BS EN 60601-2-66:2013
$189.07
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 | 2013 | 48 |
IEC 60601-2-66:2012 International Standard applies to the basic safety of hearing instruments and hearing instrument systems. Hazards inherent in the intended physiological function of hearing instruments or hearing instrument systems within the scope of this standard are not covered by specific requirements in this standard except in 201.7.9.2 and 201.9.6. Accessories to hearing instruments in the home healthcare environment (e.g. remote control units, audio streamers, battery chargers, power supplies) are covered by the most applicable standard, IEC 60065, IEC 60950-1 or other applicable IEC safety standards. Accessories connected to a hearing instrument may form a hearing instrument system. Only the hearing instrument and its detachable parts are subject to all applicable clauses of this particular standard. The remaining components of the hearing instrument system are subject to requirements of this particular standard that result from their connection to the hearing instrument system. This standard does not apply to: – cochlear implants or other implanted hearing instruments; – bone conduction hearing instruments; – educational hearing instruments (i.e. group hearing instruments, auditory trainers etc.); – the application of a hearing instrument for the measurement of hearing levels. IEC 60645-1 applies; – audio-frequency induction-loop systems or their component parts, as described in IEC 60118-4 and IEC 62489-1; – assisted hearing instrument systems using infra-red or radio; – and the sound generating function of a tinnitus masker.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 8 | English CONTENTS |
| 9 | INTRODUCTION |
| 10 | 201.1 Scope, object and related standards |
| 12 | 201.2 Normative references |
| 13 | 201.3 Terms and definitions |
| 14 | 201.4 General requirements |
| 15 | 201.5 General requirements for testing me equipment |
| 16 | 201.6 Classification of me equipment and me systems |
| 17 | 201.7 Me equipment identification, marking and documents |
| 22 | 201.8 *Protection against electrical hazards from me equipment |
| 24 | Figure 201.101 – Measuring circuit for the leakage current |
| 25 | 201.9 *Protection against mechanical hazards of me equipment and me systems Table 201.102 – Mechanical hazards to be considered |
| 27 | 201.10 Protection against unwanted and excessive radiation hazards 201.11 *Protection against excessive temperatures and other hazards |
| 28 | 201.12 *Accuracy of controls and instruments and protection against hazardous outputs |
| 29 | 201.13 *Hazardous situations and fault conditions |
| 32 | 201.14 *Programmable electrical medical systems (pems) 201.15 *Construction of me equipment |
| 34 | 201.16 *Me systems |
| 35 | 201.17 *Electromagnetic compatibility of me equipment and me systems |
| 36 | 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 |
| 37 | 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 |
| 38 | Annex AA (informative) Particular guidance and rationale |
| 39 | Table AA.101 – Summary of the approach of this standard |
| 43 | Annex BB (informative) Abbreviations |
| 44 | Bibliography |
| 45 | Index of defined terms used in this particular standard |
