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Needle-based injection systems for medical use. Requirements and test methods - Automated functions
Description
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)
The lowest possible amount of each PAH which can be distinguished from the baseline noise has not been determined
A second objective is to determine if any correlations exist between any of the measured properties of the methods
Why should you use PD CEN/TS 16818 – Moisture dynamics of wood-based products
for example on-site tests
BS EN 16805 discusses safety requirements
BS EN 12697-8:2018 supersedes BS EN 12697‑8:2003
upstream and downstream of the unit
is outside the scope of this Technical Report
darkroom conditions
General principles for design
Periodic re-verification
Definition of the context
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