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I.S. EN ISO 8362-2:2015

Current
Current

The latest, up-to-date edition.

INJECTION CONTAINERS AND ACCESSORIES - PART 2: CLOSURES FOR INJECTION VIALS (ISO 8362-2:2015)
Amended by

I.S. EN ISO 8362-2:2015/A1:2022

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2015

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.

National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Classification
4 Shape and dimensions
5 Designation
6 Material
7 Performance requirements
8 Labelling
Bibliography

Describes the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4.

DevelopmentNote
Supersedes I.S. EN 28362-2. (09/2010)
DocumentType
Standard
Pages
24
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

Standards Relationship
ISO 8362-2:2015 Identical
EN ISO 8362-2:2015 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 2230:2002 Rubber products — Guidelines for storage
ISO 8362-4:2011 Injection containers and accessories Part 4: Injection vials made of moulded glass
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 8362-1:2009 Injection containers and accessories Part 1: Injection vials made of glass tubing
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

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Hardcopy - English
PDF - English
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