DIN ISO 11040-8:2020-11
Current
The latest, up-to-date edition.
Prefilled syringes – Part 8: Requirements and test methods for finished prefilled syringes (ISO 11040-8:2016)
Hardcopy , PDF
German, English
01-11-2020
Important note : Users cannot be edited or removed once added to your Multi user PDF.
This part of ISO 11040 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.
| Committee |
TC 76
|
| DocumentType |
Test Method
|
| Pages |
0
|
| ProductNote |
This standard is also refer as ICH Q9, ANSI/AAMI HE75
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Current
|
| Standards | Relationship |
| ISO 11040-8:2016 | Identical |
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