Over deze norm
|Commissie||Transfusie, infusie en injectieapparatuur voor medische toepassingen|
This part of ISO 11608 specifies requirements and test methods for NISs intended to be used with needles and with replaceable or non-replaceable containers. Containers covered in this standard include single and multi-dose syringe-based and cartridge-based systems; either filled by the manufacturer or by the end-user. NISs which are equipped with electronic or electromechanical components are covered by this standard as referenced by ISO 11608-4. NISs which are equipped with automated functions are also covered by this standard, as referenced by ISO 11608-5. Needle-free injectors are not covered by this standard. Requirements for methods and/or equipment associated with end-user filling of containers are not covered by this standard.
|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|