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BS EN 60601-2-8 : 2015

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BS EN 60601-2-8 : 2015

MEDICAL ELECTRICAL EQUIPMENT - PART 2-8: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF THERAPEUTIC X-RAY EQUIPMENT OPERATING IN THE RANGE 10 KV TO 1 MV

British Standards Institution

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Table of Contents

FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME
       EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME
       SYSTEMS
201.7 ME EQUIPMENT identification, marking
       and documents
201.8 Protection against electrical HAZARDS from
       ME EQUIPMENT
201.9 Protection against MECHANICAL HAZARDS
       of ME EQUIPMENT and ME SYSTEMS
201.10 Protection against unwanted and excessive
       radiation HAZARDS
201.11 Protection against excessive temperatures and
       other HAZARDS
201.12 Accuracy of controls and instruments and protection
       against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT
       and ME SYSTEMS
Bibliography
Index of defined terms used in this particular standard
Annex ZA (normative) - Normative references to
         international publications with their
         corresponding European publications
Annex ZZ (informative) - Coverage of Essential
         Requirements of EU Directives

Abstract

Pertains to the basic safety and essential performance of therapeutic X-RAY EQUIPMENT with NOMINAL X-RAY TUBE VOLTAGES in the range 10 kV to 1 MV when connected to alternating current SUPPLY MAINS, hereafter referred to as ME EQUIPMENT.

General Product Information

Document Type Standard
Status Current
Publisher British Standards Institution
Committee CH/62/3
Supersedes
  • 14/30311404 DC : DRAFT AUG 2014
  • BS 5724-2.8(1998) : 1998
  • 96/560671 DC : MAR 96
  • BS 5724-2.8(1987) : 1987
  • 09/30182052 DC : DRAFT MAY 2009