Standard

NS-EN ISO 11608-1:2012

Withdrawn

Note: This standard has a new edition: NS-EN ISO 11608-1:2022

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Abstract

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.

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 2012-04
  • Version: 1
  • Document type: NAT
  • ICS 11.040.20
  • ICS 11.040.25
  • National Committee CEN/TC 205

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