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

Defines requirements for safety of electrically operated hospital beds, and to keep the safety as low as possible for patients and operators. ALSO NUMBERED AS BS 5724:PT2:SEC2.38(1997)