DIN ISO 11040-8:2020-11
Current
Prefilled syringes – Part 8: Requirements and test methods for finished prefilled syringes (ISO 11040-8:2016)
Hardcopy , PDF
German, English
11-01-2020
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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