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prEN IEC 80601-2-89:2024

Medical electrical equipment - Part 2-89: Particular requirements for the basic safety and essential performance of medical beds for children

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Kavand
Alusdokumendid
62D/2113/CDV; prEN IEC 80601-2-89:2024
Tegevusala (ICS grupid)
11.140 Haiglavarustus
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Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
Replacement:
This standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS, hereafter referred to as MEDICAL BEDS as defined in 201.3.219, intended for CHILDREN as defined in 201.3.207, and ADULTS with atypical anatomy (ADULTS ranging outside the definition for ADULTS in 201.3.201).
This standard applies to electrical or non-electrical MEDICAL BEDS with nonadjustable and electrical / mechanical adjustable functions.
This standard applies to MEDICAL BEDS with an INTERNAL LENGTH of up to 180 cm suitable to a body length of 155 cm.
NOTE 1 The limitation of 180 cm is in order to minimize the foreseeable misuse, of a parent sharing the bed with the child or that the bed will be used by an ADULT.
If a manufacturer wishes to make a bed that can be used by both a child and an ADULT, e.g. INTERNAL LENGTH of 180 cm or more, then it shall fulfil both IEC 80601-2-52 and this particular standard.
This Standard does not apply to:
• ADULT only beds covered by IEC 80601-2-52
• incubators covered by IEC 60601-2-19;
• devices for which the INTENDED USE is mainly for examination or transportation under medical supervision (e.g. stretcher, examination table).
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 BEDS and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of MEDICAL BEDS 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.

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