Validation methods for medical devices

Validation methods for medical devices, Total:293 items.

The international standard classification for "Validation methods for medical devices" includes: Medical equipment in general , Medical equipment , Sterilization and disinfection in general , Laboratory medicine .

The Chinese standard classification for "Validation methods for medical devices" includes: Medical apparatus and devices in general , Public medical equipment .

Professional Standard - Medicine

YY/T 91050-1999 Editorial method for design documents of medical device product
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 1474-2016 Medical devices－Application of risk management to medical devices
YY/T 0316-2003 Medical devices -- Application of risk management to medical devices
YY/T 0316-2016 Medical devices-Application of risk management to medical devices
YY/T 1911-2023 Test method of coagulation for medical devices
YY 91050-1999 How to prepare medical device product design documents
YY/T 1939-2024 Test method for bacterial endotoxins in medical devices - Recombinant factor C method
YY/T 0316-2008 Medical devices - Application of risk management to medical devices
YY/T 1608-2018 Radiation sterilization of medical device—Sampling method for verification dose experiments and sterilization dose audits
YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer
YY/T 1607-2018 Radiation sterilization of medical device—Method of dose setting

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 16886.20-2015 Biological evaluation of medical devices―Part 20:Principles and methods for immunotoxicology testing of medical devices
GB/Z 44363-2024 Pyrogenicity—Principles and methods for pyrogen testing of medical devices

未注明发布机构

AAMI/ISO TIR80002-2:2017 Medical device software—Part 2: Validation of software for medical device quality systems

International Organization for Standardization (ISO)

ISO/TS 11796:2023 Biological evaluation of medical devices — Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
ISO 14971:2000 Medical devices - Application of risk management 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
ISO/TS 23128:2019 Medical devices — Transfusion set and blood bag compatibility test method
ISO 21474-2:2022 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification
ISO/DIS 23417:1975 General specifications and validation methods for non-sterile medical device packages in good distribution practice principles
ISO 14971:2019 Medical devices — Application of risk management to medical devices
ISO/TR 21582:2021 Pyrogenicity — Principles and methods for pyrogen testing of medical devices
ISO 14937:2000/Cor 1:2003 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices; Technical Corrigendum 1
ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices
ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
ISO/DIS 11135:2023 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices

British Standards Institution (BSI)

BS PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
BS PD ISO/TS 11796:2023 Biological evaluation of medical devices. Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
PD ISO/TR 80002-2:2017 Medical device software — Part 2: Validation of software for medical device quality systems
PD ISO/TS 11796:2023 Biological evaluation of medical devices. Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
BS EN ISO 11737-2:2000 Sterilization of medical devices. Microbiological methods-Tests of sterility performed in the validation of a sterilization process
BS 5736-8:1984 Evaluation of medical devices for biological hazards-Method of test for skin irritation of solid medical devices
BS 5736-7:1983 Evaluation of medical devices for biological hazards-Method of test for skin irritation of extracts from medical devices
BS 5736-4:1981 Evaluation of medical devices for biological hazards-Method of test for intracutaneous reactivity of extracts from medical devices
BS 5736-10:1988 Evaluation of medical devices for biological hazards-Method of test for toxicity to cells in culture of extracts from medical devices
BS EN 552:1994(2001) Sterilization of medical devices — Validation and routine control of sterilization by irradiation
BS EN 554:1994(1998) Sterilization ofmedical devices — Validation and routine control ofsterilization by moist heat
BS 5736-3:1981 Evaluation of medical devices for biological hazards-Method of test for systemic toxicity; assessment of acute toxicity of extracts from medical devices
BS PD ISO/TS 23128:2019 Medical devices. Transfusion set and blood bag compatibility test method
DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices
BS 5736-11:1990 Evaluation of medical devices for biological hazards-Method of test for haemolysis
BS EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
BS EN 540:1993 Clinical investigation of medical devices for human subjects
BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
BS EN 550:1994(1998) Sterilization ofmedical devices — Validation and routine control ofethylene oxide sterilization
BS 5736-9:1986 Evaluation of medical devices for biological hazards-Method of test for eye irritation
BS 5736-5:1982 Evaluation of medical devices for biological hazards-Method of test for systemic toxicity; assessment of pyrogenicity in rabbits of extracts from 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 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 5736-2:1990 Evaluation of medical devices for biological hazards-Methods of testing by tissue implantation
BS EN 868-4:2009 Packaging for terminally sterilized medical devices - Paper bags - Requirements and test methods
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
BS 5736-2:1981 Evaluation of medical devices for biological hazards-Method of testing by tissue implantation
25/30467464 DC BS EN ISO 15883-6 Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for noncritical medical devices and health care equipment
BS 5736-6:1983 Evaluation of medical devices for biological hazards-Methods of test for sensitization; assessment of the potential of medical devices to produce delayed contact dermatitis
BS EN 868-2:2009 Packaging for terminally sterilized medical devices - Sterilization wrap - Requirements and test methods
08/30154605 DC BS ISO 15223-2. Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 2. Symbol development, selection and validation
21/30384564 DC BS ISO 23417. General specifications and validation methods for non-sterile medical device packages in good distribution practice principles
BS EN 1174-3:1997 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Guide to the methods for validation of microbiological techniques
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

Danish Standards Foundation

DANSK DS/ISO/TS 11796:2023 Biological evaluation of medical devices – Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
DANSK DS/ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
DANSK DS/EN 552/A1:1999 Sterilization of medical devices - Validation and routine control of sterilization by irradiation
DANSK DS/ISO/TS 10993-20:2006 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
DANSK DS/EN ISO 25424:2011 Sterilization of medical devices – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices
DS/EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
DANSK DS/ISO/TS 23128:2020 Medical devices – Transfusion set and blood bag compatibility test method
DANSK DS/EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
DANSK DS/EN ISO 17665:2024 Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for 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
DS/ISO 15223-2:2011 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
DANSK DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
DANSK DS/ISO 15223-2:2011 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
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

GCC Standardization Organization

GSO ISO/TS 11796:2024 Biological evaluation of medical devices — Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
GSO ISO/TR 80002-2:2021 Medical device software — Part 2: Validation of software for medical device quality systems
BH GSO ISO/TS 11796:2024 Biological evaluation of medical devices — Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
GSO ISO 15198:2016 Clinical laboratory medicine -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer
GSO ISO/TS 10993-20:2016 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
GSO ISO 25424:2016 Sterilization of medical devices -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices
GSO ISO 23128:2022 Medical devices — Transfusion set and blood bag compatibility test method
GSO ASTM F3208:2022 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
GSO ASTM F3127:2021 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices

Korean Agency for Technology and Standards (KATS)

KS P ISO TR 80002-2-2021 Medical device software — Part 2: Validation of software for medical device quality systems
KS P ISO TR 80002-2:2021 Medical device software — Part 2: Validation of software for medical device quality systems
KS P ISO 15198-2022 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
KS T 5011-2020 Packaging—Complete, filled transport packages —Test methods for transport packaging of medical devices
KS P ISO 10993-20-2009(2019) Biological evaluation of medical devices － Part 20: Principles and methods for immunotoxicology testing of medical devices
KS P ISO 10993-20-2019 Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
KS P ISO 10993-20-2009(2024) Biological evaluation of medical devices － Part 20: Principles and methods for immunotoxicology testing of medical devices
KS P ISO 15223-2-2019 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
KS P ISO 15223-2:2019 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
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 15223-2-2019(2024) Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
KS P ISO 15225-2014(2019) Medical devices — Quality management — Medical device nomenclature data structure
KS P ISO 20857-2024 Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
KS P ISO 21474-2-2023 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification
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

TH-TISI

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

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO ISO/TR 80002-2:2022 Medical device software — Part 2: Validation of software for medical device quality systems
BH GSO ISO 15198:2017 Clinical laboratory medicine -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer
BH GSO ISO/TS 10993-20:2017 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
BH GSO ISO 25424:2017 Sterilization of medical devices -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices
BH GSO ASTM F3208:2023 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
BH GSO ISO 23128:2023 Medical devices — Transfusion set and blood bag compatibility test method
BH GSO ISO 14971:2017 Medical devices -- Application of risk management to medical devices
BH GSO ISO 15223-2:2017 Medical devices -- Symbols to be used with medical device labels, labelling, and information to be supplied -- Part 2: Symbol development, selection and validation
BH GSO ASTM F3127:2022 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices

IN-BIS

IS 12572 Pt.9-1988 Guidelines for Biohazard Evaluation of Medical Devices Part 9 Test Methods for Skin Irritation from Solid Medical Devices
IS 12572 Pt.8-1988 Guidelines for Biohazard Assessment of Medical Devices Part 8 Skin Irritation Test Methods for Medical Device Extracts
IS 12572 Pt.5-1988 Guidelines for Biohazard Evaluation of Medical Devices Part 5 Test Method for Intradermal Reactivity of Medical Device Extracts
IS 12572 Pt.4-1988 Guidelines for Biohazard Assessment of Medical Devices Part 4 Systemic Toxicity Test Methods: Assessment of Acute Toxicity of Medical Device Extracts

Bureau of Indian Standards

IS/ISO/TR 80002-2-2017 Medical Device Software Part 2 Validation of Software for Medical Device Quality Systems
IS/ISO 15198-2004 Clinical Laboratory Medicine — In vitro Diagnostic Medical Devices — Validation of User Quality Control Procedures by the Manufacturer
IS/ISO/TS 10993-20-2006 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
IS/ISO 15223-2-2010 Medical devices —— Symbols to be Used with Medical Device Labels, Labelling, and Information to be Supplied Part 2 Symbol Development, Selection and Validation
IS 12572-9-1988 Guide for Evaluation of Medical Devices for Biological Hazards Part 9 Method of Test for Skin Irritation by Solid Medical Devices
IS 12572-5-1988 Guide for Evaluation of Medical Devices for Biological Hazards Part 5 Method of Test for Intracutaneous Reactivity of Extracts from Medical Devices
IS 12572-8-1988 Guide for Evaluation of Medical Devices for Biological Hazards Part 8 Method of Test for Skin Irritation of Extracts from Medical Devices: and
IS 18319-2024 Sterilization of Health Care Products-Moist Heat-Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
IS 18866-2024 Stainless Steel Needle Tubing for the Manufacture of Medical Devices-Requirements and Test Methods

SCC

AAMI ST98:2022 Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
AAMI/ISO 14971:2019 Medical devices - Application of risk management to medical devices
AAMI/ISO 15223-2:2010 Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 2: Symbol development, selection and validation
AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices

Gosstandart of Russia

GOST R ISO 15198-2009 Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user control procedures by the manufacturer
GOST R 51352-2013 In vitro diagnostic medical devices. Test methods
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
GOST R 58976-2020 Medical devices. Software. Part 2. Validation of software for medical device quality systems
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 R 56431-2015 Quality management systems. Medical devices. Process validation guidance
GOST ISO 11135-2012 Medical devices. Validation and routine control of ethylene oxide sterilization
GOST R ISO 20857-2016 Sterilization of medical devices. Dry heat. Requirements for development, validation and routine control of a sterilization process for medical devices
GOST R ISO 11135-2000 Medical devices. Validation and routine control of ethylene oxide sterilization
GOST R ISO 10993.5-1999 Medical devices. Biological evaluation of medical devices. Part 5. Tests for cytotoxicity: in vitro methods
GOST R 56328-2014 Medical equipment. Mobile complexes for medical purpose. General specifications and test methods
GOST ISO 10993-11-2011 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST R ISO 11737-2-2003 Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the validation of a sterilization process
GOST ISO 11737-2-2011 Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the validation of a sterilization process
GOST ISO 10993-5-2011 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity

German Institute for Standardization

DIN 58921 E:2010-02 Test method to demonstrate the suitability of a medical device simulator during steam sterilisation - Medical device simulator testing
DIN 58921 E:2010 Draft Document - Test method to demonstrate the suitability of a medical device simulator during steam sterilisation - Medical device simulator testing
DIN EN ISO 13485:2001 Quality assurance systems for medical devices
DIN 58921:2011 Test method to demonstrate the suitability of a medical device simulator during steam sterilisation - Medical device simulator testing; Text in German and English
DIN EN 550:1994 Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization
DIN EN 15424:2007-08 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
DIN EN 540:1993 Clinical testing of medical devices on humans
DIN EN ISO 11137-1 A1 E:2012-05 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
DIN EN ISO 11135:2014-10 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
DIN EN 556-1 E:2023-02 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 EN 556-2 E:2023-02 Draft Document - 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
DIN 5343:2020 Cleanliness of medical devices - Process design and test methods; Text in German and English
DIN /TS 5343:2022 Cleanliness of medical devices - Risk orientated validation of cleanliness, development of acceptance criteria and selection of test methods; Text in German and English
DIN 96110:2006-12 Medical instruments - Technical specifications for evidence examples
DIN EN ISO 11607-2 A1 E:2013-04 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
DIN 58921:2011-01 Test method to demonstrate the suitability of a medical device simulator during steam sterilisation - Medical device simulator testing; Text in German and English
DIN 58921 E:2008-12 Draft Document - Test method to demonstrate the suitability of a process challenge device in simulating medical devices during steam sterilisation - Medical device simulator testing
DIN EN ISO 25424:2011-09 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
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 ISO 14971:2020-07 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
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 556-2:2023-02 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...

Ente Nazionale Italiano di Unificazione

UNI EN 554:1996 Sterilization of medical devices. Validation and routine control of sterilization by moist heat.
UNI EN 550:1996 Sterilization of medica devices. Validation and routine control of ethylene oxide sterilization.
UNI EN ISO 11737-2:2001 Sterilization of medical devices - Microbiological methods - Tests of sterility performed in the validation of a sterilization process.
UNI EN 1174-3:1998 Sterilization of medical devices - Estimation of the population of micro- organisms on product - Guide to the methods for validation of microbiological techniques.
UNI EN 552:1996 Sterilization of medical devices. Validation and routine control of sterilization by irradiation.
UNI EN 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
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 EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
UNI EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ?STERILE? - Requirements for terminally sterilized medical devices
EC 1-2004 UNI CEI EN ISO 14971:2004 Medical devices - Application of risk management to medical devices
UNI EN ISO 14937:2002 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
UNI CEI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
UNI EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
UNI EN ISO 17665:2024 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
UNI CEI EN ISO 14971:2022 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 13726-4:2004 Non-active medical devices - Test methods for primary wound dressings - Conformability
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 ISO 11135:2020 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
EC 1-2015 UNI EN ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices

Standards Norway

NS-EN 556:1994 Sterilization of medical devices — Requirements for medical devices to be labelled "Sterile"
NS-EN 552:1994 Sterilization of medical devices — Validation and routine control of sterilization by irradiation
NS-EN 554:1994 Sterilization of medical devices — Validation and routine control of sterilization by moist heat
SN-ISO/TS 10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
NS-EN 15424:2007 Sterilization of medical devices — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
NS-EN 540:1993 Clinical investigation of medical devices for human subjects
NS-EN ISO 25424:2011 Sterilization of medical devices — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
NS-EN 550:1994 Sterilization of medical devices — Validation and routine control of ethylene oxide sterilization

The Directorate General of Specifications and Metrology (DGSM)

OS GSO ISO 15198:2016 Clinical laboratory medicine -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer
OS GSO ISO 25424:2016 Sterilization of medical devices -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices
OS GSO ISO/TS 10993-20:2016 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
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

European Committee for Standardization (CEN)

prEN 556-1991 Sterilization of medical devices; sterility assurance level for medical devices labelled "Sterile"; requirements
EN ISO 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
EN 554:1994 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Moist Heat
EN ISO 11737-2:2000 Sterilization of Medical Devices - Microbiological Methods - Part 2: Tests of Sterility Performed in the Validation of a Sterilization Process ISO 11737-2: 1998
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
EN 550:1994 Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
EN ISO 11137-1:2015/A2:2019 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
EN ISO 11137-1:2006/A1:2013 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006/Amd 1:2013)
CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
EN 1174-3:1996 Sterilization of Medical Devices - Estimation of the Population of Micro-Organisms on Product - Part 3: Guide to the Methods for Validation of Microbiological Techniques

American Society for Testing and Materials (ASTM)

ASTM F3321-19 Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
ASTM F3293-18 Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices

American National Standards Institute （ANSI)

ANSI/AAMI ST98-2022 Requirements for cleaning validation in medical device manufacturing Requirements for developing and validating cleaning processes for medical devices
ANSI/AAMI/ISO TIR10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
AAMI/ISO TIR10993-20:2006(R2021) Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management to medical devices

CEN - European Committee for Standardization

EN ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition@ validation and maintenance of a sterilization process
EN 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development@ validation and routine control of a sterilization process for medical devices
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 14971:2000 Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

Association Francaise de Normalisation

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 S98-107-1*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 EN 554:1994 Sterilization of medical devices. Validation and routine control of sterilization by moist heat.
NF S99-211:2013 Medical devices - Application of risk management to medical devices
NF EN ISO 14937:2009 Sterilization of healthcare products - General requirements for the characterization of a sterilizing agent and for the development, validation and routine verification of a sterilization process for medical devices
NF EN 550:1994 Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization.
NF EN ISO 17665:2024 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
NF S98-105*NF EN ISO 17665:2024 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
NF EN ISO 14971:2019 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 EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
NF EN ISO 20857:2013 Sterilization of healthcare products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
NF ISO 21474-2:2022 In vitro diagnostic medical devices - Multiplex molecular tests for nucleic acids - Part 2: validation and verification
NF ISO 15223-2:2010 Medical devices - Symbols for use with labels, labeling and information requirements relating to medical devices - Part 2: development, selection and validation of symbols
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

Swedish Institute for Standards

SS-EN 554:1995 Sterilization of medical devices - Validation androutine control of sterilization by moist heat
SS-EN 552:1995 Sterilization of medical devices - Validation androutine control of sterilization by irradiation
SS-EN ISO 13004:2023 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)
SS-EN ISO 17665:2024 Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices (EN ISO 17665:2024,IDT)
SS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)

Canadian Standards Association (CSA)

CAN/CSA-ISO 11135-1998(R2003) Medical devices - Validation and routine control of ethylene oxide sterilization
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 11137-1998(C2003) Sterilization of medical devices - Requirements for validation and routine control - Sterilization by irradiation
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

Spanish Association for Standardization (UNE)

UNE-EN 552:1995 STERILIZATION OF MEDICAL DEVICES. VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
UNE-EN 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
UNE-EN 554:1995 STERILIZATION OF MEDICAL DEVICES. VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
UNE-EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
UNE-EN 550:1995 STERILIZATION OF MEDICAL DEVICES. VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
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

Indonesia Standards

SNI ISO 15198:2009 Clinical laboratory medicine - In vitro diagnostic medical devices - validation of user quality control procedures by the manufacturer

Association of German Mechanical Engineers

VDI-MT 5702 BLATT 2-2023 Medizinprodukte-Software - Medical SPICE - Qualifizierung von Entwickelnden und Assessoren
VDI 5707 BLATT 1-2023 Repeat tests on active medical devices in medical use — test principles
VDI 5707 BLATT 1-2023 Repeat tests on active medical devices in medical use — test principles

American Society of Mechanical Engineers (ASME)

ASME V V 40-2018 Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices

CZ-CSN

CSN 84 6620-1955 Metal pair medical device box (two wings)

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

South African Bureau of Standard

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

Lithuanian Standards Office

LST EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
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

RO-ASRO

STAS E 10719/2-1986 Medical instruments RESISTANCE TESTING AT CORROSION AND REPEATED STERILIZATIONS STAINLESS STEEL MEDICAL INSTIUMENTS

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

Comitato Elettrotecnico Italiano

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

Standard Association of Australia （SAA）

AS ISO 14971:2020 Medical devices — Application of risk management to medical devices

CENELEC - European Committee for Electrotechnical Standardization

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

Others: Verification methods for medical device products,Validation methods for medical devices,Product verification methods for medical devices