ONORM EN ISO 8536-2 : 2010

Name: ONORM EN ISO 8536-2 : 2010
Brand: ON

Superseded

View Superseded by

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

Superseded date

03-07-2023

Published date

12-01-2013

Publisher

Osterreichisches Normungsinstitut/Austrian Standards

Foreword
Introduction
1 Scope
2 Normative references
3 Dimensions and designation
   3.1 Dimensions
   3.2 Designation
4 Material
5 Physical requirements
   5.1 General
   5.2 Performance
   5.3 Hardness
   5.4 Fragmentation
   5.5 Spike penetration force
   5.6 Sealability and spike retention
   5.7 Storage
6 Chemical requirements
7 Biological requirements
8 Sample
9 Marking
10 Conformance
Annex A (normative) Determination of fragments
Annex B (normative) Determination of spike penetration
        force
Annex C (normative) Spike retention/sealability
Annex D (normative) Closure piercing device

Specifies the design, dimensions, material, performance requirements and test of closures for infusion bottles as specified in ISO 8536-1.

Committee	TC 179
DocumentType	Standard
PublisherName	Osterreichisches Normungsinstitut/Austrian Standards
Status	Superseded
SupersededBy	ÖNORM EN ISO 8536-2:2023 06 01

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
NF 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

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