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08/30172616 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS EN ISO 8536-2 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 2: CLOSURES FOR INFUSION BOTTLES
Available format(s)

Hardcopy , PDF

Superseded date

04-30-2010

Language(s)

English

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Superseded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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