NF EN ISO 8536-2 : 2010

Superseded

View Superseded by

INFUSION EQUIPMENT FOR MEDICAL USE - PART 2: CLOSURES FOR INFUSION BOTTLES

Superseded date

04-04-2023

Published date

01-12-2013

Publisher

Association Francaise de Normalisation

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)
DocumentType	Standard
PublisherName	Association Francaise de Normalisation
Status	Superseded
SupersededBy	NF EN ISO 8536-2:2023
Supersedes	NF ISO 8536-2 : 1992

Standards	Relationship
ISO 8536-2:2010	Identical
UNE-EN 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
SN 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
UNI EN ISO 8536-2 : 2010	Identical
ONORM 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