Norm

NEN-EN-ISO 11608-3:2010 Ontw. en

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

  • Deze norm is ingetrokken sinds 11-10-2012

25,62

Over deze norm

Status Ingetrokken
Aantal pagina's 16
Commissie Transfusie, infusie en injectieapparatuur voor medische toepassingen
Gepubliceerd op 01-12-2010
Taal Engels
This part of ISO 11608 specifies the functional and design considerations for containers to be used with Needle-based Injection Systems (NIS) which fulfil the specifications of ISO 11608-1. Containers covered in this standard include single and multi-dose containers (either filled by the manufacturer or by the end-user) which can be provided to the end user integrated in the NIS or assembled with the NIS at the time of use. The standard includes specifications and standardized test methods to describe and evaluate cartridges for use in NIS with pen needles (defined in ISO 11608-2) and outlines design considerations for other potential containers, including syringes when they are intended to be used with the NIS. Syringes and needles that are sold separately and not intended for use in a NIS are excluded from this standard, as they are covered by other standards (e.g. ISO 7864 (needles), ISO 8537 (insulin syringes), ISO 7886 (manual syringes). Cartridge-based containers described herein are used with needles described in ISO 11608-2.

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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