IEC 60601-2-51:2003
Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
OVERVIEW
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.
COMMENTS
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PRODUCT DETAILS
| Status | Withdrawn - 02 Jan 2026 |
|---|---|
| Edition | 2003 |
| No. of Pages | 175 |
| ICS Classification | 11.040.60 Therapy equipment |
| Committee | TC 62/SC 62D |
| Available for Purchase | For sale in Singapore only |
| Adoption | IEC : 0 |