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
15-01-2019
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.
Dates of withdrawal of national standards are available from NSAI.
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
This document specifies test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4.
Committee |
CEN/TC 102
|
DocumentType |
Test Method
|
Pages |
26
|
ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THIS STANDARD IS ALSO REFERS TO : EN ISO 11140-1,EN ISO 11607-1:2017,EN 1041,EN ISO 15223-1:2016,EN ISO 11607-2
|
PublisherName |
National Standards Authority of Ireland
|
Status |
Current
|
Supersedes |
Standards | Relationship |
EN 868-5:2009 | Identical |
EN 868-5:2018 | Identical |
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