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Specification and demonstration of system reliability of single-use drug delivery systems
This document addresses the specification and demonstration of capability and system reliability to successfully deliver a medicinal product as part of design verification and manufacture, utilizing empirical methods as well as modelling.
This includes risk-based techniques to establish and demonstrate the required reliability level for all disposable single use drug delivery systems (DDSs) for which there is a single opportunity to deliver a single dose of a medicinal product.
DDSs covered by this document include, but are not limited to:
This document does not cover:
In this document system reliability is limited to assessing functional performance of the DDS and does not address human factors or user interface considerations.
These will be covered by a usability engineering program in accordance with IEC 62366-1.
NOTE DDSs not in scope of this document can still benefit from elements in this document but provisions of this document might not completely fulfil the basic safety and effectiveness of such DDSs.
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