Standards Development

Scope

The scope of the proposed work item is to clearly describe the biocontainment systems intended for the ambulance transportation of infectious patients.

Proposal for Scope: The standard specifies the requirements for design, the minimum performance level and testing of the biocontainment systems. It aims to ensure maximum protection for operators from exposure to infectious agents, patient’s safety and comfort and ergonomic handling.

Purpose

The recent health emergency situation due to Covid-19 pandemic has highlighted the widespread need for protected transport (in biocontainment) of infectious or potentially infectious patients.

New products have appeared among the ambulance equipment. However, the lack of a reference standard did not allow to harmonize the performances of these systems and to guarantee their correct use within the operating procedures of the emergency medical service professionals.

This standard intends to fill this gap by defining requirements for design and minimum performance level for such transport systems. In accordance to the “European Medical Device Nomenclature” (EMDN), which is recalled in the Regulation (EU) 2017/745 on medical devices, systems such as biocontainment stretchers are classified within the class “Patient transfer equipment”, in the relative sub-class “Patient transfer stretchers”. For this reason, the standardisation of biocontainment systems is proposed as a new work item within the EN 1865 series.

The main topics to be discussed about biocontainment systems are: (i) performance of the system, (ii) safety of the system, (iii) interoperability, (iv) patient comfort and handling ergonomics, (v) dynamic crash test and (vi) link with Medical Device Regulation.