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DIN ISO 11040-8:2020-11

Current

Current

The latest, up-to-date edition.

Prefilled syringes – Part 8: Requirements and test methods for finished prefilled syringes (ISO 11040-8:2016)

Available format(s)

Hardcopy , PDF

Language(s)

German, English

Published date

01-11-2020

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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