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Biological Evaluation of Medical Devices

Biological Evaluation of Medical Devices, Total:259 items.

In the international standard classification, Biological Evaluation of Medical Devices involves: Laboratory medicine, Medical equipment, Dentistry, Information sciences. Publishing, Medical sciences and health care facilities in general, Pharmaceutics.


未注明发布机构, Biological Evaluation of Medical Devices

British Standards Institution (BSI), Biological Evaluation of Medical Devices

  • BS EN ISO 10993-2:2022 Biological evaluation of medical devices - Animal welfare requirements
  • BS EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
  • DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices
  • 21/30379304 DC BS EN ISO 10993-17. Biological evaluation of medical devices - Part 17. Toxicological risk assessment of medical device constituents
  • 18/30355036 DC BS EN ISO 10993-7 AMD1. Biological evaluation of medical devices - Part 7. Ethylene oxide sterilization residuals
  • PD ISO/TR 10993-22:2017 Biological evaluation of medical devices. Guidance on nanomaterials
  • BS PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices. General requirements
  • PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices. General requirements
  • BS EN ISO 10993-12:2012 Biological evaluation of medical devices. Sample preparation and reference materials
  • BS EN ISO 10993-11:2018 Biological evaluation of medical devices. Tests for systemic toxicity
  • BS EN ISO 10993-6:2009 Biological evaluation of medical devices. Tests for local effects after implantation
  • BS EN ISO 10993-10:2023 Tracked changes. Biological evaluation of medical devices. Tests for skin sensitization

Korean Agency for Technology and Standards (KATS), Biological Evaluation of Medical Devices

Association Francaise de Normalisation, Biological Evaluation of Medical Devices

  • NF EN ISO 10993-23:2021 Evaluation biologique des dispositifs médicaux - Partie 23 : essais d'irritation
  • NF EN ISO 10993-11:2018 Évaluation biologique des dispositifs médicaux - Partie 11 : essais de toxicité systémique
  • NF EN ISO 10993-10:2023 Évaluation biologique des dispositifs médicaux - Partie 10 : essais de sensibilisation cutanée
  • NF EN ISO 10993-2:2022 Évaluation biologique des dispositifs médicaux - Partie 2 : Exigences relatives à la protection des animaux
  • NF EN ISO 10993-5:2010 Évaluation biologique des dispositifs médicaux - Partie 5 : essais concernant la cytotoxicité in vitro
  • NF EN ISO 10993-7:2008 Évaluation biologique des dispositifs médicaux - Partie 7 : résidus de stérilisation à l'oxyde d'éthylène
  • NF EN ISO 10993-6:2017 Évaluation biologique des dispositifs médicaux - Partie 6 : essais concernant les effets locaux après implantation
  • NF EN ISO 10993-17:2009 Évaluation biologique des dispositifs médicaux - Partie 17 : établissement des limites admissibles des substances relargables
  • NF EN ISO 10993-12:2021 Evaluation biologique des dispositifs médicaux - Partie 12 : préparation des échantillons et matériaux de référence
  • NF EN ISO 10993-14:2009 Évaluation biologique des dispositifs médicaux - Partie 14 : identification et quantification des produits de dégradation des céramiques
  • XP ISO/TS 10993-19:2022 Évaluation biologique des dispositifs médicaux - Partie 19 : caractérisations physicochimique, morphologique et topographique des matériaux
  • NF EN ISO 10993-3:2014 Évaluation biologique des dispositifs médicaux - Partie 3 : essais concernant la génotoxicité, la cancérogénicité et la toxicité sur la reproduction
  • NF EN ISO 10993-13:2010 Évaluation biologique des dispositifs médicaux - Partie 13 : identification et quantification de produits de dégradation de dispositifs médicaux à base de polymères
  • NF EN ISO 10993-7/A1:2022 Evaluation biologique des dispositifs médicaux - Partie 7 : résidus de stérilisation à l'oxyde d'éthylène - Amendement 1
  • NF S99-501-23*NF EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23 : tests for irritation
  • NF S99-501-11:2009 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
  • FD S99-501-22*FD ISO/TR 10993-22:2017 Biological evaluation of medical devices - Part 22 : guidance on nanomaterials
  • FD ISO/TR 10993-22:2017 Évaluation biologique des dispositifs médicaux - Partie 22 : lignes directrices sur la nanomatériaux

国家食品药品监督管理局, Biological Evaluation of Medical Devices

  • YY/T 1532-2017 Medical device biological evaluation nanomaterials hemolysis test
  • YY/T 0127.13-2018 Biological evaluation of oral medical devices Part 13: Oral mucosal irritation test
  • YY/T 1512-2017 Implementation Guidelines for Biological Evaluation in the Risk Management Process of Biological Evaluation of Medical Devices
  • YY/T 0127.7-2017 Biological Evaluation of Oral Medical Devices Part 7: Pulp Dentin Application Test
  • YY/T 1535-2017 Biological evaluation of medical devices for human in vitro assisted reproductive technology and human sperm survival test
  • YY/T 0127.15-2018 Biological Evaluation of Oral Medical Devices Part 15: Subacute and Subchronic Systemic Toxicity Tests: Oral Route

VN-TCVN, Biological Evaluation of Medical Devices

  • TCVN 7391-1-2004 Biological evaluation of medical devices.Part 1: Evaluation and testing
  • TCVN 7391-18-2007 Biological evaluation of medical devices.Part 18: Chemical characterization of materials
  • TCVN 7391-2-2005 Biological evaluation of medical devices.Part 2: Animal welfare requirements
  • 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
  • TCVN 7391-12-2007 Biological evaluation of medical devices.Part 12: Sample preparation and reference materials
  • TCVN 7391-6-2007 Biological evaluation of medical devices.Part 6: Tests for local effects after implantation
  • TCVN 7391-7-2004 Biological evaluation of medial devices.Part 7: Etylen oxide sterilization residuals
  • TCVN 7391-17-2007 Biological evaluation of medical devices.Part 17: Establishment of allowable limits for teachable substances
  • TCVN 7391-10-2007 Biological evaluation of medical devices.Part 10: Tests for irritation and delayed-type hypersensitivity
  • TCVN 7391-4-2005 Biological evaluation of medical devices.Part 4: Selection of test for interactions with blood
  • TCVN 7391-14-2007 Biological evaluation of medical devices.Part 14: Identification and quantification of degradation products from ceramics
  • TCVN 7391-3-2005 Biological evaluation of medical devices.Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • TCVN 7391-15-2007 Biological evaluation of medical devices.Part 15: Identification and quantification of degradation products from metals and alloys
  • TCVN 7391-16-2007 Biological evaluation of medical devices.Part 16: Toxicokinetic study design for degradation products and leachables

TH-TISI, Biological Evaluation of Medical Devices

  • TIS 2395.1-2008 Biological evaluation of medical devices.part 1: evaluation and testing
  • TIS 2395.18-2008 Biological evaluation of medical devices.part 18: chemical characterization of materials
  • TIS 2395.11-2008 Biological evaluation of medical devices.part 11: tests for systemic toxicity
  • TIS 2395.2-2008 Biological evaluation of medical devices.part 2: animal welfare requirements
  • TIS 2395.5-2008 Biological evaluation of medical devices.part 5: tests for in vitro cytotoxicity
  • TIS 2395.6-2008 Biological evaluation of medical devices.part 6: tests for local effects after implantation
  • TIS 2395.7-2008 Biological evaluation of medical devices.part 7: ethylene oxide sterilization residuals
  • TIS 2395.12-2008 Biological evaluation of medical devices.part 12: sample preparation and reference materials
  • TIS 2395.4-2008 Biological evaluation of medical devices.part 4: selection of tests for interactions with blood
  • TIS 2395.14-2008 Biological evaluation of medical devices.part 14: identification and quantification of degradation products from ceramics
  • TIS 2395.17-2008 Biological evaluation of medical devices.part 17: establishment of allowable limits for leachable substances
  • TIS 2395.10-2008 Biological evaluation of medical devices.part 10: tests for irritation and delayed-type hypersensitivity
  • TIS 2395.3-2008 Biological evaluation of medical devices.part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity
  • TIS 2395.9-2008 Biological evaluation of medical devices.part 9: framework for identification and quantification of potential degradation products
  • TIS 2395.13-2008 Biological evaluation of medical devices.part 13: identification and quantification of degradation products from polymeric medical devices
  • TIS 2395.15-2008 Biological evaluation of medical devices.part 15: identification and quantification of degradation products from metals and alloys
  • TIS 2395.16-2008 Biological evaluation of medical devices.part 16: toxicokinetic study design for degradation products and leachables

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Biological Evaluation of Medical Devices

  • GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1: Evaluation and testing
  • GB/T 16886.18-2011 Biological evaluation of medical devices.Part 18: Chemical characterization of materials
  • GB/T 16886.2-2000 Biological evaluation of medical devices--Part 2: Animal welfare requirements
  • GB/T 16886.2-2011 Biological evaluation of medical devices.Part 2: Animal welfare requirements
  • GB/T 16886.11-1997 Biological evaluation of medical devices--Part 11: Tests for systemic toxicity
  • GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials
  • GB/T 16886.11-2011 Biological evaluation of medical devices.Part 11: Tests for systemic toxicity
  • GB/T 16886.10-2000 Biological evaluation of medical devices--Part 10: Tests for irritation and sensitization
  • GB/T 16886.5-2017 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests
  • GB/T 16886.5-2003 Biological evaluation of medical devices--Part 5: Test for in vitro cytotoxicity
  • GB/T 16886.12-2005 Biological evaluation of medical devices-Part 12:Sample preparation and reference materials
  • GB/T 16886.6-2015 Biological evaluation of medical devices.Part 6:Tests for local effects after implantation
  • GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
  • GB/T 16886.12-2000 Biological evaluation of medical devices--Part 12: Sample preparation and reference materials
  • GB/T 16886.7-2001 Biological evaluation of medical devices--Part 7:Ethylene oxide sterilization residuals
  • GB/T 16886.6-1997 Biological evaluation of medical devices--Part 6: Tests for local effects after implantation
  • GB/T 16886.17-2005 Biological evaluation of medical devices.Part 17:Establishment of allowable limits for leachable substances
  • GB/T 16886.4-2003 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
  • GB/T 16886.14-2003 Biological evaluation of medical devices--Part 14: Identification and quantification of degradation products from ceramics
  • GB/T 16886.1-2011 Biological evaluation of medical devices.Part 1: Evaluation and testing within a risk management process
  • GB/T 16886.10-2005 Biological evaluation of medical devices.Part 10:Tests for irritation and delayed-type hypersensitivity
  • GB/T 16886.20-2015 Biological evaluation of medical devices.Part 20:Principles and methods for immunotoxicology testing of medical devices
  • GB/T 16886.3-2008 Biological evaluation of medical devices.Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • GB/T 16886.3-1997 Biological evaluation of medical devices--Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • GB/T 16886.9-2022 Biological Evaluation of Medical Devices Part 9: Qualitative and Quantitative Framework for Potential Degradation Products
  • GB/T 16886.9-2001 Biological evaluation of medical devices-Part 9:Framework for identification and quantification of potential degradation product
  • GB/T 16886.13-2001 Biological evaluation of medical devices--Part 13:Identification and quantification of degradation products from polymeric medical devices
  • GB/T 16886.15-2022 Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys
  • GB/T 16886.15-2003 Biological eveluation of medical devices--Part 15: Identification and quantification of degradation products from metals and alloys
  • GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process
  • GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials
  • GB/T 16886.19-2011 Biological evaluation of medical devices.Part 19: Physico-chemical,morphological and topographical characterization of materials
  • GB/T 16886.16-2013 Biological evaluation of medical devices.Part 16: Toxicokinetic study design for degradation products and leachables
  • GB/T 16886.16-2003 Biological evaluation of medical devices--Part 16: Toxicokinetic study design for degradation products and leachables

Danish Standards Foundation, Biological Evaluation of Medical Devices

  • DS/ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation
  • DS/ISO/TR 10993-22:2021 Biological evaluation of medical devices – Part 22: Guidance on nanomaterials
  • DS/ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices – Part 1: General requirements
  • DS/ISO 10993-12:2021 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
  • DS/EN ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021)
  • DS/EN ISO 10993-12:2021 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
  • DS/ISO 10993-9:2021 Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products
  • DS/ISO 10993-1:2020 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (ISO/FDIS 10993-1:2018)
  • DS/EN ISO 10993-9:2021 Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
  • DS/EN ISO 10993-1:2020 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-11)

German Institute for Standardization, Biological Evaluation of Medical Devices

  • DIN EN ISO 10993-2:2023-02 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022); German version EN ISO 10993-2:2022
  • DIN EN ISO 10993-10:2023-04 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021); German version EN ISO 10993-10:2023
  • 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 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 EN ISO 10993-6:2017-09 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016); German version EN ISO 10993-6:2016
  • DIN EN ISO 10993-12:2021-08 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021); German version EN ISO 10993-12:2021
  • DIN EN ISO 10993-17:2021-12 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO/DIS 10993-17:2021); German and English version prEN ISO 10993-17:2021 / Note: Date of issue 2021-11-12*Intended as replacement for DIN...
  • DIN EN ISO 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 10993-7:2022-09 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009 + Amd 1:2019); German version EN ISO 10993-7:2008 + AC:2009 + A1:2022
  • DIN EN ISO 10993-7/A1:2018 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1 (ISO 10993-7:2008/DAM 1:2018); German and English version EN ISO 10993-7:2008/prA1:2018

Professional Standard - Medicine, Biological Evaluation of Medical Devices

  • YY/T 0127.11-2014 Biological evaluation of medical devices used in dentistry.Part 11:Pulp capping test
  • YY/T 1295-2015 Biological evaluation of medical devices.Nanomaterial: Endotoxin test
  • YY/T 0127.5-2014 Biological evaluation of medical devices used in dentistry.Part 5:Inhalation toxicity test
  • YY/T 0268-2008 Dentistry.Biological evaluation of medical devices used in dentistry.Part 1:Evaluation and test
  • YY/T 0127.3-2014 Biological evaluation of medical devices used in dentistry.Part 3: Endodontic usage test
  • YY/T 0127.4-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method Bone implant test
  • YY/T 0127.12-2008 Dentistry.Biological evaluation of medical devices used in dentistry Part 2:Test method.Micronucleus test
  • YY/T 0127.18-2016 Biological evaluation of medical devices used in dentistry.Part 18:Dentine barrier cytotoxicity test
  • YY/T 0127.13-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method.Oral mucous membrane irritation test
  • YY/T 1815-2022
  • YY/T 0993-2015 Biological evaluation of medical devices.Nanomaterial: In vitro cytotoxicity tests (MTT assay and LDH assay)
  • YY/T 1897-2023 Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test
  • YY/T 0127.17-2014 Biological evaluation of medical devices used in dentistry.Part 17: Mouse lymphoma cells (TK) gene mutation test
  • YY/T 0127.14-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method.Acute oral toxicity test
  • YY/T 1912-2023 Biological evaluation and testing of medical devices for soft tissue regeneration
  • YY/T 0127.2-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method.Acute systemic toxicity:intravenous path
  • YY/T 0127.16-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method In Vitro mammalian chromosome aberration test
  • YY/T 0127.10-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method.Salmonella typhimurium reverse mutation assay(Ames mutagenicity test)
  • YY/T 0127.15-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method Subacute and subchronic toxicity test.oral route
  • YY/T 0127.9-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method Cytotxicity tests .Agar diffusion test and filter diffusion test

国家市场监督管理总局、中国国家标准化管理委员会, Biological Evaluation of Medical Devices

  • GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
  • GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
  • GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood
  • GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
  • GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • GB/T 16886.16-2021 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables

RU-GOST R, Biological Evaluation of Medical Devices

  • GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
  • GOST ISO 10993-11-2011 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
  • GOST R ISO 10993-11-1999 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic to xicity
  • GOST ISO 10993-18-2011 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
  • GOST R ISO 10993-10-1999 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and sensitization
  • GOST ISO 10993-5-2011 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
  • GOST ISO 10993-7-2016 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
  • GOST ISO 10993-7-2011 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
  • GOST R ISO 10993-12-1999 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
  • GOST ISO 10993-6-2011 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
  • GOST ISO 10993-12-2011 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials
  • GOST R ISO 10993-6-1999 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
  • GOST ISO 10993-10-2011 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity
  • GOST ISO 10993-17-2011 Medical devices. Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substances
  • GOST ISO 10993-14-2011 Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics
  • GOST R ISO 10993-14-2001 Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics
  • GOST ISO 10993-4-2011 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
  • GOST ISO 10993-9-2011 Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products
  • GOST ISO 10993-9-2015 Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products
  • GOST ISO 10993-13-2011 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
  • GOST ISO 10993-3-2011 Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • GOST ISO 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
  • GOST ISO/TS 10993-20-2011 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
  • GOST ISO 10993-15-2011 Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys
  • GOST R ISO 10993-15-2001 Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys
  • GOST ISO/TS 10993-19-2011 Medical devices. Biological evaluation of medical devices. Part 19. Tests physico-chemical, morphological and topographical characterization of materials
  • GOST ISO 10993-16-2016 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
  • GOST ISO 10993-16-2011 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
  • GOST R ISO 10993.7-1999 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
  • GOST R ISO 10993.5-1999 Medical devices. Biological evaluation of medical devices. Part 5. Tests for cytotoxicity: in vitro methods

International Organization for Standardization (ISO), Biological Evaluation of Medical Devices

  • ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices — Part 1: General requirements
  • ISO 10993-1:2003 Biological evaluation of medical devices - Part 1: Evaluation and testing
  • ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation
  • ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements
  • ISO 10993-2:1992 Biological evaluation of medical devices; part 2: animal welfare requirements
  • ISO 10993-2:2022 Biological evaluation of medical devices — Part 2: Animal welfare requirements
  • ISO 10993-11:1993 Biological evaluation of medical devices; part 11: tests for systemic toxicity
  • ISO 10993-10:2021 Biological evaluation of medical devices — Part 10: Tests for skin sensitization
  • ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials

American National Standards Institute （ANSI), Biological Evaluation of Medical Devices

KR-KS, Biological Evaluation of Medical Devices

  • KS P ISO 10993-7-2017 Biological evaluation of medical devices－Part 7：Ethylene oxides sterilization residuals
  • KS P ISO 10993-14-2017 Biological evaluation of medical devices — Part14:Identification and quantification of degradation products from ceramics
  • KS P ISO 10993-4-2017 Biological evaluation of medical devices－Part 4：Selection of tests for interactions with blood
  • KS P ISO 10993-16-2017 Biological evaluation of medical devices — Part16:Toxicokinetic study design for degradation products and leachables
  • KS P ISO 10993-23-2022 Biological evaluation of medical devices — Part 23: Tests for irritation
  • KS P ISO 10993-11-2021 Biological evaluation of medical devices —Part 11: Tests for systemic toxicity
  • KS P ISO 10993-10-2022 Biological evaluation of medical devices — Part 10: Tests for skin sensitization

CEN - European Committee for Standardization, Biological Evaluation of Medical Devices

  • EN ISO 10993-6:2009 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
  • EN ISO 10993-6:2007 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
  • 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
  • EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
  • EN ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials

PL-PKN, Biological Evaluation of Medical Devices

Japanese Industrial Standards Committee (JISC), Biological Evaluation of Medical Devices

  • JIS T 0993-7:2012 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
  • JIS T 0993-1:2012 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
  • JIS T 0993-1:2005 Biological evaluation of medical devices -- Part 1: Evaluation and testing

中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会, Biological Evaluation of Medical Devices

  • GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization
  • GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
  • GB/T 16886.13-2017 Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices
  • GB/T 16886.9-2017 Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products

ES-UNE, Biological Evaluation of Medical Devices

  • UNE-EN ISO 10993-12:2022 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
  • UNE-EN ISO 10993-2:2023 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
  • UNE-EN ISO 10993-10:2023 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
  • UNE-EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
  • UNE-EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

Standard Association of Australia （SAA）, Biological Evaluation of Medical Devices

European Committee for Standardization (CEN), Biological Evaluation of Medical Devices

  • EN 15354:2022 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
  • EN 12929-2:2015+A1:2022 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
  • EN ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
  • FprEN ISO 10993-17 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO/FDIS 10993-17:2023)
  • EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
  • EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
  • EN ISO 10993-11:1995 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity (ISO 10993-11 : 1993)
  • EN ISO 10993-18:2020 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)

国家药监局, Biological Evaluation of Medical Devices

  • YY/T 1775.1-2021 Biological Evaluation of Absorbable Medical Devices Part 1: Guidelines for Absorbable Implants
  • YY/T 1863-2023 Biological evaluation of nanomedical devices Release and characterization methods of nanosilver particles and silver ions in nanosilver-containing dressings

Group Standards of the People's Republic of China, Biological Evaluation of Medical Devices

  • T/CAMDI 034-2020 Biological evaluation of medical devices Medical catheter with hydrophilic polymer coating：Sample preparation

AENOR, Biological Evaluation of Medical Devices

  • UNE-EN ISO 10993-7:2009 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
  • UNE-EN ISO 10993-3:2015 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

RO-ASRO, Biological Evaluation of Medical Devices

  • STAS SR EN 30993-3-1996 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenity and reproductive toxicity

GOSTR, Biological Evaluation of Medical Devices

  • GOST ISO 10993-4-2020 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
  • GOST ISO 10993-3-2018 Medical levices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicit
  • GOST ISO/TR 10993-22-2020 Medical devices. Biological evaluation of medical devices. Part 22. Guidance on nanomaterials

Lithuanian Standards Office , Biological Evaluation of Medical Devices

  • LST EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)

US-AAMI, Biological Evaluation of Medical Devices

  • ANSI/AAMI/ISO 10993-16:2017 Biological evaluation of medical devices-Part 16: Toxicokinetic study design for degradation products and leachables

IT-UNI, Biological Evaluation of Medical Devices

PH-BPS, Biological Evaluation of Medical Devices

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