ISO 11608-4
Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
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

