ISO 10993-12:2012 — Biological evaluation — Part 12: Sample preparation and reference materials

Specifies requirements and guidance for the preparation of samples and the selection of reference materials used in the biological evaluation of medical devices. Covers extraction conditions (polar and non-polar solvents, temperatures, ratios), and reference materials for cytotoxicity, sensitization, and other biological tests.

Standard Details

• Standard Number: ISO 10993-12:2012
• Type: ISO 10993 Series
• Published by: ISO
• Official Link: https://www.iso.org/standard/53468.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.