ISO 10993-6:2016 — Biological evaluation — Part 6: Tests for local effects after implantation

Specifies test methods for the assessment of local effects after implantation of medical device materials in appropriate animal models. Covers implantation test site selection, implantation periods, histopathological evaluation, and scoring systems for biological responses.

Standard Details

• Standard Number: ISO 10993-6:2016
• Type: ISO 10993 Series
• Published by: ISO
• Official Link: https://www.iso.org/standard/61089.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.