Chemical Evaluation of Medical Devices

Chemical Evaluation of Medical Devices, Total:388 items.

The international standard classification for "Chemical Evaluation of Medical Devices" includes: Medical equipment in general , Laboratory medicine , Dental materials , Surgical instruments and materials , Sterilization and disinfection in general , Other medical equipment .

The Chinese standard classification for "Chemical Evaluation of Medical Devices" includes: Medical apparatus and devices in general , Stomatologic device, equipment and material , Public medical equipment .

未注明发布机构

ANSI/AAMI/ISO TIR10993-19:2006 Biological evaluation of medical devices — Part 19: Physico- chemical, morphological, and topographical characterization of materials
DIN EN ISO 10993-18 E:2018-09 Biological evaluation of medical devices Part 18: Chemical characterization of medical device materials during risk management (draft)
DIN EN ISO 7405 E:2017-04 Biocompatibility evaluation of dental medical devices in dentistry (draft)
ANSI/AAMI/ISO 10993-5:2009(2014) Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
DIN EN ISO 10993-1:1998 Biological evaluation of medical devices – Part 1: Evaluation and testing
ANSI/AAMI/ISO TIR10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
DIN EN ISO 10993-1:2003 Biological assessment of medical devices Part 1: Assessment and testing
ANSI/AAMI/ISO 10993-1:2018 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
ANSI/AAMI/ISO 10993-2:2006(2010) Biological evaluation of medical devices— Part 2: Animal welfare requirements
ANSI/AAMI/ISO 10993-11:2017 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
ANSI/AAMI/ISO 10993-13:2010(2014) Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
DIN EN ISO 10993-18:2009 Biological assessment of medical devices

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

GB/T 16886.5-2017 Biological evaluation of medical devices―Part 5:Tests for in vitro cytotoxicity
GB/T 16886.11-1997 Biological evaluation of medical devices--Part 11: Tests for systemic toxicity
GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials
GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials
GB/T 16886.18-2011 Biological evaluation of medical devices—Part 18:Chemical 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 16886.20-2015 Biological evaluation of medical devices―Part 20:Principles and methods for immunotoxicology testing of medical devices
GB/T 16886.2-2000 Biological evaluation of medical devices--Part 2:Animal welfare requirements
GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1:Evaluation and testing
GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements
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 16886.5-2003 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity
GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
GB/T 16886.10-2000 Biological evaluation of medical devices-Part 10:Tests for irritation and sensitization
GB/T 16886.13-2001 Biogical evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.23-2023 Biological evaluation of medical devices—Part 23: Tests for irritation
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Professional Standard - Medicine

YY/T 0268-2008 Dentistry - Biological evaluation of medical devices used in dentistry Part1: Evaluation and test
YY/T 0127.11-2014 Biological evaluation of medical devices used in dentistry―Part 11:Pulp capping test
YY/T 0127.4-2023 Biological evaluation of medical devices used in dentistry-Part 4: Bone implant test
YY/T 1295-2015 Biological evaluation of medical devices―Nanomaterial:Endotoxin test
YY/T 1912-2023 Biological evaluation and testing of medical devices for soft tissue regeneration
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
YY/T 1266-2015 Evaluation of materials of medical device subject to hydrogen peroxide sterilization

Group Standards of the People's Republic of China

T/CSYLQX 0001-2021 Standards for Credit Evaluation of Medical Device Operating Enterprises
T/CAMDI 033-2020 Guide for biological evaluation of packaging materials for medical devices
T/SXS 129-2023 Medical device enterprise management credit evaluation standards
T/CAMDI 034-2020 Biological evaluation of medical devices Medical catheter with hydrophilic polymer coating：Sample preparation
T/CSBME 009-2019 Quality evaluation method of cybersecurity in medical devices

Jiangsu Provincial Standard of the People's Republic of China

DB3212/T 1065-2021 Standards for Quality Evaluation of Medical Devices Used in Medical Institutions

国家食品药品监督管理局

YY/T 1512-2017 Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process
YY/T 1532-2017 Biological evaluation of medical devices—Nanomaterials—Hemolysis test

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

GB/T 16886.13-2017 Biological evaluation of medical devices-Part 13:Identification and quantification of degradation products from polymeric 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/T 16886.1-2022 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity

Professional Standard - Agriculture

GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization

Henan Provincial Standard of the People's Republic of China

DB41/T 2320-2022 Medical device adverse event reporting and evaluation specification

International Organization for Standardization (ISO)

ISO/CD 10993-1.2:2023 Biological evaluation of medical devices
ISO 10993-18:2020 Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
ISO 10993-1:1997 Biological evaluation of medical devices - Part 1: Evaluation and testing
ISO 10993-1:2003 Biological evaluation of medical devices - Part 1: Evaluation and testing
ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
ISO/TR 15499:2016 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-13:1998 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation
ISO 10993-2:2022 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 10993-10:2021 Biological evaluation of medical devices — Part 10: Tests for skin sensitization
ISO 10993-2:2006 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/TS 10993-19:2020 Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
ISO/TR 15499:2012 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices — Part 1: General requirements
ISO 10993-14:2001 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-1:2009/Cor 11:2010 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

SCC

BS EN ISO 10993-18:2005 Biological evaluation of medical devices-Chemical characterization of materials
BS EN ISO 10993-18:2009 Biological evaluation of medical devices-Chemical characterization of materials
BS EN ISO 10993-1:1998 Biological evaluation of medical devices-Evaluation and testing
DANSK DS/ISO 10993-17:2023 Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents
AAMI/ISO 10993-1:2003 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
CAN/CSA-ISO 10993-1-01:2001 Biological evaluation of medical devices - Part 1: Evaluation and Testing
DANSK DS/EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
BS EN 30993-1:1994 Biological evaluation of medical devices-Guidance on selection of tests
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 EN ISO 10993-2:1998 Biological evaluation of medical devices-Animal welfare requirements
DANSK DS/ISO/TS 10993-20:2006 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
SN-ISO/TS 10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
AS ISO 10993.10:2002 Biological evaluation of medical devices - Tests for irritation and sensitization
BS EN ISO 10993-13:2009 Biological evaluation of medical devices-Identification and quantification of degradation products from polymeric medical devices
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
DIN EN ISO 10993-17 E:2021 Draft Document – 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
UNE-EN ISO 10993-1:2004 Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)
BS PD ISO/TR 10993-22:2017 Biological evaluation of medical devices-Guidance on nanomaterials
BS DD ISO/TS 10993-19:2006 Biological evaluation of medical devices-Physico-chemical, morphological and topographical characterization of materials
BS PD ISO/TS 10993-19:2020 Biological evaluation of medical devices-Physico-chemical, morphological and topographical characterization of materials
NS-EN ISO 10993-1:1997 Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:1997)
08/30156451 DC BS EN ISO 10993-13. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
UNE-EN ISO 10993-13:2000 BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES (ISO 10993-13:1998)
DANSK DS/EN 13612/AC:2003 Performance evaluation of in vitro diagnostic medical devices
NS-EN ISO 10993-1:2003 Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003)
NS-EN ISO 10993-1:2009 Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003)
BS EN ISO 10993-12:2009 Biological evaluation of medical devices-Sample preparation and reference materials
AS ISO 10993.12:2002 Biological evaluation of medical devices - Sample preparation and reference materials
BS EN 30993-6:1995 Biological evaluation of medical devices-Tests for local effects after implantation
NS-EN ISO 10993-18:2005 Biological evaluation of medical devices — Part 18: Chemical characterization of materials (ISO 10993-18:2005)
DANSK DS/EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
NS-EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
NS-EN ISO 10993-18:2009 Biological evaluation of medical devices — Part 18: Chemical characterization of materials (ISO 10993-18:2005)
BS EN ISO 10993-7:1996 Biological evaluation of medical devices-Ethylene oxide sterilization residuals
BS EN ISO 10993-12:1997 Biological evaluation of medical devices-Sample preparation and reference materials
BS EN ISO 10993-10:1996 Biological evaluation of medical devices-Tests for irritation and sensitization
UNE-EN ISO 10993-18:2006 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
BS EN ISO 10993-6:2007 Biological evaluation of medical devices-Tests for local effects after implantation
DANSK DS/EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
AAMI/ISO 10993-16:1997(R2009) Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables from medical devices
DIN EN ISO 10993-1/A1 E:2009 Draft Document - Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003); English version FprEN ISO 10993-1:2009, Amendment 1
CAN/CSA-ISO 10993-13-00:2000 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
CAN/CSA-ISO 10993.2-1997(R2006) Biological evaluation of medical devices - Part 2: Animal welfare requirements
CAN/CSA-ISO 10993.11-1998(R2002) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
AAMI/ISO TIR15499:2012 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
BS 5736-8:1984 Evaluation of medical devices for biological hazards-Method of test for skin irritation of solid medical devices
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
CAN/CSA-ISO 10993-1-98:1998 Biological evaluation of medical devices - Part 1: Guidelines for the selection of tests
DANSK DS/ISO 10993-10:2023 Biological evaluation of medical devices – Part 10: Tests for skin sensitization
AAMI/ISO 10993-2:1993 Biological Evaluation of Medical Devices - Part 2: Animal Protection Requirements
BS PD ISO/TR 10993-55:2023 Biological evaluation of medical devices-Interlaboratory study on cytotoxicity
DANSK DS/ISO 10993-2:2022 Biological evaluation of medical devices – Part 2: Animal welfare requirements
DANSK DS/EN ISO 10993-11:2009 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
BS PD ISO/TR 10993-33:2015 Biological evaluation of medical devices-Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3
DANSK DS/ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation
SN-ISO/TR 15499:2012 Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process
AENOR UNE-EN 13612/AC:1970 Performance evaluation of in vitro diagnostic medical devices.
AENOR UNE-EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices.
DANSK DS/ISO/TR 15499:2016 Biological evaluation of medical devices – Guidance on the conduct of biological evaluation within a risk management process
CAN/CSA-ISO 10993.2-1997(C2006) Biological evaluation of medical devices - Part 2: Animal protection requirements
BS EN 30993-5:1994 Biological evaluation of medical devices-Tests for cytotoxicity, in vitro methods
SN-ISO/TS 10993-19:2020 Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
BS 5736-7:1983 Evaluation of medical devices for biological hazards-Method of test for skin irritation of extracts from medical devices
SN-ISO/TS 10993-19:2006 Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
DANSK DS/EN ISO 10993-2:2006 Biological evaluation of medical devices – Part 2: Animal welfare requirements
ADA 41-2020 Evaluation of Biocompatibility of Medical Devices Used in Dentistry
DANSK DS/ISO/TR 10993-22:2021 Biological evaluation of medical devices – Part 22: Guidance on nanomaterials
BS 5736-4:1981 Evaluation of medical devices for biological hazards-Method of test for intracutaneous reactivity of extracts from medical devices
ADA 41-2015 Evaluation of Biocompatibility of Medical Devices Used in Dentistry
DANSK DS/ISO/TS 10993-19:2020 Biological evaluation of medical devices – Part 19: Physico-chemical, morphological and topographical characterization of materials
NS-EN ISO 10993-13:1998 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymers medical devices (ISO 10993-13:1998)
AAMI/ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for In Vitro Cytotoxicity
DANSK DS/ISO 10993-18/AMD 1:2020 Biologisk vurdering af medicinsk udstyr – Del 18: Kemisk karakterisering af materialer til medicinsk udstyr inden for rammerne af en risikostyringsproces
DANSK DS/ISO 10993-18:2020 Biologisk vurdering af medicinsk udstyr – Del 18: Kemisk karakterisering af materialer til medicinsk udstyr inden for rammerne af en risikostyringsproces
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
AS ISO 10993.4:2002 Biological evaluation of medical devices - Selection of tests for interactions with blood
BS EN 30993-4:1994 Biological evaluation of medical devices-Selection of tests for interactions with blood
BS 5736-1:1989 Evaluation of medical devices for biological hazards-Guide for the selection of biological methods of test
NS-EN ISO 10993-13:2009 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)
CAN/CSA-ISO 10993-5-01:2001 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
BS 5736-1:1979 Evaluation of medical devices for biological hazards-Guide for the selection of biological methods of test
DANSK DS/EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
AENOR UNE-EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
NS-EN ISO 10993-13:2010 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
DANSK DS/ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices – Part 1: General requirements
DANSK DS/ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
UNE-EN ISO 10993-13:2009 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)
AAMI/ISO TIR10993-19:2006 Biological evaluation of medical devices - Part 19: Physio-chemical, morphological and topographical characterization of materials [Historical]
CAN/CSA-ISO 10993.7-1998(R2007) Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
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/TR 15499:2012 Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process

British Standards Institution (BSI)

BS EN ISO 10993-17:2023 Biological evaluation of medical devices - Toxicological risk assessment of medical device constituents
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
BS EN ISO 10993-2:2022 Biological evaluation of medical devices - Animal welfare requirements
PD ISO/TR 10993-22:2017 Biological evaluation of medical devices. Guidance on nanomaterials
BS EN ISO 10993-13:2010 Biological evaluation of medical devices. Part 13: Identification and quantification of degradation products from polymeric medical devices
BS EN ISO 10993-10:2023 Biological evaluation of medical devices. Tests for skin sensitization
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
18/30358832 DC BS EN ISO 10993-18. Biological evaluation of medical devices. Part 18. Chemical characterization of medical device materials within a risk management process
PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices. General requirements
BS PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices. General requirements
PD ISO/TS 10993-19:2020 Biological evaluation of medical devices. Physico-chemical, morphological and topographical characterization of materials
24/30482502 DC BS EN ISO 10993-17:2023/Amd 1 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents — Amendment
BS EN ISO 10993-18:2020+A1:2023 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
ISO 10993-18:2020/Amd.1:2022 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
BS EN ISO 10993-1:2003 Biological evaluation of medical devices - Evaluation and testing
BS EN ISO 10993-12:2021 Biological evaluation of medical devices. Sample preparation and reference materials
BS EN 29073-3:1992 Biological evaluation of medical devices. Framework for identification and quantification of potential degradation products
BS EN ISO 10993-7:2008+A1:2022 Biological evaluation of medical devices. Ethylene oxide sterilization residuals
BS EN ISO 10993-12:2012 Biological evaluation of medical devices. Sample preparation and reference materials
BS EN ISO 10993-11:2018(2022) Biological evaluation of medical devices Part 11 : Tests for systemic toxicity
BS EN ISO 10993-6:2016 Biological evaluation of medical devices. Tests for local effects after implantation
BS EN ISO 10993-9:2021 Biological evaluation of medical devices. Framework for identification and quantification of potential degradation products
BS EN ISO 10993-18:2020 Biological evaluation of medical devices Part 18 : Chemical characterization of medical device materials within a risk management process
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 PD ISO/TR 15499:2016 Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
BS EN ISO 10993-1:2020 Biological evaluation of medical devices. Evaluation and testing within a risk management process
PD ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants
PD ISO/TR 10993-55:2023 Biological evaluation of medical devices. Interlaboratory study on cytotoxicity
24/30453873 DC BS EN ISO 10993-6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

RU-GOST R

GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST ISO 10993-18-2011 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
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 10993-11-2011 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/TS 10993-20-2011 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
GOST ISO 10993-14-2011 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 R ISO 10993-10-1999 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and sensitization
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 10993-5-2011 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 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
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 10993-7-2011 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
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 R ISO 10993-12-1999 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
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 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 10993-4-2011 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST ISO 10993-9-2015 Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products
GOST R ISO 10993.7-1999 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST ISO 10993-16-2016 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST ISO 10993-3-2011 Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
GOST R ISO 10993.5-1999 Medical devices. Biological evaluation of medical devices. Part 5. Tests for cytotoxicity: in vitro methods
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 10993.4-1999 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood

Standard Association of Australia （SAA）

ISO 10993-17:2023 Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
AS ISO 10993.11:2002/Amdt 1:2005 Biological evaluation of medical devices Systemic toxicity testing
AS ISO 10993.17:2004 Biological evaluation of medical devices - Establishment of allowable limits for leachable substances

German Institute for Standardization

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 10993-17:2024-02 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023); German version EN ISO 10993-17:2023
DIN EN 13612:2002-08 Performance evaluation of in vitro diagnostic medical devices; German version EN 13612:2002, German and English texts
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 10993-11:2018-09 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 10993-10:2023-04 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 10993-18/A1:2021-10 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/DAM 1:2021); German and English version...
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 10993-13:2010-11 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010); German version EN ISO 10993-13:2010
DIN EN ISO 10993-1:2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009

VN-TCVN

TCVN 7391-18-2007 Biological evaluation of medical devices.Part 18: Chemical characterization of materials
TCVN 7391-1-2004 Biological evaluation of medical devices.Part 1: Evaluation and testing
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 7391-14-2007 Biological evaluation of medical devices.Part 14: Identification and quantification of degradation products from ceramics
TCVN 7391-5-2005 Biological evaluation of medical devices.Part 5: Tests for in vitro cytotoxicity
TCVN 7391-7-2004 Biological evaluation of medial devices.Part 7: Etylen oxide sterilization residuals

TH-TISI

TIS 2395.18-2008 Biological evaluation of medical devices.part 18: chemical characterization of materials
TIS 2395.1-2008 Biological evaluation of medical devices.part 1: evaluation and testing
TIS 2395.13-2008 Biological evaluation of medical devices.part 13: identification and quantification of degradation products from polymeric medical devices
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 2395.12-2008 Biological evaluation of medical devices.part 12: sample preparation and reference materials

Korean Agency for Technology and Standards (KATS)

KS P ISO 10993-18:2021 Biological evaluation of medical devices —Part 18: Chemical characterization of medical device materials within a risk management process
KS P ISO 10993-18-2009(2019) Biological evaluation of medical devices－Part 18：Chemical characterization of materials
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(2019) Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
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 TS 20993-2020 Biological evaluation of medical devices－Guidance on a risk－management process
KS P ISO TS 20993-2009(2014) Biological evaluation of medical devices－Guidance on a risk－management process
KS P ISO 10993-13-2023 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
KS P ISO 10993-2-2010(2021) Biological evaluation of medical devices－Part 2：Animal welfare requirements
KS P ISO TR 15499-2021 Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process
KS P ISO 10993-11-2007(2017) Biological evaluation of medical devices－Part 11：Tests for systemic toxicity
KS P ISO 10993-2-2010(2016) Biological evaluation of medical devices－Part 2：Animal welfare requirements
KS P ISO 10993-2-2021 Biological evaluation of medical devices－Part 2：Animal welfare requirements
KS P ISO 10993-19-2009(2019) Biological evaluation of medical devices－Part 19：Physico-chemical, morphological and topographical characterization of materials
KS P ISO TS 10993-19:2021 Biological evaluation of medical devices —Part 19: Physico-chemical, morphological and topographical characterization of materials
KS P ISO 10993-11:2021 Biological evaluation of medical devices —Part 11: Tests for systemic toxicity
KS P ISO 10993-5-2023 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
KS P ISO TS 37137-1-2023 Biological evaluation of absorbable medical devices — Part 1: General requirements

GSO

GSO ISO 10993-18:2016 Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
BH GSO ISO 10993-18:2017 Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
OS GSO ISO 10993-18:2016 Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
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 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/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 10993-23:2024 Biological evaluation of medical devices — Part 23: Tests for irritation
OS GSO ISO/TR 15499:2016 Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process
GSO ISO/TR 15499:2016 Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process
OS GSO ISO 10993-13:2016 Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices
BH GSO ISO 10993-13:2017 Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices
GSO ISO 10993-13:2016 Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices
GSO ISO 10993-11:2015 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
OS GSO ISO/TS 10993-19:2016 Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials
GSO ISO/TR 10993-22:2021 Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
BH GSO ISO 10993-2:2017 Biological evaluation of medical devices -- Part 2: Animal welfare requirements
OS GSO ISO 10993-11:2015 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
BH GSO ISO/TR 10993-22:2022 Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
BH GSO ISO 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
GSO ISO/TS 10993-19:2016 Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials
BH GSO ISO/TS 10993-19:2017 Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials
GSO ISO/TR 37137:2024 Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
BH GSO ISO/TS 37137-1:2023 Biological evaluation of absorbable medical devices — Part 1: General requirements
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 ISO/TS 37137-1:2023 Biological evaluation of absorbable medical devices — Part 1: General requirements

IT-UNI

UNI EN ISO 10993-18:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
UNI EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation
UNI EN ISO 10993-1:2021 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

KR-KS

KS P ISO 10993-18-2021 Biological evaluation of medical devices —Part 18: Chemical characterization of medical device materials within a risk management process
KS P ISO 10993-13-2018(2023) Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
KS P ISO 10993-23-2022 Biological evaluation of medical devices — Part 23: Tests for irritation
KS P ISO 10993-10-2022 Biological evaluation of medical devices — Part 10: Tests for skin sensitization
KS P ISO 10993-11-2021 Biological evaluation of medical devices —Part 11: Tests for systemic toxicity
KS P ISO TS 10993-19-2021 Biological evaluation of medical devices —Part 19: Physico-chemical, morphological and topographical characterization of materials
KS P ISO 10993-5-2018(2023) Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
KS P ISO 10993-6-2018(2023) Biological evaluation of medical devices — Part 6: Tests for local effects after implantation

Association Francaise de Normalisation

NF S99-501-18*NF EN ISO 10993-18:2020 Biological evaluation of medical devices - Part 18 : chemical characterization of medical device materials within a risk management process
NF S99-501:1998 Biological evaluation of medical devices. Part 1 : evaluation and testing.
NF EN ISO 10993-23:2021 Evaluation biologique des dispositifs médicaux - Partie 23 : essais d'irritation
NF S99-501-23*NF EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23 : tests for irritation
NF EN ISO 10993-13:2010 Biological assessment of medical devices - Part 13: identification and quantification of degradation products of polymer-based medical devices
NF EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
NF S99-501-13*NF EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13 : identification and quantification of degradation products from polymeric medical devices
NF EN ISO 10993-10:2023 Biological evaluation of medical devices - Part 10: skin sensitization testing
NF EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: systemic toxicity testing
XP ISO/TS 10993-19:2022 Évaluation biologique des dispositifs médicaux - Partie 19 : caractérisations physicochimique, morphologique et topographique des matériaux
NF EN ISO 10993-18:2020 Biological evaluation of medical devices - Part 18: chemical characterization of medical device materials within a risk management process
NF S99-501-11:2009 Biological evaluation of medical devices - Part 11 : tests for systemic toxicity.
FD ISO/TR 10993-22:2017 Biological evaluation of medical devices - Part 22: guidance on nanomaterials
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
NF EN ISO 10993-2:2022 Biological evaluation of medical devices - Part 2: Animal protection requirements
FD S99-516*FD ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
NF EN ISO 10993-5:2010 Biological evaluation of medical devices - Part 5: testing for in vitro cytotoxicity
NF S99-518:2005 Biological evaluation of medical devices - Part 18 : chemical characterization of materials.

Japanese Industrial Standards Committee (JISC)

JIS T 0993-1:2005 Biological evaluation of medical devices -- Part 1: Evaluation and testing
JIS T 0993-1:2012 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

CEN - European Committee for Standardization

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
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 10993-14:2009 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
EN ISO 10993-14:2001 Biological Evaluation of Medical Devices - Part 14: Identification and Quantification of Degradation Products from Ceramics

DIN

DIN EN ISO 10993-17:2024 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
DIN EN ISO 10993-13:1999 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)
DIN EN ISO 10993-13:2009 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)

European Committee for Standardization (CEN)

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)
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 10993-17:2023 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
EN ISO 10993-18:2020/prA1 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
EN ISO 10993-18:2020/prA1:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/DAM 1:2021)
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)

GOST

GOST R ISO/TS 10993-20-2009 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
GOST R ISO/TS 10993-19-2009 Medical devices. Biological evaluation of medical devices. Part 19. Tests physico-chemical, morphological and topographical characterization of materials

American National Standards Institute （ANSI)

AAMI/ISO TIR10993-20:2006(R2021) Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
ANSI/AAMI BE83-2006 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
ANSI/AAMI/ISO 10993-11:2017(R2023) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
AAMI/ISO TIR10993-19:2020 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials
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

AT-ON

OENORM EN ISO 10993-18:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
OENORM EN ISO 10993-18/A1:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020/DAM 1:2021) (Amendment)

PL-PKN

PN-EN ISO 10993-18-2020-11 E Biological evaluation of medical devices -- Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
PN-EN ISO 10993-23-2021-08 E Biological evaluation of medical devices -- Part 23: Tests for irritation (ISO 10993-23:2021)

CH-SNV

SN 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)

GOSTR

GOST ISO/TR 10993-22-2020 Medical devices. Biological evaluation of medical devices. Part 22. Guidance on nanomaterials
GOST R EN 13612-2010 Performance evaluation of in vitro diagnostic 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/TR 10993-33-2018 Medical levices. Biological evaluation of medical devices. Part 33. Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3
GOST ISO 10993-3-2018 Medical levices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicit
GOST R ISO 10993-2-2009 Standardization in the Russian Federation. Medical devices. Biological evaluation of medical devices. Part 2. Animal welfare requirements
GOST R ISO 7405-2011 Dentistry. Evaluation of biocompatibility of medical devices used in dentistry

AENOR

UNE-EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
UNE-EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices.
UNE-EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)

Danish Standards Foundation

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

Canadian Standards Association (CSA)

CSA ISO-10993.2-97-CAN/CSA:1997 Biological Evaluation of Medical Devices - Part 2: Animal Protection Requirements

ES-UNE

UNE-EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
UNE-EN 13612/AC:2003 Performance evaluation of in vitro diagnostic medical devices.
UNE-EN ISO 10993-18:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
UNE-EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
UNE-EN ISO 10993-12:2022 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

US-AAMI

ANSI/AAMI/ISO TIR15499:2012 Biological evaluation of medical devices - Guideance on the conduct of biological evaluation within a risk management process
ANSI/AAMI/ISO 10993-1:2009 Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process

PH-BPS

PNS ISO 10993-11:2021 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
PNS ISO 10993-2:2021 Biological evaluation of medical devices - Part 2: Animal welfare requirements