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Medical special equipment

Medical special equipment, Total:499 items.

In the international standard classification, Medical special equipment involves: Medical equipment, Radiation protection, Sterilization and disinfection, Vocabularies, Applications of information technology, Pharmaceutics, Radiation measurements, Surface treatment and coating, Dentistry, Hospital equipment, Laboratory medicine, Graphical symbols, Wastes, Radiocommunications, Medical sciences and health care facilities in general, Domestic electrical appliances in general, Miscellaneous domestic and commercial equipment, Aids for disabled or handicapped persons, Ergonomics, Acoustics and acoustic measurements, Quality, Body care equipment.

Association Francaise de Normalisation, Medical special equipment

NF EN IEC 62667:2018 Appareils électromédicaux - Appareils médicaux par faisceau d'ions légers - Caractéristiques de performances
NF C74-122/A2:2008 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 C74-054:2008 Medical devices - Application of usability engineering to medical devices.
NF C74-122:1996 Medical electrical equipment. Part 2 : particular requirements for the safety of magnetic resonance equipment for medical diagnosis.
NF C74-309:1973 ELECTROMEDICAL EQUIPMENT ACTINOLOGY APPARATUS
NF EN 1640:2009 Art dentaire - Dispositifs médicaux pour l'art dentaire - Matériel
NF EN IEC 60336:2021 Appareils électromédicaux - Gaines équipées pour diagnostic médical - Dimensions des foyers et caractéristiques connexes
NF EN 60976:2008 Appareils électromédicaux - Accélérateurs médicaux d'électrons - Caractéristiques fonctionnelles de performance
NF S90-251:1986 Medico-surgical equipment. Syringe pumps. Operating characteristics.
NF C74-208:2000 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics.
NF C74-054-1*NF EN 62366-1:2015 Medical devices - Part 1 : application of usability engineering to medical devices
NF EN 62366-1/A1:2020 Dispositifs médicaux - Partie 1 : application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux
NF EN 62366-1:2015 Dispositifs médicaux - Partie 1 : application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux
NF C74-116*NF EN IEC 60336:2021 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics
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 62353:2015 Appareils électromédicaux - Essai récurrent et essai après réparation d'un appareil électromédical
NF C74-116*NF EN 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
NF C74-209:1991 Medical electrical equipment - Medical electron accelerators in the range of 1 MeV to 50 MeV - Guidelines for functional performance characteristics
NF C74-372:1985 Electromedical equipment. Microwave therapy equipment. Particular safety requirements.
NF C74-122/A11*NF EN 60601-2-33/A11:2012 Medical electrical equipment - Part 2-33 : particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
NF C74-122*NF EN 60601-2-33:2011 Medical electrical equipment - Part 2-33 : particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
NF EN 60601-2-64:2015 Appareils électromédicaux - Partie 2-64 : exigences particulières pour la sécurité de base et les performances essentielles des appareils électromédicaux par faisceau d'ions légers
NF EN ISO 17664-1:2021 Traitement de produits de soins de santé - Informations relatives au traitement des dispositifs médicaux à fournir par le fabricant du dispositif - Partie 1 : dispositifs médicaux critiques et semi-critiques
NF C74-122:2005 Medical electrical equipment - Part 2-33 : particular requirements for the safety of magnetic resonance equipment for medical diagnosis.
NF C15-211:2006 Low-voltage electrical installations - Installations in medically used rooms
NF S90-316:1987 Medico-surgical equipment. Operating tables.
NF C74-352/A1*NF EN 60601-2-52/A1:2015 Medical electrical equipment - Part 2-52 : particular requirements for basic safety and essential performance of medical beds
NF ISO 17664-2:2021 Traitement de produits de soins de santé - Informations relatives au traitement des dispositifs médicaux à fournir par le fabricant du dispositif - Partie 2 : dispositifs médicaux non critiques
NF C74-341:1996 Medical electrical equipment. Part 2: particular requirements for the safety of diagnostic and therapeutic laser equipment
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 C74-335:2005 Medical electrical equipment - Part 2-37 : particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.
NF C74-335/A11*NF EN 60601-2-37/A11:2012 Medical electrical equipment - Part 2-37 : particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
NF C74-370/A1:2005 Medical electrical equipment - Part 2 : particular requirements for the safety of short-wave therapy equipment.
NF C74-365:1993 Medical electrical equipment. Part 2 : particular requirements for the safety of high frequency surgical equipment.
NF C74-318:1997 Medical electrical equipment. Part 2 : particular requirements for the safety of endoscopic equipment.
NF C74-335/A1:2005 Medical electrical equipment - Part 2-37 : particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.
NF C74-335/A2:2006 Medical electrical equipment - Part 2-37 : particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.
NF S90-201:1990 Medico-surgical equipment. Transfusion sets.
NF S90-202:1990 Medico-surgical equipment . Infusion sets.
NF EN 1641:2009 Art dentaire - Dispositifs médicaux pour l'art dentaire - Produits
NF EN 1639:2009 Art dentaire - Dispositifs médicaux pour l'art dentaire - Instruments
NF EN ISO 19054:2006 Systèmes de rails de support pour appareils médicaux
NF C74-118:1993 Medical electrical equipment. Part 2 : particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis.
NF C74-306:1986 Medical electrical equipment. Ultrasonic therapy equipment. Part 2 : particular requirements for safety.
NF C74-369:1990 Medical electrical equipment. Part 2 : particular requirements for safety of electroconvulsive therapy equipment.
NF C74-370:1994 Medical electrical equipment. Part 2 : particular requirements for the safety of short-wave therapy equipment.
NF C74-372*NF EN 60601-2-6:2015 Medical electrical equipment - Part 2-6 : particular requirements for the basic safety and essential performance of microwave therapy equipment
NF C74-350/A11*NF EN 60601-2-50/A11:2012 Medical electrical equipment - Part 2-50 : particular requirements for the basic safety and essential performance of infant phototherapy equipment
NF C74-370*NF EN 60601-2-3:2015 Medical electrical equipment - Part 2-3 : particular requirements for the basic safety and essential performance of short-wave therapy equipment
NF EN 60601-2-11:2015 Appareils électromédicaux - Partie 2-11 : exigences particulières pour la sécurité de base et les performances essentielles des appareils de gammathérapie
NF EN 60601-2-3/A1:2016 Appareils électromédicaux - Partie 2-3 : exigences particulières pour la sécurité de base et les performances essentielles des appareils de thérapie à ondes courtes
NF EN 60601-2-3:2015 Appareils électromédicaux - Partie 2-3 : exigences particulières pour la sécurité de base et les performances essentielles des appareils de thérapie à ondes courtes
NF S98-116:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices.
NF S95-186:2005 Medical devices for conserving oxygen and oxygen mixtures - Particular requirements.
NF C74-211*NF EN 61168:1994 Medical electrical equipment. Functional performance characteristics of radiotherapy simulators.
NF C74-350:2005 Medical electrical equipment - Part 2-50 : particular requirements for the safety of infant phototherapy equipment.
NF C74-365:2006 Medical electrical equipment - Part 2-2 : particular requirements for the safety of high frequency surgical equipment.
NF C74-327:1993 Medical electrical equipment. Particular requirements for the safety of peritoneal dialysis equipment.
NF EN 60601-2-5:2015 Appareils électromédicaux - Partie 2-5 : exigences particulières pour la sécurité de base et les performances essentielles des appareils à ultrasons pour physiothérapie
NF EN IEC 60601-2-50:2021 Appareils électromédicaux - Partie 2-50 : exigences particulières pour la sécurité de base et les performances essentielles des appareils de photothérapie pour nouveau-nés
NF C74-330:1997 Medical electrical equipment. Part 2 : particular requirements for the safety of blankets, pads and mattresses,intended for heating in medical use.
NF C74-203:2000 Medical electrical equipment - Part 2 : particular requirements for the safety of gamma beam therapy equipment.
NF S97-317/A1:2002 Rail systems for supporting medical equipment.
NF S95-317*NF EN ISO 19054:2006 Rail systems for supporting medical equipment
NF S91-300*NF EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment
NF S95-156:1997 Medical electrical equipment. Capnometers for use with humans. Particular requirements.
NF EN 61267:2006 Équipement de diagnostic médical à rayonnement X - Conditions de rayonnement pour utilisation dans la détermination des caractéristiques
NF C74-203/A1:2005 Medical electrical equipment - Part 2-11 : particular requirements for the safety of gamma beam therapy equipment.
NF C74-203*NF EN 60601-2-11:2015 Medical electrical equipment - Part 2-11 : particular requirements for basic safety and essential performance of gamma beam therapy equipment

British Standards Institution (BSI), Medical special equipment

BS EN 60976:2008 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
BS EN 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
BS EN 556-2:2004 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices
BS EN IEC 62667:2018 Medical electrical equipment. Medical light ion beam equipment. Performance characteristics
BS EN 60601-2-3:1992 Medical electrical equipment. Particular requirements for safety. Specification for short-wave therapy equipment
BS EN 60601-2-3:1993 Medical electrical equipment. Particular requirements for safety. Specification for short-wave therapy equipment
BS EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
BS EN 62366:2008 Medical devices - Application of usability engineering to medical devices
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 60601-2-33:2010+A12:2016 Medical electrical equipment. Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
BS EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
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 60601-2-37:2008 Medical electrical equipment - Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
BS EN 60601-2-3:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of short-wave therapy equipment
BS EN 60601-2-6:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of microwave therapy equipment
BS EN 60601-2-6:2015+A1:2016 Medical electrical equipment. Particular requirements for the basic safety and essential performance of microwave therapy equipment
BS EN IEC 60601-2-83:2020 Medical electrical equipment. Particular requirements for the basic safety and essential performance of home light therapy equipment
BS EN 60601-2-3:2015+A1:2016 Medical electrical equipment. Particular requirements for the basic safety and essential performance of short-wave therapy equipment
BS EN 60601-2-33:2002 Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
BS EN ISO 10079-1:2015 Medical suction equipment. Electrically powered suction equipment
BS EN ISO 10079-2:2000 Medical suction equipment - Manually powered suction equipment
BS EN ISO 10079-2:1997 Medical suction equipment. Manually powered suction equipment
BS EN ISO 10079-1:2015+A1:2019 Medical suction equipment. Electrically powered suction equipment
BS EN 60601-2-50:2002 Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety of infant phototherapy equipment
BS EN ISO 18779:2005 Medical devices for conserving oxygen and oxygen mixtures - Particular requirements
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 EN 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
PD IEC/TR 60977:2008 Medical electrical equipment. Medical electron accelerators. Guidelines for functional performance characteristics
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 60601-2-25:1996 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 IEC 60336:2021 Medical electrical equipment. X-ray tube assemblies for medical diagnosis. Focal spot dimensions and related characteristics
DD ENV 12611-1998 Medical informatics. Categorical structure of systems of concepts. Medical devices
BS EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices
BS EN IEC 60601-2-50:2021 Tracked Changes. Medical electrical equipment. Particular requirements for the basic safety and essential performance of infant phototherapy equipment
BS EN 60601-2-5:2015 Tracked Changes. Medical electrical equipment. Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
BS EN 60601-2-52:2010+A1:2015 Medical electrical equipment. Particular requirements for basic safety and essential performance of medical beds
BS EN 15986:2011 Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
BS EN 80601-2-60:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of dental equipment
BS EN 60601-2-37:2001 Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
BS EN 60601-2-62:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
BS EN ISO 9170-1:2008 Terminal units for medical gas pipeline systems - Terminal units for use with compressed medical gases and vacuum
BS EN ISO 10079-3:2000 Medical suction equipment - Suction equipment powered from a vacuum or pressure source
BS EN ISO 10079-3:1997 Medical suction equipment. Suction equipment powered from vacuum or pressure source
BS EN 62220-1:2004 Medical electrical equipment. Characteristics of digital X-ray imaging devices. Determination of the detective quantum efficiency
BS EN 60601-2-11:2015 Tracked Changes. Medical electrical equipment. Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
BS DD ISO/TS 10993-20:2006 Biological evaluation of medical devices - Principles and methods for immunotoxicology testing of medical devices
22/30461075 DC BS EN 60601-2-37. Medical electrical equipment - Part 2-37. Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
20/30423003 DC BS EN IEC 60601-2-33. Medical electrical equipment. Part 2-33. Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
BS EN ISO 19054:2006+A1:2016 Rail systems for supporting medical equipment
PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
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 60601-2-8:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
BS EN 60601-2-27:2014 Medical electrical equipment. Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
PD IEC/TR 80002-1:2009 Medical device software. Guidance on the application of ISO 14971 to medical device software
18/30370883 DC BS EN ISO 14971. Medical devices. Application of risk management to medical devices
BS EN IEC 60601-2-75:2019 Medical Electrical Equipment. Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment
BS EN ISO 80601-2-84:2020 Medical electrical equipment. Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
BS ISO 28620:2010 Medical devices - Non-electrically driven portable infusion devices
BS EN ISO 10079-2:2022 Tracked Changes. Medical suction equipment. Manually powered suction equipment
BS EN ISO 10079-1:2022 Tracked Changes. Medical suction equipment. Electrically powered suction equipment
BS ISO 28620:2020 Tracked Changes. Medical devices. Non-electrically driven portable infusion devices
PD IEC/TR 62266:2002 Medical electrical equipment. Guidelines for implementation of DICOM in radiotherapy
18/30372517 DC BS EN 60336. Medical electrical equipment. X-ray tube assemblies for medical diagnosis. Characteristics of focal spots
BS ISO/IEEE 11073-20702:2018 Health informatics. Point-of-care medical device communication. Medical devices communication profile for web services

Korean Agency for Technology and Standards (KATS), Medical special equipment

KS C IEC 62667:2019 Medical electrical equipment — Medical light ion beam equipment — Performance characteristics
KS C IEC 60976:2020 Medical electrical equipment — Medical electron accelerators — Functional performance characteristics
KS C 1103-1990 Glossary of Terms Used in Medical Electrical Equipment (General Terms)
KS C IEC TR 60977:2020 Medical electrical equipment — Medical electron accelerators — Guidelines for functional performance characteristics
KS C IEC TR 60977:2017 Medical electrical equipment－Medical electron accelerators－Guidelines for functional performance characteristics
KS C IEC 60601-2-32:2002 Medical electrical equipment－Part 2 : Particular requirements for the safety of associated equipment of X-ray equipment
KS C IEC 60601-2-33:2011 Medical electrical equipment－Part 2-33：Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
KS C IEC 60601-2-33:2017 Medical electrical equipment－Part 2-33：Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
KS C IEC 60601-2-37:2011 Medical electrical equipment－Part 2-37：Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
KS A 4001-1989(2020) Graphical symbols for medical radiological equipment
KS C IEC 60601-2-28:2011 Medical electrical equipment－Part 2-28：Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
KS C IEC 60977:2012 Medical electrical equipment－Medical electron accelerators－Guidelines for functional performance characteristics
KS C IEC 61852:2007 Medical electrical equipment－Digital imaging and communications in medicine(DICOM)－Radiotherapy objects
KS C IEC 60601-2-11:2018 Medical electrical equipment — Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
KS C IEC 80601-2-77:2020 Medical electrical equipment — Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

KR-KS, Medical special equipment

KS C IEC 62667-2019 Medical electrical equipment — Medical light ion beam equipment — Performance characteristics
KS C IEC 60976-2020 Medical electrical equipment — Medical electron accelerators — Functional performance characteristics
KS C IEC 60336-2017 Medical electrical equipment — X-ray tube assemblies for medical diagnosis — Characteristics of focal spots
KS C IEC TR 60977-2020 Medical electrical equipment — Medical electron accelerators — Guidelines for functional performance characteristics
KS C IEC 60601-2-3-2017 Medical electrical equipment — Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment
KS C IEC 60601-2-50-2017 Medical electrical equipment — Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
KS C IEC 60601-2-50-2022 Medical electrical equipment ─ Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
KS P ISO 10079-1-2017 Medical suction equipment — Part 1:Electrically powered suction equipment
KS C IEC 60601-2-11-2018 Medical electrical equipment — Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
KS C IEC 60336-2022 Medical electrical equipment — X-ray tube assemblies for medical diagnosis — Focal spot dimensions and related characteristics
KS C IEC 80601-2-77-2020 Medical electrical equipment — Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

AENOR, Medical special equipment

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-EN 60336:2006 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
UNE-EN 62366:2009 Medical devices- Application of usability engineering to medical devices
UNE-EN 60601-2-3:1996 MEDICAL ELECTRICAL EQUIPMENT. PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF SHORT-WAVE THERAPY EQUIPMENT.
UNE-EN 60601-2-11:1999 MEDICAL ELECTRICAL EQUIPMENT. PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF GAMMA BEAM THERAPY EQUIPMENT
UNE-EN 60601-2-18:1997 MEDICAL ELECTRICAL EQUIPMENT. PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ENDOSCOPIC EQUIPMENT.
UNE-EN 1640:2010 Dentistry - Medical devices for dentistry - Equipment
UNE-EN 60601-2-11:1999/A1:2005 Medical electrical equipment -- Part 2-11: Particular requirements for the safety of gamma beam therapy equipment
UNE-EN 60601-2-36:1998 MEDICAL ELECTRICAL EQUIPMENT. PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY.

SE-SIS, Medical special equipment

SIS SS-IEC 976:1991 Medical electrical equipment — Medical electron accelerators — Functionalperformance charactetistics
SIS SS-IEC 601-2-12:1991 Medical electrical equipment - Part 2: Particular requirements for the safety oflung ventilators for medical use
SIS SS IEC 601-2-3:1988 Medical e/ectrical equipment — Particular requirements for the safety ofshort-wave therapy equipment
SIS SS IEC 601-2-6:1988 Medical electrical equipment — Particular requirements for the safety of microwave therapy equipment
SIS SS 486 03 31-1990 Medical electrical equipment — Particular requirements for the safety of gamma beam therapy equipment
SIS SS-IEC 601-2-14:1991 Medical electrical equipment - Part 2: Particular requirements for the safety ofelectroconvulsive therapy equipment

Standard Association of Australia （SAA）, Medical special equipment

AS/NZS 4434.1:1996 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
AS 2514:1999 Drying cabinets for medical equipment
AS/NZS 3551:2012
AS/NZS 2500:2020 Safe use of medical electrical equipment in health care
AS/NZS 3200.2.29:2000 Medical electrical equipment - Particular requirements for safety - Radiotherapy simulators
AS/NZS 4358:1996 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics
AS/NZS 4334:1995 Graphic symbols for use on medical electrical equipment
AS/NZS IEC 61267:2022 Medical diagnostic X-ray equipment — Radiation conditions for use in the determination of characteristics
AS/NZS 4434.2:1996 Medical electrical equipment - Medical electron accelerators - Periodic function performance testing

Institute of Electrical and Electronics Engineers (IEEE), Medical special equipment

IEEE P1073.1.3.5/D04:2000 Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Defibrillator Device
IEEE P1073.1.3.11/D3.0:1999 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Capnometer
IEEE P1073.1.3.6/D6.0:1999 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - ECG
IEEE P1073.1.3.7/D4.0:1999 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Blood Pressure
IEEE P1073.1.3.8/D4.0:1999 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Temperature
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 P1073.1.3.9/D3.0:1999 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Airway Flow
IEEE Std P1073.1.3.8/D4.0 IEEE Draft Standard for Medical Device Communications -- Medical Device Data Language (MDDL) Virtual Medical Device, Specialized -- Temperature
IEEE P1073.1.3.4/D3.0 IEEE Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Medical Device Specializations - Pulse Oximeter
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 P1073.1.3.4/D3.0:1999 (Draft)Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Pulse Oximeter
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 Std P1073.1.3.11/D3.0 Unapproved IEEE Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized Capnometer
IEEE Std 11073-10207-2017 IEEE Health informatics--Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication
IEEE Std P1073.1.3.9/D3.0 Unapproved IEEE Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Airway Flow (Withdrawn PAR)
IEEE Std P1073.1.3.7/D4.0 Unapproved IEEE Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL)Virtual Medical Device, Specialized - Pulse Oximeter (Withdrawn PAR)
IEEE Std P1073.2.0/D0.05 Proposed Draft IEEE Standard - Medical Device Communications - Medical Device Application Profiles (MDAP) - Base Standard

American National Standards Institute （ANSI), Medical special equipment

ANSI/AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
ANSI/AAMI HE75-2009 Human factors engineering - Design of medical devices

German Institute for Standardization, Medical special equipment

DIN EN 62366:2008 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007); German version EN 62366:2008
DIN VDE 0750-209:1985 Medical electrical equipment; part 2: particular requirements for the safety of microwave therapy equipment; identical with IEC 60601-2-6, edition 1984
DIN EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007); German version EN ISO 14971:2007
DIN EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001
DIN EN 60601-2-3:1999 Medical electrical equipment - Part 2-3: Particular requirements for the safety of short-wave therapy equipment (IEC 60601-2-3:1991 + A1:1998); German version EN 60601-2-3:1993 + A1:1998
DIN EN 1640:2010-02 Dentistry - Medical devices for dentistry - Equipment; German version EN 1640:2009
DIN EN 60601-2-11:2005 Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment (IEC 60601-2-11:1997 + A1:2004); German version EN 60601-2-11:1997 + A1:2004
DIN EN 60336:2020 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots (IEC 62B/1138/CDV:2019); German and English version prEN 60336:2019
DIN EN 60601-2-22:1996 Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment (IEC 60601-2-22:1995); German version EN 60601-2-22:1996
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 60601-2-18:2001 Medical electrical equipment - Part 2-18: Particular requirements for the safety of endoscopic equipment (IEC 60601-2-18:1996 + A1:2000); German version EN 60601-2-18:1996 + A1:2000
DIN EN 60601-2-32:1995 Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment (IEC 60601-2-32:1994); German version EN 60601-2-32:1994
DIN EN ISO 18779:2005 Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005); German version EN ISO 18779:2005
DIN EN 60336:2020-04 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots (IEC 62B/1138/CDV:2019); German and English version prEN 60336:2019 / Note: Date of issue 2020-03-20*Intended as replacement for DIN EN 60336 (2...
DIN VDE 0750-224:2003 Medical electrical equipment - Part 224: Particular requirements for safety of electromedical bath equipment
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
DIN EN 61267:2009 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics (IEC 61267:2005); German version EN 612167:2006
DIN EN 1639:2010-02 Dentistry - Medical devices for dentistry - Instruments; German version EN 1639:2009
DIN EN ISO 19054:2006 Rail systems for supporting medical equipment (ISO 19054:2005); English version of DIN EN ISO 19054:2006-09
DIN EN ISO 19054:2017-04 Rail systems for supporting medical equipment (ISO 19054:2005 + Amd1:2016); German version EN ISO 19054:2006 + A1:2016
DIN 13411:1999 Protection of walls and apparatus in medical facilities - Terms, specific data
DIN EN 61267:2009-01 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics (IEC 61267:2005); German version EN 612167:2006
DIN EN 62366:2016 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007 + A1:2014); German version EN 62366:2008 + A1:2015
DIN EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016); German version EN ISO 15225:2016

未注明发布机构, Medical special equipment

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

Danish Standards Foundation, Medical special equipment

DS/EN 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
DS/EN 60601-2-3:1998 Medical electrical equipment - Part 2: Particular requirements for the safety of short-wave therapy equipment
DS/EN 60601-2-3/A1:1999 Medical electrical equipment - Part 2: Particular requirements for the safety of short-wave therapy equipment
DS/EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment
DS/EN ISO 18779:2005 Medical devices for conserving oxygen and oxygen mixtures - Particular requirements
DS/EN 60601-2-11:1998 Medical electrical equipment - Part 2: Particular requirements for the safety of gamma beam therapy equipment
DS/EN 60601-2-5:2001 Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment
DS/EN ISO 19054:2006 Rail systems for supporting medical equipment
DS/EN 61267:2006 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics
DS/EN 60601-2-11/A1:2005 Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment
DS/EN IEC 60336:2021 Medical electrical equipment – X-ray tube assemblies for medical diagnosis – Focal spot dimensions and related characteristics

PL-PKN, Medical special equipment

PN Z78000-1970 Medical equipmen< opular hospital beds
PN Z78006-1972 Medksal tretchers
PN Z78510-1972 Medical e?uipment Gas cylinders for medical use Marking of colours
PN Z54514-1954 Przedmiotem normy jest stopa szyny Dietrichsa ujg PN-54/Z-545I1.
PN-EN IEC 60336-2021-09 E Medical electrical equipment -- X-ray tube assemblies for medical diagnosis -- Focal spot dimensions and related characteristics (IEC 60336:2020)

Canadian Standards Association (CSA), Medical special equipment

CSA C22.2 No.60601-2-33-04-2006 Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis Appareils 閘ectrom閐icaux ?Partie 2-33: R鑗les particuli鑢es de s閏urit?relatives aux appareils ?r閟onance magn閠ique u
CSA C22.2 No.60601-2-37-03 A1-2005 Amendment 1 Medical electrical equipment ?Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
CSA C22.2 No.60601-2-38-03-2003 Medical electrical equipment ?Part 2: Particular requirements for the safety of electrically operated hospital beds First Edition; Update No. 1: 08/2006
CAN/CSA-C22.2 NO.60601-2-11-2001 Appareils Electromedicaux - Partie 2: Regles Particulieres De Securite Pour Les Appareils De Gammatherapie (Deuxieme Edition)
CSA C22.2 No.60601-2-5-02-2002 Appareils 閘ectrom閐icaux ?Partie 2-5: R鑗les particuli鑢es de s閏urit?des appareils ?ultrasons pour physioth閞apie Deuxi鑝e Edition
CSA C22.2 No.60601-2-50-03-2003 Appareils 閘ectrom閐icaux ?Partie 2-50: R鑗les particuli鑢es de s閏urit?des appareils de phototh閞apie pour nouveau-n閟 Premi鑢e Edition,
CSA C22.2 No.60601-2-50-06-2006 Medical electrical equipment ?Part 2-50: Particular requirements for the safety of infant phototherapy equipment First Edition
CSA C22.2 No.60601-2-33-04-2004 Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis Second Edition
CSA C22.2 No.60601-2-37-03-2003 Medical electrical equipment ?Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment First Edition
CSA DIR.003-99 List of CSA Certified Health Care Equipment
CSA C22.2 No.60601-2-11-01-2001 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Gamma Beam Therapy Equipment Second Edition
CSA Z9919-07-CAN/CSA-2007 Appareils 閘ectrom閐icaux ?R鑗les particuli鑢es de s閏urit?et performances essentielles du mat閞iel utilis?pour les oxym鑤res de pouls ?usage m閐ical la deuxi鑝e 閐ition

International Electrotechnical Commission (IEC), Medical special equipment

IEC 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
IEC 60601-2-33:1995 Medical electrical equipment - Part 2: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
IEC 60336:2020 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics
IEC 60601-2-14:1989 Medical electrical equipment; part 2: particular requirements for the safety of electroconvulsive therapy equipment
IEC 60601-2-11:1987 Medical electrical equipment. Part 2: Particular requirements for the safety of gamma beam therapy equipment
IEC 60601-2-2:2006 Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical 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 60601-2-5:1984 Medical electrical equipment. Part 2: Particular requirements for the safety of ultrasonic therapy equipment
IEC 60601-2-34:1994 Medical electrical equipment - Part 2: Particular requirements for the safety of direct blood pressure 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
IEC 60601-2-37:2001 Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
IEC 60601-2-33:2008 Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
IEC 60601-2-37:2004 Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
IEC 60601-2-37:2007 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
IEC 60336:2020/COR1:2022 Corrigendum 1 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics
IEC 60336:2005/COR1:2006 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots; Corrigendum 1
IEC 60601-2-50:2005 Medical electrical equipment - Part 2-50: Particular requirements for the safety of infant phototherapy equipment
IEC 60930:1988 Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment
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 60601-2-33/AMD2:2007 Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis; Amendment 2
IEC 60601-2-5:2005 Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment
IEC 60601-2-16:1989 Medical electrical equipment; part 2: particular requirements for safety of haemodialysis equipment
IEC 60601-2-8:1987 Medical electrical equipment. Part 2 : Particular requirements for the safety of therapeutic X-ray generators
IEC TR3 61852:1998 Medical electrical equipment - Digital imaging and communications in medicine (DICOM) - Radiotherapy objects

Japanese Industrial Standards Committee (JISC), Medical special equipment

JIS Z 4120:2008 Medical electrical equipment -- X-ray tube assemblies for medical diagnosis -- Characteristics of focal spots
JIS Z 4951:1999 Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
JIS Z 4951:2004 Medical electrical equipment -- Part 2-33: Particular requirements for the safety of magnetic resonance for medical diagnosis
JIS T 2009:2005 Multiple medical device for home use
JIS Q 13488:1998 Quality systems -- Medical devices -- Particular requirements for the application of JIS Z 9902
JIS Q 13485:1998 Quality systems -- Medical devices -- Particular requirements for the application of JIS Z 9901
JIS T 0601-2-201:2015 Medical electrical equipment -- Part 2-201: Particular requirements for the basic safety and essential performance of hydrotherapy and warmbaththerapy equipment
JIS Z 4701:1997 General rules for medical X-ray equipment
JIS T 0601-2-205:2015 Medical electrical equipment -- Part 2-205: Particular requirements for the basic safety and essential performance of medical practice massager
JIS T 0601-2-39:2006 Medical electrical equipment -- Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment
JIS T 0601-2-202:2015 Medical electrical equipment -- Part 2-202: Particular requirements for the basic safety and essential performance of ultraviolet therapy equipment
JIS T 0601-2-203:2015 Medical electrical equipment -- Part 2-203: Particular requirements for the basic safety and essential performance of infrared therapy equipment
JIS T 0601-2-206:2015 Medical electrical equipment -- Part 2-206: Particular requirements for the basic safety and essential performance of dry hot pack therapy equipment
JIS T 0601-2-201:2005 Medical electrical equipment -- Particular requirements for the safety of hydrotherapy and warmbaththerapy equipment
JIS T 0601-2-207:2015 Medical electrical equipment -- Part 2-207: Particular requirements for the basic safety and essential performance of xenon ray beam therapy equipment

VN-TCVN, Medical special equipment

TCVN 7008-2008 Medical supply units
TCVN 7303-2-33-2010 Medical electrical equipment.Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
TCVN 7303-2-3-2006 Medical electrical equipment.Part 2-3: Particular requirements for the safety of short-wave therapy equipment
TCVN 7303-2-5-2006 Medical electrical equipment.Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment
TCVN 7303-2-6-2007 Medical electrical equipment.Part 2-6: Particular requirements for the safety of microwave therapy equipment
TCVN 7303-2-11-2007 Medical electrical equipment.Part 2-11: Particular requirements for the safety of gamma beam therapy equipment

Indonesia Standards, Medical special equipment

SNI 16-4940.1-1998 Electrically powered medical suction equipment
SNI 16-4940.2-1998 Medical suction equipment powered from vacuum or pressure sources
SNI 04-6284.2-2000 Medical electrical equipment. Part 2: Particular requirements for the safety of short-wave therapy equipment
SNI IEC 60601-2-5:2009 Medical electrical equipment - Part 2-5: Particular requirements for the safety ultrasonic physiotherapy equipment
SNI IEC 60601-2-28:2009 Medical electrical equipment - part 2-28: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
SNI 16-4774-1998 Transfusion equipment for medical use - Blood taking set

HU-MSZT, Medical special equipment

RO-ASRO, Medical special equipment

STAS 5316-1967
STAS 3952-1987 Medical equipment SANITAHY STIiETCHER

European Committee for Standardization (CEN), Medical special equipment

EN ISO 11197:2019 Medical supply units (ISO 11197:2019)
EN ISO 11197:2009 Medical supply units
prEN 865-1992 Medical electrical equipment; pulse oximeters; particular requirements
EN ISO 11197:2016 Medical supply units
prEN 475-1991 Medical devices; electrically-generated alarms signals
HD 395.2.3 S1-1985 Medical electrical equipment; part 2: particular requirements for the safety of short-wave therapy equipment
HD 395.2.5 S1-1986 Medical electrical equipment; part 2: particular requirements for the safety of ultrasonic therapy equipment
HD 395.2.6 S1-1987 Medical electrical equipment; part 2: particular requirements for the safety of microwave therapy equipment
prEN 864-1992 Medical electrical equipment; capnometer for uses with humans; particular requirements
HD 395.2.11 S2-1990 Medical electrical equipment; part 2: particular requirements for the safety of gamma beam therapy equipment
prEN 60601-2-27-1992 Medical electrical equipment; part 2: particular requirements for the safety of electrocardiographic monitoring equipment
prEN 389-1990 Labelling of non-active medical devices
prEN 60601-2-28-1992 Medical electrical equipment; part 2: particular requirements for the safety of X-ray source assemblies for medical diagnosis
CENELEC EN 60976-2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics (IEC 60976:2007)
prEN 793-1992 Medical electrical equipment; particular requirements for safety of medical supply units
prEN 50115-1993 Medical electrical equipment; part 2: particular safety requirements for operating tables
prEN 740-1992 Medical electrical equipment; anaesthetic workstations and their modules; particular requirements
EN ISO 18779:2005 Medical devices for conserving oxygen and oxygen mixtures - Particular requirements
EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices

CEN - European Committee for Standardization, Medical special equipment

EN ISO 11197:2004 Medical supply units

Society of Automotive Engineers (SAE), Medical special equipment

SAE J3020-2014 Medical Device Shot Peening

US-FCR, Medical special equipment

FCR UFGS-11 72 13-2006 MEDICAL EQUIPMENT, MISCELLANEOUS
FCR FED FCGS 11702-1986 MEDICAL EQUIPMENT, MISCELLANEOUS
FCR FED FCGS 11700-1981 GENERAL REQUIREMENTS FOR MEDICAL EQUIPMENT
FCR 47 CFR PART 18-2014 INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT
FCR 47 CFR PART 18-2013 INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT
FCR 47 CFR PART 18-2012 INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT
FCR UFGS-01 73 19-2006 INSTALLATION OF GOVERNMENT-FURNISHED MEDICAL EQUIPMENT

GB-REG, Medical special equipment

REG AC 121-33B-2006 Emergency Medical Equipment
REG 47 CFR PART 18-2011 INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT

PT-IPQ, Medical special equipment

NP EN 556-2000 Sterilization of medical devices Requirements for terminally sterilized medical devices to be labelled"Sterile"
NP EN 1441-2000 Medical devices Risk analysis
NP EN 12218-2000 Rail systems for supporting medical equipment

International Organization for Standardization (ISO), Medical special equipment

ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
ISO/IEEE 11073-20702:2018 Health informatics — Point-of-care medical device communication — Part 20702: Medical devices communication profile for web services
ISO/TR 15223:1998 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied
ISO 14155:1996 Clinical investigation of medical devices
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 5137 Maintenance management program for medical equipment
ISO/TS 19218-2:2012 Medical devices - Hierarchical coding structure for adverse events - Part 2: Evaluation codes
ISO 18779:2005 Medical devices for conserving oxygen and oxygen mixtures - Particular requirements
ISO 19054:2005 Rail systems for supporting medical equipment
ISO 9170:1990 Terminal units for use in medical gas pipeline systems
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 28620:2010 Medical devices - Non-electrically driven portable infusion devices
ISO 10079-2:1999 Medical suction equipment - Part 2: Manually powered suction equipment
ISO 10079-1:2015 Medical suction equipment - Part 1: Electrically powered suction equipment
ISO 10079-2:1992 Medical suction equipment; part 2: manually powered suction equipment
ISO 10079-2:2014 Medical suction equipment - Part 2: Manually powered suction equipment
ISO/TS 19218-1:2011 Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes
IEC 80601-2-77:2019 Medical electrical equipment — Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

ES-AENOR, Medical special equipment

CZ-CSN, Medical special equipment

CSN EN 50072-1994 Medical electrical equipment.Particular requirements for safety of peritoneal dialysis equipment
CSN EN 60601-2-22-1994 Medical electrical equipment.Part 2:Particular requirements for the safety of diagnostic and therapeutic laser equipment
CSN IEC 601-2-16:1994 Medical electrical equipment.Part 2:Particular requirements for safety of haemodialysis equipment
CSN 85 6009-1980 Medical apparatus. Dental technics. Symbols

BE-NBN, Medical special equipment

NBN-EN 50072-1994 Medical electrical equipment. Particular requirements for the safety of peritoneal dialysis equipment
NBN-EN 46002-1994 Quality systems - Medical devices - Particular requirements for the application of EN 29002
NBN-EN 46001-1994 Quality systems - Medical devices - Particular requirements for the application of EN 29001
NBN-EN 60601-2-3-1994 Medical electrical equipment. Part 1: Particular requirements for the safety of short-wave therapy equipment
NBN C 74-336-1990

Underwriters Laboratories (UL), Medical special equipment

UL 544-1998 Medical and dental equipment

RU-GOST R, Medical special equipment

GOST R IEC 60976-2013 Medical electrical equipment. Medical electron accelerators. Functional performance characteristics
GOST R ISO 14971-2009 Medical devices. Application of risk management to medical devices
GOST R ISO 14971-2006 Medical devices. Application of risk management to medical devices
GOST R 50267.22-2002 Medical electrical equipment. Part 2. Particular requirements for the safety of diagnostic and therapeutic laser equipment
GOST R EN 556-1-2009 Sterilization of medical devices. Requirements for medical devices to be designated "sterile". Part 1. Requirements for terminally sterilized medical devices
GOST R 56331-2014 Medical electrical equipment. Medical diagnostic ultrasonic equipment. Technical requirements for governmental purchases
GOST R 50267.43-2002 Medical electrical equipment. Part 2. Particular requirements for the safety of X-ray equipment for interventional procedures
GOST R IEC 60601-2-33-2009 Medical electrical equipment. Part 2-33. Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
GOST R IEC 60336-1999 X-ray tube assemblies for medical diagnosis. Characteristics of focal spots
GOST R 57092-2016 Medical electrical equipment. Equipment for telemedicine videoconferencing. Technical requirements for governmental purchases
GOST R IEC/TR 60788-2009 Medical electrical equipment. Glossary
GOST R 57766-2017 Chairs with medical equipment. Types, technical requirements and methods of control
GOST R IEC 60601-2-33-2013 Medical electrical equipment. Part 2-33. Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
GOST R 50267.33-1999 Medical electrical equipment. Part 2. Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
GOST R 50267.3-1992 Medical electrical equipment. Part 2. Particular requirements for the safety of short-wave therapy equipment
GOST R IEC 60601-2-50-2012 Medical electrical equipment. Part 2-50. Particular requirements for the basic safety and essential performance of infant phototherapy equipment
GOST R IEC/TR 62266-2009 Medical electrical equipment. Guidelines for implementation of DICOM in radiotherapy
GOST R 50267.5-1992 Medical electrical equipment. Part 2. Particular requirements for safety of ultrasonic therapy equipment
GOST R 50267.14-1993 Medical electrical equipment. Part 2. Particular requirements for the safety of electroconvulsive therapy equipment
GOST R 50267.6-1992 Medical electrical equipment. Part 2. Particular requirements for the safety of micro-wave therapy equipment
GOST R 51536-1999 Quality systems. Medical devices. Particular requirements for the application of GOST R ISO 9001-96
GOST R 51537-1999 Quality systems. Medical devices. Particular requirements for the application of GOST R ISO 9002-96
GOST R 50267.27-1995 Medical electrical equipment. Part 2. Particular requirements for safety of electrocardiographic monitoring equipment
GOST R 50267.34-1995 Medical electrical equipment. Part 2. Particular requirements for the safety of direct blood pressure monitoring equipment
GOST R 56316-2014 Medical electrical equipment. Medical electron accelerators. Technical requirements for governmental purchases
GOST R 58024-2017 Medical devices. Equipment for thermal disinfection/neutralization of medical waste. Dry hot air method. Technical requirements for governmental purchases
GOST R ISO/TR 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 50267.11-1999 Medical electrical equipment. Part 2. Particular requirements for the safety of gamma beam therapy equipment
GOST R IEC 60601-2-43-2008 Medical electrical equipment. Part 2-43. Particular requirements for the safety of X-ray equipment for interventional procedures
GOST R 56318-2014 Medical electrical equipment. Gamma-therapy distant equipment for radiotherapy. Technical requirements for governmental purchases
GOST R 56319-2014 Medical electrical equipment. Gamma-therapy equipment for brachytherapy. Technical requirements for governmental purchases

Lithuanian Standards Office , Medical special equipment

LST EN 62366-2008 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007)
LST EN 60336-2005 Medical electrical equipment. X-ray tube assemblies for medical diagnosis. Characteristics of focal spots (IEC 60336:2005)
LST EN IEC 60336:2021 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics (IEC 60336:2020)
LST EN 60601-2-11-2000 Medical electrical equipment. Part 2: Particular requirements for the safety of gamma beam therapy equipment (IEC 60601-2-11:1997)
LST EN 60601-2-5-2002 Medical electrical equipment. Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment (IEC 60601-2-5:2000)
LST EN 62353-2008 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (IEC 62353:2007)
LST EN 1640-2010 Dentistry - Medical devices for dentistry - Equipment
LST EN 60601-2-22-2000 Medical electrical equipment. Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment (IEC 60601-2-22:1995)
LST EN 60601-2-11-2000/A1-2005 Medical electrical equipment. Part 2-11: Particular requirements for the safety of gamma beam therapy equipment (IEC 60601-2-11:1997/A1:2004)

American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE), Medical special equipment

ASHRAE 170 INT 1-2010 Ventilation of Health Care Facilities

NZ-SNZ, Medical special equipment

AS/NZS 3200.2.33:2005 Medical electrical equipment Part 2.33: Particular requirements for safetyMagnetic resonance equipment for medical diagnosis
AS/NZS 3200.2.5:2002 Medical electrical equipment Part 2.5: Particular requirements for safety Ultrasonic physiotherapy equipment
AS/NZS 3200.2.6:2005 Medical electrical equipment Part 2.6: Particular requirements for safety-Microwave therapy equipment
AS/NZS 3200.2.11:1999 Medical Electrical Equipment Part 2.11: Particular Requirements for Safety - Gamma Beam Therapy Equipment

European Committee for Electrotechnical Standardization（CENELEC）, Medical special equipment

EN 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
EN IEC 60336:2021 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics
EN 60601-2-33:2010 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (Incorporating corrigendum October 2010; Incorporates Amendment A11: 2011)
EN 60601-2-33:2010/corrigendum Oct. 2010 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
EN 60601-2-3:2015 Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment
HD 395.2.6-1987 Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Microwave Therapy Equipment
HD 395.2.3-1985 Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Short- Wave Therapy Equipment
EN 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots

US-AAMI, Medical special equipment

AAMI/IEC 62366-1:2015 Medical devices - Part 1 : Application of usability engineering to medical devices

ES-UNE, Medical special equipment

UNE-EN 62366-1:2015/A1:2020 Medical devices - Part 1: Application of usability engineering to medical devices (Endorsed by Asociación Española de Normalización in September of 2020.)
UNE-EN 62366-1:2015/AC:2015 Medical devices - Part 1: Application of usability engineering to medical devices (Endorsed by AENOR in February of 2016.)
UNE-EN 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices (Endorsed by AENOR in June of 2015.)
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-EN IEC 60336:2021/AC:2022-07 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics (Endorsed by Asociación Española de Normalización in August of 2022.)
UNE-EN IEC 60336:2021 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics (Endorsed by Asociación Española de Normalización in March of 2021.)
IEC 60601-1:2023 SER Medical electrical equipment - ALL PARTS
UNE-EN IEC 60601-2-83:2020/A11:2021 Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment (Endorsed by Asociación Española de Normalización in May of 2021.)
UNE-EN 60601-2-50:2009/A1:2016 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment (Endorsed by Asociación Española de Normalización in January of 2017.)
UNE-EN IEC 60601-2-83:2020 Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment (Endorsed by Asociación Española de Normalización in May of 2020.)
UNE-EN 50637:2017 Medical electrical equipment - Particular requirements for the basic safety and essential performance of medical beds for children (Endorsed by Asociación Española de Normalización in December of 2017.)
UNE-EN ISO 80601-2-90:2021 Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment (ISO 80601-2-90:2021) (Endorsed by Asociación Española de Normalización in November of 2021.)

Group Standards of the People's Republic of China, Medical special equipment

T/GDNS 001-2022 Safety code for medical devices
T/CHAS 10-3-4-2019 Quality and safety management of Chinese hospital—Part 3-4: Medical service support —Medical device
T/CSBME 025-2021 Reliability Management System of Medical Equipment

Military Standard of the People's Republic of China-General Armament Department, Medical special equipment

GJB 4574-1990*GJBz 20032-1990 Service ship medical cabin layout and installation of medical equipment
GJB 162-1986 Surface ship medical cabin layout and installation of medical equipment

CENELEC - European Committee for Electrotechnical Standardization, Medical special equipment

EN 60336:1995 X-Ray Tube Assemblies for Medical Diagnosis Characteristics of Focal Spots
EN 60601-2-33:1995 Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis (Incorporates Amendment A11: 1997)
PREN 50447-2004 Active implantable medical devices - Particular requirements for Heart-Lung Machines (HLM)
EN 60601-2-29:1995/A1:1996 Medical Electrical Equipment; Part 2: Particular Requirements for the Safety of Radiotherapy Simulators

IEEE - The Institute of Electrical and Electronics Engineers@ Inc., Medical special equipment

IEEE 11073-10207-2017 Health informatics - Point-of-care medical device communication - Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication
IEEE P11073-10101/D8-2019 Standard for Health Informatics—Point-of-Care Medical Device Communication—Nomenclature

NATO - North Atlantic Treaty Organization, Medical special equipment

STANAG 7112-2011 RECOMMENDED MEDICAL EQUIPMENT FOR AEROMEDICAL EVACUATIONS (ED 1; To obtain please contact your national Defense Standardization Office or the NATO Standardization Office website: http:/ so.nato.int so@ Phone: +32 (0)2 – 707 5556@ email: nso@nso.nato.int.
STANAG 2905-1981 Basic Voltage and Current Characteristics of Electro-Medical Equipment (ED 1 AMD 2; To obtain please contact your national Defense Standardization Office or the NATO Standardization Office website: http:/ so.nato.int so@ Phone: +32 (0)2 – 707 5556@ email:

AT-ON, Medical special equipment

ONORM EN 46001-1994 Quality systems. Medical devices. Particular requirements for the application of EN 29001
ONORM EN 46002-1994 Quality systems. Medical devices. Particular requirements for the application of EN 29002
ONORM EN 540-1993 Clinical investigation of medical devices for human subjects

NL-NEN, Medical special equipment

NEN-EN 46002-1994 Quality systems. Medical devices. Particular requirements for the spplication of EN 29002
NEN-EN 46001-1994 Quality systems.Medical devices.Particular requirements for the application of EN 29001

Jiangsu Provincial Standard of the People's Republic of China, Medical special equipment

DB32/T 3549-2019 Specifications for setting up facilities and equipment for temporary storage of medical waste in medical and health institutions

Jiangxi Provincial Standard of the People's Republic of China, Medical special equipment

DB36/T 609-2011 RFID Equipment Technical Criterion for Health Care Application

FI-SFS, Medical special equipment

SFS 4372-1979

Taiwan Provincial Standard of the People's Republic of China, Medical special equipment

CNS 12491-13-1989 Graphical Symbols for Use on Electrical and Electronic Equipment (Medical Equipment)
CNS 12491.13-1989 Graphical Symbols for Use on Electrical and Electronic Equipment (Medical Equipment)

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

GB/T 42204-2022 Communication specification for clinical medical equipment—Imaging equipment

American Society for Testing and Materials (ASTM), Medical special equipment

ASTM F639-98a Standard Specification for Polyethylene Plastics for Medical Applications
ASTM F997-98ae1 Standard Specification for Polycarbonate Resin for Medical Applications
ASTM F997-98a Standard Specification for Polycarbonate Resin for Medical Applications

IX-EU/EC, Medical special equipment

MEDDEV 2.4/1 PART 1-2001 Guidelines for the Classification of Medical Devices Rev 8
MEDDEV 2.1/5-1998 MEDICAL DEVICES WITH A MEASURING FUNCTION

GOSTR, Medical special equipment

GOST R 58451-2019 Medical devices. Maintenance. Basic principles
GOST R IEC 60601-2-6-2019 Medical electrical equipment. Part 2-6. Particular requirements for the basic safety and essential performance of microwave therapy equipment
GOST R IEC 60601-2-5-2020 Medical electrical equipment. Part 2-5. Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
GOST R IEC 60601-2-3-2020 Medical electrical equipment. Part 2-3. Particular requirements for the basic safety and essential performance of short-wave therapy equipment

North Atlantic Treaty Organization Military Agency for Standardization (NATO-MAS), Medical special equipment

STANAG 6541-2021 NATO SPECIAL OPERATIONS FORCES (SOF) MEDICAL SUPPORT - AMedP-4.13 EDITION A

Professional Standard - Medicine, Medical special equipment

YY/T 0083-1992 Product nameplate for medical equipment
YY 0083-1992 Product nameplate for medical equipment

Professional Standard - Commodity Inspection, Medical special equipment

SN/T 1430.1-2004 Rules for the inspection of medical electrical equipment for import--Ultrasonic medical diagnostic and therapy equipment

IN-BIS, Medical special equipment

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

AT-OVE/ON, Medical special equipment

OVE EN 62366-1-2021 Medical devices - Part 1: Application of usability engineering to medical devices ( IEC 62366-1:2015) (german version)