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Standard

NEK IEC 60601-2-51:2003

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Omfang

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; - analyzing 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 analyzing electrocardiographs.

Dokumentinformasjon

  • Standard fra NEK
  • Publisert:
  • Tilbaketrukket:
  • Utgave: 1.0
  • Versjon: 1
  • Varetype: NAT
  • Products.Specs.pages
  • ICS 11.040.60
  • National Committee NEK/NK62A+D (Arbeidsområdet ivaretas av NK62)

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