NF EN ISO 11607-1

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.

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Main informations

Collections

National standards and national normative documents

Publication date

August 2009

Number of pages

38 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 - 18/08/2009

International kinship

ISO 11607-1:2006

European kinship

EN ISO 11607-1:2009
Sumary
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.

Replaced standards (1)
NF EN ISO 11607-1
July 2006
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.

Standard replaced by (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
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Exigences générales
    5
  • 4.1 Généralités
    5
  • 4.2 Systèmes qualité
    6
  • 4.3 Échantillonnage
    6
  • 4.4 Méthodes d'essai
    6
  • 4.5 Documentation
    6
  • 5 Matériaux et systèmes de barrière stérile préformés
    7
  • 5.1 Exigences générales
    7
  • 5.2 Propriétés de barrière microbienne
    10
  • 5.3 Compatibilité avec le procédé de stérilisation
    10
  • 5.4 Compatibilité avec le système d'étiquetage
    11
  • 5.5 Stockage et transport
    11
  • 6 Exigences relatives à la conception et à la mise au point des systèmes d'emballage
    11
  • 6.1 Généralités
    11
  • 6.2 Conception
    12
  • 6.3 Essais de performance du système d'emballage
    13
  • 6.4 Essai de stabilité
    13
  • 7 Informations à fournir
    13
  • Annexe A (informative) Directives relatives à l'emballage médical
    15
  • 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
    18
  • Annexe C (normative) Méthode d'essai de la résistance des matériaux imperméables au passage de l'air
    23
  • Bibliographie
    24
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