BS EN 60601-2-66:2015 – TC:2020 Edition
$258.95
Tracked Changes. Medical electrical equipment – Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 128 |
IEC 60601-2-66:2015 applies to the basic safety of hearing instruments and hearing instrument systems, hereafter also referred to as ME equipment or ME system. This second edition cancels and replaces the first edition published in 2012. It constitutes a technical revision to adapt IEC 60601-2-66:2012 to the technical corrections introduced by Amendment 1 (2012) to IEC 60601-1:2005, as well as to clarify and correct the wording of this particular standard and to implement minor changes requested by interested parties.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 68 | European foreword Endorsement notice |
| 69 | Annex ZA (normative) Normative references to international publications with their corresponding European publications |
| 71 | Annex ZZ (informative) Coverage of Essential Requirements of EU Directives |
| 86 | English CONTENTS |
| 87 | FOREWORD |
| 89 | INTRODUCTION |
| 90 | 201.1 Scope, object and related standards |
| 92 | 201.2 Normative references 201.3 Terms and definitions |
| 94 | 201.4 General requirements 201.5 General requirements for testing me equipment |
| 96 | 201.6 Classification of me equipment and me systems |
| 97 | 201.7 Me equipment identification, marking and documents |
| 102 | 201.8 *Protection against electrical hazards from me equipment |
| 104 | Figure 201.101 – Measuring circuit for leakage current |
| 105 | 201.9 *Protection against mechanical hazards of me equipment and me systems Table 201.102 – Mechanical hazards to be considered |
| 107 | 201.10 Protection against unwanted and excessive radiation hazards 201.11 *Protection against excessive temperatures and other hazards |
| 108 | 201.12 *Accuracy of controls and instruments and protection against hazardous outputs |
| 109 | 201.13 *Hazardous situations and fault conditions for me equipment |
| 112 | 201.14 *Programmable electrical medical systems (pems) |
| 113 | 201.15 *Construction of me equipment |
| 115 | 201.16 *Me systems 201.17 *Electromagnetic compatibility of me equipment and me systems |
| 116 | Annexes Annex E (informative) Examples of the connection of the measuring device (MD) for measurement of the patient leakage current and patient auxiliary current 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 |
| 117 | Annex K (informative) Simplified patient leakage current diagrams Annex L (normative) Insulated winding wires for use without interleaved insulation |
| 118 | Annex AA (informative) Particular guidance and rationale |
| 119 | Table AA.101 – Summary of the approach of this standard |
| 123 | Annex BB (informative) Abbreviations |
| 124 | Bibliography |
| 125 | Index of defined terms used in this particular standard |
