Norm

IEC 60601-2-20:2020-RL en

Medische elektrische toestellen - Deel 2-20: Bijzondere eisen voor de veiligheid en de essentiële prestatie van transportcouveuses (Redline versie met track changes)

293,86 320,31 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 92
Commissie Medische elektrische toestellen
Gepubliceerd op 01-09-2020
Taal Engels
IEC 60601-2-20 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANTTRANSPORT INCUBATOR equipment, as defined in 201.3.208, 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.NOTE See also 4.2 of the general standard.This particular standard specifies safety requirements for INFANT TRANSPORT INCUBATORS, butalternate methods of compliance with a specific clause, by demonstrating equivalent safety,will 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. - THIS REDLINE VERSION PROVIDES YOU WITH QUICK AND EASY WAY TO COMPARE ALL THE CHANGES BETWEEN THIS STANDARD AND ITS PREVIOUS EDITION. A VERTICAL BAR APPEARS IN THE MARGIN WHEREVER A CHANGE HAS BEEN MADE. ADDITIONS AND DELETIONS ARE DISPLAYED IN RED, WITH DELETIONS BEING STRUCK THROUGH.

Details

ICS-code 11.040.10
Nederlandse titel Medische elektrische toestellen - Deel 2-20: Bijzondere eisen voor de veiligheid en de essentiële prestatie van transportcouveuses (Redline versie met track changes)
Engelse titel Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators (Redline version with track changes)

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