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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)

General information

Valid from 15.11.2023
Base Documents
ISO 11607-1:2019; EN ISO 11607-1:2020; EN ISO 11607-1:2020/A11:2022; EN ISO 11607-1:2020/A1:2023; ISO 11607-1:2019/Amd 1:2023
ICS Groups
11.080.30 Sterilized packaging
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.11.2023
Main + amendment
EVS-EN ISO 11607-1:2020+A11+A1:2023
01.11.2023
Amendment
EVS-EN ISO 11607-1:2020/A1:2023
01.07.2022
Amendment
EVS-EN ISO 11607-1:2020/A11:2022
01.07.2022
Main + amendment
EVS-EN ISO 11607-1:2020+A11:2022
03.02.2020
Main
EVS-EN ISO 11607-1:2020

ISO 11607-1 describes requirements and test methods for materials, preformed sterile and sterile barrier systems, and packaging systems. This standard can be used by anyone in the healthcare industry or healthcare facilities.

The process of designing and developing a packaging system for terminally sterilized medical devices is a complicated and critical endeavour. The device components and the packaging system should be combined to create a sterile medical device that performs efficiently, safely and effectively in the hands of the user. This text also includes an amendment A1 and A11.

The main text and the amendment can be found separately from the standard’s history.

The international standard has been approved in Europe as EN ISO 11607-1:2020 without any changes and it supersedes EN ISO 11607-1:2017.

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Standard monitoring
English (PDF 814 KB)

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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