equipment - Glossary of defined terms
OS GSO IEC/TR 60513:2015 Fundamental aspects of safety standards for medical electrical equipment
GSO IEC 60601-1-8:2007 Medical electrical equipment – Part 1-8: General requirements for safety – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

SE-SIS

SIS SS IEC 601-2-6:1988 Medical electrical equipment — Particular requirements for the safety of microwave therapy equipment
SIS SS IEC 601-2-3:1988 Medical e/ectrical equipment — Particular requirements for the safety ofshort-wave therapy equipment
SIS SS 486 03 31-1990 Medical electrical equipment — Particular requirements for the safety of gamma beam therapy equipment
SIS SS-IEC 976:1991 Medical electrical equipment — Medical electron accelerators — Functionalperformance charactetistics
SIS SS-IEC 601-2-14:1991 Medical electrical equipment - Part 2: Particular requirements for the safety ofelectroconvulsive therapy equipment
SIS SS IEC 601-2-8:1988 Medical electrical equipment — Particular requirements for the safety of therapeutic X-ray generators
SIS SS IEC 601-2-2:1987 Medical electrical equipment — Particular requirements for the safety of high frequency surgical equipment
SIS SS IEC 601-2-10:1988 Medical electrical equipment — Particular requirements for the safety of nerve andmuscle stimulators

European Committee for Standardization (CEN)

prEN 793-1992 Medical electrical equipment; particular requirements for safety of medical supply units
HD 395.1 S2 A1-1993 Medical electrical equipment; part 1: general requirements for safety
prEN 865-1992 Medical electrical equipment; pulse oximeters; particular requirements

Korean Agency for Technology and Standards (KATS)

KS C IEC 60580:2018 Medical electrical equipment — Dose area product meters
KS C 3598-2023 Medical electrical equipment ─ Glossary of defined terms
KS C IEC 62667:2019 Medical electrical equipment — Medical light ion beam equipment — Performance characteristics
KS C 1103-1990(2016) Glossary of Terms Used in Medical Electrical Equipment (General Terms)
KS C IEC 62266:2007 Medical electrical equipment－Guidelines for implementation of DICOM in radiotherapy

Japanese Industrial Standards Committee (JISC)

JIS Z 4005:2012 Medical electrical equipment -- Glossary of defined terms

IN-BIS

IS 13709-1993 Medical electrical equipment. Dental x-ray equipment. Radiation safety

GOST

GOST R 70987-2023 Medical electrical equipment. Microwave therapy equipment. Technical condition control methods

BE-NBN

NBN-EN 50072-1994 Medical electrical equipment. Particular requirements for the safety of peritoneal dialysis equipment

CZ-CSN

CSN EN 50072-1994 Medical electrical equipment.Particular requirements for safety of peritoneal dialysis equipment
CSN IEC 601-1:1994 Safety of medical electrical equipment.Part 1:General requirements

Danish Standards Foundation

DS/EN 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots