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NS-EN ISO 11608-3:2022

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Abstract

This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1.It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture.This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also scope of ISO 11608-1:2022).This document is not applicable to the following products:—    sterile hypodermic needles;—    sterile hypodermic syringes;—    sterile single-use syringes, with or without needle, for insulin;—    containers that can be refilled multiple times;—    containers intended for dental use;—    catheters or infusion sets that are attached or assembled separately by the user.

Document information

  • Standard from SN
  • Published:
  • Edition: 2022-05
  • Version: 1
  • Document type: NAT
  • ICS 11.040.25
  • National Committee CEN/TC 205

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