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Inspection of medical electrical equipment

Inspection of medical electrical equipment, Total:245 items.

In the international standard classification, Inspection of medical electrical equipment involves: Medical equipment, Electrical and electronic testing, Electricity. Magnetism. Electrical and magnetic measurements, Vocabularies, Electromagnetic compatibility (EMC), Hospital equipment, Radiation protection, Radiation measurements, Graphical symbols, Body care equipment, Pharmaceutics, Bottles. Pots. Jars, Domestic electrical appliances in general, Home economics in general, Electrical engineering in general, Applications of information technology, Electrical equipment for working in special conditions, Environmental testing, Shipbuilding and marine structures in general, Power transmission and distribution networks, Alarm and warning systems, Acoustics and acoustic measurements.

German Institute for Standardization, Inspection of medical electrical equipment

DIN EN 62274:2007 Medical electrical equipment - Safety of radiotherapy record and verify systems (IEC 62274:2005); German version EN 62274:2005
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 VDE 0404-3:2005 Testing and measuring equipment for testing the electrical safety of electrical devices - Part 3: Equipment for periodical tests and tests prior to commissioning medical electrical devices or systems
DIN EN IEC 62667:2020-10 Medical electrical equipment Medical light ion beam equipment Performance characteristics (IEC 62667:2017); German version EN IEC 62667:2018
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
DIN EN 60976:2011-02 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics (IEC 60976:2007); German version EN 60976:2007
DIN EN 60580:2001 Medical electrical equipment - Dose area product meters (IEC 60580:2000); German version EN 60580:2000
DIN EN IEC 62563-2:2020-12 Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests (IEC/CDV 62563-2:2020); German and English version prEN IEC 62563-2:2020 / Note: Date of issue 2020-11-20
DIN EN 60601-2-33:2008 Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2002 + A1:2005 + A2:2007); German version EN 60601-2-33:2002 + A1:2005 + A2:2008

Danish Standards Foundation, Inspection of medical electrical equipment

DS/EN 62353:2008 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
DS/IEC/TR 62354:2009 General testing procedures for medical electrical equipment
DS/IEC/TR 60788:2004 Medical electrical equipment - Glossary of defined terms
DS/EN 60976:2008 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
DS/EN 60580:2001 Medical electrical equipment - Dose area product meters
DS/EN 60601-1-8:2021 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
DS/EN 62274:2005 Medical electrical equipment - Safety of radiotherapy record and verify systems

AENOR, Inspection of medical electrical equipment

UNE-EN 62353:2015 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
UNE-EN 60976:2008 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
UNE-EN 60580:2001 Medical electrical equipment - Dose area product meters.
UNE-EN 62274:2005 Medical electrical equipment - Safety of radiotherapy record and verify systems

European Committee for Electrotechnical Standardization（CENELEC）, Inspection of medical electrical equipment

EN 62353:2008 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (Remains Current)
EN 62353:2014 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
EN IEC 62667:2018 Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
EN 60601-1-8:2007 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Inco
EN 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
HD 583 S1-1991 Medical Electrical Equipment Medical Electron Accelerators Functional Performance Characteristics
EN IEC 60580:2020 Medical electrical equipment - Dose area product meters
HD 395.1 S2-1988 Medical Electrical Equipment Part 1: General Requirements
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

国家质量监督检验检疫总局, Inspection of medical electrical equipment

SN/T 4445.1-2016 Technical requirements for inspection of imported medical devices Part 1: Medical electrical equipment

US-AAMI, Inspection of medical electrical equipment

AAMI/IEC TIR62354:2015 General testing procedures for medical electrical equipment

British Standards Institution (BSI), Inspection of medical electrical equipment

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 62354:2014 General testing procedures for medical electrical equipment
BS EN IEC 62667:2018 Medical electrical equipment. Medical light ion beam equipment. Performance characteristics
BS EN 62274:2005 Medical electrical equipment - Safety of radiotherapy record and verify systems
BS EN 60601-1-1:2001 Medical electrical equipment - General requirements for safety - Collateral standard - Safety requirements for medical electrical systems - Section 1.1 Collateral standard: Safety requirements for medical electrical systems
BS EN 60601-1-8:2007+A1:2013 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
BS EN 60601-1:1990 Medical electrical equipment - Part 1: General requirements for safety
BS EN 60601-2-2:2007 Medical electrical equipment - Particular requirements for the safety of high frequency surgical equipment
HB 10194-2001 Code of Practice for In-service Inspection and Testing of Electrical Equipment - 2nd edition
BS EN 60601-1-8:2007 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
BS EN 60601-1-4:1997 Medical electrical equipment - General requirements for safety - Collateral standard - General requirements for programmable electrical medical systems
BS EN 60079-17:2003 Electrical apparatus for explosive gas atmospheres. Inspection and maintenance of electrical installations in hazardous areas (other than mines)
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 62563-1:2010 Medical electrical equipment - Medical image display systems - Evaluation methods
BS EN 60601-2-36:1997 Medical electrical equipment. Particular requirements for safety. Specification for equipment for extra-corporeally induced lithotripsy
BS EN 62220-1:2004 Medical electrical equipment. Characteristics of digital X-ray imaging devices. Determination of the detective quantum efficiency
PD IEC/TR 60977:2008 Medical electrical equipment. Medical electron accelerators. Guidelines for 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 50194-1:2009 Electrical apparatus for the detection of combustible gases in domestic premises. Test methods and performance requirements
BS EN 50194-2:2006+A1:2016 Electrical apparatus for the detection of combustible gases in domestic premises. Test methods and performance requirements

Association Francaise de Normalisation, Inspection of medical electrical equipment

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 C74-309:1973 ELECTROMEDICAL EQUIPMENT ACTINOLOGY APPARATUS
NF C71-667*NF EN IEC 62667:2018 Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
NF C74-302:1964 Electromedical equipment. Galvanic current or low-medium-frequency equipment.
NF C74-301:1963 Electromedical equipment. High-frequency equipment.
NF C74-300:1973 Electromedical equipment. General requirements.
NF C74-208*NF EN 60976:2008 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
NF C74-103*NF EN 60580:2004 Medical electrical equipment - Dose area product meters
NF S95-156:1997 Medical electrical equipment. Capnometers for use with humans. Particular requirements.
NF S90-045:1985 Medico-surgical equipment. Aluminium caps for pharmaceutical use. Quality acceptance.
NF C74-208:2000 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics.
NF C74-103*NF EN IEC 60580:2020 Medical electrical equipment - Dose area product meters
NF C74-334/A1:2006 Medical electrical equipment - Part 2-38 : particular requirements for the safety of electrically operated hospital beds.
NF C74-387:1987 Electromedical equipment. Temperature monitoring equipment. Particular requirements for safety and operating.
NF C74-122/A1:2006 Medical electrical equipment - Part 2-33 : particular requirements for the safety of magnetic resonance equipment for medical diagnosis.
NF C74-208/A1:2001 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics.
NF C74-018:2005 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.
NF C74-018/A1:2006 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.
NF C74-205:1989 Medical electrical equipment. Dosimeters with ionization chambers as used in radiotherapy.
NF EN 60601-1-11:2015 Appareils électromédicaux - Partie 1-11 : exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : exigences pour les appareils électromédicaux et les systèmes électromédicaux utilisés dans l'env...
NF C74-337:1987 Medical electrical equipment - Ultrasound equipment for diagnostic Guide for the quality follow-up of ultrasonographic installations
NF C74-010:1983 ELECTROMEDICAL EQUIPMENT. SAFETY OF MEDICAL ELECTRICAL EQUIPMENT. PART 1 : GENERAL REQUIREMENTS.
NF C74-122:2005 Medical electrical equipment - Part 2-33 : particular requirements for the safety of magnetic resonance equipment for medical diagnosis.
NF C74-122:1996 Medical electrical equipment. Part 2 : particular requirements for the safety of magnetic resonance equipment for medical diagnosis.

International Electrotechnical Commission (IEC), Inspection of 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 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
IEC 60601-1:2022 Medical electrical equipment - ALL PARTS
IEC 60601-1:2023 Medical electrical equipment - ALL PARTS
IEC 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
IEC 60976:1989 Medical electrical equipment; medical electron accelerators; functional performance characteristics
IEC 60580:2000 Medical electrical equipment – Dose area product meters (Edition 2.0)
IEC 60878:1988 Graphical symbols for electrical equipment in medical practice
IEC 60580:2003 Medical electrical equipment - Dose area product meters
IEC TR3 61852:1998 Medical electrical equipment - Digital imaging and communications in medicine (DICOM) - Radiotherapy objects
IEC TR 62354:2005 General testing procedures for medical electrical equipment
IEC TR 62354:2009 General testing procedures for medical electrical equipment
IEC TR 62354:2014 General testing procedures for medical electrical equipment
IEC TR 60977:2008 Medical electrical equipment - Medical electron accelerators - Guidelines for functional performance characteristics
IEC TR 61592:2003 Household electrical appliances - Guidelines for consumer panel testing
IEC 60976/AMD1:2000 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics; Amendment 1
IEC PAS 61910-1:2007 Medical electrical equipment - Radiation dose documentation - Part 1: Equipment for radiography and radioscopy
IEC 62563-2:2021 Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays
IEC TR 60930:2008 Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems
IEC 60580:2019 RLV Medical electrical equipment - Dose area product meters
IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical el
IEC 60601-1-8:2005 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
IEC 60601-1-11:2020 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical sy
IEC 60601-1-11:2015+AMD1:2020 CSV Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical sy
IEC 60601-2-33:2010/AMD1:2013 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
IEC 60601-2-33:2006 Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
IEC 60601-1-8:2006/AMD2:2020 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical el
IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 CSV Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical el
IEC 60601-1-11:2015/AMD1:2020 Amendment 1 - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical
IEC 60601-2-27:1994 Medical electrical equipment - Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment
IEC 60601-2-33:2002 Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis

Japanese Industrial Standards Committee (JISC), Inspection of medical electrical equipment

JIS T 1003:1983 Testing methods for electrical safety of medical electrical equipment
JIS T 1004:1983 Testing methods for mechanical safety of medical electrical equipment
JIS T 0601-2-204:2005 Medical electrical equipment -- Particular requirements for the safety of pneumatic compression equipment
JIS T 1001:1992 General requirements for safety of medical electrical equipment
JIS T 1006:1992 Graphical symbols for medical electrical equipment
JIS T 0601-2-205:2005 Medical electrical equipment -- Particular requirements for the safety of medical practice massager
JIS T 1002:1992 General rules of testing methods for safety of medical electrical equipment
JIS T 0601-2-35:2005 Medical electrical equipment -- Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use
JIS T 1011:1988 Glossary of terms used in medical electrical equipment (general terms)
JIS T 0601-2-203:2005 Medical electrical equipment -- Particular requirements for the safety of infrared therapy equipment
JIS T 0601-2-3:2005 Medical electrical equipment -- Particular requirements for the safety of short-wave therapy equipment
JIS T 0601-2-5:2005 Medical electrical equipment -- Particular requirements for the safety of ultrasonic physiotherapy equipment
JIS T 0601-2-202:2005 Medical electrical equipment -- Particular requirements for the safety of ultraviolet therapy equipment
JIS T 0601-2-207:2005 Medical electrical equipment -- Particular requirements for the safety of xenon ray beam therapy equipment
JIS T 0601-2-206:2005 Medical electrical equipment -- Particular requirements for the safety of dry hot pack therapy equipment
JIS T 0601-2-208:2008 Medical electrical equipment -- Part 2-208: Particular requirements for the safety of electric potential equipment
JIS T 60601-1-8:2012 Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance -- Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
JIS T 1022:2006 Safety requirements of electrical installations for medically used rooms in hospitals and clinics
JIS T 1022:2018 Safety requirements of electrical installations for medically used rooms in hospitals and clinics
JIS Z 4951:2004 Medical electrical equipment -- Part 2-33: Particular requirements for the safety of magnetic resonance for medical diagnosis
JIS T 0601-2-37:2005 Medical electrical equipment -- Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment

Professional Standard - Medicine, Inspection of medical electrical equipment

YY/T 0841-2011 Medical electrical equipment.Recurrent test and test after repair of medical electrical equipment
YY/T 0841-2023 Medical electrical equipment Periodic testing and post-repair testing of medical electrical equipment
YY/T 1837-2022 General requirements for reliability of medical electrical equipment
YY 0319-2000 Medical electrical equipment.Part 2:Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
YY 0571-2013 Medical electrical equipment.Part 2 : Particular requirements for the safety of electrically operated hospital beds
YY 0319-2008 Medical Electrical Equipment.Part 2-33:Particular Requirements for the Safety of Magnetic Reconance Equipment for Medical Diagnosis
YY 0709-2009 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
YY 9706.264-2022 Medical electrical equipment Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
YY/T 0976-2016/IEC 60731:2011 Ionization chamber dosimeters for medical electrical equipment radiotherapy
YY 0784-2010 Medical electrical equipment.Particular requirements for the basic safety and essential performance of pulse oximeter equipement for medical use
YY/T 0063-2007 Medical electrical equipment X-ray tube assemblies for medical diagnosis- Characteristics of focal spots
YY 0721-2009 Medical electrical equipment.Safety of radiotherapy record and verify systems

ES-UNE, Inspection of medical electrical equipment

UNE-EN IEC 62667:2018 Medical electrical equipment - Medical light ion beam equipment - Performance characteristics (Endorsed by Asociación Española de Normalización in June of 2018.)
UNE-EN 60601-1-12:2015 Medical electrical equipment - Part 1-12: 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 serv...
UNE-EN 60601-1-12:2015/A1:2020 Medical electrical equipment - Part 1-12: 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 serv...

国家药监局, Inspection of medical electrical equipment

YY/T 1763-2021 Medical electrical equipment Medical light ion beam equipment performance characteristics
YY/T 1738-2020 Measurement method of energy consumption of medical electrical equipment
YY/T 1843-2022 Basic requirements for network security of medical electrical equipment

Shaanxi Provincial Standard of the People's Republic of China, Inspection of medical electrical equipment

DB61/T 1208-2018 Inspection specification for in-use medical laser equipment

Korean Agency for Technology and Standards (KATS), Inspection of medical electrical equipment

KS C 3598-2018 Medical electrical equipment ─ Glossary of defined terms
KS C IEC 62667:2019 Medical electrical equipment — Medical light ion beam equipment — Performance characteristics
KS C 1805-2020 Graphical symbols for medical electrical equipment
KS C 1005-1997(2007) General requirements for safety of medical electrical equipment
KS C IEC TR 60601-4-1:2020 Medical electrical equipment — Part 4-1: Guidance and interpretation — Medical electrical equipment and medical electrical systems employing a degree of autonomy
KS C IEC 60976:2012 Medical electrical equipment－Medical electron accelerators－Functional performance characteristics
KS C 1805-2014 Graphical symbols for medical electrical equipment
KS C 1805-1994 Graphical symbols for medical electrical equipment
KS C IEC 60580:2007 Medical electrical equipment－Dose area product meters
KS C IEC 61852:2007 Medical electrical equipment－Digital imaging and communications in medicine(DICOM)－Radiotherapy objects
KS C IEC 60601-1-11:2021 Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical sy
KS V 8017-2013 General Requirements for Degree of Protection and Inspection of Enclosures for Marine Electrical Apparatus
KS C IEC 60601-1-8:2005 Medical electrical equipment－Part 1－8：Generalrequirements for safety－Collateral standard：General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
KS C IEC 60601-1-8:2021 Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard:General requirements, tests and guidance for alarm systems in medical ele
KS C IEC 60601-1-8:2017 Medical electrical equipment－Part 1－8：Generalrequirements for safety－Collateral standard：General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
KS C IEC 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
KS C 6598-2007(2018) Electrical apparatus for the detection of combustible gases in domestic premises－Test methods and performance requirements

RU-GOST R, Inspection of medical electrical equipment

GOST R IEC 62353-2013 Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment
GOST IEC 60601-1-8-2011 Medical electrical equipment. Part 1-8. General requirements for safety. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical
GOST IEC 60976-2011 Medical electrical equipment. Medical electron accelerators. Functional characteristics
GOST R IEC 60976-2013 Medical electrical equipment. Medical electron accelerators. Functional performance characteristics
GOST IEC 60580-2011 Medical electrical equipment. Dose area product meters
GOST R 50267.33-1999 Medical electrical equipment. Part 2. Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
GOST R IEC 60336-2010 X-ray tube assemblies for medical diagnosis. Sharacteristics of focal spots

KR-KS, Inspection of medical electrical equipment

KS C IEC 62667-2019 Medical electrical equipment — Medical light ion beam equipment — Performance characteristics
KS C IEC TR 60601-4-1-2020 Medical electrical equipment — Part 4-1: Guidance and interpretation — Medical electrical equipment and medical electrical systems employing a degree of autonomy
KS C IEC 60601-1-8-2017 Medical electrical equipment－Part 1－8：Generalrequirements for safety－Collateral standard：General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrica
KS C IEC 60601-1-11-2021 Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical sy
KS C IEC 60731-2017 Medical electrical equipment－Dosimeters with ionization chambers as used in radiotherapy
KS C IEC 60601-1-8-2021 Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard:General requirements, tests and guidance for alarm systems in medical ele
KS C IEC 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
KS C 6598-2007(2023) Electrical apparatus for the detection of combustible gases in domestic premises－Test methods and performance requirements

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

GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
GB 9706.9-1997 Medical electrical equipment--Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
GB 9706.6-1992 Particular requirements for the safety of microwave therapy equipment
GB 9706.7-1994 Medical electrical equipment-Particular requirements for the safety of ultrasonic therapy equipment
GB/T 20012-2005 Medical electrical equipment.Dose area product meters
GB 9706.25-2005 Medical electrrical equipment Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment
GB/T 5170.11-2008 Inspection methods for environmental testing equipments for electric and electronic products.Corrosive gas testing equipments
GB/T 17995-1999 Guidelines for administrative,medical,and nursing staff concerned with the safe use of medical electrical equipment
GB 9706.19-2000 Medical electrical equipment-Part 2:Particular requirements for the safety of endoscopic equipment
GB 9706.14-1997 Medical electrical equipment--Part 2: Particular requirements for the safety of associated equipment of X-ray equipment
GB 9706.5-1992 Medical electrical equipment.Particular requirements for the safety of medical electron accelerators in the range 1 MeV to 50 MeV

Lithuanian Standards Office , Inspection of medical electrical equipment

LST EN 62353-2015 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (IEC 62353:2014)
LST EN 60601-1-8-2007/A1-2013/AC-2014 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
LST EN 60976-2008 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics (IEC 60976:2007)
LST EN 60601-1-12-2015 Medical electrical equipment - Part 1-12: 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 service
LST EN 60601-1-12/A1-2020 Medical electrical equipment - Part 1-12: 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 service

European Committee for Standardization (CEN), Inspection of medical electrical equipment

prEN 793-1992 Medical electrical equipment; particular requirements for safety of medical supply units
prEN 60601-2-27-1992 Medical electrical equipment; part 2: particular requirements for the safety of electrocardiographic monitoring equipment
HD 395.1 S2 prAA-1992 Medical electrical equipment; part 1: general requirements

IN-BIS, Inspection of medical electrical equipment

IS 7583-1991

BR-ABNT, Inspection of medical electrical equipment

ABNT IEC/TR 60878:2020 Graphical symbols for electrical equipment in medical practice

International Organization for Standardization (ISO), Inspection of 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
ISO 11197:1996 Medical electrical equipment - Particular requirements for safety of medical supply units
IEC 60601-1-8:2003/AMD1:2006 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 e
IEC 60601-1-8:2003/AMD 1:2006 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 e
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
ISO/CD 12487:2023 Medical electrical equipment — Clinical investigation of clinical thermometers
IEC 60601-1-8:2006/AMD 1:2012 Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical el
IEC 60601-1-8:2006/AMD 2:2020 Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical el

YU-JUS, Inspection of medical electrical equipment

JUS N.S5.006-1982 Dielectric strength tests ofmedical electrical eguipment and accessories
JUS N.S5.002-1985 Classification and marking of medica/ electrical egu/'pments
JUS N.S5.003-1987 Graphical symbols for use on electrical equipment in medical practice

RO-ASRO, Inspection of medical electrical equipment

STAS 11224-1980 MEDICAL ELECTRICAL EQUIPMENT Terminology and classification

Standard Association of Australia （SAA）, Inspection of medical electrical equipment

AS/NZS 4334:1995 Graphic symbols for use on medical electrical equipment
AS/NZS IEC 60976:2022 Medical electrical equipment — Medical electron accelerators — Functional performance characteristics
AS/NZS 2500:2020 Safe use of medical electrical equipment in health care
AS/NZS 3200.2.33:1996 Approval and test specification - Medical electrical equipment - Particular requirements for safety - Magnetic resonance equipment for medical diagnosis
AS/NZS 3200.1.4:1997 Approval and test specification - Medical electrical equipment - General requirements for safety - Collateral Standard: Programmable electrical medical systems
AS/NZS 3760:2010
AS/NZS 3200.2.27:1996 Approval and test specification - Medical electrical equipment - Particular requirements for safety - Electrocardiographic monitoring equipment
AS/NZS 3200.2.18:1997 Approval and test specification - Medical electrical equipment - Particular requirements for safety - Endoscopic equipment
AS/NZS 3200.1.1:1995 Approval and test specification - Medical electrical equipment - General requirements for safety - Collateral Standard: Safety requirements for medical electrical systems

Professional Standard - Commodity Inspection, Inspection of medical electrical equipment

SN/T 1672.6-2013 Rules for the inspection of import and export medical equipment.Part 6:Magnetic resonance imaging equipment for medical diagnosis
SN/T 1672.7-2013 Rules for the inspection of medical equipment for import and export.Part 7:Medical endoscope
SN/T 1430.1-2004 Rules for the inspection of medical electrical equipment for import--Ultrasonic medical diagnostic and therapy equipment
SN/T 1672.5-2006 Rules for the inspection of medical electrical equiment for import and export. Part 5: Medical diagnostic X-ray equipment

未注明发布机构, Inspection of medical electrical equipment

DIN EN IEC 62667:2020 Medical electrical devices – Medical light ion irradiation devices – Apparatus quality characteristics (IEC 62667:2017)

CENELEC - European Committee for Electrotechnical Standardization, Inspection of medical electrical equipment

EN 60601-1-8:2004 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 (Incorporates Amendment A1: 2006)
EN 60601-1-8:2007/A11:2017 Medical Electrical Equipment Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment
EN 62276:2005 Medical electrical equipment – Safety of radiotherapy record and verify systems
EN 60601-1-12:2015 Medical electrical equipment - Part 1-12: 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 service
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

SE-SIS, Inspection of medical electrical equipment

SIS SS-IEC 976:1991 Medical electrical equipment — Medical electron accelerators — Functionalperformance charactetistics
SIS SS 486 03 22-1985 Me di ca I electrical equipment — Particular requirements for the safety of high frequency surgical equipment

Canadian Standards Association (CSA), Inspection of medical electrical equipment

CAN/CSA-C22.2 NO.60601-1-8-2008 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Seco

NZ-SNZ, Inspection of medical electrical equipment

AS/NZS 3200.2.33:2005 Medical electrical equipment Part 2.33: Particular requirements for safetyMagnetic resonance equipment for medical diagnosis

Shanxi Provincial Standard of the People's Republic of China, Inspection of medical electrical equipment

DB14/T 2390.2-2021 Technical Specifications for Inspection of Medical Oxygen Chamber Part 2: Electrical System Inspection

PL-PKN, Inspection of medical electrical equipment

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