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I.S. EN ISO 8362-5:2016

I.S. EN ISO 8362-5:2016

Current

Current

The latest, up-to-date edition.

INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS (ISO 8362-5:2016)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2016

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 Terms and definitions
4 Shape and dimensions
5 Designation
6 Material
7 Performance requirements
8 Labelling
Annex A (informative) - Determination of moisture
Bibliography

Gives the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362-1 and ISO 8362-4, which is used in connection with the freeze drying (or lyophilization) of drugs and biological materials.

DocumentType
Standard
Pages
26
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
EN ISO 8362-5:2016 Identical
ISO 8362-5:2016 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 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 554:1976 Standard atmospheres for conditioning and/or testing — Specifications
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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