PN EN ISO 11608-5 : 2013

Describes 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, 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.