I.S. EN 868-5:2018
Current
The latest, up-to-date edition.
Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
Hardcopy , PDF
English
01-15-2019
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Information to be supplied by the manufacturer
Annex A (informative) Details of significant technical changes between this document and the previous edition
Annex B (normative) Method for the determination of resistance to the intended sterilization process
Annex C (normative) Method for the determination of pinholes in plastic laminate
Annex D (normative) Method for the determination of the strength of the seal for pouches and reel material
Annex E (normative) Method for the determination of peel characteristics of paper/plastic laminate products
Annex F (normative) Method for the determination of fibre orientation
Bibliography
Important note : All end users must be registered with an Account prior to user licenses being assigned.Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.