ISO 10993-1:2018 — Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

The overarching standard in the ISO 10993 biocompatibility series. Part 1 provides a framework for planning biological evaluation of medical devices within a risk management process. It categorizes devices by nature and duration of body contact, and specifies which biological endpoints to evaluate (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, hemocompatibility, etc.). Essential for any device that contacts the patient’s body.

Standard Details

• Standard Number: ISO 10993-1:2018
• Type: ISO 10993 Series
• Published by: ISO
• Official Link: https://www.iso.org/standard/68936.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.