DIN EN ISO 11607-2:2006-07
Superseded Standard
Historical

DIN EN ISO 11607-2:2006-07

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006); German version EN ISO 11607-2:2006
Most recent standard

Summary

This standard specifies the requirements for 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.

Notes

Amendement prévu par DIN EN ISO 11607-2/A1 (2013-04).

Technical characteristics

Publisher Deutsche Institut für Normung e.V. (DIN)
Publication Date 07/01/2006
Cancellation Date 11/01/2014
Page Count 18
EAN ---
ISBN ---
Weight (in grams) ---
No products.

Previous versions

DIN EN ISO 11607-2:2024-02

DIN EN ISO 11607-2:2024-02

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019 + Amd 1:2023); German version EN ISO 11607-2:2020 + A1:2023

Traduction automatique de l'anglais :
Emballages pour dispositifs médicaux stérilisés en phase terminale - Partie 2 : Exigences de validation pour les processus de formage, de scellage et d'assemblage (ISO 11607-2:2019 + Amd 1:2023) ; Version allemande EN ISO 11607-2:2020 + A1:2023
01/02/2024
Active
Most Recent
DIN EN ISO 11607-2/A11:2022-08

DIN EN ISO 11607-2/A11:2022-08

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); German version EN ISO 11607-2:2020/A11:2022
01/08/2022
Superseded
Historical
DIN EN ISO 11607-2/A1:2022-08

DIN EN ISO 11607-2/A1:2022-08

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1 (ISO 11607-2:2019/DAM 1:2022); German and English version EN ISO 11607-2:2020/prA1:2022
01/08/2022
Superseded
Historical
DIN EN ISO 11607-2:2020-05

DIN EN ISO 11607-2:2020-05

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); German version EN ISO 11607-2:2020
01/05/2020
Superseded
Historical
DIN EN ISO 11607-2:2017-11

DIN EN ISO 11607-2:2017-11

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Exigences de validation pour les procédés de formage, scellage et assemblage (ISO/DIS 11607-2:2017); Version allemande et anglaise prEN ISO 11607-2:2017
01/11/2017
Superseded
Historical
DIN EN ISO 11607-2:2017-10

DIN EN ISO 11607-2:2017-10

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Exigences de validation pour les procédés de formage, scellage et assemblage (ISO 11607-2:2006 + Amd 1.:2014); Version allemande EN ISO 11607-2:2017
01/10/2017
Superseded
Historical
DIN EN ISO 11607-2:2014-11

DIN EN ISO 11607-2:2014-11

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Exigences de validation pour les procédés de formage, scellage et assemblage (ISO 11607-2:2006 + Amd 1:2014); Version allemande EN ISO 11607-2:2006 + A1:2014
01/11/2014
Superseded
Historical
DIN EN ISO 11607-2/A1:2013-04

DIN EN ISO 11607-2/A1:2013-04

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Exigences de validation pour les procédés de formage, scellage et assemblage (ISO 11607-2:2006/DAM 1:2013); Version allemande EN ISO 11607-2:2006/prA1:2013
01/04/2013
Superseded
Historical
DIN EN ISO 11607-2:2006-07

DIN EN ISO 11607-2:2006-07

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006); German version EN ISO 11607-2:2006
01/07/2006
Superseded
Historical
DIN EN ISO 11607-2:2004-07

DIN EN ISO 11607-2:2004-07

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO/DIS 11607-2:2004); German version prEN ISO 11607-2:2004
01/07/2004
Superseded
Historical
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