medical equipment wheel

medical equipment wheel, Total:336 items.

The international standard classification for "medical equipment wheel" includes: Medical equipment in general , Medical equipment .

The Chinese standard classification for "medical equipment wheel" includes: Medical apparatus and devices in general , Public medical equipment , General and microsurgical devices .

Group Standards of the People's Republic of China

T/ZSJL 012-2023 Hand push medical instrument casters and wheels
T/GDMDMA 0012.13-2022 Hospital Medical Device Management Specifications Part 13: Supply Chain Management of Medical Consumables
T/CAMDI 106-2023 Guidelines for the control of polymeric materials for use in medical devices
T/CAMDI 033-2020 Guide for biological evaluation of packaging materials for medical devices
T/CAMDI 029-2024 Additive Manufacturing-General requirements for Medical-Engineering Interaction of Personalized Medical Devices

Taiwan Provincial Standard of the People's Republic of China

CNS 14393-13-2005 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
CNS 14989-2006 Medical devices - Application of risk management to medical devices
CNS 14990-2006 Medical devices - Symbols to be used with medical device labels,labelling and information to be supplied
CNS 14393.13-2005 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices

Professional Standard - Medicine

YY/T 0468-2015 Medical devices―Quality management―Medical device nomenclature data structure
YY/T 0802.2-2024 Disposal of medical devices - Information to be provided by the medical device manufacturer - Part 2: Low-risk medical devices
YY/T 0316-2003 Medical devices -- Application of risk management to medical devices
YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer
YY/T 0802.1-2024 Disposal of medical devices Information to be provided by the medical device manufacturer Part 1: Medium and high risk medical devices
YY/T 0316-2008 Medical devices - Application of risk management to medical devices
YY/T 1474-2016 Medical devices－Application of risk management to medical devices
YY/T 0316-2016 Medical devices-Application of risk management to medical devices

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

GB/T 42062-2022 Medical devices—Application of risk management to medical devices
GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process
GB/Z 42217-2022 Medical device —Validation of software for medical device quality system

Jiangsu Provincial Standard of the People's Republic of China

DB3212/T 1065-2021 Standards for Quality Evaluation of Medical Devices Used in Medical Institutions

Shaanxi Provincial Standard of the People's Republic of China

DB61/T 1304-2019 Good Manufacturing Practice for Additively Manufactured Medical Devices

German Institute for Standardization

DIN 96160:2011 Medical instruments - Wire guide
DIN EN 1641:2004-09 Dentistry - Medical devices for dentistry - Materials
DIN EN 1641:2004 Dentistry - Medical devices for dentistry - Materials
DIN EN 1641:2010-02 Dentistry - Medical devices for dentistry - Materials; German version EN 1641:2009
DIN 13145:1979-06 Medical instruments; mallet of plastic material
DIN 13145 E:2008 Draft Document - Medical instruments - Mallet of plastic material
DIN 13145:2010-02 Medical instruments - Mallet of plastic material
DIN 58298:2010 Medical instruments - Materials, finish and testing
DIN EN ISO 9626:2002 Stainless steel needle tubing for manufacture of medical devices (ISO 9626:1991 + AMD 1:2001) (including amendment A1:2001); German version EN ISO 9626:1995 + A1:2001
DIN 58298:2005 Medical instruments - Materials, finish and testing
DIN 58298-6:1983 Materials, Processing and Testing Medical Device Nest Diggers
DIN EN 1641 E:2008 Draft Document - Dentistry - Medical devices for dentistry - Materials; German version prEN 1641:2008
DIN EN 1641 E:2008-09 Draft Document - Dentistry - Medical devices for dentistry - Materials; German version prEN 1641:2008
DIN 58298-3:1979 Materials, Processing and Testing Medical Device Tweezers
DIN 58298:2010-09 Medical instruments - Materials, finish and testing
DIN 58298:2005-12 Medical instruments - Materials, finish and testing
DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
DIN 58846:2017-11 Medical instruments - Raspatories
DIN 58846:1988-07 Medical instruments; raspatories
DIN 58298 E:2010 Draft Document - Medical instruments - Materials, finish and testing
DIN 96160:2011-12 Medical instruments - Wire guide
DIN EN ISO 14971:2020-07 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
DIN EN ISO 14971 E:2018-08 Application of medical device risk management in medical devices (draft)
DIN 58298 E:2010-04 Draft Document - Medical instruments - Materials, finish and testing
DIN 13119 E:2008-09 Medical instruments bowel scissors
DIN 58852:2021-02 Medical instruments - Probes
DIN 58857:2019 Medical instruments - Directors
DIN 96056:2009 Medical instruments - Bone raspatory
DIN 96056:2023-03 Medical instruments - Bone raspatory
DIN 13117:2013 Medical instruments.Bone shears
DIN 58852:2014-09 Medical instruments - Probes
DIN 58794:2010 Medical instruments - Ear forceps
DIN 58852 E:2020-06 Medical instruments - Probes
DIN 13119:2010-02 Medical instruments - Bowel scissors
DIN 58265:1974-09 Medical instruments; needle holder Finochietto's
DIN EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
DIN 58852:1976 Medical instruments; probes
DIN 96056 E:2022-08 Medical instruments - Bone raspatory
DIN 96056 E:2015-09 Medical instruments - Bone raspatory
DIN 58794:1982 Medical instruments; ear forceps
DIN 58852:2014 Medical instruments - Probes
DIN 13117:1980 Medical instruments; bone shears
DIN 13119:2010 Medical instruments - Bowel scissors
DIN 58852 E:2014-02 Medical instruments - Probes
DIN 58852:2021 Medical instruments - Probes
DIN EN 556-2:2015-11 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015 / Note: To be replaced by DIN EN 556-2 (2023-02).
DIN 13119:1980 Medical instruments; bowel scissors
DIN 13117:2013-01 Medical instruments - Bone shears
DIN EN ISO 14971:2022-04 Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021
DIN 58852:2008 Medical instruments - Probes
DIN 96056:2016 Medical instruments - Bone raspatory
DIN EN 62304:2016-10*VDE 0750-101:2016-10 Medical device software
DIN 58852:2008-01 Medical instruments - Probes
DIN 13117:1980-06 Medical instruments; bone shears
DIN EN 556-2:2023-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: requirements for aseptically processed medical devices; German and English version prEN 556-2:2023 / Note: Date of issue 2023-01-06*Intended as r...
DIN EN 556-1 Berichtigung 1:2006-12 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, Corrigenda to DIN EN 556-1:2002-03; German version EN 556-1...
DIN EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
DIN 58298-12:1994-04 Materials, finish and testing of medical instruments; hand saws
DIN 58296:2008-01 Medical instruments - Raspatories Semb's
DIN EN ISO 17664:2018-04 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)
DIN EN ISO 14971:2007-07 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
DIN 58857:2019-12 Medical instruments - Directors
DIN 96056:2016-03 Medical instruments - Bone raspatory
DIN 13185:2005-12 Medical instruments - Onychia forceps
DIN 58846:2010-02 Medical instruments - Raspatories
DIN EN 556-1:2002-03 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 / Note: To be replaced by DIN EN 556-1 (2023-02).
DIN EN 556-1:2023-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German and English version prEN 556-1:2023 / Note: Date of issue 2023-01-06*Intended as r...
DIN 58263:1973 Medical instruments; mouth gag Heister's
DIN 58319:2008-01 Medical instruments - Elevators Williger
DIN EN ISO 17664-2:2024 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021); German version EN ISO 17664-2:2023
DIN EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
DIN EN 13824:2005-02 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
DIN 58299:2014 Toothings (Serrations) for surgical instruments - Profile angles, groove distances
DIN EN ISO 17664-2 E:2023 Draft Document - Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021); German and English version prEN ISO 176...
DIN EN 556-2 E:2014 Draft Document - Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2: Requirements for aseptically processed medical devices; German version prEN 556-2:2014

Association Francaise de Normalisation

NF S99-301:1995 Medical devices. Electrically generated alarm signals.
NF S99-172:2003 Use of medical devices - Risk management relative to the use of medical devices in health care establishments.
NF S99-003:1998 Information supplied by the manufacturer with medical devices.
NF S99-003:2008 Information supplied by the manufacturer of medical devices.
NF S99-513:1999 Biological evaluation of medical devices. Part 13 : identification and quantification of degradation products from polymeric medical devices.
NF S93-004/A1:2001 Stainless steel needle tubing for the manufacture of medical devices.
NF S90-701:1988 MEDICO-SURGICAL EQUIPMENT. BIOCOMPATIBILITY OF MATERIALS AND MEDICAL DEVICES. METHODS FOR EXTRACTION.
NF S99-211:2013 Medical devices - Application of risk management to medical devices
NF S98-116-2*NF ISO 17664-2:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2 : non-critical medical devices
NF S99-004:1996 Graphical symbols for use in the labelling of medical devices.
NF S99-401:1994 Medical Devices - Medical Grade Silicone Elastomer
NF S92-025*NF EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
NF EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
NF S99-211/A11*NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
NF S98-136:2009 Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.
NF S90-304:1989 MEDICO-SURGICAL EQUIPMENT. HAEMODIALYSIS EQUIPMENT. OPERATING DATA.
NF S99-012:2010 Medical devices - Quality management - Medical device nomenclature data structure.
NF S99-501:1998 Biological evaluation of medical devices. Part 1 : evaluation and testing.
NF S99-501-18*NF EN ISO 10993-18:2020 Biological evaluation of medical devices - Part 18 : chemical characterization of medical device materials within a risk management process
NF EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to obtain STERILE labeling - Part 1: Requirements for terminally sterilized medical devices
NF EN ISO 10993-18:2020 Biological evaluation of medical devices - Part 18: chemical characterization of medical device materials within a risk management process
NF S92-024*NF EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
NF S98-008:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices.

Danish Standards Foundation

DS/EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
DANSK DS/EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
DANSK DS/EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
DANSK DS/ISO 17664-2:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices
DANSK DS/ISO 14971:2020 Medical devices – Application of risk management to medical devices
DS/EN ISO 14971:2013 Medical devices - Application of risk management to medical devices
DANSK DS/EN ISO 15225:2016 Medical devices – Quality management – Medical device nomenclature data structure
DANSK DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
DS/EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN ISO 17664-2:2024 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices (ISO 17664-2:2021)
DANSK DS/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
DS/ISO/TS 22421:2021 Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
DS/CEN/CR 14060:2001 Medical device traceability
DANSK DS/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 (ISO 17664-1:2021)
DANSK DS/ISO 10993-18:2020 Biologisk vurdering af medicinsk udstyr – Del 18: Kemisk karakterisering af materialer til medicinsk udstyr inden for rammerne af en risikostyringsproces
DANSK DS/EN 556-1/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

Lithuanian Standards Office

LST EN 1641-2010 Dentistry - Medical devices for dentistry - Materials
LST EN 556-1-2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

Standards Norway

NS-EN 1641:2004 Dentistry — Medical devices for dentistry — Materials
NS-EN 1641:1996 Dentistry — Medical devices for dentistry — Materials
NS-EN 1641:2009 Dentistry — Medical devices for dentistry — Materials
NS 632:1980 Syringes for medical use
NS-EN ISO 17664-2:2023 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021)
NS-EN ISO 14971:2019 Medical devices — Application of risk management to medical devices (ISO 14971:2019)
NS-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 (ISO 17664-1:2021)
NS-EN 556:1994 Sterilization of medical devices — Requirements for medical devices to be labelled "Sterile"
SN-CR 14060:2000 Medical device traceability
NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
NS-EN 556-2:2003 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed medical devices
NS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
NS-EN 556-1:2001 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1: Requirements for terminally sterilized medical devices
NS-EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

Swedish Institute for Standards

SS-EN 1641:2005 Dentistry - Medical devices for dentistry - Materials
SS-EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
SIS-ISO/TS 22421:2021 Sterilization of health care products - Common requirements for sterilizers forterminal sterilization of medical devices in health care facilities (ISO/TS 22421:2021)
SS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
SS 8752430:2017 Medical gas pipeline systems - Connectors for medical gases
SS-EN ISO 17664-2:2024 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021)
SS-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

Ente Nazionale Italiano di Unificazione

UNI EN 1641:2004 Dentistry - Medical devices for dentistry - Materials
UNI EN 1641:2010 Dentistry - Medical devices for dentistry - Materials
UNI EN ISO 14971:2008 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2002 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2004 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2012 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2022 Medical devices - Application of risk management to medical devices
UNI EN ISO 17664-2:2024 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices
EC 1-2004 UNI CEI EN ISO 14971:2004 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
UNI EN ISO 17664:2018 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
UNI EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ?STERILE? - Requirements for terminally sterilized medical devices
UNI CEI EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
UNI 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
UNI EN 1641:1997 Dentistry. Medical devices for dentistry . Materials.
UNI EN ISO 10993-18:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process

Spanish Association for Standardization (UNE)

UNE-EN 1641:2010 Dentistry - Medical devices for dentistry - Materials
UNE-EN 1641:2004 Dentistry - Medical devices for dentistry - Materials
UNE-EN ISO 14971:2020/A11:2022 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN ISO/ASTM/TR 52916:2022 Additive manufacturing for medical - Data - Optimized medical image data (ISO/ASTM TR 52916:2022) (Endorsed by Asociación Española de Normalización in March of 2022.)
AENOR UNE-EN 62366:2009 Medical devices - Application of usability engineering to medical devices
AENOR UNE-EN 62366/A1:2009 Medical devices - Application of usability engineering to medical devices
UNE-EN ISO 17664-1:2022 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 (ISO 17664-1:2021)
UNE-EN ISO 10993-18:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
UNE-EN 556-1:2002/AC:2007 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
UNE-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
UNE-EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
UNE-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
AENOR UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN ISO 14971:2001 Medical devices - Application of risk management to medical devices. (ISO 14971:2000)
UNE 111-551-1989 Medical materials. Classification and definition

Polski Komitet Normalizacyjny (PKN)

PN Z54550-1973 Medicall instruments Bon? joining elements Re?uirements and tests

Gosstandart of Russia

GOST ISO 10993-18-2011 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST ISO/TR 10993-22-2020 Medical devices. Biological evaluation of medical devices. Part 22. Guidance on nanomaterials
GOST ISO 10993-12-2011 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials
GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
GOST R ISO 15225-2014 Medical devices. Quality management. Medical device nomenclature data structure
GOST R ISO 10993-18-2009 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
GOST R ISO 10993.12-1999 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
GOST EN 556-1-2011 Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized medical devices

British Standards Institution (BSI)

BS EN 1642:2011 Dentistry. Medical devices for dentistry. Dental implants
BS EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices
08/30184612 DC BS EN 1641. Dentistry. Medical devices for dentistry. Materials
BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
BS EN ISO 10993-18:2020+A1:2023 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
BS EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices
BS EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to medical devices
BS EN 556-2:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for aseptically processed medical devices
BS EN ISO 14971:2019+A11:2021 Medical devices - Application of risk management to medical devices
BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices
BS PD CEN ISO/ASTM/TR 52916:2022 Additive manufacturing for medical. Data. Optimized medical imagedata
BS EN 556-1:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices
BS EN ISO 10993-18:2005 Biological evaluation of medical devices-Chemical characterization of materials
BS EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
BS EN ISO 10993-18:2009 Biological evaluation of medical devices-Chemical characterization of materials
BS EN ISO 15225:2016 Medical devices. Quality management. Medical device nomenclature data structure
BS EN 556-2:2015 Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices
BS PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
BS ISO 17664-2:2021 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Non-critical medical devices
BS EN ISO 10993-18:2020 Biological evaluation of medical devices Part 18 : Chemical characterization of medical device materials within a risk management process
BS EN 556-1:2001(2006) Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1 : Requirements for terminally sterilized medical devices
PD ISO/TR 10993-22:2017 Biological evaluation of medical devices. Guidance on nanomaterials

European Committee for Standardization (CEN)

EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
EN 1641:1996 Dentistry - Medical Devices for Dentistry - Materials
EN 1641:2004 Dentistry - Medical devices for dentistry - Materials
EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
EN ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
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 (ISO 17664-1:2021)
EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'

GCC Standardization Organization

BH GSO ISO 14971:2024 Medical devices — Application of risk management to medical devices
OS GSO ISO 14971:2024 Medical devices — Application of risk management to medical devices
GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
GSO ISO 17664-2:2023 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
GSO ISO 15225:2016 Medical devices -- Quality management -- Medical device nomenclature data structure

International Organization for Standardization (ISO)

ISO 14971:2019 Medical devices — Application of risk management to medical devices
ISO 10993-18:2020/Amd.1:2022 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
ISO/DIS 5092:2024 Additive manufacturing for medical
ISO/IEEE 11073-20702:2018 Health informatics — Point-of-care medical device communication — Part 20702: Medical devices communication profile for web services
ISO 14971:2000 Medical devices - Application of risk management to medical devices
ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices
ISO 10993-18:2020 Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
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

Korean Agency for Technology and Standards (KATS)

KS P ISO 14971-2018 Medical devices — Application of risk management to medical devices
KS P ISO 14971:2021 Medical devices — Application of risk management to medical devices
KS P ISO 14971:2018 Medical devices — Application of risk management to medical devices
KS P ISO 14971-2021 Medical devices — Application of risk management to medical devices
KS P ISO 17664-2-2022 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
KS P ISO 15225-2023 Medical devices — Quality management — Medical device nomenclature data structure
KS P 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
KS P ISO 10993-18-2024 Biological evaluation of medical devices —Part 18: Chemical characterization of medical device materials within a risk management process
KS P ISO 10993-18-2021 Biological evaluation of medical devices —Part 18: Chemical characterization of medical device materials within a risk management process
KS P ISO 10993-18:2021 Biological evaluation of medical devices —Part 18: Chemical characterization of medical device materials within a risk management process
KS P 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
KS P ISO 15225-2014(2019) Medical devices — Quality management — Medical device nomenclature data structure

North Atlantic Treaty Organization Standards Agency

STANAG 2060-2014 IDENTIFICATION OF MEDICAL EQUIPMENT IN OPERATING MEDICAL UNITS (ED 5)
STANAG 2060-2008 IDENTIFICATION OF MEDICAL MATERIEL FOR FIELD MEDICAL INSTALLATIONS
STANAG 2178-2016 COMPATIBILITY OF MEDICAL TUBES AND CONNECTIONS IN THE CAMPAIGN (ED 2)

Japanese Industrial Standards Committee (JISC)

JIS T 14971:2003 Medical devices -- Application of risk management to medical devices
JIS T 14971:2012 Medical devices -- Application of risk management to medical devices
JIS T 14971:2020 Medical devices -- Application of risk management to medical devices

South African Bureau of Standard

SANS 14971:2008 Medical devices - Application of risk management to medical devices

Thai Industrial Standards Institute (TISI)

TIS 14971-2013 Medical devices.application of risk management to medical devices

Military Standards (MIL-STD)

MIL MIL-C-42068-1989 CHEST, MEDICAL INSTRUMENT AND SUPPLY SET

International Electrotechnical Commission (IEC)

IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
IEC 62366:2007/AMD1:2014 Medical devices - Application of usability engineering to medical devices
IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices

Canadian Standards Association (CSA)

CAN/CSA-ISO 14971:2007(R2012) Medical Devices - Application of Risk Management to Medical Devices
CAN/CSA-ISO 14971:2001(R2006) Medical Devices - Application of Risk Management to Medical Devices
CAN/CSA-ISO 14971:2007(C2012) Medical devices - Application of risk management to medical devices
CAN/CSA-ISO 14971:2001(C2006) Medical devices - Application of risk management to medical devices
CAN/CSA-ISO 17664-2-2023 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
CSA ISO 17664-2:2023 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
CAN/CSA-ISO 17664:2018 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
CAN/CSA-ISO 17664-1-2023 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
CSA ISO 14971-07-CAN/CSA:2007 Medical Devices - Application of Risk Management to Medical Devices second edition
CAN/CSA-ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices (Second Edition)

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 17664-2:2022 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices
ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management to medical devices
ANSI/AAMI/ISO 17664-1:2022 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
ANSI/AAMI/ISO 15225:2016 Medical devices—Quality management—Medical device nomenclature data structure
ANSI/AAMI/IEC 62366/A1:2014 Medical devices - Application of usability engineering to medical devices - Amendment 1

The Directorate General of Specifications and Metrology (DGSM)

OS GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
OS GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices

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

AS/NZS 4543.1:1999 Protective Medical Devices Against Diagnostic Medical X-Radiation Part 1: Determination of Attenuation Properties of Materials

Comitato Elettrotecnico Italiano

CEI UNI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
CEI UNI EN/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
CEI EN 62366:2008 Medical devices - Application of usability engineering to medical devices
CEI EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO ISO 14971:2017 Medical devices -- Application of risk management to medical devices
BH GSO ISO 17664-2:2023 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
BH GSO ISO 15225:2017 Medical devices -- Quality management -- Medical device nomenclature data structure

Association for the Advancement of Medical Instrumentation

AAMI/ISO 14971:2019 Medical devices - Application of risk management to medical devices
AAMI/ISO 14971:2007(R2016) Medical Devices - Application of Risk Management to Medical Devices
AAMI/ISO 17664-2:2022 Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 2: Non-critical medical devices
AAMI/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
AAMI/IEC 62366:2007(R2013) Medical devices - Application of usability engineering to medical devices
AAMI/ISO 17664-1:2022 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
AAMI EQ93:2019(R2025) Medical equipment management - Vocabulary used in medical equipment programs
AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
AAMI/ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
AAMI/ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.

Standard Association of Australia （SAA）

AS ISO 14971:2020 Medical devices — Application of risk management to medical devices
AS 2684:1984 Medical equipment - Humidifiers, for medical use

Bureau of Indian Standards

IS 18287-2023 Sterilization Of Health Care Products Common Requirements For Sterilizers For Terminal Sterilization Of Medical Devices In Health Care Facilities
IS/ISO 10993-18-2020 Biological evaluation of medical devices Part 18: Chemical characterization of medical device materials within a risk management process
IS 18742-2-2024 Processing of Health Care Products - Information to be Provided by the Medical Device Manufacturer for the Processing of Medical Devices - Part 2 Non-Critical Medical Devices
IS 18742-1-2024 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
IS/ISO 14971-2019 Medical devices - Application of risk management to medical devices First Revision

European Committee for Electrotechnical Standardization（CENELEC）

EN 62366:2008 Medical devices - Application of usability engineering to medical devices

Association of German Mechanical Engineers

VDI-EE 5702 BLATT 3-2024 Medizinprodukte-Software - Medical SPICE - Empfehlungen fuer die Softwareentwicklung

Czech Standards Institute (UNMZ)

CSN 36 4800-1966 Electrical medical insíruments

Indonesia Standards

SNI ISO 17664-1:2021 Pemrosesan produk pelayanan kesehatan — Informasi yang disertakan oleh produsen alat kesehatan untuk pemrosesan alat kesehatan — Bagian 1: Alat kesehatan kritikal dan semi kritikal (ISO 17664-1:2021, IDT)
SNI ISO 17664-2:2021 Pemrosesan produk pelayanan kesehatan — Informasi yang disertakan oleh produsen alat kesehatan untuk pemrosesan alat kesehatan — Bagian 2: Alat kesehatan non-kritikal (ISO 17664-2:2021, IDT)

American Society for Testing and Materials (ASTM)

ASTM F619-20 Standard Practice for Extraction of Materials Used in Medical Devices
ASTM F619-20(2025) Standard Practice for Extraction of Materials Used in Medical Devices
ASTM F619-79(1997)e1 Standard Practice for Extraction of Medical Plastics
ASTM F619-02 Standard Practice for Extraction of Medical Plastics

Swiss Association for Standardization (SNV)

SN 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 (ISO 17664-1:2021)

Austrian Standards

OENORM 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 (ISO/FDIS 17664-1:2021)

National Standardisation Body (ASRO)

STAS 1484-1950 medical instruments. Boxes for storing first aid equipment and materials

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