Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes
Also Known As:
SKU146226722
Published by
International Organization for Standardization
ISO
Publication Date2016-11
Pages CountPages16
ISO 11040-8:2016 is applicable to aseptically filled or terminally sterilized finished prefilled syringes (intended for single use only) based on ISO 11040-4 or ISO 11040-6, together with ISO 11040-5, for parenteral injection preparations with focus on quality, functional performance and safety requirements, as well as relevant test methods.
Finished prefilled syringes which have undergone an additional preparation step by the user before injection (e.g. diluent syringes that have been emptied for reconstitution and in which the reconstituted drug solution has been aspirated after reconstitution) are excluded from the scope of ISO 11040-8:2016.
Details
| Edition | 1 |
| ICS Codes | 11.040.25 - Syringes, needles and catheters |
| Language(s) | English |
| File Size | 327.7 KB |
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