Standard Swedish standard · SS-EN ISO 11608-4:2007

Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors (ISO 11608-4:2006)

Status: Valid

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.

Subjects

Syringes, needles and catheters (11.040.25)


Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-63097

Edition: 1

Approved: 9/7/2007

No of pages: 24