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Biotoxicity Assessment

Biotoxicity Assessment, Total:195 items.

The international standard classification for "Biotoxicity Assessment" includes: Laboratory medicine , Medical equipment in general .

The Chinese standard classification for "Biotoxicity Assessment" includes: Medical apparatus and devices in general .


Taiwan Provincial Standard of the People's Republic of China

  • CNS 14393-3-2004 Biological evaluation of medical devices – Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • CNS 14393-16-2006 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
  • CNS 14393.3-2004 Biological evaluation of medical devices – Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • CNS 14393-11-2005 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
  • CNS 14393-1-2004 Biological evaluation of medical devices – Part 1:Evaluation and testing
  • CNS 14393-5-2004 Biological evaluation of medical devices – Part 5:Tests for in vitro cytotoxicity
  • CNS 14393.1-2004 Biological evaluation of medical devices – Part 1:Evaluation and testing
  • CNS 14393.11-2005 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
  • CNS 14393.5-2004 Biological evaluation of medical devices – Part 5:Tests for in vitro cytotoxicity

Group Standards of the People's Republic of China

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

  • GB/T 16886.3-1997 Biological evaluation of medical devices--Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicity
  • GB/T 16886.3-2008 Biological evaluation of medical devices - Part 3: Tests for genotoxicity carcinogenicity and reproductive toxicity
  • GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity

American Society for Testing and Materials (ASTM)

Ente Nazionale Italiano di Unificazione

  • UNI EN 30993-3:1995 Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity.
  • UNI EN ISO 10993-11:1997 Biological evaluation of medical devices. Tests for systemic toxicity.
  • UNI EN ISO 10993-3:2004 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • UNI EN 30993-5:1995 Biological evaluation of medical devices. Tests for cytotossicity: in vitro methods.
  • UNI EN ISO 10993-5:2000 Biological evaluation of medical devices - Tests for in vitro cytotoxicity
  • UNI EN ISO 10993-3:2015 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • UNI CEN/TS 17459:2023 Construction products: Assessment of release of dangerous substances - Determination of ecotoxicity of construction product eluates
  • UNI EN 12689:2000 Biotechnology - Guidance on assessment of the purity, biological activity and stability of microorganism based products
  • UNI EN ISO 10993-3:2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • UNI EN ISO 10993-16:2018 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

American Petroleum Institute (API)

  • API PUBL 4608-1994 Evaluation of Sediment Toxicity Tests for Biomonitoring Programs
  • API PUBL 4607-1994 User's Guide and Technical Resource Document: Evaluation of Sediment Toxicity Tests for Biomonitoring Programs

American Water Works Association (AWWA)

  • AWWA MTC57666 Evaluation of Biologic and Non-Biologic Methods for Assessing Virus Removal by and Integrity of High Pressure Membrane Systems
  • AWWA ACE94160 Non-Biological Surrogate Indicator for Assessment of Ozone Disinfection Efficiency
  • AWWA JAW49888 Journal AWWA - Assessing Ozone Disinfection With Nonbiological Surrogates
  • AWWA ACE99446 Advances in the Toxicological Assessment of Disinfection By-Products in Rodent and Fish Biomedical Models
  • AWWA ACE54283 Standard Biodosimetric Evaluation of Low Pressure Ultraviolet Disinfection Units
  • AWWA WQTC52929 Evaluation of Vulnerability to Microbial Threats
  • AWWA JAW46204 Journal AWWA — Nonbiological Surrogate Indicators for Assessing Ozone Disinfection
  • AWWA JAW28444 Journal AWWA — Assessing Toxicity of Drinking Water Contaminants: An Overview
  • AWWA JAW6265 Journal AWWA — An Assessment of Microbial Activity on GAC
  • AWWA WQTC64091 Evaluating Potential Genotoxicity of Disinfected Drinking Water

GCC Standardization Organization

  • GSO ISO 10993-11:2024 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
  • GSO ISO 9509:2013 Water quality - Toxicity test for assessing the inhibition of nitrification of activated sludge microorganisms
  • GSO ISO/TS 21726:2021 Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
  • GSO ISO 10993-3:2015 Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • GSO ISO 21427-1:2013 Water quality -- Evaluation of genotoxicity by measurement of the induction of micronuclei -- Part 1: Evaluation of genotoxicity using amphibian larvae
  • GSO ISO/TR 10993-33:2021 Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3

IN-BIS

  • IS 12572 Pt.4-1988 Guidelines for Biohazard Assessment of Medical Devices Part 4 Systemic Toxicity Test Methods: Assessment of Acute Toxicity of Medical Device Extracts
  • IS 6582-1971 Bioassay Methods for Assessing the Acute Toxicity of Industrial Effluents and Wastewaters
  • IS 12572 Pt.6-1988 Guidelines for Biohazard Assessment of Medical Devices Part 6 Systemic Toxicity Test Methods: Assessment of Pyrogenicity of Medical Device Extracts in Rabbits

Korean Agency for Technology and Standards (KATS)

  • KS P ISO 10993-3-2018 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • KS P ISO 10993-3:2018 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • KS I ISO 21427-1:2009 Water quality-Evaluation of genotoxicity by measurement of the induction of micronuclei-Part 1:Evaluation of genotoxicity using amphibian larvae
  • KS P ISO 10993-3:2007 Biological evaluation of medical devices-Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • KS I ISO 9509:2008 Water quality-Method for assessing the inhibition of nitrification of activated sludge micro organisms by chemicals and wastewaters
  • KS I ISO 10229:2008 Water quality-Deter mination of the prolonged toxicity of substances to freshwater fish-Method for evoluting the effects of substances on the growth rate of rainbow traout[Oncorhynchus mykiss Walbaum(Teleostei, Salmonidae)]
  • KS P ISO TR 10993-33-2019 Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3
  • KS P ISO TR 10993-33:2019 Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3
  • KS P ISO 10993-5:2018 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
  • KS P ISO 10993-11:2007 Biological evaluation of medical devices-Part 11:Tests for systemic toxicity
  • KS P ISO 10993-5-2018 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
  • KS P ISO TS 21726-2023 Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
  • KS I ISO 17616:2009 Soil quality-Guidance on the choice and evaluation of bioassays for ecotoxicological characterization of soils and soil materials
  • KS P ISO 10993-3-2023 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • KS P ISO 10993-3-2018(2023) Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • KS I ISO 21427-1-2019 Water quality-Evaluation of genotoxicity by measurement of the induction of micronuclei-Part 1:Evaluation of genotoxicity using amphibian larvae
  • KS F ISO TR 9122-6:2004 Toxicity testing of fire effluents-Part 6:Guidance for regulators and specifiers on the assessment of toxic hazard in fires in buildings and transport
  • KS P ISO 10993-7:2010 Biological evaluation of medical devices-Part 7:Ethylene oxides sterilization residuals

International Organization for Standardization (ISO)

  • ISO 21427-1:2006 Water quality - Evaluation of genotoxicity by measurement of the induction of micronuclei - Part 1: Evaluation of genotoxicity using amphibian larvae
  • ISO/TS 21726:2019 Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
  • ISO/TR 10993-33:2015 Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3
  • ISO 17616:2008 Soil quality - Guidance on the choice and evaluation of bioassays for ecotoxicological characterization of soils and soil materials
  • ISO 10993-3:2003 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • ISO 10993-3:1992 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • ISO 13344:2015 Estimation of the lethal toxic potency of fire effluents
  • ISO 13344:2004 Estimation of the lethal toxic potency of fire effluents
  • ISO 10993-17:2023/DAmd 1 Biological Evaluation of Medical Devices — Part 17: Assessment of Toxicological Risk of Device Constituents — Amendment 1
  • ISO/TS 4988:2022 Nanotechnologies — Toxicity assessment and bioassimilation of manufactured nano-objects in suspension using the unicellular organism Tetrahymena sp.
  • ISO/TS 20787:2017 Nanotechnologies - Aquatic toxicity assessment of manufactured nanomaterials in saltwater lakes using Artemia sp. Nauplii

Association Francaise de Normalisation

  • NF T90-335-1*NF ISO 21427-1:2006 Water quality - Evaluation of genotoxicity by measurement of the induction of micronuclei - Part 1 : evaluation of genotoxicity using amphibian larvae
  • NF X31-621:2008 Soil quality - Guidance for the choice and evaluation of bioassays for ecotoxicological characterization of soils and soil material.
  • NF EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: tests concerning genotoxicity, carcinogenicity and reproductive toxicity
  • NF S99-501-3:2009 Biological evaluation of medical devices - Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity.
  • XP P01-028*XP CEN/TS 17459:2023 Construction products: Assessment of release of dangerous substances - Determination of ecotoxicity of construction product eluates
  • 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.
  • XP CEN/TS 17459:2023 Construction products: Assessment of the emission of dangerous substances - Determination of the ecotoxicity of construction product eluates
  • FD P01-028*FD CEN/TR 17105:2017 Construction products - Assessment of release of dangerous substances - Guidance on the use of ecotoxicity tests applied to construction products
  • NF ISO 21427-1:2006 Water quality - Assessment of genotoxicity by measuring micronucleus induction - Part 1: assessment of genotoxicity using amphibian larvae
  • FD CEN/TR 17105:2017 Construction products - Assessment of the release of hazardous substances - Recommendations for the use of ecotoxicity tests for their application to construction products

Danish Standards Foundation

  • DS/EN 30993-3:1994 Biological evaluation of medical devices. Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • DANSK DS/EN ISO 9509:2006 Water quality - Toxicity test for assessing the inhibition of nitrification of activated sludge microorganisms
  • DS/EN ISO 9509:2006 Water quality - Toxicity test for assessing the inhibition of nitrification of activated sludge microorganisms
  • DANSK DS/ISO/TR 10993-33:2015 Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3
  • DANSK DS/ISO/TS 21726:2019 Biological evaluation of medical devices – Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
  • DS/EN 30993-5:1994 Biological evaluation of medical devices-Part 5:Tests for cytotoxicity-in vitro methods
  • DS/ISO 21427-1:2007 Water quality - Evaluation of genotoxicity by measurement of the induction of micronuclei - Part 1: Evaluation of genotoxicity using amphibian larvae
  • DANSK DS/EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • DANSK DS/ISO 21427-1:2006 Water quality - Evaluation of genotoxicity by measurement of the induction of micronuclei - Part 1: Evaluation of genotoxicity using amphibian larvae
  • DANSK DS/CEN/TS 17459:2022 Construction products: Assessment of release of dangerous substances – Determination of ecotoxicity of construction product eluates
  • DANSK DS/EN 12689:1998 Biotechnology - Guidance on assessment of the purity, biological activity and stability of microorganism based products
  • DS/EN 12689:1999 Biotechnology - Guidance on assessment of the purity, biological activity and stability of microorganism based products
  • DS/ISO/TR 16312-2:2021 Guidance for assessing the validity of physical fire models for obtaining fire effluent toxicity data for fire hazard and risk assessment – Part 2: Evaluation of individual physical fire models

British Standards Institution (BSI)

  • BS 5736-3:1981 Evaluation of medical devices for biological hazards-Method of test for systemic toxicity; assessment of acute toxicity of extracts from medical devices
  • BS EN 30993-3:1994 Biological evaluation of medical devices-Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • BS EN ISO 10993-3:2009 Biological evaluation of medical devices-Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • BS EN ISO 10993-3:2003 Biological evaluation of medical devices-Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • BS PD ISO/TS 21726:2019 Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
  • PD ISO/TS 21726:2019 Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
  • BS ISO 21427-1:2006 Water quality. Evaluation of the genotoxicity by measurement of the induction of micronuclei. Evaluation of genotoxicity using amphibian larvae
  • BS 5736-5:1982 Evaluation of medical devices for biological hazards-Method of test for systemic toxicity; assessment of pyrogenicity in rabbits of extracts from medical devices
  • 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 10993-17:2023 Biological evaluation of medical devices - Toxicological risk assessment of medical device constituents
  • BS ISO 17616:2008 Soil quality - Guidance on the choice and evaluation of bioassays for ecotoxicological characterization of soils and soil materials
  • BS PD CEN/TS 17459:2022 Construction products: Assessment of release of dangerous substances. Determination of ecotoxicity of construction product eluates
  • BS ISO 21427-2:2006 Water quality - Evaluation of genotoxicity by measurement of the induction of micronuclei - Mixed population method using the cell line V79
  • BS EN ISO 10993-3:2014 Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • PD CEN/TS 17459:2022 Construction products: Assessment of release of dangerous substances. Determination of ecotoxicity of construction product eluates
  • BS ISO 13344:2004 Estimation of the lethal toxic potency of fire effluents
  • BS ISO 13344:2007 Estimation of the lethal toxic potency of fire effluents
  • BS EN ISO 10993-11:1996 Biological evaluation of medical devices-Tests for systemic toxicity
  • BS EN ISO 10993-11:2006 Biological evaluation of medical devices-Tests for systemic toxicity
  • BS ISO TR 9122-6:1996 Toxicity testing of fire effluents - Guidance for regulators and specifiers on the assessment of toxic hazard in fires in buildings and transport
  • BS EN 12689:1998 Biotechnology - Guidance on assessment of the purity, biological activity and stability of micro-organism based products
  • BS PD ISO/TS 4988:2022 Nanotechnologies. Toxicity assessment and bioassimilation of manufactured nano-objects in suspension using the unicellular organism Tetrahymena sp.
  • BS PD CEN/TR 17105:2017 Construction products. Assessment of release of dangerous substances. Guidance on the use of ecotoxicity tests applied to construction products

Canadian Standards Association (CSA)

  • CSA Z316.6-1995(R2000) Evaluation of Single Use Medical Sharps Containers for Biohazardous and Cytotoxic Waste
  • CSA Z316.6-2002 Evaluation of Single-Use Medical Sharps Containers for Biohazardous and Cytotoxic Waste
  • CSA Z316.6-02-2002 Evaluation of Single Use Medical Sharps Containers for Biohazardous and Cytotoxic Waste Second Edition
  • CAN/CSA-ISO 10993.3-1997(R2006) Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • CAN/CSA-ISO 10993.3-1997(C2006) Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • CSA ISO 10993.11-98-CAN/CSA:1998 Biological Evaluation of Medical Devices - Part 11: Test for Systemic Toxicity First Edition; ISO 10993-11: 1993
  • CSA Z316.6-2007(R2012) Evaluation of Single-Use and Reusable Medical Sharps Containers for Biohazardous and Cytotoxic Waste

Association of German Mechanical Engineers

  • VDI 3957 Blatt-21 E:2017-02 Biometric techniques for assessing the impact of air pollutants (biomonitoring) Assessment of phytotoxic effects using exposure to Hypogymnia physodes lichens
  • VDI 3957 BLATT 21-2019 Biological measuring techniques for the determination and evaluation of effects of air pollutants (biomonitoring) - Evaluation of phytotoxic effects of ambient air pollutants with lichen exposure of Hypogymnia physodes
  • VDI 3957 BLATT 6-2003 Biological measurement methods for determining and assessing the effect of air pollutants on plants (bioindication) — Determination and assessment of the phytotoxic effect of ozone and other photooxidants — Standardized table method...
  • VDI 3957 BLATT 6-2003 Biological measurement methods for determining and assessing the effect of air pollutants on plants (bioindication) — Determination and assessment of the phytotoxic effect of ozone and other photooxidants — Standardized table method...

German Institute for Standardization

  • DIN EN ISO 9509:2006-10 Water quality - Toxicity test for assessing the inhibition of nitrification of activated sludge microorganisms (ISO 9509:2006); German version EN ISO 9509:2006
  • 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 CEN/TS 17459:2023 Construction products: Assessment of release of dangerous substances - Determination of ecotoxicity of construction product eluates; German version CEN/TS 17459:2022
  • DIN CEN/TS 17459:2023-02 Construction products: Assessment of release of dangerous substances - Determination of ecotoxicity of construction product eluates; German version CEN/TS 17459:2022
  • DIN CEN/TR 17105:2018-02*DIN SPEC 18904:2018-02 Construction products - Assessment of release of dangerous substances - Guidance on the use of ecotoxicity tests applied to construction products; German version CEN/TR 17105:2017
  • DIN EN ISO 10993-3:2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • DIN CEN/TR 17105:2018*DIN SPEC 18904:2018 Construction products - Assessment of release of dangerous substances - Guidance on the use of ecotoxicity tests applied to construction products
  • DIN EN ISO 10993-3 E:2011-08 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (draft)

The Directorate General of Specifications and Metrology (DGSM)

  • OS GSO ISO 9509:2013 Water quality - Toxicity test for assessing the inhibition of nitrification of activated sludge microorganisms
  • OS GSO ISO 21427-1:2013 Water quality -- Evaluation of genotoxicity by measurement of the induction of micronuclei -- Part 1: Evaluation of genotoxicity using amphibian larvae

Kingdom of Bahrain Testing and Metrology Directorate

  • BH GSO ISO 9509:2016 Water quality - Toxicity test for assessing the inhibition of nitrification of activated sludge microorganisms
  • BH GSO ISO/TS 21726:2022 Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
  • BH GSO ISO/TR 10993-33:2022 Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3

Standards Norway

  • NS-EN ISO 9509:2006 Water quality — Toxicity test for assessing the inhibition of nitrification of activated sludge microorganisms (ISO 9509:2006)
  • NS-ISO 10993-3:1992 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • SN-CEN/TS 17459:2022 Construction products: Assessment of release of dangerous substances - Determination of ecotoxicity of construction product eluates
  • SN-CEN/TR 17105:2017 Construction products — Assessment of release of dangerous substances — Guidance on the use of ecotoxicity tests applied to construction products
  • NS-EN 12689:1998 Biotechnology — Guidance on assessment of the purity, biological activity and stability of microorganism based products
  • NS-EN ISO 10993-3:2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)

Gosstandart of Russia

  • GOST ISO/TS 21726-2021 Medical devices. Evaluation system of biological effects. Application of the threshold of toxicological concern for assessing biocompatibility of medical device constituents
  • GOST R ISO 10993-3-2009 Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • GOST 34554-2019 Methods of testing the hemical of human hazard. Tests for the estimation of reproductive toxicity of two generations
  • GOST R ISO 10993-11-2009 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
  • GOST ISO 10993-11-2021 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
  • GOST ISO/TR 21582-2024 Medical products. Evaluation of biological action of medical products. Principles and methods of pyrogenicity research

Spanish Association for Standardization (UNE)

  • AENOR UNE-EN ISO 9509:2007 Water quality - Toxicity test for assessing the inhibition of nitrification of activated sludge microorganisms (ISO 9509:2006)
  • UNE-EN ISO 9509:2007 Water quality - Toxicity test for assessing the inhibition of nitrification of activated sludge microorganisms (ISO 9509:2006)
  • UNE-EN 12689:1999 Biotechnology - Guidance on assessment of the purity, biological activity and stability of microorganism based products

Lithuanian Standards Office

  • LST EN ISO 9509:2006 Water quality - Toxicity test for assessing the inhibition of nitrification of activated sludge microorganisms (ISO 9509:2006)
  • LST EN 12689-2000 Biotechnology - Guidance on assessment of the purity, biological activity and stability of microorganism based products

Swedish Institute for Standards

  • SS-EN ISO 9509:2006 Water quality - Toxicity test for assessing the inhibition of nitrification of activated sludge microorganisms (ISO 9509:2006)
  • SS-EN 12689:1999 Biotechnology - Guidance on assessment of the purity, biological activity and stability of microorganism based products

Bureau of Indian Standards

  • IS 12572-6-1988 Guide for Evaluation of Medical Devices for Biological Hazards Part 6 Method of Test for Systemic Toxicity; Assessment of Pyrogenicity In Rabits of Extracts from Medical Devices
  • IS 12572-13-1995 Biological Evaluation of Medical Devices - Part 13 : Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity

American Association of Textile Chemists and Colorists

European Committee for Standardization (CEN)

  • EN ISO 17616:2022 Soil quality - Guidance on the choice and evaluation of bioassays for ecotoxicological characterization of soils and soil materials (ISO 17616:2019)
  • CEN/TS 17459:2022 Construction products: Assessment of release of dangerous substances - Determination of ecotoxicity of construction product eluates
  • CEN/TR 17105:2017 Construction products - Assessment of release of dangerous substances - Guidance on the use of ecotoxicity tests applied to construction products
  • PD CEN/TR 17105:2017 Construction products - Assessment of release of dangerous substances - Guidance on the use of ecotoxicity tests applied to construction products
  • EN 12689:1998 Biotechnology - Guidance on assessment of the purity, biological activity and stability of microorganism based products
  • EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

CEN - European Committee for Standardization

  • EN ISO 10993-3:2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity@ carcinogenicity and reproductive toxicity

RO-ASRO

  • STAS SR EN 30993-3-1996 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenity and reproductive toxicity

TH-TISI

  • TIS 2395.3-2008 Biological evaluation of medical devices.part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity

American National Standards Institute (ANSI)

VN-TCVN

  • TCVN 7391-3-2005 Biological evaluation of medical devices.Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

SCC

  • SPC GB/T 16886.3-2019 Biological evaluation of medical devices -- Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity (TEXT OF DOCUMENT IS IN CHINESE)

US-AAMI

  • ANSI/AAMI/ISO 10993-3:2014 Biological evaluation of medical devices. Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

South African Bureau of Standard

  • SANS 10993-3:2004 Biological evaluation of medical devices Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity

PH-BPS

  • PNS ISO 10993-3:2021 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity