90.93 Standard confirmed Jul 5, 2024
ISO
ISO/TC 198 Sterilization of health care products
International Standard
11.080.30 Sterilized packaging
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.
PUBLISHED
ISO 11607-2:2019
90.93
Standard confirmed
Jul 5, 2024
PUBLISHED
ISO 11607-2:2019/Amd 1:2023