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NF ISO 8362-5 : 2008

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS

Superseded date

01-04-2016

Published date

12-01-2013

Avant-propos
Introduction
1 Domaine d'application
2 Références normatives
3 Termes et définitions
4 Forme et dimensions
5 Désignation
6 Matériau
7 Exigences de performance
  7.1 Généralités
  7.2 Exigences physiques
  7.3 Exigences chimiques
  7.4 Exigences biologiques
8 Étiquetage
Annexe A (informative) Détermination de l'humidité
Bibliographie

La présente partie de l'ISO 8362 spécifie la forme, les dimensions, le matériau, les exigences de performance et l'étiquetage des bouchons de flacons pour produits injectables faisant l'objet de l'ISO 8362-1 et de l'ISO 8362-4, utilisés pour les médicaments et les produits biologiques à lyophiliser. Les exigences dimensionnelles ne s'appliquent pas aux bouchons avec revêtement protecteur. Les bouchons faisant l'objet de la présente partie de l'ISO 8362 sont à usage unique.

DevelopmentNote
Indice de classement: S93-112-5. PR NF ISO 8362-5 December 2006. (12/2006)
DocumentType
Standard
PublisherName
Association Francaise de Normalisation
Status
Superseded
SupersededBy

Standards Relationship
ISO 8362-5:2016 Identical

NF ISO 48 : 2010 RUBBER, VULCANIZED OR THERMOPLASTIC - DETERMINATION OF HARDNESS (HARDNESS BETWEEN 10 IRHD AND 100 IRHD)
NF ISO 7619-1 : 2010 RUBBER, VULCANIZED OR THERMOPLASTIC - DETERMINATION OF INDENTATION HARDNESS - PART 1: DUROMETER METHOD (SHORE HARDNESS)
ISO 3302-1:2014 Rubber — Tolerances for products — Part 1: Dimensional tolerances
ISO 3302-2:2008 Rubber Tolerances for products Part 2: Geometrical tolerances
NF EN ISO 8871-1 : 2005 ELECTROMETRIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLES IN AQUEOUS AUTOCLAVATES
ISO 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing
NF EN ISO 8871-4 : 2006 ELASTOMERIC PARTS FOR PARENTERAL AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 4: BIOLOGICAL REQUIREMENTS AND TEST METHODS

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