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EVS-EN ISO 11608-1:2015

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)

General information

Withdrawn from 17.05.2022
Base Documents
ISO 11608-1:2014; EN ISO 11608-1:2015
Directives or regulations
None

Standard history

Status
Date
Type
Name
17.05.2022
Main
04.02.2015
Main
03.05.2012
Main
EVS-EN ISO 11608-1:2012
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.

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