The standard VDE 0750-2-52 - Therapy tables is currently in the preliminary standardisation stage
Medical electrical equipment - Part 2-52-2: Particular requirements for the safety, including essential performance, of couches.
Therapy tables are used by the therapist(s) to treat patients in physiotherapy and offer various positioning options for treatment. The majority are now height-adjustable using a foot switch. Due to several accidents in recent years in which cleaning staff were injured, some of them fatally, the supervisory authorities have become active and the hazard potential of the VDE V 0750-2-52-2:2021 standard has been investigated in more detail. The main cause of the incidents were foot switches that were unintentionally operated by the cleaning staff and activated the height adjustment of the therapy bed.
This preliminary standard defines safety objectives and design features in combination with the DIN EN 60601-1 series that prevent these hazards. DKE/UK 812.9 "Patient positioning equipment" of DKE Deutsche Kommission Elektrotechnik Elektronik Informationstechnik in DIN and VDE (Verband der Elektrotechnik Elektronik und Informationstechnik e.V.) is responsible.
Department Dr Renate Förch
Stresemannallee
60596 Frankfurt am Main
renate.foerch@vde.com
Phone +49 69 6308 344
Many beds today fulfil the requirements of EN 60601-2-52 (Particular requirements for the safety, including essential performance, of medical beds), probably due to a lack of other applicable standards, although these were explicitly excluded;
EN 60601-2-52 cl 201.3.213: "Excluded are devices whose INTENDED USE is support during examination or transport under medical supervision (e.g. patient transport stretcher, examination table)". This closes the gap in product-specific verification of treatment tables.
According to MTD-Instant, manufacturers have criticised the fact that the preliminary standard does not take into account the actual purpose of couches, but equates them with medical beds (see EN 60601-2-52) in terms of test lists, permanent loads, safety distances, designs and versions. The beds would only be operated by specialised staff and not predominantly by patients like beds.
Further standards in focus can be found here:
- DIN EN ISO 80601-2-70:2021-06 Medical electrical equipment
-
DIN EN ISO 15223-1:2020-04 - Draft
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