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IEC 60601-2-1 : 3.1

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IEC 60601-2-1 : 3.1

MEDICAL ELECTRICAL EQUIPMENT - PART 2-1: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTRON ACCELERATORS IN THE RANGE 1 MEV TO 50 MEV

International Electrotechnical Committee

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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 EQUIPMENT <br>201.6 Classification of ME EQUIPMENT and ME SYSTEMS<br>201.7 ME EQUIPMENT identification, marking and documents<br>201.8 Protection against electrical HAZARDS from ME EQUIPMENT<br>201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and ME SYSTEMS<br>201.10 Protection against unwanted and excessive radiation <br>&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;HAZARDS<br>201.12 Accuracy of controls and instruments and protection <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;against hazardous outputs<br>201.13 HAZARDOUS SITUATIONS and fault conditions <br>201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)<br>201.15 Construction of ME EQUIPMENT<br>201.16 ME SYSTEMS <br>201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ME SYSTEMS <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

Abstract

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTRON ACCELERATORS, hereafter referred to as ME EQUIPMENT, in the range 1 MeV to 50 MeV, used for treatment of PATIENTS.

General Product Information

Document Type Standard
Status Current
Publisher International Electrotechnical Committee
Committee TC 62