IEC 60601-2-68 : 1ED 2014

IEC 60601-2-68 : 1ED 2014

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

International Electrotechnical Committee

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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
        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 for
        me equipment
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
201.101 Reference data for X-IGRT
201.102 X-IGRT IMAGING
201.103 IGRT analysis and correction
203 RADIATION protection in diagnostic X-RAY EQUIPMENT
206 Usability
Annex B (informative) - Sequence of testing
Annex I (informative) - ME SYSTEMS aspects
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Measuring CTDI[free air]
Bibliography
Index of defined terms used in this standard

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 International Electrotechnical Committee
Committee TC 62

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