dnaSRPS EN IEC 80601-2-52:2024

Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds for adults

Scope

IEC 80601-2-52:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS as defined in 201.3.214, intended for ADULTS as defined in 201.3.222. Included in the scope are both electrical and non-electrical (manual) MEDICAL BEDS with or without adjustable functions.
This document is applicable to either a BED-LIFT or a detachable MATTRESS SUPPORT PLATFORM or both. The combination of BED-LIFT or a detachable MATTRESS SUPPORT PLATFORM with a compatible non-MEDICAL BED as specified by the MANUFACTURER is also considered a MEDICAL BED.
This document does not apply to:
- MEDICAL BEDS for CHILDREN and ADULTS with atypical anatomies (ADULTS ranging outside the definition for ADULTS in 202.3.222) covered by IEC 80601-2-89;
- SPECIALITY MATTRESS covered by ISO 20342 series;
- devices for which the INTENDED USE is mainly for examination or transportation under medical supervision (e.g. stretcher, examination table);
- all requirements for MEDICAL BEDS with special functionality.
If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MEDICAL BED and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of MEDICAL BED or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.