NF EN ISO 11607-1
- Consult online for free
- Consult the entire collection of French and European standards for free in the regional delegations of the AFNOR Group by clicking here
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.
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.
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.
- 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
The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.
The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.
With Requirements, quickly access the main part of the normative text!
At a glance, you will be able to identify the additions, deletions or modifications to a text, table, figure and formula.
The Redlines + service is offered to you on the collection of French standards in force, in French language and in HTML and PDF format.
For an overview of the service, click on View a standard in redline format
COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.
Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!
Request your free, no-obligation live demo
I discover COBAZ