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ISO 11607-2:2019

Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes

General information

Valid from 31.01.2019
ICS Groups
11.080.30 Sterilized packaging
Directives or regulations
None

Standard history

Status
Date
Type
Name
13.09.2023
Amendment
ISO 11607-2:2019/Amd 1:2023
31.01.2019
Main
ISO 11607-2:2019
07.07.2014
Amendment
ISO 11607-2:2006/Amd 1:2014
07.04.2006
Main
ISO 11607-2:2006
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

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Paper
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Standard monitoring
English (PDF 2 MB)

Related products

Amendment

ISO 11607-2:2019/Amd 1:2023

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1: Application of risk management
Newest version Valid from 13.09.2023
Main

EVS-EN ISO 11607-1:2020

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
Valid from 03.02.2020
Main

EVS-EN ISO 11607-2:2020

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
Valid from 03.02.2020
Main

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
Newest version Valid from 03.01.2019

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ISO 11607-1:2019

Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems
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Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
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EVS-EN 62366-1:2015

Medical devices - Part 1: Application of usability engineering to medical devices
Valid from 07.05.2015

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