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BSI - BS EN ISO 11608-1 - TC

Tracked Changes (Redline) - Needle-based injection systems for medical use — Requirements and test methods Part 1: Needle-based injection systems

active, Most Current
Organization: BSI
Publication Date: 25 February 2020
Status: active
Page Count: 108
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

BS EN ISO 11608-1 - TC
February 25, 2020
Tracked Changes (Redline) - Needle-based injection systems for medical use — Requirements and test methods Part 1: Needle-based injection systems
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....

References

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