DS/ISO 11608-4
Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
inactive
| Organization: | DS |
| Publication Date: | 30 May 2006 |
| Status: | inactive |
| Page Count: | 19 |
| ICS Code (Syringes, needles and catheters): | 11.040.25 |
scope:
This part of ISO 11608 specifies requirements and test methods for electromechanically driven injectors 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
May 9, 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...
DS/ISO 11608-4
May 30, 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 to be used with needles and with replaceable or non-replaceable cartridges. The injector may be...
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