Table of Contents

Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 General requirements<br>5 Syringe barrel<br>6 Sterilized subassembled syringes ready for filling<br>7 Packaging<br>8 Labelling<br>Annex A (informative) - Examples of types of sterilized<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;subassembled syringes ready for filling<br>Annex B (informative) - Head designs<br>Annex C (normative) - Test methods for syringe barrels<br>Annex D (informative) - Sample preparation for endotoxin<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and particulate determination<br>Annex E (informative) - Glide force test method to evaluate<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;syringe lubrication<br>Annex F (informative) - Needle penetration test<br>Annex G (normative) - Test methods for closure systems<br>Annex H (informative) - Dye solution tightness test<br>Bibliography

Abstract

Pertains to: - tubing-glass barrels (single-chamber design) for injection preparations, and - sterilized subassembled syringes ready for filling.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	British Standards Institution
Pages
ISBN
Committee	CH/212
Supersedes	13/30273499 DC : 0