Norm

NEN-EN-IEC 60601-2-25:2015 en

Medische elektrische toestellen - Deel 2-25: Bijzondere eisen voor de veiligheid en essentiƫle prestatie van elektrocardiografen

271,71

Over deze norm

Status Definitief
Aantal pagina's 100
Commissie Medische elektrische toestellen
Gepubliceerd op 01-10-2015
Taal Engels
NEN-EN-IEC 60601-2-25 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHS as defined in 201.3.63 intended by themselves or as a part of an ME SYSTEM, for the production of ECG REPORTS for diagnostic purposes, hereinafter referred to as ME EQUIPMENT. Not included within the scope of this particular standard are: a) the part of ME EQUIPMENT that provides vectorcardiographic loops; b) ambulatory electrocardiographic ME EQUIPMENT covered by IEC 60601-2-47 where not intended for obtaining ECG REPORTS for diagnostic purposes; c) cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining ECG REPORTS for diagnostic purposes.

Details

ICS-code 11.040.55
11.040.99
Nederlandse titel Medische elektrische toestellen - Deel 2-25: Bijzondere eisen voor de veiligheid en essentiƫle prestatie van elektrocardiografen
Engelse titel Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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