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Biotoxicity Evaluation

Biotoxicity Evaluation, Total:70 items.

In the international standard classification, Biotoxicity Evaluation involves: Laboratory medicine, Medical equipment, Pharmaceutics, Dentistry, Medical sciences and health care facilities in general.


Professional Standard - Agriculture, Biotoxicity Evaluation

  • 水和废水监测分析方法 5.3.3-2003 Chapter Five Biomonitoring Methods for Water and Wastewater Chapter Three Determination and Evaluation of Acute Biological Toxicity Three Fish Acute Toxicity Test (B)
  • 水和废水监测分析方法 5.3.4-2003 Chapter 5 Biomonitoring Methods of Water and Wastewater Chapter 3 Determination and Evaluation of Acute Biological Toxicity 4 Acute Toxicity Test of Luminescent Bacteria
  • 水和废水监测分析方法 5.3.1-2003 Chapter 5 Biomonitoring Methods for Water and Wastewater Chapter 3 Determination and Evaluation of Acute Biological Toxicity - Algae Growth Inhibition Test (B)
  • 水和废水监测分析方法 5.3.5-2003 Chapter 5 Biomonitoring Methods of Water and Wastewater Chapter 3 Determination and Evaluation of Acute Biological Toxicity Five Seed Germination and Root Elongation Toxicity Tests (C)
  • 水和废水监测分析方法 5.3.2-2003 Chapter 5 Biological Monitoring Methods for Water and Wastewater Chapter 3 Determination and Evaluation of Acute Biological Toxicity Activity Inhibition Test for Daphnia (B)

Standard Association of Australia (SAA), Biotoxicity Evaluation

GOSTR, Biotoxicity Evaluation

  • GOST ISO/TR 10993-33-2018 Medical levices. Biological evaluation of medical devices. Part 33. Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3
  • GOST ISO 10993-3-2018 Medical levices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicit

British Standards Institution (BSI), Biotoxicity Evaluation

  • PD ISO/TR 10993-33:2015 Biological evaluation of medical devices. Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3
  • PD ISO/TR 10993-55:2023 Biological evaluation of medical devices. Interlaboratory study on cytotoxicity
  • BS EN ISO 10993-11:2018 Biological evaluation of medical devices. Tests for systemic toxicity
  • 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)
  • BS EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

VN-TCVN, Biotoxicity Evaluation

  • TCVN 7391-11-2007 Biological evaluation of medical devices.Part 11: Tests for systemic toxicity
  • TCVN 7391-3-2005 Biological evaluation of medical devices.Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

TH-TISI, Biotoxicity Evaluation

  • TIS 2395.11-2008 Biological evaluation of medical devices.part 11: tests for systemic toxicity
  • TIS 2395.3-2008 Biological evaluation of medical devices.part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity

Association Francaise de Normalisation, Biotoxicity Evaluation

  • NF S99-511:2007 Biological evaluation of medical devices - Part 11 : tests for systemic toxicity.
  • NF S99-511:1996 Biological evaluation of medical devices. Part 11 : tests for systemic toxicity.
  • NF EN ISO 10993-11:2018 Évaluation biologique des dispositifs médicaux - Partie 11 : essais de toxicité systémique
  • 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
  • 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 S99-501-3:2009 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.

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

  • GB/T 16886.11-1997 Biological evaluation of medical devices--Part 11: Tests for systemic toxicity
  • GB/T 16886.11-2011 Biological evaluation of medical devices.Part 11: Tests for systemic toxicity
  • 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

ZA-SANS, Biotoxicity Evaluation

  • SANS 10993-11:2008 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
  • SANS 10993-3:2004 Biological evaluation of medical devices Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity

Korean Agency for Technology and Standards (KATS), Biotoxicity Evaluation

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

  • GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
  • GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

未注明发布机构, Biotoxicity Evaluation

German Institute for Standardization, Biotoxicity Evaluation

  • 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 10993-3:2015-02 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 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
  • DIN EN ISO 10993-3:2015 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

PH-BPS, Biotoxicity Evaluation

  • PNS ISO 10993-11:2021 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
  • PNS ISO 10993-3:2021 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

European Committee for Standardization (CEN), Biotoxicity Evaluation

  • EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
  • EN ISO 10993-11:1995 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity (ISO 10993-11 : 1993)
  • EN 30993-3:1993 Biological Evaluation of Medical Devices - Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity (ISO 10993-3 : 1992) Superseded by EN ISO 10993-3: 2003

CEN - European Committee for Standardization, Biotoxicity Evaluation

  • 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

International Organization for Standardization (ISO), Biotoxicity Evaluation

  • ISO 10993-11:1993 Biological evaluation of medical devices; part 11: tests for systemic toxicity
  • ISO 10993-3:1992 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • ISO 10993-5:1992 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
  • ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
  • ISO/TR 9122-6:1994 Toxicity testing of fire effluents; part 6: guidance for regulators and specifiers on the assessment of toxic hazard in fires in buildings and transport
  • ISO/TR 10993-55:2023 Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity

KR-KS, Biotoxicity Evaluation

ES-UNE, Biotoxicity Evaluation

  • UNE-EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

RO-ASRO, Biotoxicity Evaluation

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

Professional Standard - Medicine, Biotoxicity Evaluation

  • YY/T 1897-2023 Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test
  • YY/T 0127.5-2014 Biological evaluation of medical devices used in dentistry.Part 5:Inhalation toxicity test

US-AAMI, Biotoxicity Evaluation

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

AENOR, Biotoxicity Evaluation

  • 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 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

RU-GOST R, Biotoxicity Evaluation

  • 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 10993-3-2011 Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • GOST R ISO 10993.5-1999 Medical devices. Biological evaluation of medical devices. Part 5. Tests for cytotoxicity: in vitro methods
  • GOST R ISO 10993.3-1999 Biological evaluation of medical devices. Part 3. Tests of genotoxicity, carcinogenicity and reproductive toxicity / Note: To be replaced by GOST R ISO 10993-3 (2009).

API - American Petroleum Institute, Biotoxicity Evaluation





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