ISO/TS 4452:2025

OVERVIEW

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 intended for dental use;

—     finished needles;

—     empty syringes;

—     catheters;

—     DDSs for multi-patient use;

—     pumps [IEC 60601-2-24 (if electronic) or ISO 28620 (if non-electronic)];

—     stand-alone prefilled syringes defined by ISO 11040-8.

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

COMMENTS

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