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DS/EN ISO 11608-4

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

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Organization: DS
Publication Date: 11 September 2007
Status: active
Page Count: 21
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.

Document History

May 9, 2022
Needle-based injection systems for medical use – Requirements and test methods – Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022)
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...
DS/EN ISO 11608-4
September 11, 2007
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...
Needle-based injection systems for medical use – Requirements and test methods – Part 4: Needle-based injection systems containing electronics (ISO/DIS 11608-4:2020)
This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software. The needle-based injection system containing...
Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO/DIS 11608-4:2016)
This part of ISO 11608 specifies reference requirements and test methods for needle-based injection systems (NIS) containing electronics (with or without software) intended to be used with needles...
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