ISO 11608-4:2006 PDF

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.

ISO 11608-4:2006 Referenced Document

IEC 60068-2-27:1987 Environmental testing. Part 2: Tests. Test Ea and guidance: Shock
IEC 60068-2-30:1980 Basic environmental testing procedures. Part 2 : Tests. Test Db and guidance: Damp heat, cyclic (12 + 12-hour cycle)
IEC 60068-2-64:1993 Environmental testing; part 2: test methods; test Fh: vibration, broad-band random (digital control) and guidance
IEC 60529:2001 Degrees of protection provided by enclosure (IP code)*， 2024-04-18 Update
ISO 11608-1:2000 Pen-injectors for medical use - Part 1: Pen-injectors; Requirements and test methods

2022 ISO 11608-4:2022 Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics
2006 ISO 11608-4:2006 Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors