Standards Development

Scope

This PWI document will specify requirements for medical devices used in road ambulances which are used for monitoring, treatment and care of patients.

This document is applicable to road ambulances capable of transporting at least one patient on a stretcher and excludes the transportation of hospital beds.

This document also specifies requirements for ambulances intended to carry transport incubator systems.

This document gives general requirements for medical devices carried in road ambulances and used therein and outside hospitals and clinics in situations where the ambient conditions can differ from normal indoor conditions.

Purpose

During the 63rd CEN/TC 239/WG 1 meeting it was agreed by recommendation Recommendation 2022-09 to split EN 1789:2020 in two parts and hence splitting requirements related to the vehicle and medical devices. This approach will follow the already existing structure established for air-ambulances (see EN 13718-1 and EN 13718-2). CEN/TC 239/WG 1 expects that splitting the existing EN 1789:2020 will simplify the application for the end user and produces a clearer structure. Furthermore, the requirements from MDR and type approval are expected to be implemented more easily. The final content of future EN1789-1 and EN1789-2 needs careful consideration and discussion. Those are complex and therefore the project should be registered as Preliminary Work Item (PWI). An ad-hoc group is asked to work out the possible new structure and content.