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 ME EQUIPMENT<br>201.6 Classification of ME EQUIPMENT and ME SYSTEMS<br>201.7 ME EQUIPMENT identification, marking and<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;documents<br>201.8 Protection against electrical HAZARDS from<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ME EQUIPMENT<br>201.9 Protection against MECHANICAL HAZARDS of<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ME EQUIPMENT and ME SYSTEMS<br>201.10 Protection against unwanted and excessive radiation<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;HAZARDS<br>201.11 Protection against excessive temperatures and<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;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>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;for ME EQUIPMENT<br>201.14 PROGRAMMABLE ELECTRICAL MEDICAL 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 of<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;the measuring device (MD) for measurement of<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;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<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;DEVELOPMENT 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<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;CURRENT diagrams<br>Annex L (normative) - Insulated winding wires for use<br>&nbsp;&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<br>Annex ZA (normative) - Normative references to<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;international publications with their<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;corresponding European publications<br>Annex ZZ (informative) - Coverage of Essential<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Requirements of EU Directives

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

Published
Document Type	Standard
Status	Current
Publisher	British Standards Institution
Pages
ISBN
Committee	EPL/29
Supersedes	14/30315340 DC : 0 10/30240267 DC : 0