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I.S. EN ISO 8536-2:2010

I.S. 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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 2: CLOSURES FOR INFUSION BOTTLES

Available format(s)

Hardcopy , PDF

Superseded date

02-16-2023

Language(s)

English

Published date

01-01-2010

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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
Bibliography

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

DocumentType
Standard
Pages
24
PublisherName
National Standards Authority of Ireland
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Superseded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/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 3302-1:2014 Rubber — Tolerances for products — Part 1: Dimensional tolerances
ISO 15378:2017 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
ISO 3302-2:2008 Rubber Tolerances for products Part 2: Geometrical tolerances
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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Hardcopy - English
PDF - English
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