This part of ISO 11608 specifies requirements and test methods for the automated functions of needle-basedinjectionsystemswithautomatedfunctions(NIS-AUTO),fortheadministrationofmedicinalproductsinhumans,including but not limited to:a) drug product preparation (e.g. reconstitution);b) needle preparation;c) air removal;d) priming;e) dose setting;f) actuation;g) needle insertion;h) injection of the medicinal product;i) disabling the NIS-AUTO;j) needle retraction;k) needle shielding;l) needle hiding;m) sharps injury protection;n) needle removal.
EN ISO 11608-5:2012 history
2023EN ISO 11608-5:2023 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)
2012EN ISO 11608-5:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)