Biomaterial Medical Devices

Biomaterial Medical Devices, Total:249 items.

The international standard classification for "Biomaterial Medical Devices" includes: Medical equipment in general , Surgical instruments and materials , Implants for surgery, prosthetics and orthotics .

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

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

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 16886.1-2001 Biological evaluation of medical devices--Part 1:Evaluation and testing
GB/T 16886.13-2001 Biogical evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.2-2011 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 16886.18-2011 Biological evaluation of medical devices—Part 18:Chemical characterization of materials
GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12: Sample preparation and reference materials
GB/T 16886.6-2015 Biological evaluation of medical devices―Part 6:Tests for local effects after implantation

Group Standards of the People's Republic of China

T/CAMDI 039-2020 Special requirements for the production quality system of bioprinted medical devices
T/CAMDI 033-2020 Guide for biological evaluation of packaging materials for medical devices

国家食品药品监督管理局

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
YY/T 1532-2017 Biological evaluation of medical devices—Nanomaterials—Hemolysis test

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 10993-12 E:2010-05 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials (Draft)
DIN 13173 E:2016-07 Medical instruments - Dressing forceps
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
DIN 13173 E:2022-08 Medical instruments - Dressing forceps
DIN EN ISO 10993-18:2009 Biological assessment of medical devices
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)
ANSI/AAMI/ISO 10993-13:2010(2014) Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
ASTM RR-F02-1005 1989 F1251-Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
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

Professional Standard - Medicine

YY/T 1295-2015 Biological evaluation of medical devices―Nanomaterial:Endotoxin test
YY/Y 1576-2017 Implantation Test of Absorbable Biomaterials for Tissue Engineering Medical Devices
YY/T 1815-2022 Biological evaluation of medical devices-Application for the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents

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
GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials

国家市场监督管理总局、中国国家标准化管理委员会

GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity

Taiwan Provincial Standard of the People's Republic of China

CNS 14393-13-2005 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
CNS 14393-12-2005 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
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

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 ISO 10993-12-2015 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
GOST R ISO 10993-12-1999 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

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 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
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
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
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
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)
BS EN ISO 10993-13:2009 Biological evaluation of medical devices-Identification and quantification of degradation products from polymeric medical devices
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
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)
DANSK DS/ISO 10993-17:2023 Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents
NS-EN ISO 10993-18:2005 Biological evaluation of medical devices — Part 18: Chemical characterization of materials (ISO 10993-18:2005)
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
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
NS-EN ISO 10993-12:2009 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2007)
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)
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
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
DANSK DS/ISO/TS 10993-20:2006 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of 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
BS EN 30993-1:1994 Biological evaluation of medical devices-Guidance on selection of tests

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 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.

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
PD ISO/TS 10993-19:2020 Biological evaluation of medical devices. Physico-chemical, morphological and topographical characterization of materials
BS EN ISO 10993-13:2010 Biological evaluation of medical devices. Part 13: Identification and quantification of degradation products from polymeric medical devices
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

GOSTR

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

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

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
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 10993-13:2016 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
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
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

VN-TCVN

TCVN 7391-18-2007 Biological evaluation of medical devices.Part 18: Chemical characterization of materials

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

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

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

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

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

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

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)

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

GOST

GOST R ISO 10993-18-2009 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
GOST R ISO 10993.12-1999 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference 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

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 - 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

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

Lithuanian Standards Office

LST EN 1641-2010 Dentistry - Medical devices for dentistry - Materials

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)

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)

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)

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)

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)

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

Standard Association of Australia （SAA）

ISO 10993-17:2023 Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents