SSH EN 60601-2-51:2003

Pajisje mjekësore elektrike - Kërkesat e veçanta për sigurinë - Pjesa 2 - 51: Kërkesat e veçanta për sigurinë, përfshirë performancën thelbësore, të elektrokardiografëve të regjistrimit dhe analizës me një kanal të vetëm dhe shumëkanalësh.

Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

Scope

Establishes particular requirements, in addition to the requirements of EN 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.

Related directives

Directives related to this standards.