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I.S. EN ISO 8871-5:2016

I.S. EN ISO 8871-5:2016

Current

Current

The latest, up-to-date edition.

ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING (ISO 8871-5:2016)

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 Requirements
5 Preparation of elastomeric closures for testing
Annex A (normative) - Test for penetrability
Annex B (normative) - Test for fragmentation
Annex C (normative) - Test for self-sealing and dye
        solution tightness
Annex D (normative) - Test for dye solution tightness
Bibliography

Defines requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.

DocumentType
Standard
Pages
28
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

Standards Relationship
EN ISO 8871-5:2016 Identical
ISO 8871-5:2016 Identical

ISO 8536-2:2010 Infusion equipment for medical use — Part 2: Closures for infusion bottles
ISO 8362-4:2011 Injection containers and accessories Part 4: Injection vials made of moulded glass
ISO 8536-6:2016 Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles
ISO 8362-3:2001 Injection containers and accessories Part 3: Aluminium caps for injection vials
ISO 8362-6:2010 Injection containers and accessories Part 6: Caps made of aluminium-plastics combinations for injection vials
ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
ISO 8362-1:2009 Injection containers and accessories Part 1: Injection vials made of glass tubing

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Hardcopy - English
PDF - English
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