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BS EN 60601-2-3 : 2015

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BS EN 60601-2-3 : 2015

MEDICAL ELECTRICAL EQUIPMENT - PART 2-3: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SHORT-WAVE THERAPY EQUIPMENT (IEC 60601-2-3:2012)

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;EQUIPMENT<br>201.6 Classification of ME EQUIPMENT and<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ME SYSTEMS<br>201.7 ME EQUIPMENT identification, marking<br>&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;ME EQUIPMENT<br>201.9 Protection against MECHANICAL HAZARDS<br>&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;radiation HAZARDS<br>201.11 Protection against excessive temperatures and<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;other HAZARDS<br>201.12 Accuracy of controls and instruments and<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;protection against hazardous outputs<br>201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT<br>201.14 PROGRAMMABLE ELECTRICAL MEDICAL<br>&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;and ME SYSTEMS<br>Annexes<br>ANNEX C (informative) - Guide to marking and labelling<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;requirements for ME EQUIPMENT and ME SYSTEMS<br>Annex AA (informative) - Particular guidance and rationale<br>Index of defined terms used in this particular standard<br>Annex ZZ (informative) - Coverage of Essential<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Requirements of EU Directives

Abstract

Describes the requirements for the safety of SHORT-WAVE THERAPY EQUIPMENT, hereafter referred to as ME EQUIPMENT, as defined in subclause 201.3.206.

General Product Information

Document Type Standard
Status Current
Publisher British Standards Institution
Committee CH/62/4
Supersedes
  • BS 5724-2.3(1992) : 1992 AMD 7879
  • 10/30210934 DC : 0
  • 15/30322777 DC : 0
  • BS 5724-2.3(1983) : 1983
  • 97/560804 DC : MAR 97