Medical Refrigeration Equipment

Medical Refrigeration Equipment, Total:420 items.

The international standard classification for "Medical Refrigeration Equipment" includes: IT applications in health care technology .

The Chinese standard classification for "Medical Refrigeration Equipment" includes: General requirements on medical devices , Marking, packaing, transport and storage , Computer application .

Professional Standard - Medicine

YY 0677-2008 Liquidnitrogen cryosurgical equipment
YY/T 0083-1992 Product nameplate for medical instruments and equipment
YY/T 0678-2008 Standard performance and safety specification for cryosurgical medical instruments
YY/T 0677-2008 Liquidnitrogen cryosurgical equipment
YY 0083-1992 Product nameplate for medical equipment
YY 0678-2008 Standard performance and safety specification for cryosurgical medical instruments

Military Standard of the People's Republic of China-General Armament Department

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

Group Standards of the People's Republic of China

T/CIET 391-2024 Specification for remote control of medical equipment using robotics
T/CAS 842-2024 Evaluation of quality management maturity of medical equipment in medical institutions
T/CHAS 10-3-4-2019 Quality and safety management of Chinese hospital—Part 3-4: Medical service support —Medical device
T/GDNS 001-2022 Safety code for medical devices
T/CSBME 025-2021 Reliability Management System of Medical Equipment
T/CAMDI 008-2016 General rules for the implementation of medical device manufacturing quality management regulations for sterile medical device manufacturing equipment

Henan Provincial Standard of the People's Republic of China

DB41/T 2402-2023 Management specification for the use of medical molecular sieve oxygen-generating equipment in medical institutions

Jiangsu Provincial Standard of the People's Republic of China

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

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

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

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

Taiwan Provincial Standard of the People's Republic of China

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)

Professional Standard - Commodity Inspection

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

Standard Association of Australia （SAA）

AS 3864:1997 Medical refrigeration equipment - For the storage of blood and blood products
AS 2145:2002 Stainless steel needle tubing for manufacture of medical devices
AS 2684:1984 Medical equipment - Humidifiers, for medical use
AS 2514:1981 Drying cabinets for medical equipment
AS 2514:1999 Drying cabinets for medical equipment
AS 4484:1997 Industrial, medical and refrigerant compressed gas cylinder identification
AS 3201.1:1971 Approval and test specification electromedical equipment, Part 1: Diathermy equipment - Metric units
AS 1094:1993 Medical equipment - Single-use syringes (sterile) for general medical use
AS 2811:1985 Personal emergency medical information devices
AS 2696:1989 Medical equipment - Single-use urethral catheters (sterile) for general medical use
AS 2696:1984 Medical equipment - Single-use urethral catheters (sterile) for general medical use
AS 3864:1997/Amdt 1:1998 Medical refrigeration equipment - for storing blood and blood products
AS 3003:1976 Rules for electrical wiring and equipment in electromedical treatment areas of hospitals (known as the SAA code for electrical installations in electromedical treatment areas)

Underwriters Laboratories (UL)

UL 416-2013 UL Standard for Safety Refrigerated Medical Equipment
UL 544-2000 Medical and dental equipment
UL 544-1998 Medical and dental equipment

International Organization for Standardization (ISO)

ISO 15223-1:2021/CD Amd 1:2024 Medical devices
ISO/CD 20417:2024 Medical devices
ISO/FDIS 80601-2-80:2024 Medical electrical equipment
ISO 80601-2-55:2018/Amd 1:2023 Medical electrical equipment
ISO/FDIS 80601-2-79:2024 Medical electrical equipment
ISO 80601-2-13:2022/AWI Amd 1:2024 Medical electrical equipment
IEC 80601-2-26:2019/AMD1:2024 Medical electrical equipment
IEC 80601-2-77:2019/AMD1:2023 Medical electrical equipment
ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
ISO/CD 80601-2-74.2:2024 Medical electrical equipment
ISO/CD 80601-2-90.2:2024 Medical electrical equipment
IEC 80601-2-58:2024 Medical electrical equipment
ISO/TR 20416:2020 Medical devices — Post-market surveillance for manufacturers
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
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 14155:1996 Clinical investigation of medical devices
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
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
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 19054:2005 Rail systems for supporting medical equipment
ISO/TS 19218-1:2011 Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes
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 10079-1:2015 Medical suction equipment - Part 1: Electrically powered suction equipment
ISO 9170:1990 Terminal units for use in medical gas pipeline systems
ISO 10079-2:1999 Medical suction equipment - Part 2: Manually powered suction equipment
IEC/TR 80001-2-2:2012 Application of risk management for IT-networks incorporating medical devices — Part 2-2: Guidance for the communication of medical device security needs, risks and controls
IEC TR 80001-2-2:2012 Application of risk management for IT-networks incorporating medical devices — Part 2-2: Guidance for the communication of medical device security needs, risks and controls

British Standards Institution (BSI)

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
PD ISO/TR 25555:2024 Ageing societies. Accessibility and usability considerations for home healthcare products, related services and environments
BS ISO 24163-2:2024 Clamp-in tyre valves for tyre pressure monitoring systems - Test methods and performance
BS EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
PD CEN ISO/TR 20416:2020 Medical devices. Post-market surveillance for manufacturers
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 556-2:2004 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices
BS EN ISO 10079-1:2015 Medical suction equipment. Electrically powered suction equipment
BS EN ISO 10079-2:2022 Medical suction equipment. Manually powered suction equipment
BS EN 62353:2014 Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment
BS EN 62353:2008 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
BS EN ISO 10079-2:2000 Medical suction equipment - Manually powered suction equipment
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 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 ISO 10079-1:2022 Medical suction equipment. Electrically powered suction equipment
BS EN 15424:2007 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
BS EN ISO 25424:2011 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
BS EN ISO 25424:2019 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for 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 ISO 17664-1:2021 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Critical and semi-critical medical devices
BS EN IEC 62667:2018 Medical electrical equipment. Medical light ion beam equipment. Performance characteristics
BS EN 15986:2011 Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
DD ENV 12611-1998 Medical informatics. Categorical structure of systems of concepts. Medical devices
BS EN 60601-2-3:1993 Medical electrical equipment. Particular requirements for safety. Specification for short-wave therapy equipment
BS EN 60601-2-3:1992 Medical electrical equipment. Particular requirements for safety. Specification for short-wave therapy equipment
19/30401776 DC PD ISO/TR 20416. Medical devices. Post-market surveillance for manufacturers
PD CEN ISO/TR 24971:2020 Medical devices. Guidance on the application of ISO 14971
19/30370858 DC BS EN ISO 20417. Medical devices. Information to be provided by the manufacturer
BS EN ISO 10079-3:1997 Medical suction equipment. Suction equipment powered from vacuum or pressure source
BS EN 60601-2-17:2004 Medical electrical equipment. Particular requirements for the safety of automatically-controlled brachytherapy afterloading 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 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 ISO 10079-3:2000 Medical suction equipment - Suction equipment powered from a vacuum or pressure source
BS DD ISO/TS 10993-20:2006 Biological evaluation of medical devices - Principles and methods for immunotoxicology testing of medical devices
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…
PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
18/30370883 DC BS EN ISO 14971. Medical devices. Application of risk management to medical devices
BS EN ISO 19054:2006+A1:2016 Rail systems for supporting medical equipment
BS ISO 28620:2020 Medical devices. Non-electrically driven portable infusion devices
PD IEC/TR 80002-1:2009 Medical device software. Guidance on the application of ISO 14971 to medical device software
BS ISO 28620:2010 Medical devices - Non-electrically driven portable infusion devices
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
PD IEC/TR 62266:2002 Medical electrical equipment. Guidelines for implementation of DICOM in radiotherapy
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 ISO/IEEE 11073-20702:2018 Health informatics. Point-of-care medical device communication. Medical devices communication profile for web services
BS EN 60601-1-11:2015+A1:2021 Medical electrical equipment - General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Institute of Electrical and Electronics Engineers (IEEE)

IEEE P1073.1.3.5/D04:2000 Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Defibrillator Device
IEEE P1073.1.3.7/D4.0:1999 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Blood Pressure
IEEE P1073.1.3.11/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 P1073.1.3.8/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
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 P1073.1.3.11/D3.0 Unapproved IEEE Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized Capnometer
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 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 P1073.1.3.7/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 P1073.1.3.9/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 P1073.2.0/D0.05 Proposed Draft IEEE Standard - Medical Device Communications - Medical Device Application Profiles (MDAP) - Base Standard

German Institute for Standardization

DIN EN 62366:2008 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007); German version EN 62366:2008
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 1640:2010-02 Dentistry - Medical devices for dentistry - Equipment; German version EN 1640:2009
DIN EN ISO 15225 E:2015-08 Medical device quality management medical device nomenclature data structure (draft)
DIN EN 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices; English version of DIN EN 15424:2007-08
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 1639:2010-02 Dentistry - Medical devices for dentistry - Instruments; German version EN 1639:2009
DIN EN ISO 8362-5:2014 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
DIN EN IEC 62667:2020 Medical electrical devices – Medical light ion irradiation devices – Apparatus quality characteristics (IEC 62667:2017)
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 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 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004); German version EN ISO 17664:2004
DIN EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010); German version EN ISO 15225:2010
DIN EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016); German version EN ISO 15225:2016

American Society for Testing and Materials (ASTM)

ASTM F882-84(1996) Standard Performance and Safety Specification for Cryosurgical Medical Instruments
ASTM F639-98a Standard Specification for Polyethylene Plastics for Medical Applications
ASTM F997-98a Standard Specification for Polycarbonate Resin for Medical Applications
ASTM F997-98ae1 Standard Specification for Polycarbonate Resin for Medical Applications

American National Standards Institute （ANSI)

ANSI/AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
AAMI TIR12:2020(R2023) Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
AAMI TIR18:2010 Guidance on electromagnetic compatibility of medical devices in healthcare facilities
AAMI TIR12:1994 Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers, 1ed
ANSI/AAMI HE75-2009 Human factors engineering - Design of medical devices
NEMA/MITA RMD P1-2019 Considerations for Remanufacturing of Medical Imaging Devices - White Paper

Association Francaise de Normalisation

NF C74-054:2008 Medical devices - Application of usability engineering to medical devices.
NF EN ISO 17664-1:2021 Processing of healthcare products - Information relating to the processing of medical devices to be provided by the device manufacturer - Part 1: critical and semi-critical medical devices
NF EN ISO 17664-2:2023 Processing of healthcare products - Information relating to the processing of medical devices to be provided by the device manufacturer - Part 2: non-critical medical devices
NF ISO 17664-2:2021 Processing of healthcare products - Information relating to the processing of medical devices to be provided by the device manufacturer - Part 2: non-critical medical devices
NF EN IEC 62667:2018 Medical electrical devices - Light ion beam medical devices - Performance characteristics
NF S98-116:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices.
NF C74-309:1973 ELECTROMEDICAL EQUIPMENT ACTINOLOGY APPARATUS
NF EN 1640:2009 Art dentaire - Dispositifs médicaux pour l'art dentaire - Matériel
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 Medical devices - Part 1: application of usability engineering to medical devices
NF EN 62366-1:2015 Medical devices - Part 1: application of usability engineering to medical devices
NF C74-053*NF EN 62353:2015 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
NF C74-053:2008 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 S98-116-1*NF EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1 : critical and semi-critical medical devices
NF S90-316:1987 Medico-surgical equipment. Operating tables.
NF C15-211:2006 Low-voltage electrical installations - Installations in medically used rooms
NF S90-045:1985 Medico-surgical equipment. Aluminium caps for pharmaceutical use. Quality acceptance.
NF C74-122/A2:2008 Medical electrical equipment - Part 2-33 : particular requirements for the safety of magnetic resonance equipment for medical diagnosis.
NF EN 1639:2009 Art dentaire - Dispositifs médicaux pour l'art dentaire - Instruments
NF S90-202:1990 Medico-surgical equipment . Infusion sets.
NF EN 1641:2009 Art dentaire - Dispositifs médicaux pour l'art dentaire - Produits
NF EN ISO 19054:2006 Support rail systems for medical devices
NF S90-201:1990 Medico-surgical equipment. Transfusion sets.
NF C74-208/A1:2001 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics.
NF C74-122:1996 Medical electrical equipment. Part 2 : particular requirements for the safety of magnetic resonance equipment for medical diagnosis.
NF S97-317:1998 Rail systems for supporting medical equipment.
NF S91-300*NF EN 1640:2009 Dentistry - Medical devices for dentistry - 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 EN ISO 9626:2016 Stainless Steel Needle Tubes for Medical Equipment Manufacturing – Requirements and Test Methods
NF S90-325:1989 Medical surgical equipment. Steam disinfecting equipment.

GSO

GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
GSO IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
OS GSO IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
BH GSO IEC 62366-1:2017 Medical devices - Part 1: Application of usability engineering to medical devices
BH GSO IEC TR 62366-2:2022 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
GSO IEC TR 62366-2:2021 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
BH GSO IEC/TR 80002-1:2016 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
GSO EN 1639:2021 Dentistry — Medical devices for dentistry —Instruments
BH GSO EN 1641:2022 Dentistry. Medical devices for dentistry. Materials
BH GSO EN 1639:2022 Dentistry — Medical devices for dentistry —Instruments
GSO IEC TR 60601-4-2:2021 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
BH GSO IEC TR 60601-4-2:2022 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
GSO IEC/TR 80002-1:2015 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
GSO EN 1641:2021 Dentistry. Medical devices for dentistry. Materials
GSO IEC 60580:2014 Medical electrical equipment - Dose area product meters

GOST

GOST R 70987-2023 Medical electrical equipment. Microwave therapy equipment. Technical condition control methods
GOST R IEC 62366-1-2023 Medical devices. Part 1. Application of usabilityengineering to medical devices

PL-PKN

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.

SCC

AAMI EQ93:2019 Medical equipment management - Vocabulary used in medical equipment programs
CSA C22.2 No.125-1979 Electromedical equipment
CSA C22.2 No.125-M1984-1984(R2004) Electromedical Equipment
CSA C22.2 No.125-1973 Electro-Medical Equipment
CSA C22.2 No.125-M1984-1984(C2004) Electromedical equipment
BS EN 1640:1997 Dentistry. Medical devices for dentistry. Equipment
DANSK DS/EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment
AAMI ES1-1993 Safe Current Limits for Electromedical Apparatus
BS ISO 20417:2021 Medical devices. Information to be supplied by the manufacturer
BS PD CEN ISO/TR 20416:2020 Medical devices. Post-market surveillance for manufacturers
DANSK DS/EN 62366-1/A1:2020 Medical devices – Part 1: Application of usability engineering to medical devices
DANSK DS/EN 62366-1/AC:2019 Medical devices – Part 1: Application of usability engineering to medical devices
ISO 13485:2016 - Medical Devices - A Practical Guide Medical devices - A practical guide
BS EN 60601-2-33:1996 Medical electrical equipment. Particular requirements for safety-Specification for magnetic resonance equipment for medical diagnosis
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
CEI 62-17:1998 Electrical medical equipment - Special safety regulations for microwave therapy equipment
DANSK DS/IEC TR 62366-2:2016 Medical devices – Part 2: Guidance on the application of usability engineering to medical devices
AAMI/IEC TIR80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
DANSK DS/IEC/TR 80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
DIN EN 62366 E:2006 Draft Document - Medical devices - Application of usability engineering to medical devices (IEC 62A/535/CDV:2006); German version prEN 62366:2006
BS EN 62366:2008+A1:2015 Medical devices. Application of usability engineering to medical devices
NS-EN 1640:2004 Dentistry — Medical devices for dentistry — Equipment
BS 5724-2-2.3:1983 Medical electrical equipment. Particular requirements for safety-Specification for short wave therapy equipment
NS-EN 1640:2009 Dentistry — Medical devices for dentistry — Equipment
NS-EN 1639:2009 Dentistry — Medical devices for dentistry — Instruments
BS EN 1641:1997 Dentistry. Medical devices for dentistry. Materials
BS PD ISO/TR 24971:2013 Medical devices. Guidance on the application of ISO 14971
NS-EN 1640:1996 Dentistry — Medical devices for dentistry — Equipment
DANSK DS/IEC TR 60601-4-2:2016 Medical electrical equipment – Part 4-2: Guidance and interpretation – Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
DANSK DS/EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments
BS PD ISO/TR 24971:2020 Medical devices. Guidance on the application of ISO 14971
BS PD CEN ISO/TR 24971:2020 Medical devices. Guidance on the application of ISO 14971
CAN/CSA-Z9919-2007(C2012) Electromedical devices - Special safety rules and essential performance of equipment used for pulse oximeters for medical use
BS 5724-2.14:1989 Medical electrical equipment. Particular requirements for safety-Specification for electroconvulsive therapy equipment
CSA Z387-2013(R2018) Safe use of electrosurgical medical devices and systems in health care
CSA C22.2 No.120-2013(R2023) Refrigeration equipment
DIN EN 60601-1-11 E:2014 Draft Document - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare e...
DIN EN 60601-1-11/A1 E:2018 Draft Document - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare e...
DIN IEC 60601-1-11 E:2008 Draft Document - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare e...
CAN/CSA-IEC 62366-2014 Medical devices - Application of usability engineering to medical devices (Adopted IEC 62366:2007, first edition, 2007-10)
CAN/CSA C22.2 No.120-M91-1991(R2008) Refrigeration Equipment
DANSK DS/IEC TR 80002-3:2014 Medical device software - Part 3: Process reference model of medical device software life cycle processes
DANSK DS/EN ISO 19054/A1:2006 Rail systems for supporting medical equipment
CSA DIR.003-1998 List of CSA Certified Health Care Equipment
CSA C22.2 No.121-1959 Electric Heating Equipment for Medical and Dental Use
DANSK DS/EN ISO 19054:2006 Rail systems for supporting medical equipment
DIN EN 62366-1/A1 E:2019 Draft Document - Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62A/1288/CDV:2018); German and English version EN 62366-1:2015/prA1:2018
BS 5724-2-2.11:1989 Medical electrical equipment. Particular requirements for safety-Specification for gamma beam therapy equipment
AENOR UNE-EN 60601-2-17:2005 Electromedical equipment. Part 2-17: Particular requirements for the safety of automatically controlled brachytherapy afterloading equipment.
DIN EN 62366-1 E:2014 Draft Document - Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62A/900A/CDV:2014); German version FprEN 62366-1:2013
DANSK DS 2451-13 E:2011 Infection control in the health care sector - Part 13: Requirements for reprocessing of reusable medical equipment
CAN/CSA-C22.2 No.60601-2-33-2004(C2009) Electromedical devices - Part 2-33: Particular safety requirements for magnetic resonance devices used for medical diagnosis
CAN/CSA-C22.2 No.601.2.5-1992 Electromedical devices - Part two: Special safety rules for ultrasound therapy devices
CAN/CSA-C22.2 No.601.2.3-1992(C2009) Electromedical devices - Part two: Special safety rules for short-wave therapy devices
BS ISO /IEEE 11073-20702:2018 Health informatics. Point-of-care medical device communication-Medical devices communication profile for web services
BS EN 60601-2-33:2010+A1:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
CAN/CSA-C22.2 No.601.2.6-1992(C2009) Electromedical devices - Part two: Special safety rules for microwave therapy devices
AENOR UNE-EN 60601-2-11:1999 Electromedical equipment. Part 2: Particular requirements for the safety of gamma therapy equipment.

Spanish Association for Standardization (UNE)

UNE-EN 62366:2009 Medical devices- Application of usability engineering to medical devices
UNE-EN 1041:1998 INFORMATION SUPPLIED BY THE MANUFACTURER WITH MEDICAL DEVICES.
UNE-EN 1640:2004 Dentistry - Medical devices for dentistry - Equipment
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 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 20613-2-6:1988 MEDICAL ELECTRICAL EQUIPMENT. PARTICULAR REQUIREMENTS FOR THE SAFETY OF MICROWAVE THERAPY EQUIPMENT
UNE 20613-2-14:1993 MEDICAL ELECTRICAL EQUIPMENT. PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROCONSULSIVE THERAPY EQUIPMENT.
IEC 60601-1:2023 SER Medical electrical equipment - ALL PARTS
UNE-EN 1640:2010 Dentistry - Medical devices for dentistry - Equipment
UNE-EN 1639:2004 Dentistry - Medical devices for dentistry - Instruments
UNE-EN 60336:2006 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
UNE-EN 60601-2-3:1996 MEDICAL ELECTRICAL EQUIPMENT. PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF SHORT-WAVE THERAPY EQUIPMENT.

PT-IPQ

NP EN 1041-2000 Information supplied by the manufacturer with medical devices
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
I-1606-1981 Refrigeration equipment. Symbolic refrigeration raw materials and equipment
NP EN 552-2001 Sterilization of medical devices Validation and routine control of sterilization by irradiation
NP 3814-1988 Refrigeration Equipments, apparatus and refrigerators
NP EN 12218-2000 Rail systems for supporting medical equipment

International Electrotechnical Commission (IEC)

IEC 80601-2-77:2023 Medical electrical equipment
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
IEC 62353:2007 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
IEC 62353:2014 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
IEC 60601-1:2024 SER Medical electrical equipment - ALL PARTS
IEC 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 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
IEC TR3 61852:1998 Medical electrical equipment - Digital imaging and communications in medicine (DICOM) - Radiotherapy objects

GB-REG

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

Indonesia Standards

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 16-4774-1998 Transfusion equipment for medical use - Blood taking set

HU-MSZT

MNOSZ 14708-1955 Medical and health equipment
MNOSZ 15520-1953 Medical equipment. operating table
MNOSZ 14706-1954 Medical equipment. operating table
MNOSZ 14729-1954 Medical equipment. surgical box
MNOSZ 4049-1952 Medical equipment. metal plate
MNOSZ 15519-1953 Medical equipment. operating table
MNOSZ 14676-1955 Expansion rack for medical equipment
MNOSZ 14725-1954 Medical equipment. internal medicine examination table
MNOSZ 14709-1954 Medical equipment. pediatric examination table
MNOSZ 14746-1954 Medical equipment. baby placing table
MNOSZ 14728-1954 Medical equipment. sink. Bracket
MNOSZ 15514-1953 Medical equipment, cylindrical examination light
MNOSZ 14659-1955 Medical equipment. Examination and surgical chairs
MNOSZ 14658-1955 Medical equipment gynecological examination tools

US-FCR

FCR UFGS-11 72 13-2006 MEDICAL EQUIPMENT, MISCELLANEOUS
FCR FED FCGS 11702-1986 MEDICAL EQUIPMENT, MISCELLANEOUS
FCR 47 CFR PART 18-2014 INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT
FCR 47 CFR PART 18-2012 INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT
FCR 47 CFR PART 18-2013 INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT
FCR FED FCGS 11700-1981 GENERAL REQUIREMENTS FOR MEDICAL EQUIPMENT
FCR UFGS-23 69 00.00 20-2006 REFRIGERATION EQUIPMENT FOR COLD STORAGE
FCR COE RPMAS 46680-1978 REFRIGERANT EQUIPMENT
FCR UFGS-01 73 19-2006 INSTALLATION OF GOVERNMENT-FURNISHED MEDICAL EQUIPMENT
FCR AF 91-8-1998 MEDICAL FACILITIES

CEN - European Committee for Standardization

EN ISO 11197:2004 Medical supply units
EN ISO 9626:1995 Stainless Steel Needle Tubing for Manufacture of Medical Devices

Society of Automotive Engineers (SAE)

SAE J3020-2014 Medical Device Shot Peening

VN-TCVN

TCVN 7008-2008 Medical supply units

European Committee for Standardization (CEN)

EN ISO 11197:2009 Medical supply units
EN ISO 11197:2019 Medical supply units (ISO 11197:2019)
EN ISO 11197:2016 Medical supply units
prEN 475-1991 Medical devices; electrically-generated alarms signals
EN ISO 9626:2001/A1:2001 Stainless steel needle tubing for the manufacture of medical devices; Amendment A1 (ISO 9626:1991/AM 1:2001)
prEN 389-1990 Labelling of non-active medical devices
prEN 793-1992 Medical electrical equipment; particular requirements for safety of medical supply units
EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices

RO-ASRO

STAS 5316-1967 Medical equipment. Otoscope
STAS 3952-1987 Medical equipment SANITAHY STIiETCHER
STAS 12480/2-1986 ANTISTATIC AND CONDUC- TIVE VULCANISED RUBBER PRODUCTS FOR MEDICAL EQUIPMENT Electrical resistance limits

RU-GOST R

GOST R 57184-2016 Medical electrical equipment. Devices and apparatus for cryoablation. Technical requirements for governmental purchases
GOST R ISO 14971-2006 Medical devices. Application of risk management to medical devices
GOST R ISO 14971-2009 Medical devices. Application of risk management to medical devices
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 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 50267.33-1999 Medical electrical equipment. Part 2. Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
GOST R IEC/TR 62266-2009 Medical electrical equipment. Guidelines for implementation of DICOM in radiotherapy
GOST R 56316-2014 Medical electrical equipment. Medical electron accelerators. 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 58024-2017 Medical devices. Equipment for thermal disinfection/neutralization of medical waste. Dry hot air method. Technical requirements for governmental purchases
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
GOST R ISO 13485-2004 Medical devices. Quality management systems. System requirements for requlatory purposes

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

ASHRAE 170 INT 1-2010 Ventilation of Health Care Facilities

Lithuanian Standards Office

LST EN 62366-2008 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007)
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

SE-SIS

SIS SS IEC 601-2-6:1988 Medical electrical equipment — Particular requirements for the safety of microwave therapy equipment
SIS SS IEC 601-2-3:1988 Medical e/ectrical equipment — Particular requirements for the safety ofshort-wave therapy equipment
SIS SS 486 03 31-1990 Medical electrical equipment — Particular requirements for the safety of gamma beam therapy equipment
SIS SS-IEC 976:1991 Medical electrical equipment — Medical electron accelerators — Functionalperformance charactetistics
SIS SS-IEC 601-2-14:1991 Medical electrical equipment - Part 2: Particular requirements for the safety ofelectroconvulsive therapy equipment
SIS SS 486 03 01-1985 Electromedical equipment — General sa fety requirements

European Committee for Electrotechnical Standardization（CENELEC）

EN 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices

US-AAMI

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

Korean Agency for Technology and Standards (KATS)

KS C 1103-1990 Glossary of Terms Used in Medical Electrical Equipment (General Terms)
KS C IEC 62667:2019 Medical electrical equipment — Medical light ion beam equipment — Performance characteristics
KS A 4001-1989(2020) Graphical symbols for medical radiological equipment
KS C IEC 60976:2020 Medical electrical equipment — Medical electron accelerators — Functional performance characteristics
KS C IEC 61852:2007 Medical electrical equipment－Digital imaging and communications in medicine(DICOM)－Radiotherapy objects
KS C 0913-1986(2001) SAFETY REQUIREMENTS OF ELECTRICAL INSTALLATIONS FOR MEDICALLY USE DROOMS IN HOSPITALS AND CLINICS
KS C 0913-1986 SAFETY REQUIREMENTS OF ELECTRICAL INSTALLATIONS FOR MEDICALLY USE DROOMS IN HOSPITALS AND CLINICS

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

AS/NZS 3551:2012(R2016) Medical Equipment Management Program
AS/NZS 2500:2020 Safe use of medical electrical equipment in health care
AS/NZS 3551:2012/AMD 1:2013 Medical Equipment Management Program
AS/NZS 3551:2012 Medical Equipment Management Program
AS/NZS 4434.1:1996 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
AS/NZS 4334:1995 Graphic symbols for use on medical electrical equipment
AS/NZS 4434.2:1996 Medical electrical equipment - Medical electron accelerators - Periodic function performance testing
AS/NZS 4334:1995/AMD 1:1996 Graphic symbols for use on medical electrical equipment

International Telecommunication Union (ITU)

ITU-R SM.1056-2007 Limitation of radiation from industrial, scientific and medical (ISM) equipment

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

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

ITU-R - International Telecommunication Union/ITU Radiocommunication Sector

ITU-R SM.1056-1 SPANISH-2007 Limitación de las radiaciones procedentes de equipos industriales@ científicos y médicos (ICM)
ITU-R SM.1056-1994 Limitation of Radiation from Industrial@ Scientific and Medical (ISM) Equipment

NATO - North Atlantic Treaty Organization

STANAG 7112-2011 RECOMMENDED MEDICAL EQUIPMENT FOR AEROMEDICAL EVACUATIONS (ED 1)

Japanese Industrial Standards Committee (JISC)

JIS T 2009:2005 Multiple medical device for home use
JIS Z 4701:1997 General rules for medical X-ray equipment
JIS T 0601-2-201:2005 Medical electrical equipment -- Particular requirements for the safety of hydrotherapy and warmbaththerapy equipment
JIS Z 4120:2008 Medical electrical equipment -- X-ray tube assemblies for medical diagnosis -- Characteristics of focal spots

FI-SFS

SFS 4372-1979 Electrical installation of medical equipment

KR-KS

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 3598-2018(2023) Medical electrical equipment ─ Glossary of defined terms
KS P ISO 10079-1-2017 Medical suction equipment — Part 1:Electrically powered suction equipment

IX-EU/EC

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

GOST R 58451-2019 Medical devices. Maintenance. Basic principles

CZ-CSN

CSN 85 6009-1980 Medical apparatus. Dental technics. Symbols

DIN

DIN EN 1640:2004 Dentistry - Medical devices for dentistry - Equipment

Danish Standards Foundation

DS/EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment
DS/EN 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
DS/EN ISO 19054:2006 Rail systems for supporting medical equipment

Canadian Standards Association (CSA)

CSA C22.2 No.120-M91-CAN/CSA-1991(R1999) Materiel Frigorifique Fiche No 1
CSA Z387-2019 Safe use of electrosurgical medical devices and systems in health care
CSA DIR.003-99 List of CSA Certified Health Care Equipment

YU-JUS

JUS M.E7.012-1993 Refrigerating plants - Flow sheets of refrigerating plants - Graphical symbols
JUS M.E7.011-1993 Refrigerating plants - Flow sheets of refrigerating plants - Types of flow sheets

TH-TISI

TIS 2237-2005 Industrial, scientific and medical (ism) radio frequiency equipment: electromagnetic disturbancelimits

AT-ON

ONORM EN 540-1993 Clinical investigation of medical devices for human subjects

AT-OVE/ON

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

IN-BIS

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