OS GSO ISO 11607-2:2021
ISO 11607-2:2019
Omani Standard
Current Edition
·
Approved on
01 July 2021
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
OS GSO ISO 11607-2:2021 Files
No files for this standard are available in the store currently.
OS GSO ISO 11607-2:2021 Scope
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.
Best Sellers From Health Sector
OS GSO 2017:2023
GSO 2017:2023
Omani Standard
Personal Care and Baby Wet Wipes
GSO 2017:2023
Gulf Standard
Personal Care and Baby Wet Wipes
OS GSO 2241:2023
GSO 2241:2023
Omani Standard
Cosmetic Products - Body Cleaners
GSO 2241:2023
Gulf Standard
Cosmetic Products - Body Cleaners
Recently Published from Health Sector
GSO ISO 18562-3:2025
ISO 18562-3:2024
Gulf Standard
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic substances
GSO IEC TS 60601-4-6:2025
IEC TS 60601-4-6:2024
Gulf Standard
Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances
GSO ISO 22112:2025
ISO 22112:2017
Gulf Standard
Dentistry — Artificial teeth for dental prostheses
GSO EN 14988:2017+A2:2025
EN 14988:2017+A2:2024
Gulf Standard
Children's high chairs - Requirements and test methods