ISO 11040-4:2015
Withdrawn
View Superseded by
Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
Hardcopy , PDF
French, English
02-04-2015
09-04-2025
ISO 11040-4:2015 applies to
- tubing-glass barrels (single-chamber design) for injection preparations, and
- sterilized subassembled syringes ready for filling.
It specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods.
ISO 11040-4:2015 also specifies those components that are part of the sterilized subassembled syringe ready for filling.
Glass barrels and sterilized subassembled syringes ready for filling in accordance with ISO 11040-4:2015 are intended for single use only.
Components to complete the subassembled syringe, such as plunger and rod, are not specified in ISO 11040‑4:2015.
| Committee |
ISO/TC 76
|
| DevelopmentNote |
Supersedes ISO/DIS 11040-4. (04/2015) NEW CHILD AMD 1 2020 IS ADDED.
|
| DocumentType |
Standard
|
| Pages |
54
|
| ProductNote |
THIS STANDARD ALSO REFERS TO ISO 3951 (all parts) NEW CHILD AMD 1 2020 IS ADDED.
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes | |
| UnderRevision |
| Standards | Relationship |
| DIN ISO 11040-4:2017-07 | Identical |
| IS/ISO 11040 : Part 4 : 2015 | Identical |
| DIN ISO 11040-4:2007-10 | Identical |
| NF ISO 11040-4 : 2015 | Identical |
| BS ISO 11040-4:2015 | Identical |
| SS-ISO 11040-4:2016 | Identical |
| NEN ISO 11040-4 : 2015 | Identical |
| DS/ISO 11040-4:2015 | Identical |
A newer version of this standard is available.