Codes & Standards - Purchase
ISO 11607-2:2019
Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes
SKU: iso_070800_166011
Published by ISO
Publication Year 2019
2 Edition
13 pages
Product Details
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.