ISO 11607-2:2019 — Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
Summary
Specifies requirements for the development and validation of packaging processes for medical devices that are terminally sterilized. Covers installation qualification, operational qualification, performance qualification, and process control requirements for forming, sealing, and assembly operations.
Standard Details
- Standard Number: ISO 11607-2:2019
- Type: Sterilization Standard
- Published by: ISO
- Official Link: https://www.iso.org/standard/70800.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 11607-2:2019
TypeSterilization Standard
AuthorityISO
Publication Date2019-02-01