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EVS-EN 868-5:2018

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

General information

Valid from 03.01.2019
Base Documents
EN 868-5:2018
ICS Groups
11.080.30 Sterilized packaging
Directives or regulations
None

Standard history

Status
Date
Type
Name
03.01.2019
Main
EVS-EN 868-5:2018
07.08.2009
Main
EVS-EN 868-5:2009

EN 868-5 specifies test methods and values for sealable pouches and reels manufactured from porous materials. These sealable pouches and reels are used as sterile barrier systems or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.

EN 868-5 specifies materials, test methods and values that are specific to the products. The materials specified are intended for single use only. General requirements for all types of sterile barrier systems are provided by EN ISO 11607-1. The EN 868 series can be used to demonstrate compliance with one or more of the requirements specified in EN ISO 11607-1.

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Standard monitoring
English (PDF 311 KB) Estonian (PDF 169 KB)

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EVS-EN ISO 11607-1:2020

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EVS-EN ISO 11607-2:2020

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Main + amendment

EVS-EN ISO 11607-1:2020+A11:2022

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Main + amendment

EVS-EN ISO 11607-1:2020+A11+A1:2023

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019 + ISO 11607-1:2019/Amd 1:2023)
Newest version Valid from 15.11.2023

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English