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ISO - ISO 10993-1:2018 - Biological evaluation of …
- https://www.iso.org/standard/68936.html
- This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the nature and duration of their contact with the body; …
Use of ISO 10993-1, Biological evaluation of medical …
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and
- The purpose of this guidance is to provide further clarification and updated information on the use of International Standard ISO 10993-1, "Biological evaluation of medical …
ISO - ISO 10993-1:2009 - Biological evaluation of …
- https://www.iso.org/standard/44908.html
- ISO 10993-1:2009 describes: the general principles governing the biological evaluation of medical devices within a risk management process; the general categorization …
Use of International Standard ISO 10993-1, …
- https://www.fda.gov/media/85865/download
- outlined in ISO 10993-1. In contrast, some device-specific guidances include recommendations regarding biocompatibility evaluations, that should be considered in …
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