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

Available format(s)

Hardcopy

Published date

01-07-2010

Publisher

Swiss 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	ISO/TC 76
DocumentType	Standard
Pages	0
PublisherName	Swiss Standards
Status	Current

Standards	Relationship
ONORM EN ISO 8536-2 : 2010	Identical
NF EN ISO 8536-2 : 2010	Identical
ISO 8536-2:2010	Identical
EN ISO 8536-2:2010	Identical
I.S. EN ISO 8536-2:2010	Identical
UNE-EN ISO 8536-2:2010	Identical
BS EN ISO 8536-2:2010	Identical
NS EN ISO 8536-2 : 2010	Identical
NEN EN ISO 8536-2 : 2010	Identical
DIN EN ISO 8536-2:2010-08	Identical
NBN EN ISO 8536-2 : 2010	Identical
UNI EN ISO 8536-2 : 2010	Identical