Maintenance and maintenance of Class II medical devices

Maintenance and maintenance of Class II medical devices, Total:275 items.

The international standard classification for "Maintenance and maintenance of Class II medical devices" includes: Medical equipment in general , Medical equipment .

The Chinese standard classification for "Maintenance and maintenance of Class II medical devices" includes: Medical apparatus and devices in general , Public medical equipment .

Shanghai Provincial Standard of the People's Republic of China

DB31/T 1378-2022 Service Specifications for Class II Medical Device Registration

Group Standards of the People's Republic of China

T/GDMDMA 0012.9-2022 Specifications for the Management of Medical Equipment in Hospitals - Part 9: Maintenance and Repair Management

Professional Standard - Medicine

YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer
YY/T 0316-2003 Medical devices -- Application of risk management to medical devices
YY/T 1474-2016 Medical devices－Application of risk management to medical devices
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 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 0316-2016 Medical devices-Application of risk management to medical devices
YY/T 0316-2008 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/Z 42217-2022 Medical device —Validation of software for medical device quality system
GB/T 42062-2022 Medical devices—Application of risk management to medical devices

Association Francaise de Normalisation

NF S99-170:2013 Maintenance of medical devices - Quality management system for the maintenance and management of risks associated with the operation of medical devices
NF S99-172:2017 Use and maintenance of medical devices - Risk management system for risks associated with the use of medical devices
NF S99-015*NF EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates.
NF S99-171:2006 Maintenance of medical devices - Model and definition for establishment and management of the medical device security, quality and maintenance register (RSQM).
NF EN 15986:2011 Symbol for use in the labeling of medical devices - Requirements for the labeling of medical devices containing phthalates
NF S99-211:2013 Medical devices - Application of risk management to 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 S98-116-2*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 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 S98-107-2*NF EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2 : requirements for aseptically processed medical devices
NF S98-107-2*NF EN 556-2:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2 : requirements for aseptically processed medical devices
NF EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
NF EN 556-2:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2 : requirements for aseptically processed medical devices
NF S98-107-1*NF EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
NF S98-136:2009 Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.

Association of German Mechanical Engineers

VDI/VDE 2426 Blatt 4-2000 Catalogues in maintenance and management of medical devices - Maintenance measures
VDI/VDE 2426 Blatt 1-2000 Catalogues in maintenance and management of medical devices - General
VDI VDE 2426 Blatt 3-2000 Fault catalogues in maintenance and management of medical devices
VDI/VDE 2426 Blatt 2-2000 Catalogues in maintenance and management of medical devices - Standardized device catalogue
VDI VDE 2426 Blatt 2-2000 Catalogues in maintenance and management of medical devices - Standardized Device Catalogue
VDI/VDE 2426 BLATT 1-2019 Catalogues in maintenance and management of medical devices - Fundamentals
VDI/VDE 2426 Blatt 3-2000 Catalogues in maintenance and management of medical devices - Fault catalogues
VDI VDE 2426 Blatt 4-2000 Maintenance measures catalogue in maintenance and management of medical devices

Gosstandart of Russia

GOST R 57501-2017 Maintenance of medical devices. Requirements for governmental purchases
GOST R EN 13718-1-2015 Medical vehicles and their equipment. Air Ambulances. Part 1. Requirements for medical devices used in air ambulances
GOST 18250-1980 Medical apparatus and devices. Fiber lightguides. Connecting dimensions
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
GOST ISO 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO 2628:2022 Medical devices and supplies classification criteria
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

GCC Standardization Organization

GSO 2628:2021 Medical devices and supplies classification criteria
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

Canadian Standards Association (CSA)

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)
CAN/CSA-ISO 14971-2007(R2017) Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2007, second edition, 2007-03-01)
CAN/CSA-ISO 14971:2007(C2012) Medical devices - Application of risk management to medical devices
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 14971:2001(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 Z8002-2025 Operation and maintenance of health care facilities
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 17664-1-2023 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

Military Standards (MIL-STD)

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

Spanish Association for Standardization (UNE)

AENOR UNE 209001 IN:2002 Guide for the management and maintenance of non-implantable active medical devices.
UNE 209001:2002 IN Guide for the management and the maintenance of active non implantable medical devices.
UNE-EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
AENOR UNE-EN 15986:2011 Symbol for use in the labeling of medical devices - Requirements for labeling of medical devices containing phthalates
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)
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 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 556-1:2002/AC:2007 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
UNE-EN 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 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
UNE-EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices
AENOR 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-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)

US Federal Contractor Registration (USFCR)

FCR 21 CFR PART 860-2013 MEDICAL DEVICE CLASSIFICATION PROCEDURES
FCR 21 CFR PART 860-2015 MEDICAL DEVICE CLASSIFICATION PROCEDURES

Standard Association of Australia （SAA）

AS 4187:1998 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities
AS ISO 14971:2020 Medical devices — Application of risk management to medical devices

Ente Nazionale Italiano di Unificazione

UNI CEI EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
UNI EN 13718-1:2008 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
UNI EN 13718-1:2014 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
UNI EN 13718-1:2021 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
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 EN ISO 14971:2008 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2012 Medical devices - Application of risk management to medical devices
EC 1-2004 UNI CEI EN ISO 14971:2004 Medical devices - Application of risk management to 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 14971:2022 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 14971:2009 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
UNI EN 556:1996 Sterilization of medical devices. Requirements for medical devices to be labelled "Sterile".
UNI EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
UNI CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
UNI ENV 12611:1997 Medical informatics. Categorial structure of systems of concepts. 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 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

Swedish Institute for Standards

SS-EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
SS-EN 13718-1:2014+A1:2020 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
SS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
SS-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
SS-EN 556-2:2024 Sterilization of medical devices — Requirements for medical devices to be designated ''STERILE" — Part 2: requirements for aseptically processed medical devices
SS-EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
SS-EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
SS-EN 556-1:2024 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1: Requirements for terminally sterilized medical devices

Standards Norway

NS-EN 13718-1:2014+A1:2020 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
NS-EN 15986:2011 Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices containing phthalates
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 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
NS-EN 556-2:2015 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed medical devices
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 ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
NS-EN 556:1994 Sterilization of medical devices — Requirements for medical devices to be labelled "Sterile"
NS-EN ISO 14971:2019 Medical devices — Application of risk management to medical devices (ISO 14971:2019)

German Institute for Standardization

DIN 58860:2010-02 Medical instruments - Osteotomes type Lexer
DIN 58257:1983-02 Medical instruments; needle holder type Crile
DIN 58858:2008-01 Medical Instruments - Director Type KÃ¶nig
DIN 13452:2017-11 Medical instruments - Scissors type Kilner
DIN 58785:2010-02 Medical instruments - Ear specula type Hartmann
DIN 58257:2010-02 Medical instruments - Needle holder type Crile
DIN 58259:2010-02 Medical instruments - Needle holder type Masson
DIN 13452:2006-12 Medical instruments - Scissors type Kilner
DIN 58262:2010-02 Medical instruments - Mouth gag type Jennings
DIN 58259:1976-03 Medical instruments; needle holder type Masson
DIN EN 15986:2011-05 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version EN 15986:2011, with CD-ROM
DIN 58788:1982-09 Medical instruments; nasal specula type Hartmann-Halle
DIN 96111:2010-12 Medical instruments - Plaster knife type Körte
DIN 96035:2009-12 Medical instruments - Haemostatic forceps type Semb
DIN EN 15986 E:2009-08 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
DIN 58263 E:2008 Draft Document - Medical instruments - Mouth gag type Heister
DIN 58286:2010-02 Medical instruments - Retractor type Kocher
DIN 96086:2010-12 Medical instruments - Bone wire tightener type Loute
DIN 96076:2010-12 Medical instruments - Self-retaining retractor type Wullstein
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
DIN 96057:2009-12 Medical instruments - Raspatory type Sedillot
DIN EN 15986 E:2009 Draft Document - Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version prEN 15986:2009
DIN 58867:2010-02 Medical instruments - Septum knife type Brünings
DIN 96115 E:2010-05 Draft Document - Medical instruments - Gauges type Lexer
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 58785:1982-09 Medical instruments; ear specula type Hartmann
DIN 58295:1983-02 Medical instruments; retractor type Volkmann
DIN 96101:2010-12 Medical instruments - Bone raspatory type Jansen
DIN 96082:2010-12 Medical instruments - Self-retaining retractor type Beckmann-Adson
DIN 58783:2010-02 Medical instruments - Ear curette type Buck
DIN EN ISO 14971:2020-07 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
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 556-1:2002-03 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 58285:2008-01 Medical instruments - Retractor type Volkmann
DIN EN ISO 14971 E:2018-08 Application of medical device risk management in medical devices (draft)
DIN EN 13824:2005-02 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
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 58795:2010 Medical instruments - Mouth gags - Dimensions for slide bars and tongue depressors
DIN EN 556-2:2004-03 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices
DIN EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
DIN 58858:2020-06 Draft Document - Medical instruments - Director type KÃ¶nig
DIN EN ISO 14971:2007-07 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
DIN EN 556-1 E:2023 Draft Document - 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
DIN 96025:2009-12 Medical instruments - Ethmoid rongeur forceps type Craig
DIN 13191:2005-12 Medical instruments - Rongeur type Stille
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 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
DIN EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
DIN EN 556-2:2025 Sterilization of Medical Devices - Requirements for Medical Devices to be Designated "STERILE" - Part 2: Requirements for Aseptically Processed Medical Devices
DIN 13188:1983-02 Medical instruments; plaster cast spreader type Henning
DIN EN 556-1:2024-09 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
DIN 58259 E:2008-09 Draft Document - Medical instruments - Needle holder type Masson
DIN 58240:2022-08 Draft Document - Medical instruments - Retractors type Israel
DIN 13199:2010 Medical instruments - Ethmoid rongeur forceps type Weil-Blakesley and Watson-Williams

Danish Standards Foundation

DANSK DS/EN 13718-1+A1:2020 Medical vehicles and their equipment – Air ambulances – Part 1: Requirements for medical devices used in air ambulances
DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
DANSK DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
DANSK DS/EN ISO 14971:2012 Medical devices – Application of risk management to 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 62366:2008 Medical devices - Application of usability engineering to medical devices
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 556-1/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized 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/EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
DS/EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
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
DS/EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices
DANSK DS/EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
DS/EN 556:1995 Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile"

European Committee for Standardization (CEN)

EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
EN ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
EN ISO 14971:2009 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 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
EN 556-2:2015 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices"
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)

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 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 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

National Standardisation Body (ASRO)

STAS 10719/1-1984 MEDICAL INSTRUMENTS Clasification and terminology

Lithuanian Standards Office

LST EN 15986-2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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
LST EN 556-2-2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
LST EN 556-1-2002/AC-2006 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices

Comitato Elettrotecnico Italiano

CEI UNI EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
CEI UNI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
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

British Standards Institution (BSI)

BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
BS EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
19/30378069 DC BS ISO 17664-2. 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
09/30205582 DC BS EN 15986. Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
06/30106983 DC EN 13718-1. Medical vehicles and their equipment. Air ambulances. Part 1 . Requirements of medical devices used in air ambulances
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 556-1:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices
BS EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
BS EN 556-2:2015 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
18/30371211 DC BS EN 13718-1. Medical vehicles and their equipment. Air ambulances. Part 1. Requirements for medical devices used in air ambulances
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
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 PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
BS EN ISO 10993-2:2006 Biological evaluation of medical devices - Animal welfare requirements
BS PD ISO/TS 11633-1:2019 Health informatics. Information security management for remote maintenance of medical devices and medical information systems-Requirements and risk analysis
BS PD ISO/TR 11633-1:2009 Health informatics. Information security management for remote maintenance of medical devices and medical information systems-Requirements and risk analysis

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

International Organization for Standardization (ISO)

ISO 14971:2019 Medical devices — Application of risk management to medical devices
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 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

South African Bureau of Standard

SANS 14971:2008 Medical devices - Application of risk management to medical devices
SANS 1593:1994 Disinfectants based on glutaraldehyde for use on medical instruments

European Union/Commission

MEDDEV 2.4/1 PART 2-2001 Guidelines for the Classification of Medical Devices Rev 8

Thai Industrial Standards Institute (TISI)

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

International Electrotechnical Commission (IEC)

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

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/IEC 62366:2007(R2013) Medical devices - Application of usability engineering to 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 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 20857:2010(R2015) Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
AAMI/ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of 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

Czech Standards Institute (UNMZ)

CSN 84 7106-1983 Medlcal eguipment. Methods, means and processes of sterllization and desinfection of items for medical use. Terms and definitions.
CSN 07 8611-1969 Small valve with protective tube for cylinders for oxygen intended for medical apparatus

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

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management to medical devices
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 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/IEC 62366/A1:2014 Medical devices - Application of usability engineering to medical devices - Amendment 1

Bureau of Indian Standards

IS 23485-2019 Medical Devices —— Quality Management System Requirements and Essential Principles of Safety and Performance for Medical Devices
IS/ISO 15223-1-2016 Medical Devices — Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part — General Requirements ( Second Revision )
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/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

National Certification and Accreditation Administration

CNCA 08C-035-2001 Implementation Rules for Compulsory Certification of Medical Device Products Hollow Fiber Dialyzer

Indonesia Standards

SNI ISO 14971:2019 Healthcare Devices – Application of Risk Management to Healthcare Devices (ISO 14971:2019, IDT)

Others: Maintenance and maintenance of Class II medical devices