ISO/TS 4452:2025

Description

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 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.