SN EN 60601-2-51 : 2003

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>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;OR EXCESSIVE RADIATION<br>SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;FLAMMABLE ANAESTHETIC MIXTURES<br>SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;AND OTHER SAFETY HAZARDS<br>SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;AGAINST HAZARDOUS OUTPUT<br>50 Accuracy of operating data<br>&nbsp;&nbsp;&nbsp;50.101 Automated measurements on ECGs (for ANALYSING<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ELECTROCARDIOGRAPHS)<br>&nbsp;&nbsp;&nbsp;50.102 Automated ECG interpretation (for ANALYSING<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ELECTROCARDIOGRAPHS)<br>51 Protection against hazardous output<br>&nbsp;&nbsp;&nbsp;51.101 LEADS<br>&nbsp;&nbsp;&nbsp;51.102 Input circuit<br>&nbsp;&nbsp;&nbsp;51.103 CALIBRATION<br>&nbsp;&nbsp;&nbsp;51.104 SENSITIVITY<br>&nbsp;&nbsp;&nbsp;51.105 Reduction of the effects of unwanted external<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;voltages<br>&nbsp;&nbsp;&nbsp;51.106 Base-line<br>&nbsp;&nbsp;&nbsp;51.107 Distortion<br>&nbsp;&nbsp;&nbsp;51.108 Printing, electronic storage and transmission<br>&nbsp;&nbsp;&nbsp;51.109 Use with cardiac pacemakers<br>SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS;<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ENVIRONMENTAL TESTS<br>SECTION TEN - CONSTRUCTIONAL REQUIREMENTS<br>56 Components and general assembly<br>&nbsp;&nbsp;&nbsp;56.7 BATTERIES<br>Appendix L (normative) References - Publications<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;mentioned in this standard<br>Annex AA (informative) General guidance and rationale<br>Annex BB (informative) ELECTRODES, their positions,<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;identifications and colour codes<br>Annex CC (informative) LEADS and their identification <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(other than described in 51.101)<br>Annex DD (informative) Polarity of PATIENT LEADS<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(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>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;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>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;publications with their corresponding European publications<br>Annex ZB (normative) Other international publications mentioned in<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;this standard with the reference of the relevant European <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;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.