Needle-based injection systems for medical use. Requirements and test methods - Automated functions1 Scope 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, 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)

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Advanced manufacturing techniques increasingly dependent upon digital data transfer

compared to the previous edition

but complementary

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Why use the standard

With obedience and compliance of BS EN 15360

BS EN 14134 elaborates on the different stages of the design

from 800 mm up to 3 000 mm nominal diameter