Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 General requirements and requirements for tests<br>5 Classification<br>6 Identification, marking and documents<br>7 Power input<br>8 Basic safety categories<br>9 Removable protective means<br>10 Environmental conditions<br>11 Not used<br>12 Not used<br>13 General<br>14 Requirements related to classification<br>15 Limitation of voltage and/or energy<br>16 Enclosures and protective covers<br>17 Separation<br>18 Protective earthing, functional earthing and potential <br> equalization<br>19 Continuous leakage currents and patient auxiliary currents<br>20 Dielectric strength<br>21 Mechanical strength<br>22 Moving parts<br>23 Surfaces, corners and edges<br>24 Stability in normal use<br>25 Expelled parts<br>26 Vibration and noise<br>27 Pneumatic and hydraulic power<br>28 Suspended masses<br>29 X-Radiation<br>30 Alpha, beta, gamma, neutron radiation and other particle <br> radiation<br>31 Microwave radiation<br>32 Light radiation (including lasers)<br>33 Infra-red radiation<br>34 Ultraviolet radiation<br>35 Acoustical energy (including ultrasonics)<br>36 Electromagnetic compatibility<br>37 Locations and basic requirements<br>38 Marking, accompanying documents<br>39 Common requirements for category AP and category APG <br> equipment<br>40 Requirements and tests for category AP equipment, parts <br> and components thereof<br>41 Requirements and tests for category APG equipment, parts <br> and components thereof<br>42 Excessive temperatures<br>43 Fire prevention<br>44 Overflow, spillage, leakage, humidity, ingress of liquids, <br> cleaning, sterilization, disinfection and compatibility<br>45 Pressure vessels and parts subject to pressure<br>46 Human errors<br>47 Electrostatic charges<br>48 Biocompatibility<br>49 Interruption of the power supply<br>50 Accuracy of operating data<br>51 Protection against hazardous output<br>52 Abnormal operation and fault-conditions<br>53 Environmental tests<br>54 General<br>55 Enclosures and covers<br>56 Components and general assembly<br>57 Mains parts, components and layout<br>58 Protective earthing - Terminals and connections<br>59 Construction and layout<br>101 Signal inadequacy<br>102 Pulse oximeter probes and probe cable extenders<br>103 Saturation pulse information signal<br>104 Alarm systems<br>105 Appendices of IEC 60601-1:1988<br>Annex AA (informative) - Rationale<br>Annex BB (informative) - Skin temperature at the pulse <br> oximeter probe<br>Annex CC (informative) - Determination of accuracy<br>Annex DD (informative) - Calibration standards<br>Annex EE (informative) - Guideline for evaluating and <br> documenting SpO[2] accuracy in human subjects<br>Annex FF (informative) - Simulators, calibrators and <br> functional testers for pulse oximeter equipment<br>Annex GG (informative) - Concepts of equipment response <br> time<br>Annex HH (informative) - Reference to the Essential <br> Principles<br>Annex II informative) - Environmental aspects<br>Annex JJ (informative) - Index of defined terms<br>Bibliography