Cart ( 0 ) Register Login

Webstore





RS ISO 11607-2: 2019/Amd 1: 2023
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
Abstract

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.

General Information

CodeClassificationThemePagesPublisherAvailability
RS ISO 11607-2: 2019/Amd 1: 2023ADOPTED ISO STANDARDSHealth care technology33Second Edition
Apr 2025		Available
Price: RWF 9,000


View: All

View by: Classification

View by: Group
Agriculture ( 260 )
Metallurgy ( 133 )
Services ( 8 )
Testing ( 5 )
Rwanda Standards Board

© Rwanda Standards Board 2020  - All rights reserved

KK 15 Rd, 49; PO Box: 7099 Kigali-Kicukiro, Tel: +250 0788303492, Hotline: 3250, Email:info@rsb.gov.rw