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Standards Development
This standard applies to the basic safety and essential performance of stationary and transportable medical couches with a lying support surface. Note 1 Contracting parties might wish to consider if this document or specific clauses or subclauses can be used for non-medical couches with similar functionality (e.g. usage for cosmetics, wellness, tattooing). This standard does not apply to: Couches intended for use in rescue services (these are covered by EN 1789). Patient positioning systems defined in the scope of EN 60601-2-46. Patient positioning systems of diagnostic, interventional and therapeutic facilities (see IEC 60601-2-54 or IEC 60601-2-43) Medical beds (see IEC 80601-2-52 and IEC 80601-2-89). Field operating tables Dental patient chairs (see ISO 7494-1) Stretchers (see DIN 13024-N) Products where the patient enters primarily in a sitting position and the product is used in a sitting position of the patient Products used for transporting patients according to their intended use (e.g., stretchers, transport couches, recovery couches) Wall- mounted folding couches
The committee responsible for this document is the German national working group UK 812.9 Patientenlagerungs einrichtungen of the DKE (German Commission for Electrical, Electronic and Information Technologies) of DIN and VDE. The German National Committee has published this document as a VDE pre-standard. The German National Committee has prepared this document because of the appearance of additional hazards and the occurrence of several terminal accidents during the use of couches in practice. These hazards are not specifically addressed by applying the general standard of the EN IEC 60601 series.
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