Norm

NEN-EN-ISO 11608-3:2012 en

Naaldvormige injectoren voor medisch gebruik - Eisen en beproevingmethoden - Deel 3: Afgewerkte containers

52,53

Over deze norm

Status Definitief
Aantal pagina's 10
Commissie Transfusie, infusie en injectieapparatuur voor medische toepassingen
Gepubliceerd op 01-10-2012
Taal Engels
This part of ISO 11608 specifies the functional and design considerations for containers to be used with needle-based injection systems (NIS) that fulfil the specifications of ISO 11608-1. It is applicable to single and multi-dose containers (either filled by the manufacturer or by the end-user) which can be provided to the enduser integrated in the NIS or assembled with the NIS at the time of use. This part of ISO 11608 includes specifications and test methods to describe and evaluate cartridges for use in NIS with pen needles (as defined in ISO 11608-2) and outlines design considerations for other potential containers, including syringes to be used with a NIS. This part of ISO 11608 is not applicable to cartridges intended for dental use. Syringes and needles that are sold separately and not intended for use in a NIS are outside the scope of this part of ISO 11608.

Details

ICS-code 11.040.20
11.040.25
Nederlandse titel Naaldvormige injectoren voor medisch gebruik - Eisen en beproevingmethoden - Deel 3: Afgewerkte containers
Engelse titel Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers
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