Automatic Analysis of Medical Devices

Automatic Analysis of Medical Devices, Total:383 items.

The international standard classification for "Automatic Analysis of Medical Devices" includes: Medical equipment in general , Sterilization and disinfection in general , Medical equipment .

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

未注明发布机构

DIN 58319 E:2019-05 Medical instruments - Elevators Williger
DIN 13465 E:2016-07 Medical instruments haemostatic forceps type Adson
DIN 13465 E:2022-08 Medical instruments haemostatic forceps type Adson
DIN 96057 E:2015-09 Medical instruments - Raspatory type Sedillot
DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices
DIN 58241 E:2015-09 Medical instruments Crile's haemostatic forceps
DIN 58318 E:2019-05 Medical instruments - Elevators Langenbeck's
DIN 58242 E:2022-08 Medical instruments - Haemostatic forceps type Dandy
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
DIN 13119 E:2008-09 Medical instruments bowel scissors
DIN EN 556-2 E:2014-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
DIN 96057:2016-03 Medical instruments - Raspatory type Sedillot
DIN 58852 E:2020-06 Medical instruments - Probes
DIN 13193 E:2016-07 Medical instruments - Rongeurs type Luer
DIN 96057 E:2022-08 Medical instruments - Raspatory type Sedillot
DIN 13145 E:2008-09 Medical instruments - Mallet of plastic material
DIN 58241 E:2022-08 Medical instruments Crile's haemostatic forceps
DIN EN ISO 17664-1 E:2021-02 Handling of Healthcare Products Information provided by medical device manufacturers for medical devices Part 1: Critical and semi-critical medical devices (draft)
DIN 96056 E:2015-09 Medical instruments - Bone raspatory
ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management to medical devices
DIN 58852 E:2014-02 Medical instruments - Probes
DIN 13173 E:2022-08 Medical instruments - Dressing forceps
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
DIN 13193 E:2022-08 Medical instruments - Rongeurs type Luer
DIN 96082 E:2017-03 Medical instruments - Self-retaining retractor type Beckmann-Adson
ANSI/AAMI/ISO 15225:2016 Medical devices—Quality management—Medical device nomenclature data structure
DIN 58846 E:2017-06 Medical instruments - Raspatories
DIN 58242:2023-03 Medical instruments - Haemostatic forceps type Dandy
DIN 96056:2016-03 Medical instruments - Bone raspatory
DIN 13176 E:2016-07 Medical instruments - Organ grasping forceps
DIN 96056:2023-03 Medical instruments - Bone raspatory
DIN 58241:2023-03 Medical instruments; Crile's haemostatic forceps
DIN 13173 E:2016-07 Medical instruments - Dressing forceps
DIN EN ISO 14971 E:2018-08 Application of medical device risk management in medical devices (draft)
DIN 58242 E:2015-09 Medical instruments - Haemostatic forceps type Dandy
DIN 96056 E:2022-08 Medical instruments - Bone raspatory
DIN 58247 E:2016-07 Medical instruments retractor Roux's
DIN 13465 E:2008-09 Medical instruments haemostatic forceps type Adson

Professional Standard - Medicine

YY/T 0316-2016 Medical devices-Application of risk management to medical devices
YY/T 0316-2003 Medical devices -- Application of risk management to medical devices
YY/T 1406.1-2016 Medical device software—Part 1:Guidance on the application of ISO 14971 to medical device software
YY/T 0468-2015 Medical devices―Quality management―Medical device nomenclature data structure
YY/T 1406.1-2016/IEC/TR 80002-1 Medical Device Software Part 1: Guidelines for YY/T 0316 Applied to Medical Device Software
YY/T 0615.2-2007 Requirements for medical devices to be designated“STERILE” - Part 2: Requirements for aseptically processed medical devices
YY/T 0316-2008 Medical devices - Application of risk management to medical devices
YY/T 0615.1-2007 Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized 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

国家药监局

YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer
YY/T 1737-2020 Analytical method for bioburden control level of medical device

国家食品药品监督管理局

YY/T 1474-2016 Medical devices－Application of risk management to medical devices

Group Standards of the People's Republic of China

T/SAMD 0003-2023 Mechanically actuated micro-plunger pumps for medical devices
T/SZZX 015-2023 Mechanically actuated micro-plunger pumps for medical devices
T/ZGXX 0003-2019 Medical device cleaning agent

SCC

NS-EN 1441:1997 Medical devices — Risk analysis
DIN 96082:2017 Medical instruments - Self-retaining retractor type Beckmann-Adson
DIN 96076 E:2010 Draft Document - Medical instruments - Self-retaining retractor type Wullstein
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
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
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
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
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
DIN 96082 E:2017 Draft Document - Medical instruments - Self-retaining retractor type Beckmann-Adson
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
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
CAN/CSA-ISO 14971:2007(C2012) Medical devices - Application of risk management to medical devices
CEI UNI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
AAMI/ISO 14971:2019 Medical devices - Application of risk management to medical devices
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 556-2:2015 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed medical devices
CAN/CSA-ISO 14971:2007(R2012) Medical Devices - Application of Risk Management to Medical Devices
DANSK DS/EN ISO 14971:2012 Medical devices – Application of risk management to 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
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
DANSK DS/ISO 14971:2020 Medical devices – Application of risk management to medical devices
CAN/CSA-ISO 14971:2001(R2006) Medical Devices - Application of Risk Management to 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
ISO 14971:2019 Plus Redline Medical devices - Application of risk management to 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
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
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
BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices
CAN/CSA-ISO 14971:2001(C2006) Medical devices - Application of risk management 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)
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)
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
DANSK DS/EN 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
AENOR UNE-EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing.
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
DANSK DS/EN ISO 15225:2016 Medical devices – Quality management – Medical device nomenclature data structure
AAMI/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
CEI UNI EN/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
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
AAMI/ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
CEI EN 62366-1:2016 Medical devices Part 1: Application of usability engineering to medical devices
CAN/CSA-ISO 14971-1-99:1999 Medical devices - Risk management - Part 1: Application of risk analysis
CEI EN 62366:2008 Medical devices - Application of usability engineering to medical devices
AENOR UNE-EN 62366:2009 Medical devices - Application of usability engineering to medical devices
MIL MIL-C-42068-1989 CHEST, MEDICAL INSTRUMENT AND SUPPLY SET
DANSK DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
AENOR UNE-EN 62366/A1:2009 Medical devices - Application of usability engineering to medical devices
CEI EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
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)
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)
DIN 58857:2019 Medical instruments - Directors
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...
BS PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
DIN 96056:2016 Medical instruments - Bone raspatory
NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
DANSK DS/EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
NS-EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
SN-CR 14060:2000 Medical device traceability
UNE-EN 13824:2005 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)
NS-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 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
DIN 58318:2019 Medical instruments - Elevators Langenbeck's
DIN 13184:2016 Medical instruments - Bone holding forceps Farabeuf's
DIN 58274:2016 Medical instruments - Iris forceps
NS-EN ISO 15225:2010 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2010)
BS PD IEC/TR 80002-1:2009 Medical device software-Guidance on the application of ISO 14971 to medical device software
DIN 96057:2016 Medical instruments - Raspatory type Sedillot
DANSK DS/ISO 10993-17:2023 Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents
DIN 58319:2019 Medical instruments - Elevators Williger
NS-EN ISO 15225:2016 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2016)
CAN/CSA-ISO 14971-2021 Medical devices – Application of risk management to medical devices (ISO 14971:2019, IDT)
ISO 14971:2000/AMD1:2003 Amendment 1 - Medical devices - Application of risk management to medical devices
AAMI/ISO 10993-16:1997(R2009) Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables from 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.
DIN 13460 E:2016 Draft Document - Medical instruments - Needle holder type Heaney
DIN 58295:2017 Medical instruments - Retractor type Volkmann

German Institute for Standardization

DIN 96076:2010 Medical instruments - Self-retaining retractor type Wullstein
DIN 96115:2010 Medical instruments - Gauges type Lexer
DIN 96082:2010 Medical instruments - Self-retaining retractor type Beckmann-Adson
DIN 96082:2017-08 Medical instruments - Self-retaining retractor type Beckmann-Adson
DIN 58242:2009 Medical instruments - Haemostatic forceps type Dandy
DIN 58241:2009 Medical instruments - Haemostatic forceps type Crile
DIN 58241:2016 Medical instruments - Haemostatic forceps type Crile
DIN 58242:1970 Medical instruments; Dandy's haemostatic forceps
DIN 58241:1970 Medical instruments; Crile's haemostatic forceps
DIN 58242:2016 Medical instruments - Haemostatic forceps type Dandy
DIN 58318:2008 Medical instruments - Elevators Langenbeck's
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 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 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 556-2:2023-02 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 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
DIN 58846:2017-11 Medical instruments - Raspatories
DIN 13193:2023-03 Medical instruments - Rongeurs type Luer
DIN EN 13532:2002-08 General requirements for in vitro diagnostic medical devices for self-testing; German version EN 13532:2002, German and English texts
DIN EN ISO 17664-1:2021-11 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); German version EN ISO 17664-1:2021
DIN 58794:1982 Medical instruments; ear forceps
DIN 58857:2019-12 Medical instruments - Directors
DIN 13117:2013 Medical instruments.Bone shears
DIN 96056:2009 Medical instruments - Bone raspatory
DIN 58852:2008 Medical instruments - Probes
DIN 58794:2010 Medical instruments - Ear forceps
DIN 13119:1980 Medical instruments; bowel scissors
DIN 58852:2014 Medical instruments - Probes
DIN 13119:2010 Medical instruments - Bowel scissors
DIN 13117:1980 Medical instruments; bone shears
DIN 58852:2021 Medical instruments - Probes
DIN 13465:1982 Medical instruments; haemostatic forceps type Adson
DIN 58852:1976 Medical instruments; probes
DIN EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2003
DIN 58319:2008 Medical instruments - Elevators Williger
DIN 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); German and English version prEN ISO 17664-2:2023
DIN EN ISO 17664-2:2024-04 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 14971:2022-04 Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021
DIN EN ISO 10993-17:2021-12 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO/DIS 10993-17:2021); German and English version prEN ISO 10993-17:2021 / Note: Date of issue 2021-11-12*Intended as replacement for DIN...
DIN EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
DIN 58263:1973 Medical instruments; mouth gag Heister's
DIN 58862:2010 Medical instruments - Bone curettes
DIN 13145:2010 Medical instruments - Mallet of plastic material
DIN 58846:1988 Medical instruments; raspatories
DIN 58846:2017 Medical instruments - Raspatories
DIN 13111:2018 Medical instruments - Bandage scissors
DIN 58318:2019-12 Medical instruments - Elevators Langenbeck's
DIN 13111:2006 Medical instruments - Bandage scissors
DIN 13173:2023-03 Medical instruments - Dressing forceps
DIN 13103:1973 Medical instruments; dissecting scalpels
DIN 96057:2023-03 Medical instruments - Raspatory type Sedillot
DIN 58319:2019-12 Medical instruments - Elevators Williger
DIN 13104:2010 Medical instruments - Cartilage knife
DIN 58857:1976 Medical instruments; directors
DIN 58292:2010 Medical instruments - Tracheal hook
DIN 13173:2005 Medical instruments - Dressing forceps
DIN 58292:1972 Medical instruments; tracheal hook
DIN 58230:1974 Medical instruments; amputation knives
DIN 58862:1988 Medical instruments; bone curettes
DIN 58858:2021-02 Medical instruments - Director type König
DIN 58230:2010 Medical instruments - Amputation knives
DIN 13458:2009 Medical instruments - Ligature needle
DIN 13145:1979 Medical instruments; mallet of plastic material
DIN 58846:2010 Medical instruments - Raspatories
DIN 13173:2016 Medical instruments - Dressing forceps
DIN 13458:1988 Medical instruments; ligature needle
DIN 58259:1976 Medical instruments; needle holder type Masson

CEN - European Committee for Standardization

EN 1441:1997 Medical Devices - Risk Analysis
EN ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
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
EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
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 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

RU-GOST R

GOST ISO 10993-16-2016 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST R 55991.1-2014 In vitro diagnostics medical devices. Part 1. Automatic analyzers for biochemical assays. Technical requirements for public procurement
GOST R 55991.4-2014 In vitro diagnostics medical devices. Part 4. Automatic analyzers for coagulation tests. Technical requirements for public procurement
GOST R 55991.2-2014 In vitro diagnostics medical devices. Part 2. Automatic analyzer for immunoassays. Technical requirements for public procurement
GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
GOST R 55991.6-2014 In vitro diagnostics medical devices. Part 6. Automatic analyzers for hematology tests. Technical requirements for public procurement
GOST ISO 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST R 55991.3-2014 In vitro diagnostics medical devices. Part 3. Automatic analyzers for biomolecular assays. Technical requirements for public procurement
GOST R 55991.7-2014 In vitro diagnostics medical devices. Part 7. Automatic analyzers for general clinical tests. Technical requirements for public procurement
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 10993-13-2011 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST R 55544-2013 Medical devices software. Part 1. Guidance on the application of ISO 14971 medical devices software
GOST R ISO 15225-2014 Medical devices. Quality management. Medical device nomenclature data structure
GOST ISO/TS 10993-20-2011 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST ISO 10993-11-2011 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST R ISO 10993-11-1999 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic to xicity
GOST R ISO 10993-10-1999 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and sensitization
GOST ISO 10993-18-2011 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
GOST ISO 10993-5-2011 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST ISO 10993-7-2016 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals

Korean Agency for Technology and Standards (KATS)

KS P 2223-2023 In vitro diagnostic medical devices — Guideline for analytical performance evaluation for automated antinuclear antibody indirect immunofluorescence assay
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 IEC 62366-1:2021 Medical devices — Part 1: Application of usability engineering to 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 14971-1-2007 Medical devices－Risk management－Part 1：Application of risk analysis
KS P ISO 14971-1:2002 Medical devices－Risk management－Part 1：Application of risk analysis
KS P IEC 62366-1:2018 Medical devices — Part 1:Application of usability engineering to medical devices
KS P ISO 15225-2023 Medical devices — Quality management — Medical device nomenclature data structure
KS P ISO TR 80002-2:2021 Medical device software — Part 2: Validation of software for medical device quality systems
KS P ISO 15225-2014(2019) Medical devices — Quality management — Medical device nomenclature data structure
KS P IEC TR 62366-2:2020 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices

Association Francaise de Normalisation

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 S99-211:2013 Medical devices - Application of risk management to medical devices
NF EN 556-1:2002 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage STERILE - Partie 1 : exigences relatives aux dispositifs médicaux stérilisés au stade terminal
NF S90-305:1986 MEDICO-SURGICAL EQUIPMENT. PERITONEAL DIALYSIS CYCLER. FUNCTIONAL APTITUDE.
NF S99-211/A11*NF EN ISO 14971/A11:2021 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 EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
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 S99-012:2010 Medical devices - Quality management - Medical device nomenclature data structure.
NF EN 556-2:2015 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage "STÉRILE" - Partie 2 : exigences pour les dispositifs médicaux soumis à un traitement aseptique
NF S99-401:1994 Dispositifs médicaux - Élastomère de silicone de qualité médicale
NF S98-136:2009 Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.
NF S98-107-1*NF EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1 : requirements for terminally sterilized medical devices
NF S98-107-2:2004 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2 : requirements for aseptically processed medical devices".
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 S90-300:1981 MEDICAL AND SURGICAL EQUIPMENT. OXYGENATORS.

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 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

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 7203:1989 Oxygen analyzers for medical use
JIS T 62366-1:2022 Medical devices -- Part 1: Application of usability engineering to medical devices

British Standards Institution (BSI)

BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices
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 14971:2012 Medical devices. Application of risk management to medical devices
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 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 ISO 14971:2019+A11:2021 Medical devices - Application of risk management to medical devices
BS EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
BS EN ISO 10993-17:2023 Biological evaluation of medical devices - Toxicological risk assessment of medical device constituents
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 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 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
23/30457243 DC BS EN 556-1. Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Part 1. Requirements for terminally sterilized medical devices
23/30457240 DC BS EN 556-2. Sterilization of medical devices. Requirements for medical devices to be designated ''STERILE" - Part 2. requirements for aseptically processed 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

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
IEC/TR 62366-2:2016 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
IEC TR 62366-2-2016 Medical devices — Part 2: Guidance on the application of usability engineering 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
IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
IEC TR 80002-1:2009 Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
IEC/TR 80002-1:2009 Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
IEC TR 80002-1:2009 Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
IEC 62366-1:2015/AMD1:2020 Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1
IEC 62366-1:2015/AMD 1:2020 Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1

GSO

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 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 14971:2015 Medical devices -- Application of risk management to medical devices
BH GSO ISO 14971:2017 Medical devices -- Application of risk management to medical devices
OS GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
BH GSO EN 13532:2022 General requirements for in vitro diagnostic medical devices for self-testing
GSO EN 13532:2021 General requirements for in vitro diagnostic medical devices for self-testing
OS GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
BH GSO ISO 15225:2017 Medical devices -- Quality management -- Medical device nomenclature data structure
GSO ISO 15225:2016 Medical devices -- Quality management -- Medical device nomenclature data structure
GSO ISO/TR 80002-2:2021 Medical device software — Part 2: Validation of software for medical device quality systems
BH GSO ISO/TR 80002-2:2022 Medical device software — Part 2: Validation of software for medical device quality systems

KR-KS

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 IEC 62366-1-2018 Medical devices — Part 1:Application of usability engineering to medical devices
KS P IEC 62366-1-2021 Medical devices — Part 1: Application of usability engineering to medical devices
KS P ISO 14971-1-2002 Medical devices－Risk management－Part 1：Application of risk analysis
KS P ISO TR 80002-2-2021 Medical device software — Part 2: Validation of software for medical device quality systems
KS P IEC TR 62366-2-2020 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices

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 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)
CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
EN 556-2:2003 Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2: Requirements for aseptically processed medical devices
EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
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)
EN ISO 14971:2019/A11:2021 Medical devices - Application of risk management to medical devices (ISO 14971:2019)

ZA-SANS

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

International Electrotechnical Commission (IEC)

IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
IEC TR 62366-2:2016 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
IEC 62366-1:2020 Medical devices - Part 1: Application of usability engineering to medical devices
IEC 62366-1:2015+AMD1:2020 CSV Medical devices - Part 1: Application of usability engineering to medical devices
IEC 62366-1:2015/COR1:2016 Medical devices - Part 1: Application of usability engineering to medical devices
ISO/TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
ISO TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
ISO/TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
IEC 62366:2007/AMD1:2014 Medical devices - Application of usability engineering to medical devices

TH-TISI

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

ES-UNE

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 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 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)

AENOR

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

Lithuanian Standards Office

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
LST EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)

US-FCR

FCR 21 CFR PART 860-2015 MEDICAL DEVICE CLASSIFICATION PROCEDURES
FCR 21 CFR PART 860-2013 MEDICAL DEVICE CLASSIFICATION PROCEDURES
FCR 21 CFR PART 810-2015 MEDICAL DEVICE RECALL AUTHORITY
FCR 21 CFR PART 810-2013 MEDICAL DEVICE RECALL AUTHORITY
FCR 21 CFR PART 810-2014 MEDICAL DEVICE RECALL AUTHORITY

Standard Association of Australia （SAA）

AS ISO 14971:2020 Medical devices — Application of risk management to medical devices
ISO 10993-17:2023 Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents

Danish Standards Foundation

DS/EN ISO 14971:2013 Medical devices - Application of risk management to 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
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
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
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)
DS/CEN/CR 14060:2001 Medical device traceability
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/IEC/TR 80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software

GOSTR

GOST R EN 13532-2010 General requirements for in vitro diagnostic medical devices for self-testing

PL-PKN

PN-EN 62366-1-2015-07/A1-2021-03 E Medical devices -- Part 1: Application of usability engineering to medical devices
PN Z54061-1986 Medical instruments Ears Dimensions

NZ-SNZ

AS/NZS 4810.1:2000 Medical Devices - Risk Management Part 1: Application of Risk Analysis

CENELEC - European Committee for Electrotechnical Standardization

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

AT-ON

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)

RO-ASRO

STAS 10719/1-1984 MEDICAL INSTRUMENTS Clasification and terminology

DIN

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 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
DIN 96056:2023 Medical instruments - Bone raspatory
DIN 13173:2023 Medical instruments - Dressing forceps
DIN 13176:2023 Medical instruments - Organ grasping forceps

CH-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)

American Society for Testing and Materials (ASTM)

ASTM F561-97(2003) Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated Tissues

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)

IX-EU/EC

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

GOST

GOST R ISO/TS 10993-20-2009 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices

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