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EVS-EN ISO 11607-2:2020/A11:2022

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

General information

Valid from 01.07.2022
Base Documents
EN ISO 11607-2:2020/A11:2022
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 11607-2:2020+A11+A1:2023
01.07.2022
Amendment
EVS-EN ISO 11607-2:2020/A11:2022
01.07.2022
Main + amendment
EVS-EN ISO 11607-2:2020+A11:2022
03.02.2020
Main
EVS-EN ISO 11607-2:2020

ISO 11607-2 sets out requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. EN ISO 11607-2:2020/A11:2022 modifies the European standard EN ISO 11607-2:2020. The main text and the consolidated version which consists of the main text and the amendment can be found in the standard’s history.

In this amendment you can find the following:

— the relationship between EN ISO 11607-2 and the requirements of Directive 93/42/EEC,

— the relationship between EN ISO 11607-2 and the requirements of Directive 90/385/EEC,

— the relationship between EN ISO 11607-2 and the requirements of Directive 98/79/EC.

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Related products

Main + amendment

EVS-EN ISO 11607-2:2020+A11+A1:2023

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019 + ISO 11607-2:2019/Amd 1:2023)
Newest version Valid from 15.11.2023
Main + amendment

EVS-EN ISO 11607-2:2020+A11:2022

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
Valid from 01.07.2022
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 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

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Amendment

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

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
Valid from 01.07.2022
Main + amendment

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

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
Valid from 01.07.2022
Main

EVS-EN ISO 10993-1:2020

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
Newest version Valid from 31.12.2020
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EVS-EN ISO 15223-1:2021

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
Newest version Valid from 01.10.2021

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