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Pen-injectors and needle-based injection systems

Normative References  



ISO 11608-1: Pen-injectors for medical use - Part 1: Pen-injectors - Requirements and test methods

ISO 11608-2: Pen-injectors for medical use - Part 2: Needles – Requirements and test methods

ISO 11608-3: Pen-injectors for medical use - Part 3: Finished cartridges - Requirements and test methods

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

ISO 11608-5: Needle-based injection systems for medical use - Part 5: Automated functions – Requirements and test methods

Part 1 of this test standard is intended to investigate the dosage precision of a pen injector after different types of conditioning. Part 2 covers mechanical testing of the pen injector needles and part 3 of the corresponding carpules.
In part 4 of the standard the test methods are applied for electronic and electromechanical pen injectors and part 5 describes testing of product-specific, automated functions of needle-based injection systems.
A number of additional tests for pen injectors is available at EndoLab®.