Iso 10993 Biological Evaluation Of Medical Devices

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

Regulatory Information Search for FDA Guidance Documents GUIDANCE DOCUMENT Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part …

ISO - ISO 10993-12:2021 - Biological evaluation of …

https://www.iso.org/standard/75769.html

Specifically, this document addresses the following: — test sample selection; — selection of representative portions from a medical device; — test sample preparation; — …

ISO - ISO 10993-23:2021 - Biological evaluation of …

https://www.iso.org/standard/74151.html

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are …

ISO - ISO 10993-2:2022 - Biological evaluation of …

https://www.iso.org/standard/78866.html

Biological evaluation of medical devices — Part 2: Animal welfare requirements This document specifies the minimum requirements to be satisfied to ensure and demonstrate …