SN EN 60601-2-38 : 1996 AMD 1 2000

Committees responsible<br>National foreword<br>Foreword<br>Section 1 - General<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 2 - Environmental conditions<br>Section 3 - Protection against electrical shock hazards<br>17 Separation<br>18 Protective earthing, functional earthing and potential <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;equalization<br>Section 4 - Protection against mechanical hazards<br>21 Mechanical strength<br>22 Moving parts<br>23 Surface, corners and edges<br>24 Stability in normal use<br>26 Vibration and noise<br>28 Suspended masses<br>Section 5 - Protection against hazards from unwanted or <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;excessive radiation<br>36 Electromagnetic compatibility<br>Section 6 - Protection against hazards of ignition of <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;flammable anaesthetic mixtures<br>Section 7 - Protection against excessive temperatures and <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;other safety hazards<br>44 Overflow, spillage, leakage, humidity, ingress of <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;liquids, cleaning, sterilization and disinfection<br>Section 8 - Accuracy of operating data and protection against<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;hazardous output<br>Section 9 - Abnormal operation and fault conditions; <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;environmental tests<br>52 Abnormal operation and fault conditions<br>Section 10 - Constructional requirements<br>54 General<br>56 Components and general assembly<br>57 MAINS PARTS, components and layout<br>Appendix L - References - Publications mentioned in this <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;standard<br>Annex AA (informative) Guidance and rationale for particular <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;subclauses<br>Annex BB (informative) Possible considerations and tests for <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ELECTRICALLY OPERATED HOSPITAL BEDS<br>Annex ZA (normative) Normative references to international <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;publications with their corresponding <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;European publications<br>Figure 101 - ELECTRICALLY OPERATED HOSPITAL BED, general <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;arrangement<br>Figure 102 - Distribution of the SAFE WORKING LOAD for tests<br>Figure 103 - Lateral stability test: load arrangement (plan<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;view)<br>Figure 104 - Longitudinal stability test: load arrangement <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(plan view)<br>Figure 105 - Lateral stability test: load arrangement (end <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;elevation)<br>Figure 106 - Longitudinal stability test: load arrangement <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(side elevation)<br>Figure 107 - BED function controls and/or actuators; <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;guidelines for creating graphic symbols<br>Figure 108 - Graphic symbols for SAFE WORKING LOAD<br>Figure 109 - Typical spacings for SQUEEZING and SHEARING <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;POINTS<br>Figure 110 - Clearance measurements around barriers<br>Figure 111 - APPLIED PARTS region and potential equalization<br>Figure 112 - Minimum angle between the back and leg/upper <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;leg sections for various configurations of the <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;MATTRESS SUPPORT PLATFORM<br>Figure 113 - Application of forces for test of SIDE RAILS<br>Figure 114 - Examples (only) of BEDS with segmented SIDE <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;RAILS and single-piece SIDE RAILS<br>Figure 115 - Test cone<br>Figure BB.1 - Impactor<br>Figure BB.2 - Loading positions<br>Figure BB.3 - Loading pad<br>Figure BB.4 - Recommended range of adjustment for sections of<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;the MATTRESS SUPPORT PLATFORM<br>Figure BB.5 - Position of the LIFTING POLE handle