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NS EN ISO 8536-2 : 2010

Current

Current

The latest, up-to-date edition.

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

Published date

12-01-2013

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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.

DocumentType
Standard
PublisherName
Norwegian Standards (Norges Standardiseringsforbund)
Status
Current

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