NF EN ISO 8536-2 : 2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
INFUSION EQUIPMENT FOR MEDICAL USE - PART 2: CLOSURES FOR INFUSION BOTTLES
12-01-2013
04-04-2023
Avant-propos
Introduction
1 Domaine d'application
2 Références normatives
3 Dimensions et désignation
3.1 Dimensions
3.2 Désignation
4 Matériaux
5 Propriétés physiques
5.1 Généralités
5.2 Performances
5.3 Dureté
5.4 Fragmentation
5.5 Force de perforation du trocart
5.6 Tenue du trocart et étanchéité autour du trocart
5.7 Stockage
6 Exigences chimiques
7 Exigences biologiques
8 Échantillons
9 Marquage
10 Conformité
Annexe A (normative) Essai de fragmentation
Annexe B (normative) Détermination de la force de
perforation du trocart
Annexe C (normative) Tenue du trocart et étanchéité autour
du trocart
Annexe D (normative) Dispositif de perçage du bouchon
Specifies the design, dimensions, material, performance requirements and test of closures for infusion bottles as specified in ISO 8536-1.
| DevelopmentNote |
PR NF EN ISO 8536-2 April 2002. Indice de classement: S93-123-2. (05/2002) Supersedes NF ISO 8536-2. (08/2003) PR NF EN ISO 8536-2 March 2009. (03/2009)
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| DocumentType |
Standard
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| PublisherName |
Association Francaise de Normalisation
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 8536-2:2010 | Identical |
| NEN EN ISO 8536-2 : 2010 | Identical |
| NBN EN ISO 8536-2 : 2010 | Identical |
| EN ISO 8536-2:2010 | Identical |
| I.S. EN ISO 8536-2:2010 | Identical |
| BS EN ISO 8536-2:2010 | Identical |
| NS EN ISO 8536-2 : 2010 | Identical |
| DIN EN ISO 8536-2:2010-08 | Identical |
| UNE-EN ISO 8536-2:2010 | Identical |
| ISO 8871-1:2003 | Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates |
| ISO 7619-1:2010 | Rubber, vulcanized or thermoplastic — Determination of indentation hardness — Part 1: Durometer method (Shore hardness) |
| ISO 8536-3:2009 | Infusion equipment for medical use — Part 3: Aluminium caps for infusion bottles |
| ISO 3302-1:2014 | Rubber — Tolerances for products — Part 1: Dimensional tolerances |
| ISO 3302-2:2008 | Rubber — Tolerances for products — Part 2: Geometrical tolerances |
| ISO 48:2010 | Rubber, vulcanized or thermoplastic — Determination of hardness (hardness between 10 IRHD and 100 IRHD) |
| ISO 8871-4:2006 | Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 4: Biological requirements and test methods |
| ISO 8536-1:2011 | Infusion equipment for medical use — Part 1: Infusion glass bottles |