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BS EN ISO 8536-2:2010

BS EN ISO 8536-2:2010

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Infusion equipment for medical use Closures for infusion bottles

Amendment of

BS EN ISO 8536-2:2002

Available format(s)

Hardcopy , PDF

Superseded date

17-02-2023

Language(s)

English

Published date

31-08-2010

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Shape and dimensions
4 Designation
5 Material
6 Requirements
7 Labelling
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

Describes the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1.

This part of ISO8536 specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO8536-1.

The dimensional requirements are not applicable to barrier-coated closures.

Closures specified in this part of ISO8536 are intended for single use only.

NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.

Committee
CH/212
DevelopmentNote
Supersedes 99/565171 DC (10/2002) Supersedes 08/30172616 DC. (04/2010)
DocumentType
Standard
Pages
18
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

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 8536-3:2009 Infusion equipment for medical use Part 3: Aluminium caps for infusion bottles
ISO 3302-1:2014 Rubber — Tolerances for products — Part 1: Dimensional tolerances
ISO 3302-2:2008 Rubber Tolerances for products Part 2: Geometrical tolerances
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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Hardcopy - English
PDF - English
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