Norm

NEN-EN-IEC 60601-2-51:2003 en

Medische elektrische toestellen - Deel 2-51: Speciale eisen voor veiligheid, inclusief essentiƫle prestaties, van opname en analyserend enkel- en meer-kanaals electrocardiografen

  • Deze norm is ingetrokken sinds 15-12-2011

191,11

Over deze norm

Status Ingetrokken
Aantal pagina's 83
Commissie Medische elektrische toestellen
Gepubliceerd op 01-08-2003
Taal Engels
Establishes particular requirements, in addition to the requirements of IEC 60601-2-25, for the safety, including essential performance of recording and analysing single channel and multichannel electrocardiographs. These requirements shall apply particularly to;recording electrocardiographs;;electrocardiographs which are part of other medical electrical equipment, for example exercise testing systems, if this equipment is used to record ECGs for diagnostic purposes;;electrocardiographs which are used as output units for ECG data base management systems or electrocardiographs which are used as output units located at other places than the recording unit;;analysing electrocardiographs, systems, and computing devices which by means of electronic data processing and pattern recognition derive measurements (e.g. intervals and amplitudes) and diagnostic statements from the ECG;;those parts of patient monitors or other specialised electrocardiographs that are capable of performing the functions of the analysing electrocardiographs.

Details

ICS-code 11.040.55
Nederlandse titel Medische elektrische toestellen - Deel 2-51: Speciale eisen voor veiligheid, inclusief essentiƫle prestaties, van opname en analyserend enkel- en meer-kanaals electrocardiografen
Engelse titel Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
Vervangen door
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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