SS-EN-ISO-11608-1 › Historical Revision Information
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)

SS-EN-ISO-11608-1 - 2015 EDITION - SUPERSEDED
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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.

To find similar documents by classification:

11.040.20 (Transfusion, infusion and injection equipment Including blood packs Syringes, needles and catheters, see 11.040.25)

11.040.25 (Syringes, needles and catheters)


Medical devices

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Designation Name

SS-EN ISO 11608-1:2015

Revision Level

2015 EDITION

Status

Superseded

Publication Date

Jan. 18, 2015

Language(s)

English

Page Count

56

International Equivalent

EN ISO 11608-1:2015(IDT); ISO 11608-1:2014(IDT)