prEN IEC 80601-2-52:2024

Clause 1 of the general standard1) 229 applies, except as follows:
201.1.1  Scope
Replacement:
This International Standard 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 scope are both electrical and non-electrical (manual) MEDICAL BEDS with or without adjustable features.
This standard does not apply for MEDICAL BEDS intended for CHILDREN covered by IEC 80601-2-89 Medical electrical equipment – Particular requirements for the basic safety and essential performance of medical beds for children.
A BED-LIFT and/or a detachable MATTRESS SUPPORT PLATFORM in combination with a compatible non-MEDICAL BED as specified by the MANUFACTURER is also considered a MEDICAL BED.
Excluded are devices for which the intended use is mainly for examination or transportation under medical supervision (e.g. stretcher, examination table).
This standard does not apply in all requirements to MEDICAL BEDS with special functionality. Beds that are intended to be used for ADULTS with atypical anatomy shall state what atypical anatomies are meant. Additional requirements for the stated atypical anatomies shall be determined in the product RISK MANAGEMENT process and implemented as appropriate in the bed design.
EXAMPLE A bed intended for bariatric PATIENTS would require consideration of the differences in anthropomorphic ranges, and having implemented those ranges would label appropriately for the intended PATIENT population.
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 standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.