Medical Devices and Biomaterials

Medical Devices and Biomaterials, Total:426 items.

The international standard classification for "Medical Devices and Biomaterials" includes: Surgical instruments and materials , Implants for surgery, prosthetics and orthotics , Medical equipment in general , Laboratory medicine , Sterilization and disinfection .

The Chinese standard classification for "Medical Devices and Biomaterials" includes: Medical apparatus and devices in general , Extracorporeal circulation, artificial organ and prosthesis device , .

Group Standards of the People's Republic of China

T/CAMDI 106-2023 Guidelines for the control of polymeric materials for use in medical devices
T/CAMDI 033-2020 Guide for biological evaluation of packaging materials for medical devices
T/CAMDI 039-2020 Special requirements for the production quality system of bioprinted medical devices

国家食品药品监督管理局

YY/T 1532-2017 Biological evaluation of medical devices—Nanomaterials—Hemolysis test
YY/T 1562-2017 Tissue engineering medical device products-Biomaterial scaffolds-Guide for cell viability evaluation
YY/T 1616-2018 Tissue engineering medical device products—Standard guide for characterization and testing of biomaterial scaffolds

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

GB/T 16886.13-2001 Biogical evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12: Sample preparation and reference materials
GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials
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 16886.20-2015 Biological evaluation of medical devices―Part 20:Principles and methods for immunotoxicology testing of medical devices
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 16886.23-2023 Biological evaluation of medical devices—Part 23: Tests for irritation
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 27949-2011 Hygienic requirements for medical items disinfection
GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements

未注明发布机构

DIN 13173 E:2022-08 Medical instruments - Dressing forceps
DIN 13469 E:2016-07 Medical instruments - Dissecting forceps type Adson
DIN 13469 E:2022-08 Medical instruments - Dissecting forceps type Adson
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 58276 E:2017-03 Medical instruments - Forceps type Adson
DIN 58953-6 E:2008-06 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
DIN 13145 E:2008-09 Medical instruments - Mallet of plastic material
DIN EN ISO 10993-12:2009 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ANSI/AAMI/ISO TIR10993-19:2006 Biological evaluation of medical devices — Part 19: Physico- chemical, morphological, and topographical characterization of materials
DIN EN ISO 10993-12 E:2010-05 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials (Draft)
DIN EN ISO 10993-18:2009 Biological assessment of medical devices
DIN 13173 E:2016-07 Medical instruments - Dressing forceps
DIN 13469 E:2008-09 Medical instruments - Dissecting forceps type Adson
ANSI/AAMI/ISO 10993-2:2006(2010) Biological evaluation of medical devices— Part 2: Animal welfare requirements
ANSI/AAMI/ISO TIR10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
ASTM RR-F02-1005 1989 F1251-Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
DIN 58953-6 E:2016-06 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
ANSI/AAMI/ISO 10993-13:2010(2014) Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices

Taiwan Provincial Standard of the People's Republic of China

CNS 14393-15-2006 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
CNS 14393.13-2005 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
CNS 14393.14-2005 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
CNS 14393-8-2005 Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests
CNS 14393-12-2005 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
CNS 14393.8-2005 Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests
CNS 14393.12-2005 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
CNS 14393-13-2005 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
CNS 14393-14-2005 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics

Professional Standard - Medicine

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 0993-2015 Biological evaluation of medical devices―Nanomaterial:In vitro cytotoxicity tests(MTT assay and LDH assay)
YY/Y 1576-2017 Implantation Test of Absorbable Biomaterials for Tissue Engineering Medical Devices
YY/T 1295-2015 Biological evaluation of medical devices―Nanomaterial:Endotoxin 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 16886.12-2017 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

Shaanxi Provincial Standard of the People's Republic of China

DB61/T 1304-2019 Good Manufacturing Practice for Additively Manufactured Medical Devices

RU-GOST R

GOST ISO 10993-18-2011 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
GOST ISO 10993-12-2011 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials
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 10993-13-2011 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
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 10993-1-2011 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 10993-7-2011 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 10993-12-2015 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
GOST R ISO 10993-10-1999 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and sensitization
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 10993-5-2011 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 10993-17-2011 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 ISO 10993-6-2011 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST R ISO 10993-6-1999 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST R ISO 10993-14-2001 Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics
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 10993-10-2011 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity
GOST ISO 10993-3-2011 Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
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 10993.13-1999 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices / Note: To be replaced by GOST R ISO 10993-13 (2009).
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 R 57502-2017 Medical equipment. Industrial production regulation
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 10993-15-2011 Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys
GOST ISO 10993-4-2011 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST ISO 10993-9-2015 Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products

SCC

BS EN ISO 10993-18:2009 Biological evaluation of medical devices-Chemical characterization of materials
BS EN ISO 10993-18:2005 Biological evaluation of medical devices-Chemical characterization of materials
BS PD ISO/TR 10993-22:2017 Biological evaluation of medical devices-Guidance on nanomaterials
AS ISO 10993.12:2002 Biological evaluation of medical devices - Sample preparation and reference materials
CAN/CSA-ISO 10993.9-98:1998 Biological evaluation of medical devices - Part 9: Degradation of materials related to biological testing
DANSK DS/ISO/TR 10993-22:2021 Biological evaluation of medical devices – Part 22: Guidance on nanomaterials
BS EN ISO 10993-12:2009 Biological evaluation of medical devices-Sample preparation and reference materials
BS EN ISO 10993-12:1997 Biological evaluation of medical devices-Sample preparation and reference materials
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
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 13145 E:2008 Draft Document - Medical instruments - Mallet of plastic material
NS-EN 1641:1996 Dentistry — Medical devices for dentistry — Materials
DANSK DS/EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
DANSK DS/EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
NS-EN 1641:2009 Dentistry — Medical devices for dentistry — Materials
NS-EN 1641:2004 Dentistry — Medical devices for dentistry — Materials
UNE-EN 1641:2004 Dentistry - Medical devices for dentistry - Materials
AENOR 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)
BS 5736-7:1983 Evaluation of medical devices for biological hazards-Method of test for skin irritation of extracts from medical devices
BS DD ISO/TS 10993-19:2006 Biological evaluation of medical devices-Physico-chemical, morphological and topographical characterization of materials
BS EN ISO 10993-13:2009 Biological evaluation of medical devices-Identification and quantification of degradation products from polymeric medical devices
NS-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)
DANSK DS/EN ISO 10993-18/A1:2020 Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
BS PD ISO/TS 10993-19:2020 Biological evaluation of medical devices-Physico-chemical, morphological and topographical characterization of materials
AAMI/ISO 10993-12:2007 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
AAMI/ISO 10993-12:2012 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
AAMI/ISO 10993-12:2002 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
BS 5736-4:1981 Evaluation of medical devices for biological hazards-Method of test for intracutaneous reactivity of extracts from medical devices
MIL MIL-C-42068-1989 CHEST, MEDICAL INSTRUMENT AND SUPPLY SET
BS 5736-8:1984 Evaluation of medical devices for biological hazards-Method of test for skin irritation of solid medical devices
NS-EN 12287:1999 In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Description of reference materials
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
DIN EN 1641 E:2008 Draft Document - Dentistry - Medical devices for dentistry - Materials; German version prEN 1641:2008
DIN EN ISO 10993-18 E:2018 Draft Document - Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO/DIS 10993-18:2018); German and English version prEN ISO 10993-18:2018
DANSK DS/EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
CAN/CSA-ISO 10993-13-00:2000 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
BS EN ISO 10993-2:1998 Biological evaluation of medical devices-Animal welfare requirements
SN-ISO/TS 10993-19:2020 Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
SN-ISO/TS 10993-19:2006 Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
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
NS-EN ISO 10993-18:2009 Biological evaluation of medical devices — Part 18: Chemical characterization of materials (ISO 10993-18:2005)
NS-EN ISO 10993-18:2005 Biological evaluation of medical devices — Part 18: Chemical characterization of materials (ISO 10993-18:2005)
DANSK DS/ISO 10993-17:2023 Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents
08/30184612 DC BS EN 1641. Dentistry. Medical devices for dentistry. Materials
UNE-EN ISO 10993-18:2006 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
BS EN ISO 10993-1:1998 Biological evaluation of medical devices-Evaluation and testing
ADA 41-2020 Evaluation of Biocompatibility of Medical Devices Used in Dentistry
BS EN ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives-Application of risk management
NS-EN ISO 10993-8:2000 Biological evaluation of medical devices — Part 8: Selection and qualification of reference materials for biological tests (ISO 10993-8:2000)
ADA 41-2015 Evaluation of Biocompatibility of Medical Devices Used in Dentistry
UNE-EN ISO 10993-12:2005 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2002)
DANSK DS/ISO/TS 10993-19:2020 Biological evaluation of medical devices – Part 19: Physico-chemical, morphological and topographical characterization of materials
UNE-EN ISO 10993-12:2008 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)
UNE-EN ISO 10993-12:2009 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)
DANSK DS/EN ISO 10993-12:2021 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
AENOR UNE-EN ISO 10993-12:2013 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
NS-EN ISO 10993-12:2021 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
NS-EN ISO 10993-12:2007 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)
NS-EN ISO 10993-12:2009 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2007)
NS-EN ISO 10993-12:2004 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2002)
06/30145887 DC EN ISO 10993-12. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
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 30993-1:1994 Biological evaluation of medical devices-Guidance on selection of tests
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)
AENOR UNE-EN ISO 10993-8:2001 Biological evaluation of medical devices. Part 8: Selection and qualification of reference materials for biological assays. (ISO 10993-8:2000)
SN-ISO/TS 10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
DANSK DS/ISO/TS 10993-20:2006 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
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
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)
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)
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)
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
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
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]
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)
DIN 58298 E:2010 Draft Document - Medical instruments - Materials, finish and testing
AS ISO 10993.10:2002 Biological evaluation of medical devices - Tests for irritation and sensitization
BS 5736-11:1990 Evaluation of medical devices for biological hazards-Method of test for haemolysis
DIN 13173 E:2016 Draft Document - Medical instruments - Dressing forceps
BS EN ISO 22442-2:2007 Medical devices utilizing animal tissues and their derivatives-Controls on sourcing, collection and handling
BS 5736-1:1989 Evaluation of medical devices for biological hazards-Guide for the selection of biological methods of test
BS 5736-1:1979 Evaluation of medical devices for biological hazards-Guide for the selection of biological methods of test
NS-EN 12442-1:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices — Part 1: Analysis and management of risk
UNE-EN 12287:2000 In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Description of reference materials.
CAN/CSA-ISO 10993.2-1997(R2006) Biological evaluation of medical devices - Part 2: Animal welfare requirements
DIN EN ISO 10993-13 E:2008 Draft Document - Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO/DIS 10993-13:2008); German version prEN ISO 10993-13:2008
DIN EN ISO 10993-12/A1 E:2009 Draft Document - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007); English version prEN ISO 10993-12:2008, Amendment 1
BS EN ISO 7405:1997 Dentistry. Preclinical evaluation of biocompatibility of medical devices used in dentistry. Test methods for dental materials
AAMI/ISO 10993-2:1993 Biological Evaluation of Medical Devices - Part 2: Animal Protection Requirements
CAN/CSA-ISO 10993.2-1997(C2006) Biological evaluation of medical devices - Part 2: Animal protection requirements

Association Francaise de Normalisation

NF S90-701:1988 MEDICO-SURGICAL EQUIPMENT. BIOCOMPATIBILITY OF MATERIALS AND MEDICAL DEVICES. METHODS FOR EXTRACTION.
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 S99-501-18*NF EN ISO 10993-18:2020 Biological evaluation of medical devices - Part 18 : chemical characterization of medical device materials within a risk management process
FD ISO/TR 10993-22:2017 Biological evaluation of medical devices - Part 22: guidance on nanomaterials
FD S99-501-22*FD ISO/TR 10993-22:2017 Biological evaluation of medical devices - Part 22 : guidance on nanomaterials
NF S90-231:1978 Medical and surgical equipment. Transfusion apparatus for medical use. Physical and dimensional properties of multiple flexible plastic bags for blood and its derivates.
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 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
XP ISO/TS 10993-19:2022 Évaluation biologique des dispositifs médicaux - Partie 19 : caractérisations physicochimique, morphologique et topographique des matériaux
NF S99-518:2005 Biological evaluation of medical devices - Part 18 : chemical characterization of materials.
NF S91-224/A1:2013 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Amendment 1 : positive control material
NF S91-224:2009 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.
NF S91-224*NF EN ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
NF S90-230:1978 Medical and surgical equipment. Transfusion apparatus for medical use. Physical and dimensional properties of simple flexible plastic bags for blood and its derivatives.
NF S99-501:1998 Biological evaluation of medical devices. Part 1 : evaluation and testing.
NF EN ISO 22442-1:2020 Medical devices using animal tissues and their derivatives - Part 1: application of risk management
NF EN ISO 10993-23:2021 Evaluation biologique des dispositifs médicaux - Partie 23 : essais d'irritation
NF S99-211:2013 Medical devices - Application of risk management to medical devices

British Standards Institution (BSI)

PD ISO/TR 10993-22:2017 Biological evaluation of medical devices. Guidance on nanomaterials
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 10993-18:2020+A1:2023 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
BS EN ISO 10993-12:2007 Biological evaluation of medical devices - Sample preparation and reference materials
BS EN ISO 10993-12:2021 Biological evaluation of medical devices. Sample preparation and reference materials
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 10993-12:2012 Biological evaluation of medical devices. Sample preparation and reference materials
BS EN ISO 10993-8:2001 Biological evaluation of medical devices - Selection and qualification of reference materials for biological tests
BS EN ISO 10993-17:2023 Biological evaluation of medical devices - Toxicological risk assessment of medical device constituents
BS EN ISO 10993-13:2010 Biological evaluation of medical devices. Part 13: Identification and quantification of degradation products from polymeric medical devices
PD ISO/TS 10993-19:2020 Biological evaluation of medical devices. Physico-chemical, morphological and topographical characterization of materials
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
21/30439273 DC BS EN ISO 10993-18 AMD1. Biological evaluation of medical devices - Part 18. Chemical characterization of medical device materials within a risk management process
BS EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices
BS EN ISO 10993-2:2006 Biological evaluation of medical devices - Animal welfare requirements
BS EN ISO 10993-2:2022 Biological evaluation of medical devices - Animal welfare requirements
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
BS EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
BS EN ISO 15225:2016 Medical devices. Quality management. Medical device nomenclature data structure
BS EN ISO 10993-1:2003 Biological evaluation of medical devices - Evaluation and testing
BS EN ISO 10993-13:1999 Biological evaluation of medical devices - Identification and quantification of degradation products from polymeric medical devices
BS EN ISO 10993-15:2001 Biological evaluation of medical devices - Identification and quantification of degradation products from metals and alloys
19/30376763 DC BS EN ISO 10993-12. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
BS EN ISO 7405:2018 Dentistry. Evaluation of biocompatibility of medical devices used in dentistry
BS EN ISO 10993-10:2023 Biological evaluation of medical devices. Tests for skin sensitization
21/30379304 DC BS EN ISO 10993-17. Biological evaluation of medical devices - Part 17. Toxicological risk assessment of medical device constituents
PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices. General requirements
BS EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
BS EN ISO 10993-7:2008+A1:2022 Biological evaluation of medical devices. Ethylene oxide sterilization residuals
BS EN ISO 10993-12:2004 Biological evaluation of medical devices - Sample preparation and reference materials
BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices
BS EN ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
BS PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices. General requirements
BS EN ISO 7405:2009 Dentistry. Evaluation of biocompatibility of medical devices used in dentistry

GOSTR

GOST ISO/TR 10993-22-2020 Medical devices. Biological evaluation of medical devices. Part 22. Guidance on nanomaterials
GOST R ISO 22442-1-2011 Medical devices utilizing animal tissues and their derivatives. Part 1. Application of risk management
GOST ISO 10993-3-2018 Medical levices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicit
GOST R ISO 7405-2011 Dentistry. Evaluation of biocompatibility of medical devices used in dentistry
GOST ISO 10993-4-2020 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood

TH-TISI

TIS 2395.18-2008 Biological evaluation of medical devices.part 18: chemical characterization of materials
TIS 2395.2-2008 Biological evaluation of medical devices.part 2: animal welfare requirements
TIS 2395.13-2008 Biological evaluation of medical devices.part 13: identification and quantification of degradation products from polymeric medical devices

GSO

BH GSO ASTM F2475:2023 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
GSO ASTM F2475:2022 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
BH GSO ISO/TR 10993-22:2022 Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
GSO ISO/TR 10993-22:2021 Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
GSO ISO 10993-18:2016 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
BH GSO ISO 10993-18:2017 Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
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
OS GSO ISO/TS 10993-19:2016 Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials
GSO ISO 10993-13:2016 Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric 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 10993-19:2017 Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials
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 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 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
OS GSO ISO 7405:2016 Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry
BH GSO ISO 7405:2017 Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry
GSO ISO 7405:2016 Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry
GSO ISO 10993-2:2015 Biological evaluation of medical devices -- Part 2: Animal welfare requirements
BH GSO 2628:2022 Medical devices and supplies classification criteria
GSO 2628:2021 Medical devices and supplies classification criteria
BH GSO ISO 22442-1:2017 Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk manag ement

VN-TCVN

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

American Society for Testing and Materials (ASTM)

ASTM F1251-89(2003) Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
ASTM F2475-20 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
ASTM F619-79(1997)e1 Standard Practice for Extraction of Medical Plastics
ASTM F619-20 Standard Practice for Extraction of Materials Used in Medical Devices
ASTM F619-02 Standard Practice for Extraction of Medical Plastics

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/TR 10993-22:2017 Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
ISO/TR 10993-9:1994 Biological evaluation of medical devices — Part 9: Degradation of materials related to biological testing
ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
ISO 10993-12:1996 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO 10993-12:2007 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
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/TS 10993-19:2020 Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
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 7405:2008/Amd 1:2013 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Amendment 1: Positive control material
ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
ISO/CD 7405:2023 Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
ISO 14971:2019 Medical devices — Application of risk management to medical devices

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 22442-1:2021 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management

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 TR 10993-22:2020 Biological evaluation of medical devices —Part 22: Guidance on nanomaterials
KS P ISO 10993-18-2009(2019) Biological evaluation of medical devices－Part 18：Chemical characterization of materials
KS P ISO 10993-18:2009 Biological evaluation of medical devices－Part 18：Chemical characterization of materials
KS P ISO 10993-13:2007 Biological evaluation of medical devices－Part 13：Identification and quantification of degradation products from polymeric medical devices
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 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 10993-19-2009(2019) Biological evaluation of medical devices－Part 19：Physico-chemical, morphological and topographical characterization of materials
KS P ISO 10993-13:2018 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
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 10993-20-2009(2019) Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
KS P ISO 10993-20-2019 Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
KS P ISO 7405:2014 Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
KS P ISO 7405:2010 Dentistry-Evaluation of biocompatibility of medical devices used in dentistry
KS P ISO 14971:2021 Medical devices — Application of risk management to medical devices
KS P ISO 10993-2-2010(2021) Biological evaluation of medical devices－Part 2：Animal welfare requirements
KS P ISO TS 20993-2020 Biological evaluation of medical devices－Guidance on a risk－management process
KS P ISO 10993-2-2021 Biological evaluation of medical devices－Part 2：Animal welfare requirements
KS P ISO 10993-12-2014(2019) Biological evaluation of medical devices —Part 12: Sample preparation and reference materials
KS P ISO TS 20993-2009(2014) Biological evaluation of medical devices－Guidance on a risk－management process

Danish Standards Foundation

DS/ISO/TR 10993-22:2021 Biological evaluation of medical devices – Part 22: Guidance on nanomaterials
DS/EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
DS/EN ISO 7405/A1:2013 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Amendment 1: Positive control material
DS/EN ISO 7405:2009 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
DS/ISO 17664-2:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices
DS/ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices

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 TR 10993-22-2020 Biological evaluation of medical devices —Part 22: Guidance on nanomaterials
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 10993-13-2018 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
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 22442-1-2022 Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
KS P ISO 14971-2018 Medical devices — Application of risk management to medical devices

ES-UNE

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 10993-12:2022 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
UNE-EN ISO 7405:2019 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)

American National Standards Institute （ANSI)

ANSI/AAMI BE83-2006 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
AAMI/ISO TIR10993-19:2020 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials
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 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements

GOST

GOST R ISO 10993.12-1999 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
GOST R ISO 10993-18-2009 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
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
GOST R ISO 10993-13-2009 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
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 10993-23-2023 Medical devices. Biological evaluation of medical devices. Part 23. Irritant studies
GOST ISO 10993-10-2023 Medical devices. Biological evaluation of medical devices. Part 10. Sensitization tests
GOST R ISO 10993-1-2009 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST ISO 10993-11-2021 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST R ISO 10993-3-2009 Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
GOST R ISO 10993-11-2009 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST ISO 10993-18-2022 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of medical device materials within a risk management process
GOST R ISO 10993-17-2009 Medical devices. Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substance

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)
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 1641:2009 Dentistry - Medical devices for dentistry - Materials
EN 1641:1996 Dentistry - Medical Devices for Dentistry - Materials
CEN EN ISO 10993-12:2004 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials ISO 10993-12:2002
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 10993-13:1998 Biological Evaluation of Medical Devices - Part 13: Identification and Quantification of Degradation Products from Polymeric Medical Devices ISO 10993-13:1998
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 10993-2:2022 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
EN ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2008)
EN ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

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 1641:2004 Dentistry - Medical devices for dentistry - Materials
EN 12287:1999 In Vitro Diagnostic Medical Devices - Measurement of Quantities in Samples of Biological Origin - Description of Reference Materials
EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
EN ISO 14971:2009 Medical devices - Application of risk management to medical devices

German Institute for Standardization

DIN EN 1641:2010-02 Dentistry - Medical devices for dentistry - Materials; German version EN 1641:2009
DIN EN ISO 10993-18:2021-03 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020); German version EN ISO 10993-18:2020 / Note: To be amended by DIN EN ISO 10993-18/A1 (2021-10).
DIN EN ISO 10993-12:2008 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007); German version EN ISO 10993-12:2007
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 58298:2005 Medical instruments - Materials, finish and testing
DIN 58298:2010 Medical instruments - Materials, finish and testing
DIN EN ISO 10993-18:2023-11 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020 + Amd 1:2022); German version EN ISO 10993-18:2020 + A1:2023
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 13173:2023-03 Medical instruments - Dressing forceps
DIN 13173:2005 Medical instruments - Dressing forceps
DIN 13145:1979 Medical instruments; mallet of plastic material
DIN 13145:2010 Medical instruments - Mallet of plastic material
DIN 13173:2016 Medical instruments - Dressing forceps
DIN 96160:2011 Medical instruments - Wire guide
DIN 58953-6:2010 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
DIN 58953-6:2016 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
DIN 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); German version EN ISO 10993-18:2020
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 10993-13:2010-11 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 58276:2010 Medical instruments - Forceps type Adson
DIN EN ISO 7405:2019-03 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12); German version EN ISO 7405:2018
DIN EN ISO 10993-18:2023 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020 + Amd 1:2022) (includes Amendment A1:2023)
DIN EN ISO 10993-12:2019 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO/DIS 10993-12:2019); German and English version prEN ISO 10993-12:2019
DIN 58953-6:2016-12 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
DIN 13465:2016 Medical instruments - Haemostatic forceps type Adson
DIN 58953-6:2023-04 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized / Note: Date of issue 2023-03-17*Intended as replacement for DIN 58953-6 (2016-12).
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 13469:2010 Medical instruments - Dissecting forceps type Adson
DIN 13469:2016 Medical instruments - Dissecting forceps type Adson
DIN 13469:1988 Medical instruments; dissecting forceps type Adson
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 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006); English version of DIN EN ISO 10993-2:2006-10
DIN 13465:2010 Medical instruments - Haemostatic forceps type Adson

Lithuanian Standards Office

LST EN 1641-2010 Dentistry - Medical devices for dentistry - Materials
LST EN ISO 10993-12:2021 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

DIN

DIN EN 1641:2004 Dentistry - Medical devices for dentistry - Materials
DIN EN 12287:1999 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials
DIN 13173:2023 Medical instruments - Dressing forceps
DIN EN ISO 10993-12:2005 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2002)
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)
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 10993-17:2024 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)

AENOR

UNE-EN 1641:2010 Dentistry - Medical devices for dentistry - Materials
UNE-EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
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)
UNE-EN ISO 10993-12:2013 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

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)

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)
SN EN ISO 10993-12:2021 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

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)
OENORM EN ISO 10993-12:2021 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

Canadian Standards Association (CSA)

CSA ISO 10993.12-98-CAN/CSA:1998 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials First Edition; ISO 10993-12: 1996
CSA ISO 10993-13-00-CAN/CSA:2000 Biological Evaluation of Medical Devices - Part 13: Identification and Quantification of Degradation Products from Polymeric Medical Devices First Edition; ISO 10993-13: 1998
CSA ISO-10993.2-97-CAN/CSA:1997 Biological Evaluation of Medical Devices - Part 2: Animal Protection Requirements

IN-BIS

IS 12572 Pt.10-1988 Guidelines for Biohazard Assessment of Medical Devices Part 10 Methods for Biological Testing and Assessment of Dental Materials
IS 12572 Pt.8-1988 Guidelines for Biohazard Assessment of Medical Devices Part 8 Skin Irritation Test Methods for Medical Device Extracts
IS 12572 Pt.5-1988 Guidelines for Biohazard Evaluation of Medical Devices Part 5 Test Method for Intradermal Reactivity of Medical Device Extracts
IS 12572 Pt.9-1988 Guidelines for Biohazard Evaluation of Medical Devices Part 9 Test Methods for Skin Irritation from Solid Medical Devices

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

Japanese Industrial Standards Committee (JISC)

JIS T 6001:2021 Evaluation of biocompatibility of medical devices used in dentistry
JIS T 14971:2003 Medical devices -- Application of risk management to medical devices

RO-ASRO

STAS 1484-1950 medical instruments. Boxes for storing first aid equipment and materials

Others: Microbial barrier test of packaging materials for medical devices to be sterilized,Microbial barrier test of packaging materials for sterilized medical devices,Evaluation of the Compatibility of Biomaterials for Surgical Implants with the Effects of Muscle and Bone Materials,Biomaterial Medical Devices