Inspection of medical electrical equipment

Inspection of medical electrical equipment, Total:186 items.

The international standard classification for "Inspection of medical electrical equipment" includes: Diagnostic equipment , Radiographic equipment , Medical equipment , Hospital equipment .

The Chinese standard classification for "Inspection of medical electrical equipment" includes: Medical optical instrument and endoscope , Medical apparatus and devices in general , Medical radiographic equipment , Medical ultrasound, laser, high-frequency instrument and equipment , Physiotherapy and TCM instrument and equipment .

Professional Standard - Commodity Inspection

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 1672.1-2013 Rules for the inspection of import and export medical equipment - Part 1: General requirements
SN/T 1672.7-2013 Rules for the inspection of medical equipment for import and export - Part 7: Medical endoscopes

国家质量监督检验检疫总局

SN/T 4445.1-2016 Technical requirements for the inspection of medical apparatus for import-Part 1: Medical electrical equipment

Shaanxi Provincial Standard of the People's Republic of China

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

Professional Standard - Medicine

YY/T 0841-2023 Medical electrical equipment---Recurrent test and test after repair ofmedical electrical equipment
YY/T 0841-2011 Medical electrical equipment—Recurrent test and test after repair of medical electrical equipment
YY/T 1837-2022 Medical electrical equipment—General requirements for reliability
YY 0319-2000 Medical electrical equipment―Part 2:Particular requirements for the safety of magnetic resonance equipment for medical diagnosis

国家药监局

YY/T 1738-2020 Energy consumption measurement methods for medical electrical equipment
YY/T 1763-2021 Medical electrical equipment—Medical light ion beam equipment—Performance characteristics

未注明发布机构

DIN EN IEC 62667:2020 Medical electrical devices – Medical light ion irradiation devices – Apparatus quality characteristics (IEC 62667:2017)
IEC 80601-2-77:2023 Medical electrical equipment
AS/NZS 4334:1995/AMD 1:1996 Graphic symbols for use on medical electrical equipment
PD IEC TS 60601-4-2:2024 Medical electrical equipment Part 4-2: Guidance and interpretation — Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems

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

GB 9706.9-1997 Medical electrical equipment-Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
GB 9706.7-1994 Medical electrical equipment－Particular requirements for the safety of ultrasonic therapy equipment
GB 9706.6-1992 Particular requirements for the safety of microwave therapy equipment
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment

Shanxi Provincial Standard of the People's Republic of China

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

AENOR

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

Danish Standards Foundation

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

European Committee for Electrotechnical Standardization（CENELEC）

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

SCC

CEI EN 62353:2015 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
DANSK DS/EN 62353:2014 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
UNE-EN 62353:2009 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
AENOR UNE-EN 62353:2015 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
05/30107843 DC IEC 62353. Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment
BS PD IEC TS 60601-4-2:2024 Medical electrical equipment-Guidance and interpretation. Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
CEI EN IEC 62667:2018 Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
DANSK DS/EN IEC 62667:2018 Medical electrical equipment – Medical light ion beam equipment – Performance characteristics
DANSK DS/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
BS EN ISO 8359:1997 Medical electrical equipment. Oxygen concentrators for medical use. Safety requirements
AAMI/IEC TIR62354:2009 General testing procedures for medical electrical equipment
DANSK DS/IEC/TR 62354:2009 General testing procedures for medical electrical equipment
BS PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
DIN EN 62353 E:2012 Draft Document - Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (IEC 62A/798/CD:2012)
AS 2290.2:1989 Electrical equipment for coal mines - Maintenance and overhaul - Overhaul of electrical equipment for hazardous areas
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
UNE-EN 60976:2001 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics.
AENOR UNE-EN 60976:2008 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
CEI EN 60976:2009 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
BS EN 60976:2001 Medical electrical equipment. Medical electron accelerators. Functional performance characteristics
BS 5724-2-2.28:1993 Medical electrical equipment. Particular requirements for safety-Specification for electrically powered suction equipment
DANSK DS/EN 60976:2008 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
BS 5724-2-2.28:1990 Medical electrical equipment. Particular requirements for safety-Specification for suction equipment
BS 5724-2.11.2:1993 Medical electrical equipment. Particular requirements for safety-Methods of test for radiation safety
AS 3009:1985 Electrical installations - Emergency power supplies in hospitals

GSO

OS GSO IEC 62353:2017 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
GSO IEC 62353:2017 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
GSO IEC TR 60601-4-1:2021 Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
GSO IEC 62058-11:2012 ELECTRICITY METERING EQUIPMENT (AC) – ACCEPTANCE INSPECTION – Part 11: General acceptance inspection methods
OS GSO IEC/TR 62354:2014 General testing procedures for medical electrical equipment
BH GSO IEC/TR 62354:2016 General testing procedures for medical electrical equipment
OS GSO IEC 60976:2014 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
GSO IEC 60976:2014 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
BH GSO IEC/TR 60930:2017 Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems
OS GSO IEC/TR 60930:2016 Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems
GSO IEC/TR 60930:2016 Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems

VDE - VDE Verlag GmbH@ Berlin@ Germany

VDE 0751-1-2015 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (IEC 62353:2014); German version EN 62353:2014
VDE 0750-224-2003 Medizinische elektrische Geraete - Teil 224: Besondere Festlegungen fuer die Sicherheit von elektromedizinischen Badeeinrichtungen

Korean Agency for Technology and Standards (KATS)

KS P 1007-1997 Test methods for electrical safety of Medical Electrical Equipment
KS P 1008-1997 Test methods for mechanical safety 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 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 1805-2020 Graphical symbols for medical electrical equipment
KS C IEC 60976:2012 Medical electrical equipment－Medical electron accelerators－Functional performance characteristics
KS C 1005-1997(2007) General requirements for safety of 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 1805-2014 Graphical symbols for medical electrical equipment
KS C 1805-1994 Graphical symbols for medical electrical equipment
KS C 0915-2002 ELECTRICAL APPARATUS FOR EXPLOSIVE GAS ATMOSPHERES-CONSTRUNCTION AND VERTIFICATION TEST OF FLAMEPROOF ENCLOSURES OF ELECTRICAL APPARATUS

US-AAMI

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

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 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 C74-208*NF EN 60976:2008 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
NF C74-300:1973 Electromedical equipment. General requirements.
NF S90-045:1985 Medico-surgical equipment. Aluminium caps for pharmaceutical use. Quality acceptance.
NF S95-156:1997 Medical electrical equipment. Capnometers for use with humans. Particular requirements.
NF C74-103*NF EN 60580:2004 Medical electrical equipment - Dose area product meters
NF C74-387:1987 Electromedical equipment. Temperature monitoring equipment. Particular requirements for safety and operating.
NF C74-208:2000 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics.

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 62274:2007 Medical electrical equipment - Safety of radiotherapy record and verify systems (IEC 62274:2005); German version EN 62274:2005
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

International Electrotechnical Commission (IEC)

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 60976:1989 Medical electrical equipment; medical electron accelerators; functional performance characteristics
IEC 60601-1:2023 Medical electrical equipment - ALL PARTS
IEC 60601-1:2022 Medical electrical equipment - ALL PARTS
IEC 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
IEC TR 62354:2009 General testing procedures for medical electrical equipment
IEC TR 62354:2014 General testing procedures for medical electrical equipment
IEC TR 62354:2005 General testing procedures for medical electrical equipment
IEC 60580:2003 Medical electrical equipment - Dose area product meters
IEC 60580:2000 Medical electrical equipment – Dose area product meters (Edition 2.0)
IEC TR3 61852:1998 Medical electrical equipment - Digital imaging and communications in medicine (DICOM) - Radiotherapy objects
IEC 60878:1988 Graphical symbols for electrical equipment in medical practice
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 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 60976/AMD1:2000 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics; Amendment 1

British Standards Institution (BSI)

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 62274:2005 Medical electrical equipment - Safety of radiotherapy record and verify systems
PD ISO/TR 25555:2024 Ageing societies. Accessibility and usability considerations for home healthcare products, related services and environments
BS EN IEC 62667:2018 Medical electrical equipment. Medical light ion beam equipment. Performance characteristics
BS ISO 24163-2:2024 Clamp-in tyre valves for tyre pressure monitoring systems - Test methods and performance
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 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
BS EN 60601-1:2006+A13:2024 Medical electrical equipment - General requirements for safety
PD IEC/TR 60601-4-2:2016 Medical electrical equipment. Guidance and interpretation. Electromagnetic immunity: performance of medical electrical equipment and 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
HB 10194-2001 Code of Practice for In-service Inspection and Testing of Electrical Equipment - 2nd edition

Japanese Industrial Standards Committee (JISC)

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 1002:1992 General rules of testing methods 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 1001:1992 General requirements 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 0601-2-203:2005 Medical electrical equipment -- Particular requirements for the safety of infrared therapy equipment
JIS T 1011:1988 Glossary of terms used in medical electrical equipment (general terms)
JIS T 0601-2-5:2005 Medical electrical equipment -- Particular requirements for the safety of ultrasonic physiotherapy equipment
JIS T 0601-2-3:2005 Medical electrical equipment -- Particular requirements for the safety of short-wave therapy equipment

ES-UNE

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.)

RU-GOST R

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 R IEC 62353-2013 Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment
GOST IEC 60976-2011 Medical electrical equipment. Medical electron accelerators. Functional characteristics

International Organization for Standardization (ISO)

IEC 80601-2-26:2019/AMD1:2024 Medical electrical equipment
ISO 80601-2-13:2022/AWI Amd 1:2024 Medical electrical equipment
ISO/FDIS 80601-2-79:2024 Medical electrical equipment
ISO 80601-2-55:2018/Amd 1:2023 Medical electrical equipment
ISO/FDIS 80601-2-80:2024 Medical electrical equipment
IEC 80601-2-77:2019/AMD1:2023 Medical electrical equipment
IEC 80601-2-58:2024 Medical electrical equipment
ISO/CD 80601-2-90.2:2024 Medical electrical equipment
ISO/CD 80601-2-74.2:2024 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
ISO 11197:1996 Medical electrical equipment - Particular requirements for safety of medical supply units
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 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/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

Lithuanian Standards Office

LST EN 62353-2015 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (IEC 62353:2014)

KR-KS

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

IEC - International Electrotechnical Commission

IEC 62667:2017 Appareils électromédicaux – Appareils médicaux par faisceau d'ions légers – Caractéristiques de performances (Edition 1.0)

YU-JUS

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

IN-BIS

IS 7583-1991 Medical electrical equipment—High frequency surgical equipment—Specifications

BR-ABNT

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

European Committee for Standardization (CEN)

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

HU-MSZT

MNOSZ 14658-1955 Medical equipment gynecological examination tools

CENELEC - European Committee for Electrotechnical Standardization

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

RO-ASRO

STAS 11224-1980 MEDICAL ELECTRICAL EQUIPMENT Terminology and classification

Standard Association of Australia （SAA）

AS/NZS 3760:2010 In-service safety inspection and testing of electrical equipment
AS/NZS 4334:1995 Graphic symbols for use on medical electrical equipment
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 IEC 60976:2022 Medical electrical equipment — Medical electron accelerators — Functional performance characteristics
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 2500:2020 Safe use of medical electrical equipment in health care

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