Norm

NEN-ISO 11040-8:2016 en

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

52,53

Over deze norm

Status Definitief
Aantal pagina's 9
Commissie Transfusie, infusie en injectieapparatuur voor medische toepassingen
Gepubliceerd op 01-11-2016
Taal Engels
NEN-ISO 11040-8 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.

Details

ICS-code 11.040.25
Engelse titel Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes

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