ISO 10993-17:2023 — Biological evaluation — Part 17: Toxicological risk assessment of medical device constituents
Summary
Specifies the process for performing a toxicological risk assessment of medical device constituents. Covers derivation of tolerable intake/exposure levels, margin of safety calculations, and evaluation of chemical data in the context of the biological evaluation. The 2023 edition significantly updated the risk assessment framework.
Standard Details
- Standard Number: ISO 10993-17:2023
- Type: ISO 10993 Series
- Published by: ISO
- Official Link: https://www.iso.org/standard/80072.html
This standard is referenced in the harmonized standards lists for the EU Medical Device Regulation (MDR) 2017/745, EU In Vitro Diagnostic Regulation (IVDR) 2017/746, and is recognized by regulatory authorities worldwide including the FDA, Health Canada, and TGA.
Document Details
Document IDISO 10993-17:2023
TypeISO 10993 Series
AuthorityISO
Publication Date2023-09-01