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BS EN 60601-2-68 : 2015

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BS EN 60601-2-68 : 2015

MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT

British Standards Institution

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Table of Contents

FOREWORD<br>INTRODUCTION<br>201.1 Scope, object and related standards<br>201.2 Normative references<br>201.3 Terms and definitions<br>201.4 General requirements<br>201.5 General requirements for testing ME<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;EQUIPMENT<br>201.6 Classification of me equipment and me<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;systems<br>201.7 ME EQUIPMENT identification, marking and<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;documents<br>201.8 Protection against electrical HAZARDS from<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ME EQUIPMENT<br>201.9 Protection against MECHANICAL HAZARDS<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of ME EQUIPMENT and ME SYSTEMS<br>201.10 Protection against unwanted and excessive<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;radiation HAZARDS<br>201.11 Protection against excessive temperatures and<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;other HAZARDS<br>201.12 Accuracy of controls and instruments and protection<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;against hazardous outputs<br>201.13 Hazardous situations and fault conditions for<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;me equipment<br>201.14 PROGRAMMABLE ELECTRICAL MEDICAL<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;SYSTEMS (PEMS)<br>201.15 Construction of me equipment<br>201.16 ME SYSTEMS<br>201.17 Electromagnetic compatibility of ME EQUIPMENT<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and ME SYSTEMS<br>201.101 Reference data for X-IGRT<br>201.102 X-IGRT IMAGING<br>201.103 IGRT analysis and correction<br>203 RADIATION protection in diagnostic X-RAY EQUIPMENT<br>206 Usability<br>Annex B (informative) - Sequence of testing<br>Annex I (informative) - ME SYSTEMS aspects<br>Annex AA (informative) - Particular guidance and rationale<br>Annex BB (informative) - Measuring CTDIfree air<br>Bibliography<br>Index of defined terms used in this standard<br>Annex ZA (normative) - Normative references to<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;international publications with their<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;corresponding European publications<br>Annex ZZ (informative) - Coverage of Essential<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Requirements of EU Directives

Abstract

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-ray based IMAGE-GUIDED RADIOTHERAPY equipment for use with EXTERNAL BEAM EQUIPMENT (EBE).

General Product Information

Document Type Standard
Status Current
Publisher British Standards Institution
Committee CH/62/3
Supersedes
  • 12/30246621 DC : 0