Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, French

Published date

11-04-2016

Publisher

International Organization for Standardization

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.

DevelopmentNote	Supersedes ISO/DIS 11040-8. (11/2016)
DocumentType	Standard
Pages	9
PublisherName	International Organization for Standardization
Status	Current

Standards	Relationship
NEN ISO 11040-8 : 2016	Identical
NF ISO 11040-8 : 2017	Identical
DIN ISO 11040-8:2020-11	Identical
BS ISO 11040-8:2016	Identical

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