IEC 60601-1 : 3.1

MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE

International Electrotechnical Committee

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FOREWORD
INTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terminology and definitions
4 General requirements
5 General requirements for testing ME EQUIPMENT
6 Classification of ME EQUIPMENT and ME SYSTEMS
7 ME EQUIPMENT identification, marking and documents
8 Protection against electrical HAZARDS from ME EQUIPMENT
9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and
   ME SYSTEMS
10 Protection against unwanted and excessive radiation HAZARDS
11 Protection against excessive temperatures and other HAZARDS
12 Accuracy of controls and instruments and protection
   against hazardous outputs
13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT
14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
15 Construction of ME EQUIPMENT
16 ME SYSTEMS
17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
Annex A (informative) - General guidance and rationale
Annex B (informative) - Sequence of testing
Annex C (informative) Guide to marking and labelling
        requirements for ME EQUIPMENT and ME
        SYSTEMS
Annex D (informative) - Symbols on marking
Annex E (informative) - Examples of the connection of the
        measuring device (MD) for measurement
        of the PATIENT LEAKAGE CURRENT and
        PATIENT AUXILIARY CURRENT
Annex F (informative) - Suitable measuring supply circuits
Annex G (normative) - Protection against HAZARDS of ignition
        of flammable anaesthetic mixtures
Annex H (informative) - PEMS structure, PEMS DEVELOPMENT
        LIFE-CYCLE and documentation
Annex I (informative) - ME SYSTEMS aspects
Annex J (informative) - Survey of insulation paths
Annex K (informative) - Simplified PATIENT LEAKAGE CURRENT
        diagrams
Annex L (normative) - Insulated winding wires for use without
        interleaved insulation
Annex M (normative) - Reduction of pollution degrees
Bibliography
INDEX OF ABBREVIATIONS AND ACRONYMS
INDEX

Abstract

Applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.