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Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
Publisher: National Standards Authority of Ireland
Published:
Available Formats: PDF - English, Hardcopy - English More Info on product formats
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
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.
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