GSO ISO 11607-2:2021
ISO 11607-2:2019
Gulf Standard
Current Edition
·
Approved on
01 July 2021
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
GSO ISO 11607-2:2021 Files
English
13 Pages
Current Edition
Reference Language
USD
124.83
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
GSO 2017:2023
Gulf Standard
Personal Care and Baby Wet Wipes
YSMO GSO 2017:2023
GSO 2017:2023
Yemeni Standard
Personal Care and Baby Wet Wipes
GSO 2241:2023
Gulf Standard
Cosmetic Products - Body Cleaners
GSO 2156:2023
Gulf Standard
Cosmetic Products – Natural Henna
Recently Published from Health Sector
GSO ISO 23217:2025
ISO 23217:2024
Gulf Standard
Injection systems for self-administration by paediatric patients — Requirements and guidelines for design
GSO ISO 25649-4:2025
ISO 25649-4:2024
Gulf Standard
Floating leisure articles for use on and in the water — Part 4: Additional specific safety requirements and test methods for Class B devices
GSO ASTM F1004:2025
ASTM F1004:23
Gulf Standard
Standard Consumer Safety Specification for Expansion Gates and Expandable Enclosures
GSO EN 16779-2:2025
EN 16779-2:2022
Gulf Standard
Textile child care articles - Safety requirements and test methods for children's cot duvets - Part 2: Duvet covers (excluding duvet)