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genetic therapy

genetic therapy, Total:58 items.

In the international standard classification, genetic therapy involves: Radiation protection, Nuclear energy engineering, Medical sciences and health care facilities in general, Medical equipment, Laboratory medicine, Dentistry, Pharmaceutics, Acoustics and acoustic measurements, Buildings.


Association Francaise de Normalisation, genetic therapy

  • NF M60-525*NF ISO 21243:2009 Radiation protection - Performance criteria for laboratories performing cytogenetic triage for assessment of mass casualties in radiological or nuclear emergencies - General principles and application to dicentric assay.
  • NF EN 62555:2014 Ultrasons - Mesurage de puissance - Transducteurs et systèmes ultrasonores thérapeutiques de haute intensité (HITU)
  • 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.

NZ-SNZ, genetic therapy

  • AS/NZS 2394:1994 Conditioning Equipment for the Treatment of Nocturnal Enuresis (Bedwetting)

Jilin Provincial Standard of the People's Republic of China, genetic therapy

US-FCR, genetic therapy

British Standards Institution (BSI), genetic therapy

  • 18/30376344 DC BS ISO 21291. Traditional Chinese medicine. Therapeutic fumigation 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 10993-3:2014 Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity

Professional Standard - Medicine, genetic therapy

  • YY/T 0870.1-2013 Test for genotoxicity of medical devices.Part 1:Bacterial reverse mutation test
  • YY/T 0870.4-2014 Test for genotoxicity of medical devices.Part 4:Mammalian bone marrow erythocyte micronucleus test
  • YY/T 0870.5-2014 Test for genotoxicity of medical devices.Part 5:Mammalian bone marrow chromosome aberration test
  • YY/T 0870.2-2013 Test for genotoxicity of medical devices.Part 2:In vitro mammalian chromosome aberration test
  • YY/T 1897-2023 Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test

RU-GOST R, genetic therapy

  • GOST ISO 10993-3-2011 Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • GOST R ISO 10993.3-1999 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).

GOSTR, genetic therapy

  • GOST ISO 10993-3-2018 Medical levices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicit
  • 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

CEN - European Committee for Standardization, genetic therapy

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

国家药监局, genetic therapy

  • YY/T 0870.6-2019 Medical device genotoxicity testing Part 6: In vitro mammalian cell micronucleus test
  • YY/T 0870.7-2023 Genotoxicity testing for medical devices Part 7: Alkaline comet test in mammals
  • YY/T 0870.2-2019 Medical device genotoxicity testing Part 2: In vitro mammalian cell chromosome aberration testing
  • YY/T 0870.3-2019 Test for genotoxicity of medical devices.Part 3: In vitro mammalian cell gene mutation test using mouse lymphoma cells

VN-TCVN, genetic therapy

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

TH-TISI, genetic therapy

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

RO-ASRO, genetic therapy

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

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, genetic therapy

  • 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

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

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

German Institute for Standardization, genetic therapy

  • 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 62555:2015-03 Ultrasonics - Power measurement - High intensity therapeutic ultrasound (HITU) transducers and systems (IEC 62555:2013); German version EN 62555:2014

ES-UNE, genetic therapy

  • UNE-EN 62555:2014 Ultrasonics - Power measurement - High intensity therapeutic ultrasound (HITU) transducers and systems (Endorsed by AENOR in June of 2014.)

PH-BPS, genetic therapy

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

International Organization for Standardization (ISO), genetic therapy

  • 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 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • ISO/TR 10993-33:2015 Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3

Danish Standards Foundation, genetic therapy

  • DS/EN 30993-3:1994 Biological evaluation of medical devices. Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

Korean Agency for Technology and Standards (KATS), genetic therapy

  • KS P ISO 10993-3:2007 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 P ISO TR 10993-33:2019 Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3

US-AAMI, genetic therapy

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

ZA-SANS, genetic therapy

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

KR-KS, genetic therapy

  • KS P ISO 10993-3-2018 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • 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

European Committee for Standardization (CEN), genetic therapy

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

International Electrotechnical Commission (IEC), genetic therapy

  • IEC 62555:2013 Ultrasonics - Power measurement - High intensity therapeutic ultrasound (HITU) transducers and systems

BE-NBN, genetic therapy

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

NL-NEN, genetic therapy

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

AENOR, genetic therapy

  • UNE-EN ISO 10993-3:2015 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

Canadian Standards Association (CSA), genetic therapy

  • CSA ISO-10993.3-97-CAN/CSA:1997 Evaluation Biologique Des Dispositifs Medicaux - Partie 3: Essais Concernant La Genotoxicite, La Cancerogenicite Et La Toxicite Sur La Reproduction Premiere Edition
  • CSA ISO 10993.3-97-CAN/CSA:1997 Evaluation biologique des dispositifs medicaux - Partie 3: Essais concernant la genotoxicite, ia cancerogenicite et la toxicite s u r la reproduction La Premiere Edition; ISO 10993-3: 1992

Liaoning Provincial Standard of the People's Republic of China, genetic therapy

  • DB2101/T 0054-2022 Technical regulations for shelter-type temporary centralized medical facilities for the prevention and control of major infectious diseases




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