Norm

IEC 60601-2-50:2020 en;fr

Medisch-elektrische toestellen - Deel 2-50: Bijzondere veiligheidseisen en essentiële prestatie van fototherapie toestellen voor kinderen

188,85 205,85 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 61
Commissie Medische elektrische toestellen
Gepubliceerd op 01-09-2020
Taal Engels, Frans
IEC 60601-2-50 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANTPHOTOTHERAPY EQUIPMENT, as defined in 201.3.203, also referred to as ME EQUIPMENT.If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or toME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not thecase, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMSwithin the scope of this document are not covered by specific requirements in this document,except in 7.2.13 and 8.4.1 of the general standard. This particular standard specifies safety requirements for INFANT PHOTOTHERAPY EQUIPMENT,but alternate methods of compliance with a specific clause by demonstrating equivalent safetywill not be judged as non-compliant if the MANUFACTURER has demonstrated in his RISKMANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of anacceptable level when weighed against the benefit of treatment from the device.

Details

ICS-code 11.040.60
Nederlandse titel Medisch-elektrische toestellen - Deel 2-50: Bijzondere veiligheidseisen en essentiële prestatie van fototherapie toestellen voor kinderen
Engelse titel Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
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