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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

General information

Valid from 13.09.2023
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
Amendment to ISO 11607-2:2019

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ISO 11607-2:2019

Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes
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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)
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EVS-EN ISO 11607-2:2020

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Amendment

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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