Norm

NEN-EN-ISO 11608-1:2012 en

Penvormige injectoren voor medisch gebruik - Eisen en beproevingsmethoden - Deel 1: Penvormige injectoren

  • Deze norm is ingetrokken sinds 26-01-2015

143,10

Over deze norm

Status Ingetrokken
Aantal pagina's 40
Commissie Transfusie, infusie en injectieapparatuur voor medische toepassingen
Gepubliceerd op 01-04-2012
Taal Engels
This part of ISO 11608 specifies requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers. Containers covered in this part of ISO 11608 include single- and multi-dose syringe-based and cartridge-based systems, filled either by the manufacturer or by the end-user. Additional guidance for NISs equipped with electronic or electromechanical components and NISs equipped with automated functions is given in ISO 11608-4 and ISO 11608-5 respectively. Needle-free injectors, and requirements relating to methods or equipment associated with end-user filling of containers, are outside the scope of this part of ISO 11608.

Details

ICS-code 11.040.20
11.040.25
Nederlandse titel Penvormige injectoren voor medisch gebruik - Eisen en beproevingsmethoden - Deel 1: Penvormige injectoren
Engelse titel Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
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