NF EN ISO 11607-1

NF EN ISO 11607-1

January 2020
Standard Current mandatory application standard
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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.

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Main informations

Collections

National standards and national normative documents

Publication date

January 2020

Number of pages

54 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 11607-1:2019

European kinship

EN ISO 11607-1:2020
Sumary
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.

Replaced standards (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.

Table of contents
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  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales
  • 5 Matériaux, systèmes de barrière stérile préformés et systèmes de barrière stérile
  • 6 Conception et mise au point des systèmes d'emballage
  • 7 Évaluation de l'aptitude à l'utilisation pour la présentation aseptique
  • 8 Performance et stabilité du système d'emballage
  • 9 Validation et modifications du système d'emballage
  • 10 Inspection immédiatement avant la présentation aseptique
  • 11 Informations à fournir
  • Annexe C (normative) Méthode d'essai pour la résistance des matériaux imperméables au passage de l'air
  • Annexe A (informative) Recommandations 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 le présent document
  • Annexe D (informative) Aspects environnementaux
  • Annexe E (informative) Recommandations relatives aux manières de différencier un système de barrière stérile d'un emballage de protection
  • Bibliographie
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