ISO 10993-4:2017 — Biological evaluation — Part 4: Selection of tests for interactions with blood

Provides guidance on the selection of tests for evaluating the interactions of medical devices with blood. Covers thrombosis, coagulation, platelets, hematology, complement system, and hemolysis testing. Applicable to any medical device that comes into direct or indirect contact with circulating blood.

Standard Details

• Standard Number: ISO 10993-4:2017
• Type: ISO 10993 Series
• Published by: ISO
• Official Link: https://www.iso.org/standard/63448.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.