SS-EN-868-5 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods

SS-EN-868-5 - 2019 EDITION - CURRENT
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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. These sealable pouches and reels are used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. Other than the general requirements as specified in EN ISO 11607 1 and EN ISO 11607 2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document. The materials specified in this part of EN 868 are intended for single use only.

To find similar documents by classification:

11.080 (Sterilization and disinfection)

11.080.30 (Sterilized packaging)

55.040 (Packaging materials and accessories Including wrappers, paper, films, foils, cords, sealing devices, cushioning, etc. Adhesive tapes for general purposes, see 83.180)

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Designation Name

SS-EN 868-5:2019

Revision Level

2019 EDITION

Status

Current

Publication Date

Jan. 7, 2019

Language(s)

English

Page Count

32

International Equivalent

EN 868-5:2018(IDT)