ISO 11608-5 | Mecmesin

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This part of ISO 11608 specifies requirements and test methods for the automated functions of needle-based injection systems with automated functions (NIS-AUTO), for the administration of medicinal products in humans.

Reference is made to the need for force and/or torque testing in certain sections covering priming, dose setting, actuation, needle insertion and retraction, disabling the NIS-AUTO, needle shielding, needle hiding, sharps injury protection and needle removal. Foir example: "according to the instructions for use there shall be measurements made, where appropriate (for example, torque to rotate a safety lock or force to operate a button)"

Test types

needle penetration

Torque to turn

Industries

Medical & Medical Device

Pharmaceuticals

Products tested

Medical devices and aids

ISO 11608-5_{Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions}

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ISO 11608-5_{Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions}