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ISO 11608-1

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems

active, Most Current
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Organization: ISO
Publication Date: 15 December 2014
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

February 18, 2020
Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems
This document specifies requirements and test methods for Needle-Based Injection Systems (NISs) for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, through...
ISO 11608-1
December 15, 2014
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....
April 1, 2012
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....
December 15, 2000
Pen-Injectors for Medical Use - Part 1: Pen-Injectors - Requirements and Test Methods
This part of ISO 11608 specifies requirements and test methods for pen-injectors intended to be used with needles and with replaceable or non-replaceable prefilled cartridges. This part of ISO 11608...

References

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