Medical electrical equipment - Part 2-52-2: Particular requirements for basic safety and essential performance of couches

Pre-standard

DIN VDE V 0750-2-52-2:2024-05

VDE V 0750-2-52-2:2024-05

Medical electrical equipment - Part 2-52-2: Particular requirements for basic safety and essential performance of couches

German title
Medizinische elektrische Geräte - Teil 2-52-2: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Liegen
Publication date
2024-05
Original language
German
Pages
45
Procedure
Pre-Standard

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Publication date
2024-05
Original language
German
Pages
45
Procedure
Pre-Standard

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Overview

This standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE CHARACTERISTICS of medical devices used for lying down. In addition, COUCHES without a medical INTENDED USE but with a similar function are covered by this standard if their risk profile is at the same level as that of a COUCH used for medical purposes. Not all criteria apply to compliance for some COUCHES (for example, electrical criteria do not apply to manually operated COUCHES). These special provisions do not apply to: - COUCHES intended for use in rescue services (these are covered by DIN EN 1789), - PATIENT positioning devices defined in the scope of DIN EN 60601-2-46, - PATIENT positioning devices for 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 in which the PATIENT/person enters primarily in a seated position and the product is used in the seated position of the PATIENT/person for non-medical and medical purposes, are not considered COUCHES and are not covered by this standard, - products that are used for the transport of PATIENTS/persons according to their INTENDED USE (for example, stretchers, transport stretchers, recovery stretchers), - Wall-mounted FOLDING COTS. The standard differs from DIN VDE V 0750-2-52-2 (VDE V 0750-2-52-2):2021-10 as follows: a) adjustment of the scope (201.1.1) with the exclusion of various patient positioning devices; b) additional defined terms, distinction between side rails and side guards; c) marking for safe working load, operating elements, and device functions; d) Subclause 201.9.1.101 has been deleted. A replacement paragraph has been added to the informative Annex AA; e) Subclause 201.9.2.2.1 Adjustment of the distances between fixed and moving parts of the lying surface; f) replacement of b) in Subclause 201.9.2.2.5 Continuous operation; g) addition to Subclause 201.9.4.2.2 Instability - lateral stability test and longitudinal stability test; h) Subclause 201.9.4.2.4.3 Movement over a threshold has been deleted; i) Subclause 201.9.8.3.3 Dynamic forces due to the load of persons has been amended; j) The requirements for side rails and side guards have been updated in Subclauses 201.9.8.3.3.3 and 201.9.101. This standard is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE CHARACTERISTICS of MEDICAL COUCHES designed for treatment at a stationary place of use and not intended for transport of PATIENTS/persons when used as INTENDED.

Replacement amendments

Cooperation at DIN

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