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DIN EN ISO 11608-1

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

active, Most Current
Organization: DIN
Publication Date: 1 April 2015
Status: active
Page Count: 50
ICS Code (Syringes, needles and catheters): 11.040.25
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.

Document History

May 1, 2020
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO/DIS 11608-1:2020); German and English version prEN ISO 11608-1:2020
A description is not available for this item.
DIN EN ISO 11608-1
April 1, 2015
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)
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....
December 1, 2012
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (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....
May 1, 2001
Pen-injectors for medical use - Part 1: Pen-injectors; Requirements and test methods (ISO 11608-1:2000); English version of DIN EN ISO 11608-1
A description is not available for this item.

References

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