Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
Also Known As:
SKU145414637
Published by
International Organization for Standardization
ISO
Publication Date2015-04
Pages CountPages60
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.
Details
History and complementary documents
History
| Edition | 3 |
| ICS Codes | 11.040.25 - Syringes, needles and catheters |
| Language(s) | English |
| File Size | 1.0 MB |
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