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IEC 60601-2-66 : 2.0

IEC 60601-2-66 : 2.0

MEDICAL ELECTRICAL EQUIPMENT - PART 2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS

International Electrotechnical Committee

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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 <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ME 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 <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;from 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 <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and 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<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 E (informative)- Examples of the connection <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of the measuring device (MD) for measurement <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of the PATIENT LEAKAGE CURRENT and PATIENT <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;AUXILIARY CURRENT<br>Annex G (normative) - Protection against HAZARDS of <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ignition of flammable anaesthetic mixtures<br>Annex H (informative) - PEMS structure, PEMS DEVELOPMENT <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;LIFE-CYCLE and documentation <br>Annex I (informative) - ME SYSTEMS aspects<br>Annex J (informative) - Survey of insulation paths <br>Annex K (informative) - Simplified PATIENT LEAKAGE CURRENT <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;diagrams <br>Annex L (normative) - Insulated winding wires for use <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;without interleaved insulation <br>Annex AA (informative) - Particular guidance and rationale <br>Annex BB (informative) - Abbreviations <br>Bibliography <br>Index of defined terms used in this particular standard

Abstract

Pertains to the BASIC SAFETY of HEARING INSTRUMENTS and HEARING INSTRUMENT SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM.

General Product Information

Document Type Standard
Status Current
Publisher International Electrotechnical Committee
Committee TC 29

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