NF EN 868-1

NF EN 868-1

July 1997
Standard Cancelled

Packaging materials and systems for medical devices which are to be sterilized. Part 1 : general requirements and test methods.

Cette norme spécifie les exigences générales ainsi que les méthodes d'essai relatives aux matériaux et systèmes d'emballage utilisés pour emballer les dispositifs médicaux devant être stérilisés au stade terminal, et destinés à maintenir la stérilité du dispositif médical.

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Main informations

Collections

National standards and national normative documents

Publication date

July 1997

Number of pages

26 p.

Reference

NF EN 868-1

ICS Codes

11.040.01   Medical equipment in general
11.080.30   Sterilized packaging
55.040   Packaging materials and accessories

Classification index

S98-051

Print number

1 - 05/10/2006

European kinship

EN 868-1:1997
Sumary
Packaging materials and systems for medical devices which are to be sterilized. Part 1 : general requirements and test methods.

Cette norme spécifie les exigences générales ainsi que les méthodes d'essai relatives aux matériaux et systèmes d'emballage utilisés pour emballer les dispositifs médicaux devant être stérilisés au stade terminal, et destinés à maintenir la stérilité du dispositif médical.
Standard replaced by (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

<p>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.</p> <p>ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.</p> <p>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.</p> <p>ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture.</p>

Table of contents
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  • Avant-propos
    3
  • 0 Introduction
    4
  • 1 Domaine d'application
    4
  • 2 Références normatives
    4
  • 3 Définitions
    5
  • 4 Exigences
    6
  • 5 Méthodes d'essai
    9
  • 6 Documentation
    10
  • 7 Informations
    10
  • Annexe A (informative) Conseils relatifs à l'article 4 Exigences
    11
  • Annexe B (informative) Plan d'évaluation de la barrière microbienne
    13
  • Annexe C (informative) Imperméabilité à l'air - Méthodes d'essai
    14
  • Annexe D (informative) Propriétés de barrière microbienne - Méthodes d'essai pour les matériaux
    16
  • Annexe E (informative) Propriétés de barrière microbienne - Méthodes d'essai pour les fermetures perméables (assemblage de filtres, tortuosité)
    17
  • Annexe F (informative) Imperméabilité et continuité des scellages formés par fusion ou par adhésion - Méthodes d'essai
    18
  • Annexe G (informative) Imperméabilité des scellages qui ne sont formés ni par fusion ni par adhésion - Méthodes d'essai - Modes opératoires pour les conteneurs rigides
    20
  • Annexe H (informative) Bibliographie
    22
  • Annexe ZA (informative) Articles de la présente norme européenne concernant les exigences essentielles au daubes dispositions des directives UE
    24
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