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DIN EN ISO 8871-5:2017-03

Superseded

Superseded

View Superseded by

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, German

Published date

01-03-2017

Superseded date

01-07-2025

£85.11
Excluding VAT
Summarise this standard

National foreword
National Annex NA (informative) - Bibliography
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
19
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
SupersededBy
Supersedes

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

⚠

A newer version of this standard is available.

View Current Edition
£85.11
Excluding VAT