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Medical Device Evaluation

Medical Device Evaluation, Total:24 items.

In the international standard classification, Medical Device Evaluation involves: Quality, Medical equipment, Laboratory medicine, Dentistry.


RU-GOST R, Medical Device Evaluation

Professional Standard - Medicine, Medical Device Evaluation

  • YY/T 1441-2016 General requirements of performance evaluation of in vitro diagnostic medical devices

Korean Agency for Technology and Standards (KATS), Medical Device Evaluation

  • KS P ISO 16429:2010 Implants for surgery-Measurements of open-circuit potential to assess corrosion behaviour of etallic implantable materials and medical devices over extended time periods
  • KS P ISO 10993-1:2007 Biological evaluation of medical devices-Part 1:Evaluation and testing
  • KS P ISO 10993-1:2020 Biological evaluation of medical devices —Part 1: Evaluation and testing within a risk management process
  • KS P ISO 7405:2010 Dentistry-Evaluation of biocompatibility of medical devices used in dentistry
  • KS P ISO 7405:2014 Dentistry — Evaluation of biocompatibility of medical devices used in dentistry

International Organization for Standardization (ISO), Medical Device Evaluation

  • ISO 16429:2004 Implants for surgery - Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods
  • 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 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
  • ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

Canadian Standards Association (CSA), Medical Device Evaluation

  • CSA ISO-10993.2-97-CAN/CSA:1997 Evaluation Biologique Des Dispositifs Medicaux - Partie 2: Exigences Concernant La Protection Des Animaux
  • CSA ISO 10993.2-97-CAN/CSA:1997 Evaluation biologique des dispositifs medicaux - Partie 2: Exigences concernant la protection des an imaux La Premiere Edition; ISO 10993-2: 1992

KR-KS, Medical Device Evaluation

  • KS P ISO 10993-1-2020 Biological evaluation of medical devices —Part 1: Evaluation and testing within a risk management process

British Standards Institution (BSI), Medical Device Evaluation

  • BS EN ISO 10993-4:2017 Biological evaluation of medical devices. Selection of tests for interactions with blood
  • BS EN ISO 10993-4:2009 Biological evaluation of medical devices - Selection of tests for interactions with blood
  • BS EN ISO 10993-1:2009 Biological evaluation of medical devices - Evaluation and testing within a risk management process
  • BS EN ISO 10993-23:2021 Biological evaluation of medical devices. Evaluation and testing within a risk management process
  • BS EN ISO 10993-12:2007 Biological evaluation of medical devices - Sample preparation and reference materials
  • BS EN ISO 10993-7:2008 Biological evaluation of medical devices - Ethylene oxide sterilization residuals

未注明发布机构, Medical Device Evaluation

Association Francaise de Normalisation, Medical Device Evaluation

  • NF S91-224:2009 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.

ES-UNE, Medical Device Evaluation

  • UNE-EN ISO 7405:2019 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)

German Institute for Standardization, Medical Device Evaluation

  • DIN EN ISO 7405:2019-03 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12); German version EN ISO 7405:2018




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