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biological evaluation

biological evaluation, Total:498 items.

In the international standard classification, biological evaluation involves: Laboratory medicine, Medical equipment, Pesticides and other agrochemicals, Pharmaceutics, Dentistry, Microbiology, Medical sciences and health care facilities in general, Hospital equipment, Information sciences. Publishing, Aerosol containers.

未注明发布机构, biological evaluation

DIN EN ISO 10993-18:2009 Biological assessment of medical devices
DIN EN ISO 10993-1:2003 Biological assessment of medical devices Part 1: Assessment and testing
DIN EN ISO 10993-1:1998 Biological evaluation of medical devices – Part 1: Evaluation and testing
BS EN ISO 10993-11:2018(2022) Biological evaluation of medical devices Part 11 : Tests for systemic toxicity
YY 0127.7-2017 Biological Evaluation of Oral Medical Devices Part 7: Pulp Dentin Application Test
BS EN ISO 10993-1:2020 Tracked Changes. Biological evaluation of medical devices. Evaluation and testing within a risk management process
YY 0127.8-2001 Biological evaluation of oral materials. Unit 2: Biological testing methods of oral materials. Subcutaneous implantation test
YY 0127.6-1999 Biological evaluation of oral materials. Unit 2: Biological testing methods of oral materials. Manifest lethality test
BS EN ISO 10993-16:2017(2020) Biological evaluation of medical devices Part 16 : Toxicokinetic study design for degradation products and leachables
ISO 10993-15:2000/Cor 1:2001 Biologicalevaluation of medical devices - Part 15: Identificationand quantification of degradation products from metals and alloys

International Organization for Standardization (ISO), biological evaluation

ISO/TR 15499:2016 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
ISO/TR 7405:1984 Biological evaluation of dental materials
ISO/TR 15499:2012 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
ISO 10993-1:2003 Biological evaluation of medical devices - Part 1: Evaluation and testing
ISO 11930:2019 Cosmetics — Microbiology — Evaluation of the antimicrobial protection of a cosmetic product
ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation
ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements
ISO 10993-2:1992 Biological evaluation of medical devices; part 2: animal welfare requirements
ISO 10993-2:2022 Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-11:1993 Biological evaluation of medical devices; part 11: tests for systemic toxicity
ISO 10993-10:2021 Biological evaluation of medical devices — Part 10: Tests for skin sensitization
ISO 10993-8:2000 Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests
ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices — Part 1: General requirements
ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-12:2021 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
ISO 10993-6:1994 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
ISO 10993-7:1995 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
ISO 10993-5:1992 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
ISO/TR 10993-55:2023 Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity
ISO 10993-14:2001 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
ISO 10993-1:2009/Cor 11:2010 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-4:1992 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 10993-18:2020/Amd 1:2022 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO/CD TR 37137-2 Biological evaluation of absorbable medical devices — Part 2: Standard guide for absorbable metals
ISO/TS 10993-19:2020 Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
ISO 10993-7:2008/cor 1:2009 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1
ISO 10993-3:1992 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
ISO 10993-9:1999 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
ISO 10993-9:2019 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
ISO 10993-15:2000 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
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

国家食品药品监督管理局, biological evaluation

YY/T 1512-2017 Implementation Guidelines for Biological Evaluation in the Risk Management Process of Biological Evaluation of Medical Devices
YY/T 1532-2017 Medical device biological evaluation nanomaterials hemolysis test
YY/T 0127.13-2018 Biological evaluation of oral medical devices Part 13: Oral mucosal irritation test
YY/T 0127.7-2017 Biological Evaluation of Oral Medical Devices Part 7: Pulp Dentin Application Test
YY/T 1535-2017 Biological evaluation of medical devices for human in vitro assisted reproductive technology and human sperm survival test
YY/T 0719.7-2011 Ophthalmic optical contact lenses and contact lens care products - Part 7: Test methods for biological evaluation
YY/T 0127.15-2018 Biological Evaluation of Oral Medical Devices Part 15: Subacute and Subchronic Systemic Toxicity Tests: Oral Route

US-AAMI, biological evaluation

ANSI/AAMI/ISO TIR15499:2012 Biological evaluation of medical devices - Guideance on the conduct of biological evaluation within a risk management process
ANSI/AAMI/ISO 10993-1:2009 Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process
ANSI/AAMI/ISO 10993-3:2014 Biological evaluation of medical devices. Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ANSI/AAMI/ISO 10993-16:2017 Biological evaluation of medical devices-Part 16: Toxicokinetic study design for degradation products and leachables

British Standards Institution (BSI), biological evaluation

BS PD ISO/TR 15499:2016 Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
BS EN ISO 10993-2:2022 Biological evaluation of medical devices - Animal welfare requirements
PD ISO/TR 10993-22:2017 Biological evaluation of medical devices. Guidance on nanomaterials
BS PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices. General requirements
PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices. General requirements
BS EN ISO 10993-12:2012 Biological evaluation of medical devices. Sample preparation and reference materials
BS EN ISO 10993-11:2018 Biological evaluation of medical devices. Tests for systemic toxicity
BS EN ISO 10993-6:2009 Biological evaluation of medical devices. Tests for local effects after implantation
BS EN ISO 10993-10:2010 Biological evaluation of medical devices. Tests for irritation and skin sensitization
BS EN ISO 10993-10:2023 Tracked changes. Biological evaluation of medical devices. Tests for skin sensitization
PD ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants
PD ISO/TR 10993-55:2023 Biological evaluation of medical devices. Interlaboratory study on cytotoxicity
BS PD ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants
BS EN ISO 10993-14:2009 Biological evaluation of medical devices - Identification and quantification of degradation products from ceramics
BS EN ISO 10993-17:2009 Biological evaluation of medical devices. Establishment of allowable limits for leachable substances
BS EN ISO 10993-7:2008+A1:2022 Tracked Changes. Biological evaluation of medical devices. Ethylene oxide sterilization residuals
PD ISO/TS 10993-19:2020 Biological evaluation of medical devices. Physico-chemical, morphological and topographical characterization of materials
BS EN ISO 10993-6:2016 Tracked Changes. Biological evaluation of medical devices. Tests for local effects after implantation
BS EN ISO 10993-12:2021 Tracked Changes. Biological evaluation of medical devices. Sample preparation and reference materials
BS EN 29073-3:1992 Biological evaluation of medical devices. Framework for identification and quantification of potential degradation products
BS EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11:Tests for systemic toxicity (ISO 10993-11:2006)
19/30372368 DC BS EN ISO 10993-23. Biological evaluation of medical devices. Part 23. Tests for irritation
20/30398724 DC BS EN ISO 10993-2. Biological evaluation of medical devices. Part 2. Animal welfare requirements
DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices
20/30377819 DC BS EN ISO 10993-10. Biological evaluation of medical devices. Part 10. Tests for skin sensitization
BS EN ISO 10993-16:2017 Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables
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/TR 10993-33:2015 Biological evaluation of medical devices. Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3
BS EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
22/30427685 DC BS EN 455-3. Medical gloves for single use. Part 3. Requirements and testing for biological evaluation
BS EN ISO 10993-3:2014 Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity
16/30343252 DC BS EN 455-3 AMD1. Medical gloves for single use. Part 3. Requirements and testing for biological evaluation
BS EN ISO 10993-9:2021 Tracked Changes. Biological evaluation of medical devices. Framework for identification and quantification of potential degradation products
PD ISO/TR 15499:2016 Tracked Changes. Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
18/30355036 DC BS EN ISO 10993-7 AMD1. Biological evaluation of medical devices - Part 7. Ethylene oxide sterilization residuals
19/30376763 DC BS EN ISO 10993-12. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
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 21726:2019 Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
17/30344601 DC BS EN ISO 10993-1. Biological evaluation of medical devices. Part 1. Evaluation and testing within a risk management process
18/30354689 DC BS EN ISO 10993-9. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products
18/30354781 DC BS EN ISO 10993-15. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys

ZA-SANS, biological evaluation

SANS 5233:2007 Pesticides - Biological evaluation of the efficacy of mists and fogs
SANS 5695:1978 Pesticides: Biological evaluation of the efficacy of mosquito repellants
SANS 5694:2007 Pesticides - Biological testing of the efficacy of rodenticides
SANS 192:1978 Pesticides: Biological evaluation of the efficacy of molluscicides
SANS 5693:2007 Pesticides - Biological evaluation of the efficacy of insecticide dusting powders
SANS 10993-1:2003 Biological evaluation of medical devices Part 1: Evaluation and testing
SANS 5690:2003 Pesticides - Biological evaluation of the properties of solid fly baits
SANS 5471:2006 Pesticides - Biological evaluation of the resistance of materials to termite attack
SANS 5823:1978 Pesticides: Biological evaluation of the efficacy of insecticides used on compost
SANS 6136:2003 Pesticides - Biological evaluation of materials that release an insecticide upon heating
SANS 10993-5:2003 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
SANS 5422:2007 Pesticides - Biological evaluation of insecticidal sprays on compost (laboratory test)
SANS 5824:1978 Pesticides: Biological evaluation of powders that prevent decay and inhibit sprout formation in potatoes
SANS 5689:2002 Pesticides - Biological evaluation of knock-down and killing properties of liquid and aerosol formulations
SANS 5580:1969 Pesticides: Biological evaluation of mothproof textiles containing wool
SANS 5327:1978 Pesticides: Comparative biological evaluation of the susceptibility of two strains of house-flies to insecticides
SANS 5581:1978 Pesticides: Biological evaluation of wash-durability properties of mothproof textiles containing wool
SANS 10993-4:2004 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
SANS 5858:2007 Pesticides - Biological evaluation of mosquito larvicides in artificially created mosquito breeding places
SANS 5857:1976 Pesticides: Biological evaluation of mothproof textiles containing wool after exposure to artificial sunlight
SANS 5582:1978 Pesticides: Biological evaluation of dry-cleaning-durability properties of mothproof textiles containing wool
SANS 5696:1978 Pesticides: Biological evaluation of the efficacy of residual sprays against skin and hide beetles
SANS 10993-10:2004 Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity
SANS 10993-3:2004 Biological evaluation of medical devices Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity
SANS 5576:2003 Pesticides - Biological evaluation of the efficacy of insecticidal water-based and oil-based space sprays in low pressurized dispensers

Association Francaise de Normalisation, biological evaluation

NF S99-501:1998 Biological evaluation of medical devices. Part 1 : evaluation and testing.
NF EN ISO 10993-23:2021 Evaluation biologique des dispositifs médicaux - Partie 23 : essais d'irritation
NF S99-501-23*NF EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23 : tests for irritation
NF EN ISO 10993-11:2018 Évaluation biologique des dispositifs médicaux - Partie 11 : essais de toxicité systémique
NF EN ISO 10993-10:2023 Évaluation biologique des dispositifs médicaux - Partie 10 : essais de sensibilisation cutanée
NF S99-501-11:2009 Biological evaluation of medical devices - Part 11 : tests for systemic toxicity.
NF S99-501-11*NF EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11 : tests for systemic toxicity
FD S99-501-22*FD ISO/TR 10993-22:2017 Biological evaluation of medical devices - Part 22 : guidance on nanomaterials
FD ISO/TR 10993-22:2017 Évaluation biologique des dispositifs médicaux - Partie 22 : lignes directrices sur la nanomatériaux
NF S99-501-18:2009 Biological evaluation of medical devices - Part 18 : chemical characterization of materials.
FD S99-516*FD ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
NF EN ISO 10993-2:2022 Évaluation biologique des dispositifs médicaux - Partie 2 : Exigences relatives à la protection des animaux
NF EN ISO 10993-5:2010 Évaluation biologique des dispositifs médicaux - Partie 5 : essais concernant la cytotoxicité in vitro
NF S99-507:1996 Biological evaluation of medical devices. Part 7 : ethylene oxide sterilization residuals.
NF EN ISO 10993-7:2008 Évaluation biologique des dispositifs médicaux - Partie 7 : résidus de stérilisation à l'oxyde d'éthylène
NF S99-501-5*NF EN ISO 10993-5:2010 Biological evaluation of medical devices - Part 5 : tests for in vitro cytotoxicity.
NF EN ISO 10993-6:2017 Évaluation biologique des dispositifs médicaux - Partie 6 : essais concernant les effets locaux après implantation
NF EN ISO 10993-17:2009 Évaluation biologique des dispositifs médicaux - Partie 17 : établissement des limites admissibles des substances relargables
NF EN ISO 10993-12:2021 Evaluation biologique des dispositifs médicaux - Partie 12 : préparation des échantillons et matériaux de référence
NF S99-501-12:2012 Biological evaluation of medical devices - Part 12 : sample preparation and reference materials.
NF S99-501-12*NF EN ISO 10993-12:2021 Biological evaluation of medical devices - Part 12 : sample preparation and reference materials
NF S99-506:1995 Biological evaluation of medical devices. Part 6 : tests for local effects after implantation.
NF S99-501-10*NF EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10 : tests for irritation and skin sensitization
NF EN ISO 10993-14:2009 Évaluation biologique des dispositifs médicaux - Partie 14 : identification et quantification des produits de dégradation des céramiques
XP ISO/TS 10993-19:2022 Évaluation biologique des dispositifs médicaux - Partie 19 : caractérisations physicochimique, morphologique et topographique des matériaux
NF EN ISO 10993-3:2014 Évaluation biologique des dispositifs médicaux - Partie 3 : essais concernant la génotoxicité, la cancérogénicité et la toxicité sur la reproduction
NF S99-504:1994 Biological evaluation of medical devices. Part 4 : selection of tests for interactions with blood.
NF S99-501-4*NF EN ISO 10993-4:2018 Biological evaluation of medical devices - Part 4 : selection of tests for interactions with blood
NF EN ISO 10993-4:2018 Évaluation biologique des dispositifs médicaux - Partie 4 : choix des essais pour les interactions avec le sang
NF EN 455-3:2015 Gants médicaux non réutilisables - Partie 3 : exigences et essais pour évaluation biologique
NF EN ISO 10993-7/A1:2022 Evaluation biologique des dispositifs médicaux - Partie 7 : résidus de stérilisation à l'oxyde d'éthylène - Amendement 1
NF S99-501-3:2009 Biological evaluation of medical devices - Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity.
NF S99-501-3*NF EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity
NF S99-503:1994 Biological evaluation of medical devices. Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity.
NF S99-501-9*NF EN ISO 10993-9:2021 Biological evaluation of medical devices - Part 9 : framework for identification and quantification of potential degradation products
NF EN ISO 10993-9:2021 Evaluation biologique des dispositifs médicaux - Partie 9 : cadre pour l'identification et la quantification des produits potentiels de dégradation
NF S99-501-15*NF EN ISO 10993-15:2009 Biological evaluation of medical devices - Part 15 : identification and quantification of degradation products from metals and alloys
NF EN ISO 10993-15:2009 Évaluation biologique des dispositifs médicaux - Partie 15 : identification et quantification des produits de dégradation issus des métaux et alliages
NF EN ISO 10993-13:2010 Évaluation biologique des dispositifs médicaux - Partie 13 : identification et quantification de produits de dégradation de dispositifs médicaux à base de polymères
NF EN ISO 10993-16:2017 Évaluation biologique des dispositifs médicaux - Partie 16 : conception des études toxicocinétiques des produits de dégradation et des substances relargables
NF EN 60335-2-95:2017 Évaluation biologique des dispositifs médicaux - Partie 16 : conception des études toxicocinétiques des produits de dégradation et des substances relargables
NF S99-501-13*NF EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13 : identification and quantification of degradation products from polymeric medical devices
NF S99-501-16*NF EN ISO 10993-16:2017 Biological evaluation of medical devices - Part 16 : Toxicokinetic study design for degradation products and leachables
NF S99-501-18*NF EN ISO 10993-18:2020 Biological evaluation of medical devices - Part 18 : chemical characterization of medical device materials within a risk management process
NF S99-501-16:2010 Biological evaluation of medical devices - Part 16 : toxicokinetic study design for degradation products and leachables.

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, biological evaluation

GB/T 16175-2008 Biological evaluation test methods for medical organic silicon materials
GB/T 16175-1996 Organic silicon material for medical use--Biological evaluation test methods
GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1: Evaluation and testing
GB/T 16886.18-2011 Biological evaluation of medical devices.Part 18: Chemical characterization of materials
GB/T 16886.2-2000 Biological evaluation of medical devices--Part 2: Animal welfare requirements
GB/T 16886.2-2011 Biological evaluation of medical devices.Part 2: Animal welfare requirements
GB/T 16886.11-1997 Biological evaluation of medical devices--Part 11: Tests for systemic toxicity
GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials
GB/T 16886.11-2011 Biological evaluation of medical devices.Part 11: Tests for systemic toxicity
GB/T 16886.10-2000 Biological evaluation of medical devices--Part 10: Tests for irritation and sensitization
GB/T 16886.5-2017 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests
GB/T 16886.5-2003 Biological evaluation of medical devices--Part 5: Test for in vitro cytotoxicity
GB/T 16886.12-2005 Biological evaluation of medical devices-Part 12:Sample preparation and reference materials
GB/T 16886.6-2015 Biological evaluation of medical devices.Part 6:Tests for local effects after implantation
GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
GB/T 16886.12-2000 Biological evaluation of medical devices--Part 12: Sample preparation and reference materials
GB/T 16886.7-2001 Biological evaluation of medical devices--Part 7:Ethylene oxide sterilization residuals
GB/T 16886.6-1997 Biological evaluation of medical devices--Part 6: Tests for local effects after implantation
GB/T 16886.17-2005 Biological evaluation of medical devices.Part 17:Establishment of allowable limits for leachable substances
GB/T 16886.1-2011 Biological evaluation of medical devices.Part 1: Evaluation and testing within a risk management process
GB/T 16886.4-2003 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
GB/T 16886.14-2003 Biological evaluation of medical devices--Part 14: Identification and quantification of degradation products from ceramics
GB/T 16886.10-2005 Biological evaluation of medical devices.Part 10:Tests for irritation and delayed-type hypersensitivity
GB/T 16886.3-2008 Biological evaluation of medical devices.Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.3-1997 Biological evaluation of medical devices--Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.9-2022 Biological Evaluation of Medical Devices Part 9: Qualitative and Quantitative Framework for Potential Degradation Products
GB/T 16886.9-2001 Biological evaluation of medical devices-Part 9:Framework for identification and quantification of potential degradation product
GB/T 16886.19-2022 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 16886.15-2022 Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys
GB/T 16886.15-2003 Biological eveluation of medical devices--Part 15: Identification and quantification of degradation products from metals and alloys
GB/T 16886.20-2015 Biological evaluation of medical devices.Part 20:Principles and methods for immunotoxicology testing of medical devices
GB/T 16886.16-2013 Biological evaluation of medical devices.Part 16: Toxicokinetic study design for degradation products and leachables
GB/T 16886.16-2003 Biological evaluation of medical devices--Part 16: Toxicokinetic study design for degradation products and leachables
GB/T 16886.13-2001 Biological evaluation of medical devices--Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process

Group Standards of the People's Republic of China, biological evaluation

T/CAMDI 033-2020 Guide for biological evaluation of packaging materials for medical devices
T/CAMDI 034-2020 Biological evaluation of medical devices Medical catheter with hydrophilic polymer coating：Sample preparation

Standard Association of Australia （SAA）, biological evaluation

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

VN-TCVN, biological evaluation

TCVN 7391-1-2004 Biological evaluation of medical devices.Part 1: Evaluation and testing
TCVN 7391-18-2007 Biological evaluation of medical devices.Part 18: Chemical characterization of materials
TCVN 7391-2-2005 Biological evaluation of medical devices.Part 2: Animal welfare requirements
TCVN 7391-11-2007 Biological evaluation of medical devices.Part 11: Tests for systemic toxicity
TCVN 7391-5-2005 Biological evaluation of medical devices.Part 5: Tests for in vitro cytotoxicity
TCVN 7391-12-2007 Biological evaluation of medical devices.Part 12: Sample preparation and reference materials
TCVN 7391-6-2007 Biological evaluation of medical devices.Part 6: Tests for local effects after implantation
TCVN 7391-7-2004 Biological evaluation of medial devices.Part 7: Etylen oxide sterilization residuals
TCVN 7391-17-2007 Biological evaluation of medical devices.Part 17: Establishment of allowable limits for teachable substances
TCVN 7391-10-2007 Biological evaluation of medical devices.Part 10: Tests for irritation and delayed-type hypersensitivity
TCVN 7391-4-2005 Biological evaluation of medical devices.Part 4: Selection of test for interactions with blood
TCVN 7391-14-2007 Biological evaluation of medical devices.Part 14: Identification and quantification of degradation products from ceramics
TCVN 7391-3-2005 Biological evaluation of medical devices.Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
TCVN 7391-15-2007 Biological evaluation of medical devices.Part 15: Identification and quantification of degradation products from metals and alloys
TCVN 7391-16-2007 Biological evaluation of medical devices.Part 16: Toxicokinetic study design for degradation products and leachables

TH-TISI, biological evaluation

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

Korean Agency for Technology and Standards (KATS), biological evaluation

KS P ISO TS 20993-2009(2014) Biological evaluation of medical devices－Guidance on a risk－management process
KS M ISO 11930:2020 Cosmetics — Microbiology — Evaluation of the antimicrobial protection of a cosmetic product
KS P ISO 10993-2-2010(2021) Biological evaluation of medical devices－Part 2：Animal welfare requirements
KS P ISO 10993-2-2010(2016) Biological evaluation of medical devices－Part 2：Animal welfare requirements
KS P ISO 10993-11-2007(2017) Biological evaluation of medical devices－Part 11：Tests for systemic toxicity
KS P ISO 10993-18-2009(2019) Biological evaluation of medical devices－Part 18：Chemical characterization of materials
KS P ISO 10993-11:2021 Biological evaluation of medical devices —Part 11: Tests for systemic toxicity
KS P ISO 10993-8:2002 Biological evaluation of medical devices－Part 8：Selection and qualification of reference materials for biological tests
KS P ISO 10993-8:2007 Biological evaluation of medical devices－Part 8：Selection and qualification of reference materials for biological tests
KS P ISO 10993-7:2017 Biological evaluation of medical devices－Part 7：Ethylene oxides sterilization residuals
KS P ISO 10993-4:2017 Biological evaluation of medical devices－Part 4：Selection of tests for interactions with blood
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 10993-4:2021 Biological evaluation of medical devices —Part 4: Selection of tests for interactions with blood
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 10993-15-2006(2016) Biological evaluation of medical devices－Part 15：Identification and quantification ofdegradation products from metals and alloys
KS P ISO 10993-9:2021 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
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 10993-15:2021 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
KS P ISO 10993-16:2017 Biological evaluation of medical devices — Part16:Toxicokinetic study design for degradation products and leachables
KS P ISO 10993-16:2021 Biological evaluation of medical devices —Part 16: Toxicokinetic study design for degradation products and leachables
KS P ISO 10993-18:2021 Biological evaluation of medical devices —Part 18: Chemical characterization of medical device materials within a risk management process

Japanese Industrial Standards Committee (JISC), biological evaluation

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

CEN - European Committee for Standardization, biological evaluation

EN ISO 11930:2012 Cosmetics - Microbiology - Evaluation of the antimicrobial protection of a cosmetic product
EN ISO 11930:2019 Cosmetics - Microbiology - Evaluation of the antimicrobial protection of a cosmetic product
EN ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
EN ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
EN ISO 10993-6:2009 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
EN ISO 10993-6:2007 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
EN ISO 10993-14:2001 Biological Evaluation of Medical Devices - Part 14: Identification and Quantification of Degradation Products from Ceramics
EN ISO 10993-14:2009 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
EN ISO 10993-9:2021 Biological Evaluation of Medical Devices - Part 9: Framework for Identification and Quantification of Potential Degradation Products
EN ISO 10993-9:1999 Biological Evaluation of Medical Devices - Part 9: Framework for Identification and Quantification of Potential Degradation Products
EN ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products

KR-KS, biological evaluation

KS M ISO 11930-2020 Cosmetics — Microbiology — Evaluation of the antimicrobial protection of a cosmetic product
KS P ISO 10993-23-2022 Biological evaluation of medical devices — Part 23: Tests for irritation
KS P ISO 10993-11-2021 Biological evaluation of medical devices —Part 11: Tests for systemic toxicity
KS P ISO 10993-10-2022 Biological evaluation of medical devices — Part 10: Tests for skin sensitization
KS P ISO 10993-8-2002 Biological evaluation of medical devices－Part 8：Selection and qualification of reference materials for biological tests
KS P ISO 10993-7-2017 Biological evaluation of medical devices－Part 7：Ethylene oxides sterilization residuals
KS P ISO 10993-7-2022 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
KS P ISO 10993-14-2017 Biological evaluation of medical devices — Part14:Identification and quantification of degradation products from ceramics
KS P ISO 10993-4-2017 Biological evaluation of medical devices－Part 4：Selection of tests for interactions with blood
KS P ISO 10993-14-2017(2022) Biological evaluation of medical devices — Part14:Identification and quantification of degradation products from ceramics
KS P ISO 10993-4-2021 Biological evaluation of medical devices —Part 4: Selection of tests for interactions with blood
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 10993-9-2021 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
KS P ISO 10993-15-2021 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
KS P ISO 10993-16-2017 Biological evaluation of medical devices — Part16:Toxicokinetic study design for degradation products and leachables
KS P ISO 10993-16-2021 Biological evaluation of medical devices —Part 16: Toxicokinetic study design for degradation products and leachables
KS P ISO 10993-18-2021 Biological evaluation of medical devices —Part 18: Chemical characterization of medical device materials within a risk management process

Danish Standards Foundation, biological evaluation

DS/ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation
DS/ISO/TR 10993-22:2021 Biological evaluation of medical devices – Part 22: Guidance on nanomaterials
DS/ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices – Part 1: General requirements
DS/ISO 10993-12:2021 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
DS/EN ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021)
DS/EN ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
DS/EN 455-3:2007 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
DS/EN ISO 10993-12:2021 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
DS/ISO 10993-9:2021 Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products
DS/ISO 10993-1:2020 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (ISO/FDIS 10993-1:2018)
DS/EN ISO 10993-9:2021 Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
DS/EN ISO 10993-1:2020 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-11)

German Institute for Standardization, biological evaluation

DIN EN ISO 10993-2:2023-02 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022); German version EN ISO 10993-2:2022
DIN EN ISO 10993-10:2023-04 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021); German version EN ISO 10993-10:2023
DIN EN ISO 10993-11:2018-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018
DIN EN ISO 10993-5:2009-10 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009
DIN EN ISO 10993-6:2017-09 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016); German version EN ISO 10993-6:2016
DIN EN ISO 10993-12:2021-08 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021); German version EN ISO 10993-12:2021
DIN EN 455-3:2022-03 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation; German and English version prEN 455-3:2022 / Note: Date of issue 2022-02-04*Intended as replacement for DIN EN 455-3 (2015-07).
DIN EN ISO 10993-23:2021-10 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021); German version EN ISO 10993-23:2021
DIN EN ISO 10993-2:2023 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
DIN EN ISO 10993-17:2021-12 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO/DIS 10993-17:2021); German and English version prEN ISO 10993-17:2021 / Note: Date of issue 2021-11-12*Intended as replacement for DIN...
DIN EN 455-3:2022 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation; German and English version prEN 455-3:2022
DIN EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
DIN EN ISO 10993-10:2023 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
DIN EN 455-3:2015-07 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation; German version EN 455-3:2015 / Note: To be replaced by DIN EN 455-3 (2022-03).*To be amended by DIN EN 455-3/A1 (2016-11).
DIN EN ISO 10993-23:2019 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO/DIS 10993-23:2019); German and English version prEN ISO 10993-23:2019
DIN EN ISO 10993-14:2009-08 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001); German version EN ISO 10993-14:2009 / Note: DIN EN ISO 10993-14 (2002-05) remains valid alongside this stan...
DIN EN ISO 10993-17:2009-08 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002); German version EN ISO 10993-17:2009 / Note: DIN EN ISO 10993-17 (2003-06) remains valid alongside this standard until 20...
DIN EN ISO 10993-1:2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009
DIN EN ISO 10993-3:2015-02 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014
DIN EN ISO 10993-12:2019 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 EN ISO 10993-14:2009 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
DIN EN ISO 10993-1:2017 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO/DIS 10993-1:2017); German and English version prEN ISO 10993-1:2017
DIN EN ISO 10993-16:2018-02 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017); German version EN ISO 10993-16:2017
DIN EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021); German version EN ISO 10993-23:2021
DIN EN ISO 10993-4:2017-12 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017
DIN EN ISO 10993-9:2010 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
DIN EN ISO 10993-7:2022-09 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009 + Amd 1:2019); German version EN ISO 10993-7:2008 + AC:2009 + A1:2022
DIN EN ISO 10993-9:2018 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO/DIS 10993-9:2018); German and English version prEN ISO 10993-9:2018
DIN EN ISO 10993-7/A1:2018 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1 (ISO 10993-7:2008/DAM 1:2018); German and English version EN ISO 10993-7:2008/prA1:2018
DIN EN ISO 10993-15:2023-07 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019); German version EN ISO 10993-15:2023
DIN EN ISO 10993-15:2018 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO/DIS 10993-15:2018); German and English version prEN ISO 10993-15:2018
DIN EN ISO 10993-13:2010-11 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010); German version EN ISO 10993-13:2010
DIN EN ISO 10993-16:2018 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

Professional Standard - Medicine, biological evaluation

YY/T 0127.11-2014 Biological evaluation of medical devices used in dentistry.Part 11:Pulp capping test
YY/T 0616-2007 Medical gloves for single use.Requirements and testing for biological evaluation
YY/T 1912-2023 Biological evaluation and testing of medical devices for soft tissue regeneration
YY/T 1295-2015 Biological evaluation of medical devices.Nanomaterial: Endotoxin test
YY/T 0268-2008 Dentistry.Biological evaluation of medical devices used in dentistry.Part 1:Evaluation and test
YY/T 0127.5-2014 Biological evaluation of medical devices used in dentistry.Part 5:Inhalation toxicity test
YY/T 0127.3-2014 Biological evaluation of medical devices used in dentistry.Part 3: Endodontic usage test
YY/T 0616.1-2016 Medical gloves for single use.Part 1:Requirements and testing for biological evaluation
YY 0719.7-2011 Ophthalmic optics.Contact lens care products.Part 7:Biological evaluation test methods
YY/T 0127.4-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method Bone implant test
YY/T 0127.12-2008 Dentistry.Biological evaluation of medical devices used in dentistry Part 2:Test method.Micronucleus test
YY/T 0127.18-2016 Biological evaluation of medical devices used in dentistry.Part 18:Dentine barrier cytotoxicity test
YY/T 0127.4-1998 Biological evaluation of dental materials.Unit2:Biological evaluation method of dental materials.Bone implant test
YY/T 0127.13-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method.Oral mucous membrane irritation test
YY/T 0127.5-1999 Biological evaluation of dental materials.Unit 2:Biological test methods of dental materials.Inhalation toxicity test
YY/T 0127.6-1999 Biological evaluation of dental materials.Unit 2:Biological test methods of dental materials.Dominant lethal test
YY/T 0127.8-2001 Biological evaluation of dental materials.Part 2:Biological evaluation test method of dental materials.Subcutaneous implant test
YY/T 0127.3-1998 Biological evaluation of dental materials.Unit 2:Biological evaluation method of dental materials。Endodontic usage test
YY/T 0993-2015 Biological evaluation of medical devices.Nanomaterial: In vitro cytotoxicity tests (MTT assay and LDH assay)
YY/T 1897-2023 Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test
YY/T 1815-2022
YY/T 0127.17-2014 Biological evaluation of medical devices used in dentistry.Part 17: Mouse lymphoma cells (TK) gene mutation test
YY/T 0127.14-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method.Acute oral toxicity test
YY/T 0127.7-2001 Biological evaluation of of dental materials.Part 2:Biological evaluation test method of dental materials.Pulp and dentine usage test
YY/T 0127.2-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method.Acute systemic toxicity:intravenous path
YY/T 0127.16-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method In Vitro mammalian chromosome aberration test

European Committee for Standardization (CEN), biological evaluation

EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
EN ISO 10993-11:1995 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity (ISO 10993-11 : 1993)
EN ISO 10993-8:2000 Biological Evaluation of Medical Devices - Part 8: Selection and Qualification of Reference Materials for Biological Tests ISO 10993-8:2000
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 15354:2022 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
EN 12929-2:2015+A1:2022 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
EN ISO 11930:2019/A1:2022 Cosmetics - Microbiology - Evaluation of the antimicrobial protection of a cosmetic product - Amendment 1 (ISO 11930:2019/Amd 1:2022)
FprEN ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO/FDIS 10993-10:2021)
EN ISO 10993-18:2020/prA1:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/DAM 1:2021)
EN ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
CEN EN ISO 10993-12:2004 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials ISO 10993-12:2002
EN 30993-6:1994 Biological Evaluation of Medical Devices - Part 6: Tests for Local Effects After Implantation (ISO 10993-6 : 1994)
FprEN ISO 10993-17 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO/FDIS 10993-17:2023)
EN 30993-4:1993 Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood (ISO 10993-4 : 1992)
EN ISO 10993-15:2023 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
FprEN ISO 10993-15 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO/FDIS 10993-15:2019)

IT-UNI, biological evaluation

UNI EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation
UNI EN ISO 10993-12:2021 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
UNI EN ISO 10993-1:2021 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
UNI EN ISO 10993-18:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process

国家市场监督管理总局、中国国家标准化管理委员会, biological evaluation

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

ES-UNE, biological evaluation

UNE-EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
UNE-EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
UNE-EN ISO 10993-12:2022 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
UNE-EN ISO 10993-2:2023 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
UNE-EN ISO 10993-10:2023 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
UNE-EN ISO 10993-4:2018 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
UNE-EN ISO 10993-7:2009/AC:2010 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)
UNE-EN ISO 10993-16:2018 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

PH-BPS, biological evaluation

PNS ISO 10993-2:2021 Biological evaluation of medical devices - Part 2: Animal welfare requirements
PNS ISO 10993-11:2021 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
PNS ISO 10993-5:2021 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
PNS ISO 10993-7:2021 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
PNS ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
PNS ISO 10993-6:2021 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
PNS ISO 10993-4:2021 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
PNS ISO 10993-3:2021 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
PNS ISO 10993-9:2021 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products

RU-GOST R, biological evaluation

GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST ISO 10993-12-2015 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
GOST ISO 10993-11-2011 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST R ISO 10993-11-1999 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic to xicity
GOST ISO 10993-18-2011 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
GOST R ISO 10993-10-1999 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and sensitization
GOST ISO 10993-5-2011 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST ISO 10993-7-2016 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST R ISO 10993.7-1999 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST ISO 10993-7-2011 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST R ISO 10993-12-1999 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
GOST ISO 10993-6-2011 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST ISO 10993-12-2011 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials
GOST R ISO 10993-6-1999 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST R ISO 10993.5-1999 Medical devices. Biological evaluation of medical devices. Part 5. Tests for cytotoxicity: in vitro methods
GOST ISO 10993-10-2011 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity
GOST ISO 10993-17-2011 Medical devices. Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substances
GOST ISO 10993-14-2011 Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics
GOST R ISO 10993.4-1999 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST R ISO 10993-14-2001 Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics
GOST ISO 10993-4-2011 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST ISO 10993-9-2011 Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products
GOST ISO 10993-3-2011 Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
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 10993-9-2015 Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products
GOST R ISO 10993.1-1999 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing / Note: To be replaced by GOST R ISO 10993-1 (2009).
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 R ISO 10993-15-2001 Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys
GOST ISO 10993-13-2011 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
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 10993.16-1999 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST ISO 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices

RO-ASRO, biological evaluation

STAS SR EN 30993-1-1996 Biological evaluation of medical devices -Part 1: Guidance on selection of tests
STAS SR EN 30993-3-1996 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenity and reproductive toxicity
STAS SR EN 30993-5-1996 Biological evaluation of medical devices -Part 5: Tests for cytotoxicity: in vitro methods

American National Standards Institute （ANSI), biological evaluation

ANSI/AAMI/ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
BS EN ISO 10993-15:2023 Biological evaluation of medical devices Identification and quantification of degradation products from metals and alloys (British Standard)

CH-SNV, biological evaluation

SN EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
SN EN ISO 10993-12:2021 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
SN EN ISO 10993-9:2021 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)

Lithuanian Standards Office , biological evaluation

LST EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
LST EN 455-3-2007 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
LST EN ISO 10993-12:2021 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
LST EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
LST EN ISO 10993-1:2021 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)

PL-PKN, biological evaluation

PN-EN ISO 10993-23-2021-08 E Biological evaluation of medical devices -- Part 23: Tests for irritation (ISO 10993-23:2021)
PN-EN ISO 10993-1-2021-06 E Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)

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

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

AENOR, biological evaluation

UNE-EN ISO 10993-2:2007 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
UNE-EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
UNE-EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
UNE-EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
UNE-EN ISO 10993-7:2009 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
UNE-EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
UNE-EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
UNE-EN ISO 10993-12:2013 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
UNE-EN ISO 10993-6:2017 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
UNE-EN ISO 10993-1:2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
UNE-EN ISO 10993-14:2009 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
UNE-EN ISO 10993-17:2009 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
UNE-EN ISO 10993-3:2015 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
UNE-EN ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
UNE-EN ISO 10993-9:2010 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
UNE-EN ISO 10993-15:2009 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
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 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)

国家药监局, biological evaluation

YY/T 1775.1-2021 Biological Evaluation of Absorbable Medical Devices Part 1: Guidelines for Absorbable Implants

GOSTR, biological evaluation

GOST ISO/TR 10993-22-2020 Medical devices. Biological evaluation of medical devices. Part 22. Guidance on nanomaterials
GOST ISO/TR 10993-33-2018 Medical levices. Biological evaluation of medical devices. Part 33. Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3
GOST ISO 10993-4-2020 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST ISO 10993-3-2018 Medical levices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicit
GOST R ISO 10993-2-2009 Standardization in the Russian Federation. Medical devices. Biological evaluation of medical devices. Part 2. Animal welfare requirements

Malaysia Standards, biological evaluation

MS 1497-2000 Methods of biological evaluation of the efficacy of repellent-bioassay method for mosquito repellent on human skin

BE-NBN, biological evaluation

NBN EN 30993-6-1995 Biological evaluation of medical devices - Part 6 : Tests for local effects after implantation (ISO 10993-6:1994)

AT-ON, biological evaluation

OENORM EN ISO 10993-12:2021 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
OENORM EN ISO 10993-1:2021 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
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)

Canadian Standards Association (CSA), biological evaluation

CSA ISO 10993-9-00-CAN/CSA:2000 Biological Evaluation of Medical Devices - Part 9: Framework for Identification and Quantification of Potential Degradation Products Second Edition; ISO 10993-9: 1999