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Biological Evaluation Program

Biological Evaluation Program, Total:497 items.

In the international standard classification, Biological Evaluation Program involves: Pharmaceutics, Dentistry, Laboratory medicine, Medical equipment, Microbiology, Pesticides and other agrochemicals, Fertilizers, Products of the chemical industry, Medical sciences and health care facilities in general, Biology. Botany. Zoology, Sterilization and disinfection, Terminology (principles and coordination), Environmental protection, Wastes, Hospital equipment, Agricultural machines, implements and equipment, Extraction and processing of petroleum and natural gas, Protection against dangerous goods, Non-destructive testing, Water quality, Character sets and information coding, Soil quality. Pedology, Plastics, Information sciences. Publishing, Applications of information technology, Occupational safety. Industrial hygiene, Packaging and distribution of goods in general, Road vehicles in general.

GOSTR, Biological Evaluation Program

GOST R 58483-2019 Rodenticides. Methods for biological performance evaluations
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/TR 10993-22-2020 Medical devices. Biological evaluation of medical devices. Part 22. Guidance on nanomaterials
GOST R ISO 14729-2010 Ophthalmic optics. Contact lens care products. Microbiological requirements and test methods. Regimens for hygienic management of contact lenses

未注明发布机构, Biological Evaluation Program

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
YY 0127.6-1999 Biological evaluation of oral materials. Unit 2: Biological testing methods of oral materials. Manifest lethality test
YY 0127.8-2001 Biological evaluation of oral materials. Unit 2: Biological testing methods of oral materials. Subcutaneous implantation test
BS EN ISO 10993-11:2018(2022) Biological evaluation of medical devices Part 11 : Tests for systemic toxicity
BS EN ISO 10993-16:2017(2020) Biological evaluation of medical devices Part 16 : Toxicokinetic study design for degradation products and leachables
BS EN ISO 10993-1:2020 Tracked Changes. Biological evaluation of medical devices. Evaluation and testing within a risk management process
YY 0127.7-2017 Biological Evaluation of Oral Medical Devices Part 7: Pulp Dentin Application Test

Association Francaise de Normalisation, Biological Evaluation Program

NF S99-501:1998 Biological evaluation of medical devices. Part 1 : evaluation and testing.
NF EN ISO 11930/A1:2022 Cosmétiques - Microbiologie - Evaluation de la protection antimicrobienne d'un produit cosmétique - Amendement 1
NF S99-501-16:2010 Biological evaluation of medical devices - Part 16 : toxicokinetic study design for degradation products and leachables.
NF T75-600:2012 Cosmetics - Microbiology - Evaluation of the antimicrobial protection of a cosmetic product.
NF EN ISO 11930:2019 Cosmétiques - Microbiologie - Évaluation de la protection antimicrobienne d'un produit cosmétique
NF EN ISO 10993-23:2021 Evaluation biologique des dispositifs médicaux - Partie 23 : essais d'irritation
NF S99-501-18:2009 Biological evaluation of medical devices - Part 18 : chemical characterization of materials.
NF S99-501-23*NF EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23 : tests for irritation
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 10993-11:2018 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 S99-501-7/A1*NF EN ISO 10993-7/A1:2022 Biological evaluation of medical devices - Part 7 : ethylene oxide sterilization residuals - Amendment 1 : applicability of allowable limits for neonates and infants
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
XP ISO/TS 10993-19:2022 Évaluation biologique des dispositifs médicaux - Partie 19 : caractérisations physicochimique, morphologique et topographique des matériaux
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 S99-518:2005 Biological evaluation of medical devices - Part 18 : chemical characterization of materials.
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 EN ISO 10993-5:2010 Évaluation biologique des dispositifs médicaux - Partie 5 : essais concernant la cytotoxicité in vitro
NF EN ISO 10993-14:2009 Évaluation biologique des dispositifs médicaux - Partie 14 : identification et quantification des produits de dégradation des céramiques
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 S99-501-5*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 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 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 S99-501-12:2012 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 10993-7/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 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 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 S99-501-13*NF EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13 : identification and quantification of degradation products from polymeric medical devices
NF S99-501-15*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 X31-621*NF ISO 17616:2020 Soil quality - Guidance on the choice and evaluation of bioassays for ecotoxicological characterization of soils and soil materials
NF S98-118-1/A1*NF EN ISO 11737-1/A1:2021 Sterilization of health care products - Microbiological methods - Part 1 : determination of a population of microorganisms on products - Amendment 1

International Organization for Standardization (ISO), Biological Evaluation Program

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 11930:2012 Cosmetics - Microbiology - Evaluation of the antimicrobial protection of a cosmetic product
ISO 11930:2019 Cosmetics — Microbiology — Evaluation of the antimicrobial protection of a cosmetic product
ISO 7704:1985 Water quality; Evaluation of membrane filters used for microbiological analyses
ISO 7704:2023 Water quality — Requirements for the performance testing of membrane filters used for direct enumeration of microorganisms by culture methods
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/DIS 16140-7 Microbiology of the food chain — Method validation — Part 7: Protocol for the validation of identification methods of microorganisms
ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
ISO 10993-8:2000 Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests
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 10993-5:1992 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 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation
ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
ISO 10993-12:2021 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
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/TS 10993-19:2020 Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices — Part 1: General requirements
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 10993-14:2001 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
ISO 9509:1989 Water quality; method for assessing the inhibition of nitrification of activated sludge micro-organisms by chemicals and waste waters
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 10993-7:2008/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/IEC 19795-2:2007 Information technology - Biometric performance testing and reporting - Part 2: Testing methodologies for technology and scenario evaluation
ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
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 10993-13:2010 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/TR 10993-55:2023 Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity
ISO 10993-15:2000 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
ISO 17616:2019 Soil quality — Guidance on the choice and evaluation of bioassays for ecotoxicological characterization of soils and soil materials

国家食品药品监督管理局, Biological Evaluation Program

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 0719.7-2011 Ophthalmic optical contact lenses and contact lens care products - Part 7: Test methods for biological evaluation
YY/T 1535-2017 Biological evaluation of medical devices for human in vitro assisted reproductive technology and human sperm survival 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

US-AAMI, Biological Evaluation Program

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 10993-16:2017 Biological evaluation of medical devices-Part 16: Toxicokinetic study design for degradation products and leachables
ANSI/AAMI/ISO 10993-3:2014 Biological evaluation of medical devices. Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

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

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 16886.1-2011 Biological evaluation of medical devices.Part 1: Evaluation and testing within a risk management process
GB/T 16310.3-1996 Specification on evaluation methods of hazards of liquid chemicals transported in bulk by shipping--Taint testing method for aquatic organism
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 16886.19-2022 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials
GB/T 16886.19-2011 Biological evaluation of medical devices.Part 19: Physico-chemical,morphological and topographical characterization of materials
GB/T 16886.20-2015 Biological evaluation of medical devices.Part 20:Principles and methods for immunotoxicology testing of medical devices
GB/T 16310.2-1996 Specification on evaluation methods of hazards of liquid chemicals transported in bulk by shipping.Bioaccumulation testing method for aquatic organism
GB/T 42992.1-2023 General principles for chemical simulation tests to evaluate the biodegradability of chemicals discharged into wastewater
GB/T 16886.10-2000 Biological evaluation of medical devices--Part 10: Tests for irritation and sensitization
GB/T 16310.1-1996 Specification on evaluation methods of hazards of liquid chemicals transported in bulk by shipping--Acute toxicity testing methods for aquatic organism
GB/T 16886.17-2005 Biological evaluation of medical devices.Part 17:Establishment of allowable limits for leachable substances
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 16886.16-2013 Biological evaluation of medical devices.Part 16: Toxicokinetic study design for degradation products and leachables
GB/T 16886.14-2003 Biological evaluation of medical devices--Part 14: Identification and quantification of degradation products from ceramics
GB/T 16886.16-2003 Biological evaluation of medical devices--Part 16: Toxicokinetic study design for degradation products and leachables
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 20778-2006 Evaluation of biodegradability of water treatment chemicals Carbon dioxide evolution test
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 31270.7-2014 Test guidelines on environmental safety assessment for chemical pesticides.Part 7: Bioconcentration test
GB/T 16886.4-2003 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
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 16886.13-2001 Biological evaluation of medical devices--Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.10-2005 Biological evaluation of medical devices.Part 10:Tests for irritation and delayed-type hypersensitivity

VN-TCVN, Biological Evaluation Program

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 7391-12-2007 Biological evaluation of medical devices.Part 12: Sample preparation and reference materials
TCVN 7391-17-2007 Biological evaluation of medical devices.Part 17: Establishment of allowable limits for teachable substances
TCVN 7391-5-2005 Biological evaluation of medical devices.Part 5: Tests for in vitro cytotoxicity
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 7391-3-2005 Biological evaluation of medical devices.Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
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

TH-TISI, Biological Evaluation Program

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 2279.3-2006 Sterilization of medical devices.microbiological methods.part 3: guidance on evaluation and interpretation of bioburden data
TIS 2395.2-2008 Biological evaluation of medical devices.part 2: animal welfare requirements
TIS 2395.11-2008 Biological evaluation of medical devices.part 11: tests for systemic toxicity
TIS 2395.5-2008 Biological evaluation of medical devices.part 5: tests for in vitro cytotoxicity
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 2395.16-2008 Biological evaluation of medical devices.part 16: toxicokinetic study design for degradation products and leachables
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 2395.3-2008 Biological evaluation of medical devices.part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity
TIS 2395.9-2008 Biological evaluation of medical devices.part 9: framework for identification and quantification of potential degradation products
TIS 2395.4-2008 Biological evaluation of medical devices.part 4: selection of tests for interactions with blood
TIS 2395.15-2008 Biological evaluation of medical devices.part 15: identification and quantification of degradation products from metals and alloys
TIS 2395.10-2008 Biological evaluation of medical devices.part 10: tests for irritation and delayed-type hypersensitivity

ZA-SANS, Biological Evaluation Program

SANS 10993-1:2003 Biological evaluation of medical devices Part 1: Evaluation and testing
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 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 5858:2007 Pesticides - Biological evaluation of mosquito larvicides in artificially created mosquito breeding places
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 10993-3:2004 Biological evaluation of medical devices Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity
SANS 19795-2:2007 Information technology - Biometric performance testing and reporting Part 2: Testing methodologies for technology and scenario evaluation
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

British Standards Institution (BSI), Biological Evaluation Program

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
PD ISO/TR 15499:2016 Tracked Changes. Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices
BS PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices. General requirements
BS EN ISO 11930:2019+A1:2022 Cosmetics. Microbiology. Evaluation of the antimicrobial protection of a cosmetic product
PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices. General requirements
PD ISO/TS 10993-19:2020 Biological evaluation of medical devices. Physico-chemical, morphological and topographical characterization of materials
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
PD ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants
BS EN ISO 10993-16:2017 Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables
BS EN ISO 10993-12:2012 Biological evaluation of medical devices. Sample preparation and reference materials
BS EN ISO 11930:2012 Cosmetics. Microbiology. Evaluation of the antimicrobial protection of a cosmetic product
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
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
23/30452546 DC BS EN ISO 16140-7. Microbiology of the food chain. Method validation - Part 7. Protocol for the validation of identification methods of microorganisms
BS EN 29073-3:1992 Biological evaluation of medical devices. Framework for identification and quantification of potential degradation products
PD ISO/TR 10993-55:2023 Biological evaluation of medical devices. Interlaboratory study on cytotoxicity
BS EN ISO 17616:2022 Soil quality. Guidance on the choice and evaluation of bioassays for ecotoxicological characterization of soils and soil materials
BS EN ISO 10993-13:2010 Biological evaluation of medical devices. Part 13: Identification and quantification of degradation products from polymeric medical devices
20/30398724 DC BS EN ISO 10993-2. Biological evaluation of medical devices. Part 2. Animal welfare requirements
21/30379304 DC BS EN ISO 10993-17. Biological evaluation of medical devices - Part 17. Toxicological risk assessment of medical device constituents
21/30444665 DC BS EN ISO 11930 AMD1. Cosmetics. Microbiology. Evaluation of the antimicrobial protection of a cosmetic product
PD ISO/TR 10993-33:2015 Biological evaluation of medical devices. Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3
BS EN 13432:2000(2007) Packaging — Requirements for packaging recoverable through composting and biodegradation — Test scheme and evaluation criteria for the final acceptance of packaging
BS EN ISO 10993-12:2021 Tracked Changes. Biological evaluation of medical devices. Sample preparation and reference materials
BS EN ISO 10993-6:2016 Tracked Changes. Biological evaluation of medical devices. Tests for local effects after implantation
BS ISO 5834-5:2005 Implants for surgery - Ultra-high molecular weight polyethylene - Morphology assessment method
BS EN ISO 10993-3:2014 Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity
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
BS EN ISO 10993-9:2021 Tracked Changes. Biological evaluation of medical devices. Framework for identification and quantification of potential degradation products
20/30377819 DC BS EN ISO 10993-10. Biological evaluation of medical devices. Part 10. Tests for skin sensitization

Japanese Industrial Standards Committee (JISC), Biological Evaluation Program

JIS T 0993-1:2005 Biological evaluation of medical devices -- Part 1: Evaluation and testing
JIS T 0993-1:2012 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
JIS X 8101-2:2010 Information technology -- Biometric performance testing and reporting -- Part 2: Testing methodologies for technology and scenario evaluation
JIS T 0993-7:2012 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals

Professional Standard - Medicine, Biological Evaluation Program

YY/T 0268-2008 Dentistry.Biological evaluation of medical devices used in dentistry.Part 1:Evaluation and test
YY 0719.7-2011 Ophthalmic optics.Contact lens care products.Part 7:Biological evaluation test methods
YY/T 0127.4-1998 Biological evaluation of dental materials.Unit2:Biological evaluation method of dental materials.Bone implant 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 1912-2023 Biological evaluation and testing of medical devices for soft tissue regeneration
YY/T 0127.12-2008 Dentistry.Biological evaluation of medical devices used in dentistry Part 2:Test method.Micronucleus test
YY/T 1815-2022
YY/T 0127.3-1998 Biological evaluation of dental materials.Unit 2:Biological evaluation method of dental materials。Endodontic usage test
YY/T 0127.4-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method Bone implant test
YY/T 0127.7-2001 Biological evaluation of of dental materials.Part 2:Biological evaluation test method of dental materials.Pulp and dentine usage test
YY/T 0127.11-2014 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 1295-2015 Biological evaluation of medical devices.Nanomaterial: Endotoxin test
YY/T 0127.5-2014 Biological evaluation of medical devices used in dentistry.Part 5:Inhalation toxicity test
YY/T 0127.13-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method.Oral mucous membrane irritation test
YY/T 0127.3-2014 Biological evaluation of medical devices used in dentistry.Part 3: Endodontic usage test
YY/T 0127.14-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method.Acute oral toxicity test
YY/T 0616.1-2016 Medical gloves for single use.Part 1:Requirements and testing for biological evaluation
YY/T 0268-2001 Dentistry----Preclinical evaluation of biocompatibility of medical devices used in dentistry----Part 1:Evaluation and test methods selection
YY/T 0522-2009 Dentistry Preclinical evaluation of dental implant systems Animal test methods
YY/T 0127.16-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method In Vitro mammalian chromosome aberration test
YY/T 0127.9-2001 Biological evaluation of dental materials.Part 2:Biological evaluation test method of dental materials.Cytotoxicity tests:Agar diffusion test and filter dissusion test
YY/T 0127.10-2001 Biological evaluation of dental materials.Part 2:Biological evaluation test method of dental materials.Salmonella typhimurium reverse mutation assay (Ames mutagenicity test)
YY/T 0127.11-2001 Dentistry----Preclinical evaluation of biocompatibility of medical devices used in dentistry----Part 2:Biological evaluation test method of dental materials----Pulp capping 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 0511-2009 Test method for evaluation of the biodegradation and osteogenesis of porous bioceramic in vivo
YY/T 1897-2023 Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test
YY/T 0988.14-2016 Coatings of surgical implants.Part 14:Stereological evaluation method of porous coatings

Korean Agency for Technology and Standards (KATS), Biological Evaluation Program

KS M ISO 8634-2007(2012) Solid fertilizers－Sampling plan for the evaluation of a large delivery
KS M ISO 11930:2020 Cosmetics — Microbiology — Evaluation of the antimicrobial protection of a cosmetic product
KS M ISO 5307-2006(2011) Solid fertilizers－Derivation of a sampling plan for the evaluation of a large delivery
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 10993-18-2009(2019) Biological evaluation of medical devices－Part 18：Chemical characterization of materials
KS P ISO TS 20993-2009(2014) Biological evaluation of medical devices－Guidance on a risk－management process
KS P 1975-2018 Protocol for evaluation of precision performance of the quantitative test in in-vitro diagnostic medical laboratory
KS P 2069-2020 Protocol for evaluation of detection capability for measurement procedures in in-vitro diagnostic medical laboratory
KS P ISO 10993-11-2007(2017) Biological evaluation of medical devices－Part 11：Tests for systemic toxicity
KS P ISO 10993-7:2017 Biological evaluation of medical devices－Part 7：Ethylene oxides sterilization residuals
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 10993-20-2009(2019) Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
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 10993-11:2021 Biological evaluation of medical devices —Part 11: Tests for systemic toxicity
KS I ISO 9509-2008(2018) Water quality－Method for assessing the inhibition of nitrification of activated sludge micro organisms by chemicals and wastewaters
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 10993-16:2017 Biological evaluation of medical devices — Part16:Toxicokinetic study design for degradation products and leachables
KS X ISO/IEC 19795-2:2014 Information technology — Biometric performance testing and reporting — Part 2: Testing methodologies for technology and scenario evaluation
KS X ISO/IEC 19795-2:2009 Information technology-Biometric performance testing and reporting-Part 2:Testing methodologies for technology and scenario evaluation
KS P ISO 10993-16:2021 Biological evaluation of medical devices —Part 16: Toxicokinetic study design for degradation products and leachables
KS P ISO 10993-15-2006(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 10993-4:2017 Biological evaluation of medical devices－Part 4：Selection of tests for interactions with blood
KS P ISO 10993-15:2021 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
KS I ISO 17616-2009(2019) Soil quality－Guidance on the choice and evaluation of bioassays for ecotoxicological characterization of soils and soil materials

German Institute for Standardization, Biological Evaluation Program

DIN 58956-3:1986-12 Medical microbiology; medical microbiological laboratories; requirements for the organization scheme
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 58956-5:1990 Medical microbiology; medical-microbiological laboratories; hygiene scheme requirements
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 10993-17:2021-12 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO/DIS 10993-17:2021); German and English version prEN ISO 10993-17:2021 / Note: Date of issue 2021-11-12*Intended as replacement for DIN...
DIN EN ISO 10993-1:2010 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 10993-10:2023-04 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 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2005
DIN EN ISO 10993-2:2023 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
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 10993-1:2017 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 10993-6:2017-09 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 10993-14:2009-08 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 10993-3:2015-02 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 10993-23:2021-10 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021); German version EN ISO 10993-23:2021
DIN EN 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 10993-18/A1:2021-10 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/DAM 1:2021); German and English version...
DIN EN 13432:2000-12 Packaging - Requirements for packaging recoverable through composting and biodegradation - Test scheme and evaluation criteria for the final acceptance of packaging; German version EN 13432:2000
DIN EN 13432 Berichtigung 2:2007-10 Packaging - Requirements for packaging recoverable through composting and biodegradation - Test scheme and evaluation criteria for the final acceptance of packaging; German version EN 13432:2000, Corrigenda to DIN EN 13432:2000-12, German version EN 13...
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)

CEN - European Committee for Standardization, Biological Evaluation Program

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 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
EN ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
EN ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
EN ISO 10993-6:2009 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 Program

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 10993-7-2017 Biological evaluation of medical devices－Part 7：Ethylene oxides sterilization residuals
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 10993-7-2022 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
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 TS 10993-19-2021 Biological evaluation of medical devices —Part 19: Physico-chemical, morphological and topographical characterization of materials
KS P ISO 10993-16-2017 Biological evaluation of medical devices — Part16:Toxicokinetic study design for degradation products and leachables
KS P ISO 10993-14-2017 Biological evaluation of medical devices — Part14:Identification and quantification of degradation products from ceramics
KS P ISO 10993-16-2021 Biological evaluation of medical devices —Part 16: Toxicokinetic study design for degradation products and leachables
KS P ISO 10993-14-2017(2022) Biological evaluation of medical devices — Part14:Identification and quantification of degradation products from ceramics
KS P ISO TS 22911-2014 Dentistry－Preclinical evaluation of dental implant systems－Animal test methods
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 10993-4-2017 Biological evaluation of medical devices－Part 4：Selection of tests for interactions with blood
KS P ISO 10993-15-2021 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys

Malaysia Standards, Biological Evaluation Program

MS 1497-2000 Methods of biological evaluation of the efficacy of repellent-bioassay method for mosquito repellent on human skin
MS 23 Pt.2-1996 Specification for mosquito coils: Part 2: method for the evaluation of biological efficacy - glass chamber method (first revision)
MS 1044 Pt.2-1986
MS 1044 Pt.3-1998 Specification for mosquito vaporizing mats:Part 3:Method for the evaluation of biological efficacy-Glass cylinder method

PT-IPQ, Biological Evaluation Program

NP EN ISO 10993-1:2001 Biological evaluation of medical devices Part 1:Evaluation and testing(ISO 10993-1:1997)
NP EN ISO 10993-13:2000 Biological evaluation of medical devices Part 13:Identification and quantification of degradation products from polymeric medical devices(ISO 10993-13-1998)
NP EN ISO 10993-2:2000 Biological evaluation of medical devices Part 2:Animal welfare requirements(ISO 10993-2-1992)

RU-GOST R, Biological Evaluation Program

GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST 31576-2012 Evaluation of biological hazard of medical dental materials and articles. Classification and sampling
GOST R 53054-2008 Machine technology tests for plant growing production. Methods of ecological estimation
GOST ISO 10993-18-2011 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of 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 R ISO 10993.5-1999 Medical devices. Biological evaluation of medical devices. Part 5. Tests for cytotoxicity: in vitro methods
GOST ISO 10993-12-2015 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
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 10993-16-2011 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
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 10993-16-2016 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
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 R ISO 10993-10-1999 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and sensitization
GOST R ISO 10993.16-1999 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables

European Committee for Standardization (CEN), Biological Evaluation Program

EN ISO 7704:2023 Water quality - Requirements for the performance testing of membrane filters used for direct enumeration of microorganisms by culture methods (ISO 7704:2023)
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 10993-8:2000 Biological Evaluation of Medical Devices - Part 8: Selection and Qualification of Reference Materials for Biological Tests ISO 10993-8:2000
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)
EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
EN 15354:2022 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
EN 12929-2:2015+A1:2022 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
EN ISO 10993-11:2018 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)
CEN EN 13432-2000 Packaging - Requirements for Packaging Recoverable Through Composting and Biodegradation - Test Scheme and Evaluation Criteria for the Final Acceptance of Packaging
FprEN ISO 10993-17 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO/FDIS 10993-17:2023)
EN ISO 10993-18:2020/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)
FprEN ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO/FDIS 10993-10:2021)

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

T/CAMDI 033-2020 Guide for biological evaluation of packaging materials for medical devices
T/XJSL 0008-2019 Security Evaluation Criteria of Degradable Plastic Mulching Film in Cotton field in the South of Xinjiang
T/CAMDI 061-2021 Evaluation criteria for biological hazards of residual particles in metal implants manufactured by additive manufacturing
T/CAMDI 034-2020 Biological evaluation of medical devices Medical catheter with hydrophilic polymer coating：Sample preparation
T/GRM 017-2021 Method of benefit evaluation for microbial reclamation in arid and semi-arid coal mining area
T/CSAE 91-2018 Life cycle assessment methods for greenhouse gases and air pollutants emissions of the automobile

Standard Association of Australia （SAA）, Biological Evaluation Program

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

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

GB/T 38484-2020 Determination of the biological activity for plant hormone-related secondary metabolites—Cytological method
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
GB/T 16886.16-2021 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables
GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood

PH-BPS, Biological Evaluation Program

PNS ISO 10993-2:2021 Biological evaluation of medical devices - Part 2: Animal welfare requirements
PNS ISO 10993-7:2021 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
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 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
PNS ISO 10993-3:2021 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
PNS ISO 10993-6:2021 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
PNS ISO 10993-9:2021 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products

IT-UNI, Biological Evaluation Program

UNI EN ISO 10993-1:2021 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
UNI EN ISO 10993-23:2021 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 ISO 20395:2021 Biotechnology -- Requirements for evaluating the performance of quantification methods for nucleic acid target sequences -- qPCR and dPCR

Danish Standards Foundation, Biological Evaluation Program

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 10993-12:2021 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
DS/EN ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
DS/ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices – Part 1: General requirements
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 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021)
DS/EN ISO 7405/A1:2013 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Amendment 1: Positive control material
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/EN 455-3:2007 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
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)
DS/EN ISO 16140/A1:2011 Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods - Amendment 1
DS/EN 13432+AC:2006 Packaging - Requirements for packaging recoverable through composting and biodegradation - Test scheme and evaluation criteria for the final acceptance of packaging

Shanghai Provincial Standard of the People's Republic of China, Biological Evaluation Program

DB31/T 1208-2020 Biological Stability Evaluation Method for Wet Garbage Treatment Residues

ES-UNE, Biological Evaluation Program

UNE-EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
UNE-EN ISO 10993-7:2009/A1:2022 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)
UNE-EN ISO 10993-2:2023 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
UNE-EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
UNE-EN ISO 11930:2019/A1:2023 Cosmetics - Microbiology - Evaluation of the antimicrobial protection of a cosmetic product - Amendment 1 (ISO 11930:2019/Amd 1:2022)
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)
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 10993-10:2023 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
UNE-EN 13432:2001/AC:2005 Packaging - Requirements for packaging recoverable through composting and biodegradation - Test scheme and evaluation criteria for the final acceptance of packaging
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)

American Society for Testing and Materials (ASTM), Biological Evaluation Program

ASTM F624-09(2015)e1 Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
ASTM D6329-98(2003) Standard Guide for Developing Methodology for Evaluating the Ability of Indoor Materials to Support Microbial Growth Using Static Environmental Chambers
ASTM D6329-98 Standard Guide for Developing Methodology for Evaluating the Ability of Indoor Materials to Support Microbial Growth Using Static Environmental Chambers

Professional Standard - Petroleum, Biological Evaluation Program

SY/T 5740-2013 Technical requirements of polymer flooding development plan design and effect evaluation
SY 5740-2013 Technical requirements for polymer flooding development scheme design and effect evaluation

American National Standards Institute （ANSI), Biological Evaluation Program

ANSI/AAMI BE83-2006 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
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)

Professional Standard - Textile, Biological Evaluation Program

FZ/T 10017-1999 Sampling plan for production evaluation and rating of natural color cloth physical indicators

AENOR, Biological Evaluation Program

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 10993-2:2007 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
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 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 10993-16:2010 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 Program

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

RO-ASRO, Biological Evaluation Program

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

Shaanxi Provincial Standard of the People's Republic of China, Biological Evaluation Program

DB61/T 999.12-2015 Guiding principles and test requirements for functional evaluation of health care products Part 12: Animal tests for functional evaluation of women's health care products

CH-SNV, Biological Evaluation Program

SN EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

Lithuanian Standards Office , Biological Evaluation Program

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 10993-1:2021 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
LST EN 13432-2002 Packaging - Requirements for packaging recoverable through composting and biodegradation - Test scheme and evaluation criteria for the final acceptance of packaging
LST EN 13432-2002/AC-2005 Packaging - Requirements for packaging recoverable through composting and biodegradation - Test scheme and evaluation criteria for the final acceptance of packaging

PL-PKN, Biological Evaluation Program

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 Program

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

AT-ON, Biological Evaluation Program

OENORM EN ISO 10993-18/A1:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020/DAM 1:2021) (Amendment)
OENORM EN ISO 10993-1:2021 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)

Professional Standard - Energy, Biological Evaluation Program

NB/T 10012-2014 Environmental pollution control and evaluation technical methods of bio-fuel ethanol industry

Occupational Health Standard of the People's Republic of China, Biological Evaluation Program

GBZ/T(卫生) 240.29-2011 Procedures and tests for toxicological evaluations of chemicals—Part 29:Toxicokinetics test
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