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ISO 11608-4

Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors

active, Most Current
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Organization: ISO
Publication Date: 15 March 2006
Status: active
Page Count: 18
ICS Code (Syringes, needles and catheters): 11.040.25
scope:

This part of ISO 11608 specifies requirements and test methods for electromechanically driven injectors intended to be used with needles and with replaceable or non-replaceable cartridges. The injector may be for single-use or multiple-use. The injector system is intended to deliver medication to an end-user by self-administration or with assistance.

This part of ISO 11608 is neither applicable for needle-free injectors (as covered in ISO 21649) nor infusion pumps (as covered in IEC 60601-2-24).

This part of ISO 11608 is not applicable for devices that are capable of operating while connected to an external power supply.

Document History

April 1, 2022
Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics
This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software (NIS-Es). The needle-based injection system containing...
ISO 11608-4
March 15, 2006
Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
This part of ISO 11608 specifies requirements and test methods for electromechanically driven injectors intended to be used with needles and with replaceable or non-replaceable cartridges. The...

References

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