Table of Contents

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

Abstract

This part of ISO 11040 applies 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	International Organization for Standardization
Pages
ISBN
Committee	TC 76
Supersedes	ISO/DIS 11040-4 : 60.00 (2015) ISO 11040-4 : 2007