ISO 11139:2018 — Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards

Defines terms used in the sterilization of health care products including sterilization processes, sterility assurance, bioburden, sterile barrier systems, and related concepts. The authoritative vocabulary standard referenced throughout the sterilization standard series.

Standard Details

• Standard Number: ISO 11139:2018
• Type: Sterilization Standard
• Published by: ISO
• Official Link: https://www.iso.org/standard/66262.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.