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IEC 60601-2-40 : 2016

M00031105

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IEC 60601-2-40 : 2016

MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROMYOGRAPHS AND EVOKED RESPONSE 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 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 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
202 ELECTROMAGNETIC DISTURBANCES - Requirements
    and tests
Annexes
Annex C (informative) - Guide to marking and labelling
        requirements for ME EQUIPMENT and ME
        SYSTEMS
Annex AA (informative) - Particular guidance and rationale
Bibliography
Index of defined terms used in this particular standard

Abstract

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT.

General Product Information

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