BS ISO 11040-4:2015
Superseded
View Superseded by
Prefilled syringes Glass barrels for injectables and sterilized subassembled syringes ready for filling
Hardcopy , PDF
English
30-04-2015
31-03-2020
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
Pertains to: - tubing-glass barrels (single-chamber design) for injection preparations, and - sterilized subassembled syringes ready for filling.
| Committee |
CH/212
|
| DevelopmentNote |
Supersedes 13/30273499 DC. (04/2015)
|
| DocumentType |
Standard
|
| Pages |
64
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 11040-4:2015 | Identical |
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