08/30172616 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 8536-2 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 2: CLOSURES FOR INFUSION BOTTLES
Hardcopy , PDF
English
30-04-2010
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
BS EN ISO 8536-2
| Committee |
CH/212
|
| DocumentType |
Draft
|
| Pages |
22
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| PREN ISO 8536-2 : DRAFT 2008 | 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/TS 15510:2003 | Stainless steels — Chemical composition |
| ISO 8536-3:2009 | Infusion equipment for medical use — Part 3: Aluminium caps for infusion bottles |
| ISO 2230:2002 | Rubber products — Guidelines for storage |
| ISO 8871-5:2016 | Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing |
| 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 |
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