Standard Swedish standard · SS-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)

Status: Withdrawn

· Replaced by: SS-EN ISO 11608-1:2022
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Standard Swedish standard · SS-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)
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Scope
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.

Subjects

Transfusion, infusion and injection equipment (11.040.20) Syringes, needles and catheters (11.040.25)


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Standard Swedish standard · SS-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)
Subscribe on standards - Read more Dölj
Price: 1 487 SEK
standard ikon pdf

PDF

Price: 1 487 SEK
standard ikon

Paper

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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-105157

Edition: 3

Approved: 1/18/2015

No of pages: 56

Replaces: SS-EN ISO 11608-1:2012

Replaced by: SS-EN ISO 11608-1:2022