Table of Contents

Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Types of syringes<br>5 Requirements<br>6 Packaging<br>7 Information supplied by the manufacturer<br>Annex A (normative) - Fluid for determination of acidity/alkalinity<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and extractable metals<br>Annex B (normative) - Test method for air leakage past syringe<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;piston during aspiration and for separation of rubber<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;stopper and plunger<br>Annex C (normative) - Test method for determination of forces<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;required to operate piston<br>Annex D (normative) - Test method for determination of<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;dead space<br>Annex E (normative) - Test method for liquid leakage at<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;syringe piston and syringe nozzle/hub or needle/barrel<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;unions during compression<br>Annex F (normative) - Test method for air leakage past<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;nozzle/hub or needle/barrel unions during aspiration<br>Annex G (normative) - Preparation of extract for test for<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;pyrogenicity and toxicity<br>Annex H (normative) - Syringe sizes and graduated scales<br>Bibliography<br>Annex ZA (informative) - Relationship between this European <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Standard and the Essential Requirements of EU <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Directive 93/42/EEC amended by Directive 2007/47/EEC

Abstract

Defines requirements and test methods for empty, sterile, single-use syringes, with or without needles, made of plastic materials and intended solely for the injection of insulin, with which the syringes are filled by the end user.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	British Standards Institution
Pages
ISBN
Committee	CH/84
Supersedes	BS 7548(1992) : AMD 8538 98/560722 DC : MAR 98 14/30294895 DC : 0 06/30141618 DC : DRAFT JULY 2006