SN EN 60601-2-35 : 1996

INTRODUCTION<br>1 Scope and object<br>2 Terminology and definitions<br>3 General requirements<br>5 Classification<br>6 Identification, marking and documents<br>SECTION TWO - ENVIRONMENTAL CONDITIONS<br>SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK <br>HAZARDS<br>17 Separation <br>19 Continuous leakage currents and patient auxiliary <br>&nbsp;&nbsp;&nbsp;&nbsp;currents<br>SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS<br>21 Mechanical strength<br>SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED<br>OR EXCESSIVE RADIATION<br>36 Electromagnetic compatibility<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>42 Excessive temperatures<br>44 Overflow, spillage, leakage, humidity, ingress of<br>&nbsp;&nbsp;&nbsp;&nbsp;liquids, cleaning, sterilization, disinfection and<br>&nbsp;&nbsp;&nbsp;&nbsp;compatibility<br>46 Human errors<br>49 Interruption of the power supply<br>SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION<br>AGAINST HAZARDOUS OUTPUT<br>50 Accuracy of operating data<br>51 Protection against hazardous output<br>SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS:<br>ENVIRONMENTAL TESTS<br>52 Abnormal operation and fault conditions<br>SECTION TEN - CONSTRUCTIONAL REQUIREMENTS<br>54 General<br>56 Components and general assembly<br>57 Mains parts, components and layout<br>59 Construction and layout<br>Figures<br>101aPositioning of temperature sensors on the contact<br>&nbsp;&nbsp;&nbsp;&nbsp;surface of the heated area of a heating device<br>101bExample of the positioning of temperature sensors<br>&nbsp;&nbsp;&nbsp;&nbsp;on the contact surface of the heated areas of a<br>&nbsp;&nbsp;&nbsp;&nbsp;heating device having more than one separately heated<br>&nbsp;&nbsp;&nbsp;&nbsp;area<br>102 Ramp for the impact test on pads<br>103 Partial covering conditions<br>104 Method of folding blankets<br>105 Examples of folds<br>106 Positions of a blanket for the ruck-resistance test<br>107aApparatus for the spark ignition test<br>107bDetails of an apparatus for the spark ignition test<br>108 Illustration of the main requirements of this <br>&nbsp;&nbsp;&nbsp;&nbsp;Standard<br>Appendix/Annexes<br>L References - publications mentioned in this standard<br>AA (informative) Rationale to particular subclause<br>BB (normative) Determination of the lagging material<br>CC (normative) Procedure for determining whether a<br>&nbsp;&nbsp;&nbsp;&nbsp;heating device provides high or low heat transfer<br>&nbsp;&nbsp;&nbsp;&nbsp;from the heat source to the contact surface (i.e.<br>&nbsp;&nbsp;&nbsp;&nbsp;towards the patient<br>DD (normative) Procedure for determining whether a heating<br>&nbsp;&nbsp;&nbsp;&nbsp;device provides high or low heat transfer from the<br>&nbsp;&nbsp;&nbsp;&nbsp;contact surface to the heat source (i.e. away from <br>&nbsp;&nbsp;&nbsp;&nbsp;the patient)<br>EE (normative) Normative references to international<br>&nbsp;&nbsp;&nbsp;&nbsp;publications with their corresponding European<br>&nbsp;&nbsp;&nbsp;&nbsp;publications<br>ZB (informative) Normative references to international<br>&nbsp;&nbsp;&nbsp;&nbsp;publications with their corresponding European<br>&nbsp;&nbsp;&nbsp;&nbsp;publications