PD ISO/TS 4452:2025

1 Scope 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:

needle-based injection systems ( ISO 11608‑1 ); needle-free injection systems ( ISO 21649 ); aerosol drug delivery systems ( ISO 20072 ).

This document does not cover:

DDSs with containers that can be replaced; DDSs i...