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Database: 365,228(8 Aug 2026)

medical toxicity

medical toxicity, Total:344 items.

The international standard classification for "medical toxicity" includes: Laboratory medicine , Medical equipment in general , Sterilization and disinfection , Medical Sciences and health care facilities in general , Dental materials , Medical equipment , Applications of information technology in general .

The Chinese standard classification for "medical toxicity" includes: Medical apparatus and devices in general , , Sanitation in general , Medical science , Stomatologic device, equipment and material , Social and public safety in general .


Group Standards of the People's Republic of China

  • T/CACM 1266-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Acute viral hepatitis
  • T/CACM 1270-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Sepsis
  • T/CAS 404-2020 Household and similar disinfecting tableware cabinets that reach the level for disinfecting medical items
  • T/CHAS 10-2-27-2019 Quality and safety management of Chinese hospital—— Part 2-27:Patient service——Chinese medicine treatment
  • T/WSJD 51-2024 Water hygiene requirements for disinfection supply centers of medical institutions
  • T/CHAS 10-3-2-2019 Quality and safety management of Chinese hospital Part 3-2: Medical service support —— Drug supply service
  • T/CACM 1171-2019 Clinical guidelines for diagnosis and treatment of dermatology in TCM Facial Corticosteroid Addictive Dermatitis
  • T/WSJD 63-2024 Guidelines for use of disinfectant wipes in healthcare facilities

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

  • GB 16383-2014 Quality control for radiation sterilization of medical and hygienical products
  • GB/T 16886.3-1997 Biological evaluation of medical devices--Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicity
  • GB/T 16886.3-2008 Biological evaluation of medical devices - Part 3: Tests for genotoxicity carcinogenicity and reproductive toxicity
  • GB/T 16886.5-2017 Biological evaluation of medical devices―Part 5:Tests for in vitro cytotoxicity
  • GB/T 16886.20-2015 Biological evaluation of medical devices―Part 20:Principles and methods for immunotoxicology testing of medical devices
  • GB 27949-2011 General Requirements for Disinfectants for Medical Devices
  • GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity
  • GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
  • GB/T 16886.11-1997 Biological evaluation of medical devices--Part 11: Tests for systemic toxicity
  • GB/T 27949-2011 Hygienic requirements for medical items disinfection

未注明发布机构

  • DIN EN ISO 10993-3:2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • 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
  • ANSI/AAMI/ISO 10993-11:2017 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
  • DIN EN ISO 10993-3 E:2011-08 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (draft)
  • DIN EN ISO 10993-11 E:2015-12 Biological Evaluation of Medical Devices Part 11: Systemic Toxicity Testing (Draft)
  • CSA Z317.12-2020 Cleaning and disinfection of healthcare facilities
  • DIN 58953-8:2003-10 Sterilization; sterile supply; delivering of sterile medical devices for single use as well as its storage and handling
  • ANSI/AAMI/ISO TIR10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
  • DIN 58953-8 E:2018-09 Sterilization; sterile supply; delivering of sterile medical devices for single use as well as its storage and handling
  • ANSI/AAMI/ISO 10993-5:2009(2014) Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
  • DIN EN ISO 10993-3 E:2013-03 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (draft)
  • DIN 58953-8 E:2008-11 Sterilization; sterile supply; delivering of sterile medical devices for single use as well as its storage and handling

Professional Standard - Hygiene

  • WS/T 512-2016 Regulation for cleaning and disinfection management of environmental surface in healthcare
  • WS/T 367-2012 Regulation of disinfection technique in healthcare settings

Taiwan Provincial Standard of the People's Republic of China

  • CNS 14393-3-2004 Biological evaluation of medical devices – Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • CNS 14393.3-2004 Biological evaluation of medical devices – Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • CNS 14393.5-2004 Biological evaluation of medical devices – Part 5:Tests for in vitro cytotoxicity
  • CNS 14393-11-2005 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
  • CNS 14393.11-2005 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
  • CNS 14393-5-2004 Biological evaluation of medical devices – Part 5:Tests for in vitro cytotoxicity

Fujian Provincial Standard of the People's Republic of China

Professional Standard - Medicine

  • YY/T 0870.7-2023 Test for genotoxicity of medical devices-Part 7;In vivo mammalian alkaline comet assay
  • YY/T 0870.1-2013 Test for genotoxicity of medical devices - Part 1: Bacterial reverse mutation test
  • YY/T 1292.2-2015 Test for reproductive and developmental toxicity of medical devices―Part 2:Prenatal developmental toxicity test
  • YY/T 1292.3-2016 Test for reproductive/developmental toxicity of medical devices—Part 3:One-generation reproductive toxicity test
  • YY/T 1292.1-2015 Test for reproductive and developmental toxicity of medical devices―Part 1:Screening test
  • YY/T 0127.5-2014 Biological evaluation of medical devices used in dentistry―Part 5:Inhalation toxicity test
  • YY/T 1815-2022 Biological evaluation of medical devices-Application for the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents

国家食品药品监督管理局

  • YY/T 1292.4-2017 Test for reproductive and developmental toxicity of medical devices- Part 4:Two-generation reproductive toxicity test
  • YY/T 1474-2016 Medical devices-Application of risk management to medical devices

国家市场监督管理总局、中国国家标准化管理委员会

  • GB 27949-2020 General requirements of disinfectant of medical instruments
  • GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity

Beijing Provincial Standard of the People's Republic of China

  • DB11/T 1927-2021 Technical Guidelines for Environmental Impact Assessment of Construction Projects for Medical Institutions

国家药监局

  • YY/T 1670.1-2019 Evaluation of neurotoxicity of medical devices―Part 1:Standard guide for selecting tests to evaluate potential neurotoxicity
  • YY/T 0870.6-2019 Test for genotoxicity of medical devices―Part 6:In vitro mammalian cell micronucleus test

Shanghai Provincial Standard of the People's Republic of China

  • DB31/T 1430-2023 Service standards for drug addiction identification in medical institutions

Sichuan Provincial Standard of the People's Republic of China

  • DB51/T 2553-2018 Administrative norms for the administration of drug rehabilitation medical centers in compulsory isolated drug rehabilitation facilities in the judicial administration

Xinjiang Provincial Standard of the People's Republic of China

  • DB65/T 2176-2004 Rules of Disinfecting Sterilization in Medical Institute on Plateau

司法部

  • SF/T 0043-2019 Smart detoxification - Technical specification for rehabilitation management information system

RU-GOST R

  • GOST R 51148-1998 Medical devices. Requirements for samples and documentation presented for toxicological tests, sanitary and chemical analyses, tests for sterility and pyrogenicity
  • GOST ISO 10993-3-2011 Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • GOST R EN 556-1-2009 Sterilization of medical devices. Requirements for medical devices to be designated "sterile". Part 1. Requirements for terminally sterilized medical devices
  • GOST R ISO 10993-11-1999 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic to xicity
  • GOST ISO 10993-11-2011 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
  • GOST ISO 10993-5-2011 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
  • GOST R ISO 10993.5-1999 Medical devices. Biological evaluation of medical devices. Part 5. Tests for cytotoxicity: in vitro methods
  • 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 20509-1975 Medical desinfection equipment. Chambers. Boilers. Terms and definitions
  • GOST R 55765-2013 Biological medicine remedies for vteterinary use. Vaccines against a virus hemorrhagic disease of rabbits tissue inactivated. Specifications
  • GOST R ISO 14937-2012 Sterilization of health care products. General criteria for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
  • GOST R 57689-2017 Medicines for medical applications. Detection of toxicity to reproduction and male reproductivity
  • 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 22649-1983 Medical air sterilizers. General technical conditions
  • GOST R ISO 11137-2-2008 Sterilization of health care products. Radiation. Part 2. Establishing the sterilization dose
  • GOST R ISO 17665-1-2016 Sterilization of health care products. Moist heat. Part 1. Requirements for development, validation and routine control of a sterilization process for medical device
  • GOST R ISO 17664-2012 Sterilization of medical devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices
  • GOST ISO 10993-7-2016 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
  • 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 IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
  • GOST R 58024-2017 Medical devices. Equipment for thermal disinfection/neutralization of medical waste. Dry hot air method. Technical requirements for governmental purchases

German Institute for Standardization

  • DIN EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001
  • DIN EN 556-1 Berichtigung 1:2006 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 556-1:2001
  • DIN 58946-1:1987 Sterilization; steam sterilizers for medical products; terminology
  • 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 EN ISO 10993-3:2015-02 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014
  • DIN EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004); German version EN ISO 17664:2004
  • DIN EN ISO 15883-6:2016-04 Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011); German version EN ISO 15883-6:2015
  • DIN 58953-8:1993 Sterilization; sterile supply; delivering of sterile medical devices for single use as well as its storage and handling
  • DIN EN ISO 10993-11:2018-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018
  • DIN EN ISO 15883-7:2016-10 Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016); German version EN ISO 15883-7:2016
  • DIN EN 556-2:2015 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
  • 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 10993-5:2009-10 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009
  • DIN 13063:2021-09 Hospital cleaning - Requirements for cleaning and disinfection cleaning in hospitals and other health care facilities
  • DIN EN 62366:2008 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007); German version EN 62366:2008
  • DIN EN ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006); German version EN ISO 10993-11:2006
  • DIN 58953-8:2010 Sterilization - Sterile supply - Part 8: Logistics of sterile medical devices
  • 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 EN ISO 15883-7:2024-03 Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment (ISO/DIS 15883-7:2024); German and English version prEN ISO 15883-7:202...

Association Francaise de Normalisation

  • 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 S98-107:1998 Sterilization of medical devices. Requirements for terminally-sterilized medical devices to be labelled "Sterile".
  • NF S98-117:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements.
  • 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 EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: tests concerning genotoxicity, carcinogenicity and reproductive toxicity
  • NF S99-501-3*NF EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity
  • NF S99-501-3:2009 Biological evaluation of medical devices - Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity.
  • NF S99-503:1994 Biological evaluation of medical devices. Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity.
  • NF S90-325:1989 Medical surgical equipment. Steam disinfecting equipment.
  • NF S99-511:2007 Biological evaluation of medical devices - Part 11 : tests for systemic toxicity.
  • NF EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: systemic toxicity testing
  • NF S99-511:1996 Biological evaluation of medical devices. Part 11 : tests for systemic toxicity.
  • NF S99-501-11*NF EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11 : tests for systemic toxicity
  • NF S99-501-11:2009 Biological evaluation of medical devices - Part 11 : tests for systemic toxicity.
  • NF S99-401:1994 Dispositifs médicaux - Élastomère de silicone de qualité médicale
  • NF S98-008:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requiremenrs for development, validation and routine control of sterilization proces for medical devices.
  • NF S98-015:1997 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods.
  • NF X30-507:2018 Packaging for medical waste - Medical waste - Cardboard box with inner bag for infectious medical waste
  • NF S90-303:1984 MEDICO-SURGICAL EQUIPMENT. DIALYSIS APPARATUS. SINGLE-USE,STERILE LINES AND CONNECTIONS.
  • NF EN ISO 10993-5:2010 Biological evaluation of medical devices - Part 5: testing for in vitro cytotoxicity
  • NF S98-103/A2:2001 Sterilization of medical devices - Validation and routine control of sterilization by irradiation.
  • NF S99-501-5*NF EN ISO 10993-5:2010 Biological evaluation of medical devices - Part 5 : tests for in vitro cytotoxicity.
  • NF S98-008:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices.
  • NF C74-054:2008 Medical devices - Application of usability engineering to medical devices.
  • NF C74-208/A1:2001 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics.
  • NF S90-751:1990 MEDICO-SURGICAL EQUIPMENT. INTRA-OCULAR LENSES. GENERAL REQUIREMENTS FOR STERILIZATION,PACKAGING AND LABELLING.

SCC

  • 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 EN 30993-3:1994 Biological evaluation of medical devices-Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • BS EN ISO 10993-3:2009 Biological evaluation of medical devices-Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • BS EN ISO 10993-3:2003 Biological evaluation of medical devices-Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • BS EN ISO 10993-11:1996 Biological evaluation of medical devices-Tests for systemic toxicity
  • BS EN ISO 10993-11:2006 Biological evaluation of medical devices-Tests for systemic toxicity
  • 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
  • CAN/CSA-ISO 10993.3-1997(C2006) Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • CAN/CSA-ISO 10993.3-1997(R2006) Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • NS-ISO 10993-3:1992 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • DANSK DS/EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • SPC GB/T 16886.3-2019 Biological evaluation of medical devices -- Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity (TEXT OF DOCUMENT IS IN CHINESE)
  • 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
  • AS 2945:1998 Batch-type washer/disinfectors for health care facilities
  • BS PD ISO/TR 10993-55:2023 Biological evaluation of medical devices-Interlaboratory study on cytotoxicity
  • DANSK DS/EN ISO 10993-11:2009 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
  • CAN/CSA-ISO 10993.11-1998(R2002) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
  • NS-EN ISO 15883-6:2011 Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
  • CAN/CSA-ISO 10993.11-1998(C2002) Biological evaluation of medical devices - Part 11: Systemic toxicity testing
  • AAMI/ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
  • BS EN 30993-5:1994 Biological evaluation of medical devices-Tests for cytotoxicity, in vitro methods
  • NS-EN ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
  • DANSK DS/EN ISO 15883-6:2015 Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
  • NS-EN ISO 15883-6:2015 Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
  • AENOR UNE-EN ISO 15883-6:2015 Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
  • UNE-EN ISO 10993-3:2004 Biological evaluation of medical devices. Part 3: Tests for genotoxicity, carcinogenicty and reproductive toxicity (ISO10993-3:2003)
  • NS-EN ISO 10993-3:2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)
  • NS-EN ISO 10993-3:2003 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)
  • UNE-EN ISO 10993-3:2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)
  • AENOR UNE-EN ISO 10993-3:2015 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
  • 11/30212473 DC BS EN ISO 10993-3. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • BS PD ISO/TS 21726:2019 Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
  • DANSK DS/ISO/TS 21726:2019 Biological evaluation of medical devices – Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
  • AAMI/ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for In Vitro Cytotoxicity
  • CAN/CSA-ISO 10993-5-01:2001 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
  • DANSK DS/EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
  • DANSK DS/EN ISO 15883-7:2016 Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)
  • DANSK DS/ISO 10993-17:2023 Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents
  • DIN EN ISO 10993-3 E:2013 Draft Document - Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO/DIS 10993-3:2013); German version prEN ISO 10993-3:2013
  • AENOR UNE-EN ISO 15883-7:2016 Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)
  • NS-EN ISO 15883-7:2016 Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)
  • BS 1882:1966 Flexible tubing for medical use
  • DIN EN ISO 15883-6 E:2009 Draft Document - Washer-disinfectors - Part 6: Requirements and tests for general purpose washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO/DIS 15883-6:2009); German version ...
  • DIN EN ISO 15883-7 E:2014 Draft Document - Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO/DIS 15883-7:2014); German version pr...
  • DANSK DS/ISO/TS 10993-20:2006 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
  • CAN/CSA-ISO 10993.5-97:1997 Biological evaluation of medical devices - Part 5: Tests for cytotoxicity: in vitro methods
  • NS-EN ISO 10993-11:1995 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:1993)
  • CAN/CSA-ISO 15883-7-2017(R2022) Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (Adopted ISO 15883-7:2016, first edition, 2016-02-01)
  • SN-ISO/TS 10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
  • NS-ISO 10993-5:1992 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
  • NS-EN ISO 10993-11:2018 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
  • DANSK DS/ISO/TR 10993-55:2023 Biological evaluation of medical devices – Part 55: Interlaboratory study on cytotoxicity
  • UNE-EN ISO 10993-11:1996 BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 11: TESTS FOR SYSTEMIC TOXICITY. (ISO 10993-11:1993)
  • UNE-EN ISO 10993-11:2007 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
  • AENOR UNE-EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
  • NS-EN ISO 10993-11:2009 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

GOSTR

  • GOST ISO 10993-3-2018 Medical levices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicit
  • GOST 33871-2016 Biological medicine remedies for veterinary use. Vaccines against viral diseases of animals. Method of determination of activity
  • GOST ISO/TR 10993-33-2018 Medical levices. Biological evaluation of medical devices. Part 33. Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3

CEN - European Committee for Standardization

  • 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 10993-3:2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity@ carcinogenicity and reproductive toxicity
  • EN ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
  • EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

Danish Standards Foundation

  • DS/EN 556:1995 Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile"
  • DS/EN 30993-3:1994 Biological evaluation of medical devices. Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • DS/EN 554:1994 Sterilization of medical devices - Validation and routine control of sterilization by moist heat
  • DS/EN 30993-5:1994 Biological evaluation of medical devices-Part 5:Tests for cytotoxicity-in vitro methods

European Committee for Standardization (CEN)

  • 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 ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
  • EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • EN ISO 15883-6:2015 Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
  • EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
  • EN ISO 10993-11:1995 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity (ISO 10993-11 : 1993)
  • EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
  • EN ISO 10993-3:2003 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity Supersedes EN 30993-3: 1999; ISO 10993-3: 2003
  • prEN ISO 15883-7 Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment (ISO/DIS 15883-7:2024)
  • EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
  • CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices

Japanese Industrial Standards Committee (JISC)

Standard Association of Australia (SAA)

  • AS/NZS 4815 Set:2008 Sterilising Medical instruments Set
  • AS 2385:1990 Single-use (sterile) infusion sets for general medical use
  • AS ISO 10993.11:2002/Amdt 1:2005 Biological evaluation of medical devices Systemic toxicity testing
  • ISO 10993-17:2023 Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
  • AS 1079.2:1994 Packaging of items (sterile) for patient care - Non-reusable papers - For the wrapping of goods undergoing sterilization in health care facilities

GOST

  • GOST R ISO 10993-3-2009 Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • GOST ISO 10993-11-2021 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
  • GOST R ISO 10993-11-2009 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 10993-5-2009 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
  • 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 ISO 10993-5-2023 Medical devices. Biological evaluation of medical devices. Part 5. Cytotoxicity studies by in vitro methods
  • GOST ISO/TS 21726-2021 Medical devices. Evaluation system of biological effects. Application of the threshold of toxicological concern for assessing biocompatibility of medical device constituents

IN-BIS

  • 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
  • IS 12572 Pt.6-1988 Guidelines for Biohazard Assessment of Medical Devices Part 6 Systemic Toxicity Test Methods: Assessment of Pyrogenicity of Medical Device Extracts in Rabbits

British Standards Institution (BSI)

  • BS EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
  • BS EN ISO 10993-3:2014 Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • BS EN ISO 10993-17:2023 Biological evaluation of medical devices - Toxicological risk assessment of medical device constituents
  • BS EN ISO 10993-5:1999 Biological evaluation of medical devices - Tests for in vitro cytotoxicity
  • BS EN ISO 11137-1:2006+A1:2013 Sterilization of health care products - Radiation - Requirements for development, validation and routine control of a sterilization process for medical devices
  • BS EN ISO 11137-1:2015 Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices
  • BS EN ISO 10993-11:2018(2022) Biological evaluation of medical devices Part 11 : Tests for systemic toxicity
  • BS EN ISO 25424:2019 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
  • BS EN ISO 25424:2011 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
  • BS EN ISO 11135:2014 Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
  • BS EN ISO 10993-11:2018 Biological evaluation of medical devices. Tests for systemic toxicity
  • PD ISO/TS 21726:2019 Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
  • DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices
  • PD ISO/TR 10993-55:2023 Biological evaluation of medical devices. Interlaboratory study on cytotoxicity
  • BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices
  • BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices
  • BS DD ISO/TS 10993-20:2006 Biological evaluation of medical devices - Principles and methods for immunotoxicology testing of medical devices
  • BS EN 62366:2008 Medical devices - Application of usability engineering to medical devices
  • BS 3970-5:1990 Sterilizing and disinfecting equipment for medical products - Specification for low temperature steam disinfectors
  • BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to medical devices
  • BS 3970-5:1990(2011) Sterilizing and disinfecting equipment for medical products — Part 5 : Specification for low temperature steam disinfectors

Canadian Standards Association (CSA)

  • CSA ISO 14937-01-CAN/CSA:2001 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 First Edition; ISO 14937:2000
  • CSA ISO-10993.3-97-CAN/CSA:1997 Biological Evaluation of Medical Devices - Part 3: Tests Concerning Genotoxicity, Cancerogenicity and Reproductive Toxicity First Edition
  • CSA ISO 10993.3-97-CAN/CSA:1997 Biological evaluation of medical devices - Part 3: Tests concerning genotoxicity, carcinogenicity and reproductive toxicity The First Edition; ISO 10993-3:1992

International Organization for Standardization (ISO)

  • ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
  • ISO 14937:2000 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
  • ISO 10993-3:2003 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • ISO 10993-3:1992 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • 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
  • ISO 25424:2018 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for 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 25424:2009 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
  • ISO 10993-11:1993 Biological evaluation of medical devices; part 11: tests for systemic toxicity
  • ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
  • ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
  • ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
  • ISO/TS 21726:2019 Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
  • ISO 10993-5:1992 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods

GSO

  • GSO ISO 10993-3:2015 Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • OS GSO ISO 10993-11:2015 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
  • GSO ISO 10993-11:2015 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
  • BH GSO ISO 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
  • BH GSO ISO/TS 21726:2022 Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
  • GSO ISO/TS 21726:2021 Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
  • BH GSO ISO 10993-5:2017 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
  • GSO ISO 10993-5:2015 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
  • GSO ASTM F2901:2021 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
  • BH GSO ASTM F2901:2023 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
  • GSO ASTM F2901:2022 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
  • 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/TS 10993-20:2016 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
  • BH GSO ISO/TS 10993-20:2017 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
  • GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices

TH-TISI

  • TIS 2395.3-2008 Biological evaluation of medical devices.part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity
  • TIS 2395.11-2008 Biological evaluation of medical devices.part 11: tests for systemic toxicity
  • TIS 2395.5-2008 Biological evaluation of medical devices.part 5: tests for in vitro cytotoxicity

RO-ASRO

  • STAS SR EN 30993-3-1996 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenity and reproductive toxicity
  • STAS E 10719/2-1986 Medical instruments RESISTANCE TESTING AT CORROSION AND REPEATED STERILIZATIONS STAINLESS STEEL MEDICAL INSTIUMENTS

Korean Agency for Technology and Standards (KATS)

  • KS P 6115-2006(2016) Ethylene oxide gas sterilizers for medical use
  • KS P ISO 10993-3-2023 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • KS P ISO 10993-3:2018 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • KS P ISO 10993-3:2007 Biological evaluation of medical devices-Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • KS P ISO 10993-11-2007(2017) Biological evaluation of medical devices-Part 11:Tests for systemic toxicity
  • KS P ISO 10993-11:2021 Biological evaluation of medical devices —Part 11: Tests for systemic toxicity
  • KS P 6116-2006(2016) Ethylene oxide gas sterilizers for medical use(Small size)
  • KS P ISO 10993-5-2023 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
  • KS P ISO TS 21726-2023 Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
  • KS P ISO 10993-11:2007 Biological evaluation of medical devices-Part 11:Tests for systemic toxicity
  • KS P ISO 10993-5:2018 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
  • 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

VN-TCVN

  • TCVN 7391-3-2005 Biological evaluation of medical devices.Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • TCVN 7391-11-2007 Biological evaluation of medical devices.Part 11: Tests for systemic toxicity
  • TCVN 7391-5-2005 Biological evaluation of medical devices.Part 5: Tests for in vitro cytotoxicity

American National Standards Institute (ANSI)

  • ANSI/AAMI/ISO 10993-3:2014(R2023) Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
  • ANSI/AAMI ST81-2004 Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devices
  • ANSI/AAMI/ISO 10993-11:2017(R2023) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
  • ANSI/AAMI/ISO 10993-5:2009(R2022) Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
  • ANSI/AAMI/ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
  • ANSI/AAMI/ISO 17665-1:2005 Sterilization of health care products - Moist heat - Requirements for development, validation and routine control of a sterilization process for medical devices
  • AAMI TIR18:2010 Guidance on electromagnetic compatibility of medical devices in healthcare facilities
  • ANSI/AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to 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 14937:2000 Sterilization of Health Care Products - General Requirements for Characteristics of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process

KR-KS

  • KS P ISO 10993-3-2018(2023) Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • KS P ISO 10993-3-2018 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • KS P ISO 10993-11-2021 Biological evaluation of medical devices —Part 11: Tests for systemic toxicity
  • KS P ISO 10993-5-2018(2023) Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
  • KS P ISO 10993-5-2018 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

US-AAMI

  • ANSI/AAMI/ISO 10993-3:2014 Biological evaluation of medical devices. Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • ANSI/AAMI ST67-2003 Sterilization of medical devices - Requirements for products labeled "STERILE"

ZA-SANS

  • SANS 10993-3:2004 Biological evaluation of medical devices Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity
  • SANS 17664:2007 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
  • SANS 1593:1994 Disinfectants based on glutaraldehyde for use on medical instruments
  • SANS 10993-11:2003 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
  • SANS 10993-11:2008 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
  • SANS 10993-5:2003 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

PH-BPS

  • PNS ISO 10993-3:2021 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • PNS ISO 10993-11:2021 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
  • PNS ISO 10993-5:2021 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

ES-UNE

  • UNE-EN ISO 15883-6:2015 Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
  • UNE-EN ISO 15883-7:2016 Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)
  • UNE-EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

CZ-CSN

  • CSN 84 7106-1983 Medlcal eguipment. Methods, means and processes of sterllization and desinfection of items for medical use. Terms and definitions.
  • CSN 84 7102-1988 Medical steam and hot-air sterilizers. Symbols for operátor

DIN

  • DIN EN ISO 10993-3:2004 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)

AENOR

  • UNE-EN ISO 10993-3:2015 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
  • UNE-EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

BE-NBN

  • NBN-EN 30993-3-1994 Biological evaluation of medical devices - Part 3 : Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:1992)
  • NBN EN 550-1995 Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization

NL-NEN

  • NEN-ISO 10993-3:1994 Biological evaluation of medical devices. Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:1992)

International Electrotechnical Commission (IEC)

PL-PKN

  • PN Z04600-1971 Medical equipmenf ethods for testing technical e?ficiency f s?aem s?erilizers
  • PN Z78500-1972 Medical ■e?uipmeint Respirators amd anesthesia apparatus Linkage dimensions

American Society for Testing and Materials (ASTM)

  • ASTM F2901-13 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
  • ASTM F2901-19 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
  • ASTM F2901-12 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
  • ASTM E1766-95(2002) Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices
  • ASTM E1766-95 Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices
  • ASTM E1766-95(2007) Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices
  • ASTM D7102-04 Standard Guide for Determination of Endotoxin on Sterile Medical Gloves