DIN EN ISO 11607-1:2017-10
Superseded Standard
Historical

DIN EN ISO 11607-1:2017-10

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006 + Amd 1.:2014); German version EN ISO 11607-1:2017
Most recent standard

Summary

ISO 11607-1:2006 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized. ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations. ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture.

Notes

Attention: Veuillez lire l'avertissement à l'égard de ce document. À remplacer par DIN EN ISO 11607-1 (2017-11).

Technical characteristics

Publisher Deutsche Institut für Normung e.V. (DIN)
Publication Date 10/01/2017
Page Count 49
EAN ---
ISBN ---
Weight (in grams) ---
No products.

Previous versions

DIN EN ISO 11607-1:2024-02

DIN EN ISO 11607-1:2024-02

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019 + Amd 1:2023); German version EN ISO 11607-1:2020 + A1:2023

Traduction automatique de l'anglais :
Emballages pour dispositifs médicaux stérilisés en phase terminale - Partie 1 : Exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage (ISO 11607-1:2019 + Amd 1:2023) ; Version allemande EN ISO 11607-1:2020 + A1:2023
01/02/2024
Active
Most Recent
DIN EN ISO 11607-1/A11:2022-08

DIN EN ISO 11607-1/A11:2022-08

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019); German version EN ISO 11607-1:2020/A11:2022
01/08/2022
Superseded
Historical
DIN EN ISO 11607-1/A1:2022-08

DIN EN ISO 11607-1/A1:2022-08

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1 (ISO 11607-1:2019/DAM 1:2022); German and English version EN ISO 11607-1:2020/prA1:2022
01/08/2022
Superseded
Historical
DIN EN ISO 11607-1:2020-05

DIN EN ISO 11607-1:2020-05

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019); German version EN ISO 11607-1:2020
01/05/2020
Superseded
Historical
DIN EN ISO 11607-1:2017-11

DIN EN ISO 11607-1:2017-11

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1: Exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage (ISO/DIS 11607-1:2017); Version allemande et anglaise prEN ISO 11607-1:2017
01/11/2017
Superseded
Historical
DIN EN ISO 11607-1:2017-10

DIN EN ISO 11607-1:2017-10

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006 + Amd 1.:2014); German version EN ISO 11607-1:2017
01/10/2017
Superseded
Historical
DIN EN ISO 11607-1 Berichtigung 1:2016-09

DIN EN ISO 11607-1 Berichtigung 1:2016-09

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1: Exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage (ISO 11607-1:2006 + Amd 1:2014); Version allemande EN ISO 11607-1:2009 + A1:2014, Corrigendum à DIN EN ISO 11607-1:2014-11
01/09/2016
Superseded
Historical
DIN EN ISO 11607-1:2014-11

DIN EN ISO 11607-1:2014-11

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1: Exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage (ISO 11607-1:2006 + Amd 1:2014); Version allemande EN ISO 11607-1:2009 + A1:2014
01/11/2014
Superseded
Historical
DIN EN ISO 11607-1/A1:2013-04

DIN EN ISO 11607-1/A1:2013-04

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1: Exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage (ISO 11607-1:2006/DAM 1:2013); Version allemande EN ISO 11607-1:2009/prA1:2013
01/04/2013
Superseded
Historical
DIN EN ISO 11607-1:2009-09

DIN EN ISO 11607-1:2009-09

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1: Exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage (ISO 11607-1:2006); Version allemande EN ISO 11607-1:2009
01/09/2009
Superseded
Historical
DIN EN ISO 11607-1/A1:2009-03

DIN EN ISO 11607-1/A1:2009-03

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006); English version prEN ISO 11607-1:2009; Amendment 1
01/03/2009
Superseded
Historical
DIN EN ISO 11607-1 Berichtigung 1:2007-05

DIN EN ISO 11607-1 Berichtigung 1:2007-05

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006); German version EN ISO 11607-1:2006, Corrigenda to DIN EN ISO 11607-1:2006-07.
01/05/2007
Superseded
Historical
DIN EN ISO 11607-1:2006-07

DIN EN ISO 11607-1:2006-07

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1: Exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage (ISO 11607-1:2006); Version allemande EN ISO 11607-1:2006
01/07/2006
Superseded
Historical
DIN EN ISO 11607-1:2004-07

DIN EN ISO 11607-1:2004-07

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO/DIS 11607-1:2004); German version prEN ISO 11607-1:2004
01/07/2004
Superseded
Historical
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