ISO 11737-1:2018 — Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products

Specifies requirements for determining the population of viable microorganisms (bioburden) on or in a medical device, component, raw material, or package. Bioburden testing is a prerequisite for establishing and validating sterilization processes.

Standard Details

• Standard Number: ISO 11737-1:2018
• Type: Sterilization Standard
• Published by: ISO
• Official Link: https://www.iso.org/standard/66451.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.