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BS EN ISO 8871-5 : 2016

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BS EN ISO 8871-5 : 2016

ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING

British Standards Institution

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Table of Contents

Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Requirements<br>5 Preparation of elastomeric closures for testing<br>Annex A (normative) - Test for penetrability<br>Annex B (normative) - Test for fragmentation<br>Annex C (normative) - Test for self-sealing and dye<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;solution tightness<br>Annex D (normative) - Test for dye solution tightness<br>Bibliography

Abstract

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

General Product Information

Document Type Standard
Status Current
Publisher British Standards Institution
Committee CH/212
Supersedes
  • 04/30086336 DC : 0
  • 15/30324254 DC : 0