NF EN ISO 11607-1

NF EN ISO 11607-1

January 2018
Standard Cancelled

Packaging for terminally sterilized medical devices - Part 1 : Requirements for materials, sterile barrier systems and packaging systems

Le présent document spécifie les exigences et les méthodes d'essai pour les matériaux, les systèmes de barrière stérile préformés, les systèmes de barrière stérile et les systèmes d'emballage destinés à maintenir l'état de stérilité des dispositifs médicaux stérilisés au stade terminal jusqu'au point d'utilisation.

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Main informations

Collections

National standards and national normative documents

Publication date

January 2018

Number of pages

63 p.

Reference

NF EN ISO 11607-1

ICS Codes

11.080.30   Sterilized packaging
55.040   Packaging materials and accessories

Classification index

S98-052-1

Print number

1

International kinship

ISO 11607-1:2006

European kinship

EN ISO 11607-1:2017
Sumary
Packaging for terminally sterilized medical devices - Part 1 : Requirements for materials, sterile barrier systems and packaging systems

Le présent document spécifie les exigences et les méthodes d'essai pour les matériaux, les systèmes de barrière stérile préformés, les systèmes de barrière stérile et les systèmes d'emballage destinés à maintenir l'état de stérilité des dispositifs médicaux stérilisés au stade terminal jusqu'au point d'utilisation.
Replaced standards (2)
NF EN ISO 11607-1
August 2009
Standard Cancelled
Packaging for terminally sterilized medical devices - Part 1 : requirements for materials, sterile barrier systems and packaging systems

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.

NF EN ISO 11607-1/A1
September 2014
Standard Cancelled
Packaging for terminally sterilized medical devices - Part 1 : requirements for materials, sterile barrier systems and packaging systems - Amendment 1

Le présent amendement porte principalement sur la refonte de l'Annexe B (nouvelle table des Méthodes d'essai et modes opératoires normalisés pouvant être utilisés pour démontrer la conformité aux exigences contenues dans la présente partie de l'ISO 11607). Des mises à jour ont été opérées en références normatives et en Bibliographie.

Standard replaced by (1)
NF EN ISO 11607-1
January 2020
Standard Current
Packaging for terminally sterilized medical devices - Part 1 : requirements for materials, sterile barrier systems and packaging systems

This document specifies 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. It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized. It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations. It does not describe a quality assurance system for control of all stages of manufacture. It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales
  • 5 Matériaux et systèmes de barrière stérile préformés
  • 6 Exigences relatives à la conception et à la mise au point des systèmes d'emballage
  • 7 Informations à fournir
  • Annexe A (informative) Directives relatives à l'emballage médical
  • Annexe B (informative) Méthodes d'essai et modes opératoires normalisés pouvant être utilisés pour démontrer la conformité aux exigences contenues dans la présente partie de l'ISO
    11607
  • Annexe C (normative) Méthode d'essai de la résistance des matériaux imperméables au passage de l'air
  • Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences essentielles concernées de la Directive 93/42/CEE [JO L 169]
  • Annexe ZB (informative) Relation entre la présente Norme européenne et les exigences essentielles concernées de la Directive 90/385/CEE [JO L 189]
  • Annexe ZC (informative) Relation entre la présente Norme européenne et les exigences essentielles concernées de la Directive 98/79/CE [JO L 331]
  • Bibliographie
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