ISO 11607-1:2019 — Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
Summary
Specifies requirements for materials, sterile barrier systems, and packaging systems for terminally sterilized medical devices. Covers material selection, sterile barrier system design, preformed sterile barrier systems, packaging system design, and performance testing requirements.
Standard Details
- Standard Number: ISO 11607-1:2019
- Type: Sterilization Standard
- Published by: ISO
- Official Link: https://www.iso.org/standard/70799.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.
Document Details
Document IDISO 11607-1:2019
TypeSterilization Standard
AuthorityISO
Publication Date2019-02-01