NEN EN ISO 11608-5 : 2012
Current
The latest, up-to-date edition.
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS
23-11-2012
Defines requirements and test methods for the following needle-based injection systems with automated functions (referred to in the standard as NIS-AUTO), for the administration of medicinal products in humans: - drug product preparation (e.g. reconstitution); - needle preparation; - air removal; - priming; - dose setting; - actuation; - needle insertion; - injection of the medicinal product; - needle retraction; - disabling the NIS-AUTO; - needle shielding or hiding; - sharps injury protection; - needle removal.
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