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SN EN 60601-2-51 : 2003
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-51: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS
01-12-2013
INTRODUCTION<br>SECTION ONE - GENERAL<br>1 Scope and object<br>2 Terminology and definitions<br>4 General requirements for tests<br>6 Identification, marking and documents<br>SECTION TWO - ENVIRONMENTAL CONDITIONS<br>SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS<br>SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS<br>SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED<br> OR EXCESSIVE RADIATION<br>SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF<br> FLAMMABLE ANAESTHETIC MIXTURES<br>SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES<br> AND OTHER SAFETY HAZARDS<br>SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION<br> AGAINST HAZARDOUS OUTPUT<br>50 Accuracy of operating data<br> 50.101 Automated measurements on ECGs (for ANALYSING<br> ELECTROCARDIOGRAPHS)<br> 50.102 Automated ECG interpretation (for ANALYSING<br> ELECTROCARDIOGRAPHS)<br>51 Protection against hazardous output<br> 51.101 LEADS<br> 51.102 Input circuit<br> 51.103 CALIBRATION<br> 51.104 SENSITIVITY<br> 51.105 Reduction of the effects of unwanted external<br> voltages<br> 51.106 Base-line<br> 51.107 Distortion<br> 51.108 Printing, electronic storage and transmission<br> 51.109 Use with cardiac pacemakers<br>SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS;<br> ENVIRONMENTAL TESTS<br>SECTION TEN - CONSTRUCTIONAL REQUIREMENTS<br>56 Components and general assembly<br> 56.7 BATTERIES<br>Appendix L (normative) References - Publications<br> mentioned in this standard<br>Annex AA (informative) General guidance and rationale<br>Annex BB (informative) ELECTRODES, their positions,<br> identifications and colour codes<br>Annex CC (informative) LEADS and their identification <br> (other than described in 51.101)<br>Annex DD (informative) Polarity of PATIENT LEADS<br> (other than those specified in 51.101)<br>Annex EE (informative) Additional marking of electrodes<br>Annex FF (informative) Noise<br>Annex GG (normative) Definitions and rules for the<br> measurement of ELECTROCARDIOGRAMS<br>Annex HH (normative) Calibration and test data sets<br>Annex II (informative) CTS test atlas<br>Annex ZA (normative) Normative references to international <br> publications with their corresponding European publications<br>Annex ZB (normative) Other international publications mentioned in<br> this standard with the reference of the relevant European <br> publications<br>Bibliography<br>INDEX OF DEFINED TERMS<br>Figures<br>Tables
Describes 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.
DocumentType |
Standard
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PublisherName |
Swiss Standards
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Status |
Current
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Standards | Relationship |
DIN EN 60601-2-51 : 2004 | Identical |
NF EN 60601-2-51 : 2005 | Identical |
EN 60601-2-51:2003 | Identical |
I.S. EN 60601-2-51:2003 | Identical |
UNE-EN 60601-2-51:2005 | Identical |
NBN EN 60601-2-51 : 2004 | Identical |
BS EN 60601-2-51:2003 | Identical |
IEC 60601-2-51:2003 | Identical |
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