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Database: 365,228(8 Aug 2026)
  1. HOME
  2. Standards for Genotoxic and non-genotoxic

Genotoxic and non-genotoxic

Genotoxic and non-genotoxic, Total:110 items.

The international standard classification for "Genotoxic and non-genotoxic" includes: Laboratory medicine , Medical equipment in general , Pharmaceutics , Protection against dangerous goods , Environmental protection .

The Chinese standard classification for "Genotoxic and non-genotoxic" includes: Medical apparatus and devices in general , Standardization and quality management , Marking, packaging, transport and storage in general , Analysis methods for toxic substances in atmosphere .

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

  • GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • GB/T 27831-2011 Chemicals - Genetic toxicology - Test method of Saccharomyces cerevisiae gene mutation
  • GB/T 27832-2011 Chemicals—Genetic toxicology—Test method of Saccharomyces cerevisiae mitotic recombination
  • 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)
  • GB/T 16886.3-1997 Biological evaluation of medical devices--Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicity
  • GB/T 15440-1995 Guidelines for preparing samples for genetoxicity testing of organic pollutants in environment
  • GB/T 16886.3-2008 Biological evaluation of medical devices - Part 3: Tests for genotoxicity carcinogenicity and reproductive toxicity
  • GB/Z 42246-2022 Nanotechnologies—Guideline on genotoxicity test methods for nanomaterials

Professional Standard - Medicine

  • YY/T 0870.1-2013 Test for genotoxicity of medical devices - Part 1: Bacterial reverse mutation test

Group Standards of the People's Republic of China

American Water Works Association (AWWA)

  • AWWA ACE68896 Comparative Cytotoxicity and Genotoxicity of Priority DBPs
  • AWWA WQTC64091 Evaluating Potential Genotoxicity of Disinfected Drinking Water
  • AWWA WQTC71486 Genotoxicity after UV/H2O2 and GAC Treatment of Drinking Water

Korean Agency for Technology and Standards (KATS)

  • KS I ISO 21427-1-2024 Water quality － Evaluation of genotoxicity by measurement of the induction of micronuclei － Part 1: Evaluation of genotoxicity using amphibian larvae
  • KS I ISO 21427-1-2009(2019) Water quality － Evaluation of genotoxicity by measurement of the induction of micronuclei － Part 1: Evaluation of genotoxicity using amphibian larvae
  • 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 I ISO 13829:2006 Water quality－Determination of the genotoxicity ofwater and waste water using the umu-test
  • 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 P ISO 10993-3:2018 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • KS I ISO 13829-2021 Water quality-Determination of the genotoxicity of water and waste water using the umu-test
  • KS I ISO 13829-2006(2021) Water quality-Determination of the genotoxicity of water and waste water using the umu-test
  • KS P ISO 10993-3-2018 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • KS P ISO 10993-3:2007 Biological evaluation of medical devices － Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

British Standards Institution (BSI)

  • 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 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 EN 30993-3:1994 Biological evaluation of medical devices-Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • BS EN ISO 10993-3:2014 Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • 25/30482494 DC BS EN ISO 10993-3 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • 11/30212473 DC BS EN ISO 10993-3. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity

GCC Standardization Organization

  • 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 10993-3:2015 Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • GSO ISO 29200:2015 Soil quality -- Assessment of genotoxic effects on higher plants -- Vicia faba micronucleus test

Danish Standards Foundation

  • 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/ISO 21427-1:2006 Water quality - Evaluation of genotoxicity by measurement of the induction of micronuclei - Part 1: Evaluation of genotoxicity using amphibian larvae
  • DS/ISO 13829:2000 Water quality - Determination of the genotoxicity of water and waste water using the umu-test
  • DANSK DS/EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • DANSK DS/ISO 13829:2000 Water quality - Determination of the genotoxicity of water and waste water using the umu-test
  • DS/EN 30993-3:1994 Biological evaluation of medical devices. Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • DANSK DS/ISO 29200:2013 Soil quality - Assessment of genotoxic effects on higher plants - Vicia faba micronucleus test

The Directorate General of Specifications and Metrology (DGSM)

  • 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
  • OS GSO ISO 29200:2015 Soil quality -- Assessment of genotoxic effects on higher plants -- Vicia faba micronucleus test

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 10993-3:2004 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • UNI EN ISO 10993-3:2015 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • UNI EN ISO 10993-3:2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

Association Francaise de Normalisation

  • NF ISO 21427-1:2006 Water quality - Assessment of genotoxicity by measuring micronucleus induction - Part 1: assessment of genotoxicity using amphibian larvae
  • NF S99-501-3:2009 Biological evaluation of medical devices - Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity.
  • NF EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: tests concerning 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 T90-325:1992 WATER ANALYSIS. EVALUATION OF THE GENOTOXICITY WITH LARVAE OF BATRACIANS (PLEURODELES WALT).
  • NF EN ISO 29200:2020 Soil quality - Assessment of genotoxic effects on higher plants - Micronucleus assay on Vicia faba
  • NF X31-327:2013 Soil quality - Assessment of genotoxic effects on higher plants - Vicia faba micronucleus test

Federal Institute for Occupational Safety and Health

  • TRGS 905:2014-03 Technical Regulations (Gefahrstoffe) Part 905 Carcinogenic, genotoxic and reproductive toxic substances

European Committee for Standardization (CEN)

  • EN ISO 10993-3:2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity@ carcinogenicity and reproductive toxicity
  • EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
  • prEN ISO 10993-3 Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity (ISO/DIS 10993-3:2025)
  • EN ISO 10993-3:2003 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity Supersedes EN 30993-3: 1999; ISO 10993-3: 2003
  • EN ISO 29200:2020 Soil quality - Assessment of genotoxic effects on higher plants - Vicia faba micronucleus test (ISO 29200:2013)

Standards Norway

  • NS-ISO 10993-3:1992 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • NS-EN ISO 10993-3:2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)
  • NS-EN ISO 10993-3:2003 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)
  • NS-EN ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

Thai Industrial Standards Institute (TISI)

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

Canadian Standards Association (CSA)

  • CAN/CSA-ISO 10993.3-1997(C2006) Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • CAN/CSA-ISO 10993.3-1997(R2006) Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • CSA ISO 10993.3-97-CAN/CSA:1997 Biological evaluation of medical devices - Part 3: Tests concerning genotoxicity, carcinogenicity and reproductive toxicity The First Edition; ISO 10993-3:1992

German Institute for Standardization

  • 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 10993-3:2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • DIN EN ISO 10993-3 E:2011-08 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (draft)
  • DIN EN ISO 10993-3 E:2013-03 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (draft)
  • DIN EN ISO 10993-3:2004 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)
  • DIN ISO 29200 E:2012-06 Soil quality - Assessment of genotoxic effects on higher plants - Vicia faba micronucleus test
  • DIN EN ISO 10993-3:2004-02 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)
  • DIN EN ISO 10993-3:2009-08 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)
  • DIN EN ISO 29200:2020-09 Soil quality - Assessment of genotoxic effects on higher plants - Vicia faba micronucleus test (ISO 29200:2013); German version EN ISO 29200:2020
  • DIN EN ISO 10993-3 E:2013 Draft Document - Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO/DIS 10993-3:2013); German version prEN ISO 10993-3:2013
  • DIN ISO 29200:2014 Soil quality - Assessment of genotoxic effects on higher plants - Vicia faba micronucleus test (ISO 29200:2013)

American National Standards Institute （ANSI)

COMMISSION FOR THE STANDARDS, METROLOGY AND QUALITY OF VIETNAM (STAMEQ)

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

Bureau of Indian Standards

  • IS 12572-13-1995 Biological Evaluation of Medical Devices - Part 13 : Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
  • IS/ISO 10993-3-2014 Biological Evaluation of Medical Devices Part 3 Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity ( First Revision )

National Standardisation Body (ASRO)

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

Association for the Advancement of Medical Instrumentation

  • ANSI/AAMI/ISO 10993-3:2014 Biological evaluation of medical devices. Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • AAMI/ISO 10993-3:2014(R2023) Biological evaluation of medical devices, Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • AAMI/ISO 10993-3:2003(R2013) Biological evaluation of medical devices, Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

International Organization for Standardization (ISO)

  • ISO 13829:2000 Water quality - Determination of the genotoxicity of water and waste water using the umu-test
  • ISO 13829 Water quality - Determination of the genotoxicity of water and waste water using the umu-test
  • ISO 10993-3:2014 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 10993-3:2003 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • ISO 29200:2013 Soil quality.Assessment of genotoxic effects on higher plants.Vicia faba micronucleus test

South African Bureau of Standard

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

Bureau of Philippine Standards

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

Canadian General Standards Board （CGSB)

Swedish Institute for Standards

  • SS-EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
  • SS-EN ISO 10993-3:2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)

Spanish Association for Standardization (UNE)

  • UNE-EN ISO 10993-3:2004 Biological evaluation of medical devices. Part 3: Tests for genotoxicity, carcinogenicty and reproductive toxicity (ISO10993-3:2003)
  • UNE-EN ISO 10993-3:2015 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
  • UNE-EN ISO 10993-3:2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)
  • AENOR UNE-EN ISO 10993-3:2015 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

Netherlands Institute for Standardization

  • NEN-ISO 10993-3:1994 Biological evaluation of medical devices. Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:1992)

Indonesia Standards

  • SNI ISO 10993-3:2017 Evaluasi biologis alat kesehatan - Bagian 3: Uji genotoksisitas, karsinogenisitas dan toksisitas reproduksi (ISO 10993-3:2014, IDT)

Gosstandart of Russia

  • GOST ISO 10993-3-2018 Medical levices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicit
  • GOST ISO 10993-3-2011 Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • GOST 32648-2014 OECD guidelines for the testing of chemicals. Genetic Toxicology: Sex-linked Recessive Lethal Test in Drosophila melanogaster

Belgian Standards Institute

  • NBN-EN 30993-3-1994 Biological evaluation of medical devices - Part 3 : Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:1992)

Kingdom of Bahrain Testing and Metrology Directorate

  • BH GSO ISO 29200:2017 Soil quality -- Assessment of genotoxic effects on higher plants -- Vicia faba micronucleus test

Genotoxic and non-genotoxic

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