Norm

NEN-EN-ISO 11608-1:2010 Ontw. en

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

  • Deze norm is ingetrokken sinds 16-04-2012

38,91

Over deze norm

Status Ingetrokken
Aantal pagina's 44
Commissie Transfusie, infusie en injectieapparatuur voor medische toepassingen
Gepubliceerd op 01-11-2010
Taal Engels
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.

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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