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BS EN 60601-2-64 : 2015

MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL 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 of ME<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;EQUIPMENT<br>201.6 Classification of ME EQUIPMENT and<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ME SYSTEMS<br>201.7 ME EQUIPMENT identification, marking<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and 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 radiation<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;HAZARDS<br>201.11 Protection against excessive temperatures and other<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;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<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;for 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<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;EQUIPMENT and ME SYSTEMS<br>201.101 ELECTRONIC IMAGING DEVICES (EID)<br>206 Usability<br>Annexes<br>Annex B (informative) - Sequence of testing<br>Annex I (informative) - ME SYSTEMS aspects<br>Bibliography<br>Index of defined terms used in this particular 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 Light Ion Beam Medical Electrical equipment, hereafter referred to as ME equipment, used for treatment of patients.

General Product Information

Document Type Standard
Status Current
Publisher British Standards Institution
Committee CH/62/3
Supersedes
  • 13/30216789 DC : 0