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Normas DIN – AENOR
DIN ISO 11040-8:2020-11

DIN ISO 11040-8:2020-11

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

Seringues préremplies - Partie 8: Exigences et méthodes d'essai pour seringues préremplies prêtes à l'emploi (ISO 11040-8:2016)

Vorgefüllte Spritzen - Teil 8: Anforderungen und Prüfverfahren für vorgefüllte Spritzen (ISO 11040-8:2016)

Fecha:
2020-11 /Active
Equivalencias internacionales:

ISO 11040-8 (2016-11)

Relación con otras normas DIN:
Resumen:
This document 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 this part of ISO 11040.
Keywords:
Definitions, Descriptions, Disposable, Disposables, Equipment for single use, Filled, Finished product, Injection containers, Injection syringes, Medical devices, Medical instruments, Medical products, Parenteral infusion equipment, Pharmaceuticals, Prefabricated, Single use syringes, Specification (approval), Syringes, Testing, User information
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