ISO 10993-11:2017 — Biological evaluation — Part 11: Tests for systemic toxicity

Specifies requirements and gives guidance on procedures for the assessment of potential systemic toxicity of medical devices and their constituent materials. Covers acute, subacute, subchronic, and chronic systemic toxicity testing through various routes of exposure.

Standard Details

• Standard Number: ISO 10993-11:2017
• Type: ISO 10993 Series
• Published by: ISO
• Official Link: https://www.iso.org/standard/68426.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.