PREN ISO 8536-2 : DRAFT 2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
INFUSION EQUIPMENT FOR MEDICAL USE - PART 2: CLOSURES FOR INFUSION BOTTLES
01-03-2010
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Shape and dimensions
4 Designation
5 Material
6 Performance
6.1 General
6.2 Physical requirements
6.3 Chemical requirements
6.4 Biological requirements
7 Labelling
Annex A (normative) Determination of fragments
A.1 Principle
A.2 Apparatus
A.3 Procedure
A.4 Reference testing
A.5 Expression of results
A.6 Validity
Annex B (normative) Determination of spike penetration force
B.1 Principle
B.2 Apparatus
B.3 Procedure
B.4 Expression of results
Annex C (normative) Spike retention/sealability
C.1 Principle
C.2 Apparatus
C.3 Procedure
C.4 Expression of results
Annex D (normative) Closure piercing device
Bibliography
Defines the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles.
| Committee |
SS S02
|
| DocumentType |
Draft
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| Standards | Relationship |
| 08/30172616 DC : 0 | Identical |
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