BS EN IEC 60601-2-66:2020
$198.66
Medical electrical equipment – Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 68 |
IEC 60601-2-66:2019 is available as IEC 60601-2-66:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-66:2019 applies to the BASIC SAFETY of HEARING AIDS and HEARING AID SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. IEC 60601-2-66:2019 cancels and replaces the second edition published in 2015. It constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) revision of the definition about ESSENTIAL PERFORMANCE; b) revision of the application of IEC 60601-1-2:2014 for electromagnetic disturbances;c) correction of the used voltage for HEARING AIDS from 1,6 V to 4,5 V; d) correction of the drop test level from 1,5 m to 1,0 m; e) correction of the wording of IEC 60601-2-66:2015.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 5 | Annex ZA(normative)Normative references to international publicationswith their corresponding European publications |
| 7 | Annex ZZ(informative)Coverage of Essential Requirements of EU Directives |
| 13 | English CONTENTS |
| 15 | FOREWORD |
| 18 | INTRODUCTION |
| 19 | 201.1 Scope, object and related standards |
| 21 | 201.2 Normative references |
| 22 | 201.3 Terms and definitions |
| 23 | 201.4 General requirements |
| 24 | 201.5 General requirements for testing ME EQUIPMENT |
| 26 | 201.6 Classification of ME EQUIPMENT and ME SYSTEMS |
| 32 | 201.8 * Protection against electrical HAZARDS from ME EQUIPMENT |
| 33 | Figure 201.101 – Measuring circuit for leakage current (see 201.8.7.4.7) |
| 34 | 201.9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS |
| 35 | Table 201.101 – Mechanical hazards to be considered |
| 36 | 201.10 * Protection against unwanted and excessive radiation HAZARDS 201.11 * Protection against excessive temperatures and other HAZARDS |
| 38 | 201.12 * Accuracy of controls and instruments and protection against hazardous outputs |
| 39 | 201.13 * HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT |
| 41 | 201.14 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) |
| 42 | 201.15 * Construction of ME EQUIPMENT |
| 44 | 201.16 * ME SYSTEMS 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS |
| 46 | Annexes |
| 47 | Annex E (informative)Examples of the connection of the measuring device (MD) for measurement of the patient leakage current and patient auxiliary current |
| 48 | Annex G (normative)Protection against hazards of ignition of flammableanaesthetic mixtures |
| 49 | Annex H (informative)Pems structure, pems development life-cycle and documentation |
| 50 | Annex I (informative)Me systems aspects |
| 51 | Annex J (informative)Survey of insulation paths |
| 52 | Annex K (informative)Simplified patient leakage current diagrams |
| 53 | Annex L (normative)Insulated winding wires for use without interleaved insulation |
| 54 | Annex AA (informative)Particular guidance and rationale |
| 55 | Table AA.101 – Summary of the approach of this document |
| 59 | Annex BB (informative)Abbreviations |
| 60 | Annex CC (informative)Essential performance |
| 61 | Annex DD (informative)Electromagnetic compatibility of me equipment Table DD.101 – Example of applicable standards for hearing aidspecific setting for RF radiated emissions |
| 62 | Table DD.102 – Example of applicable tests |
| 63 | Bibliography |
| 65 | Index of defined terms used in this particular standard |
