Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems

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.

Appareils électromédicaux - Partie 2-66: Exigences particulières pour la sécurité de base et les performances essentielles des instruments d'audition et systèmes d'audition

La CEI 60601-2-66:2012 s'applique à la sécurité de base des instruments d'audition et des systèmes d'audition. Les dangers inhérents à la fonction physiologique prévue des instruments d'audition ou des systèmes d'audition dans le cadre du domaine d'application de la présente norme ne sont pas couverts par des exigences spécifiques contenues dans la présente norme, à l'exception de 201.7.9.2 et de 201.9.6. Les accessoires des instruments d'audition dans l'environnement des soins à domicile (par exemple, unités de commande à distance, diffuseurs de flux audio, chargeurs de batteries, alimentations) sont couverts par la norme qui s'applique le plus, la CEI 60065, la CEI 60950-1 ou d'autres normes de sécurité CEI applicables. Les accessoires connectés aux instruments d'audition peuvent former des systèmes d'audition. Seuls les instruments d'audition et leurs parties amovibles sont soumis à tous les articles applicables de cette norme particulière. Les autres éléments des systèmes d'audition sont soumis aux exigences de cette norme particulière de par leur connexion aux systèmes d'audition. La présente norme ne s'applique pas:
- aux implants cochléaires ou autres instruments d'audition implantés;
- aux instruments d'audition à conduction osseuse;
- aux instruments d'audition de formation (c'est-à-dire les instruments auditifs de groupe, les dispositifs d'entraînement auditif, etc.);
- à l'application d'un instrument d'audition à la mesure des niveaux d'audition. La CEI 60645-1 s'applique;
- aux systèmes de boucles d'induction audiofréquences ou à leurs composants, tels que décrits dans la CEI 60118-4 et la CEI 62489-1;
- aux systèmes d'audition à assistance fonctionnant par infrarouge ou radio;
- et à la fonction de génération acoustique d'un masqueur d'acouphène.

General Information

Status
Published
Publication Date
01-Oct-2012
Technical Committee
Drafting Committee
Current Stage
DELPUB - Deleted Publication
Completion Date
26-Jun-2015
Ref Project

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IEC 60601-2-66 ®
Edition 1.0 2012-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-66: Particular requirements for the basic safety and essential performance
of hearing instruments and hearing instrument systems

Appareils électromédicaux –
Partie 2-66: Exigences particulières pour la sécurité de base et les performances
essentielles des instruments d'audition et systèmes d'audition

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IEC 60601-2-66 ®
Edition 1.0 2012-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –

Part 2-66: Particular requirements for the basic safety and essential performance

of hearing instruments and hearing instrument systems

Appareils électromédicaux –
Partie 2-66: Exigences particulières pour la sécurité de base et les performances

essentielles des instruments d'audition et systèmes d'audition

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX X
ICS 11.180.15; 17.140.50 ISBN 978-2-83220-381-1

– 2 – 60601-2-66 © IEC:2012
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 8
201.3 Terms and definitions . 9
201.4 General requirements . 10
201.5 General requirements for testing ME EQUIPMENT . 11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 *Protection against electrical HAZARDS from ME EQUIPMENT . 18
201.9 *Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 21
201.10 Protection against unwanted and excessive radiation HAZARDS . 23
201.11 *Protection against excessive temperatures and other HAZARDS . 23
201.12 *Accuracy of controls and instruments and protection against hazardous
outputs . 24
201.13 *HAZARDOUS SITUATIONS and fault conditions . 25
201.14 *PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 28
201.15 *Construction of ME EQUIPMENT . 28
201.16 *ME SYSTEMS . 30
201.17 *Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 31
Annexes . 32
Annex E (informative) Examples of the connection of the measuring device (MD) for
measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT . 32
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 32
Annex H (informative) PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and
documentation . 32
Annex I (informative) ME SYSTEMS aspects . 32
Annex J (informative) Survey of insulation paths . 33
Annex K (informative) Simplified PATIENT LEAKAGE CURRENT diagrams . 33
Annex L (normative) Insulated winding wires for use without interleaved insulation . 33
Annex AA (informative) Particular guidance and rationale . 34
Annex BB (informative) Abbreviations . 39
Bibliography . 40
Index of defined terms used in this particular standard . 41

Figure 201.101 – Measuring circuit for the LEAKAGE CURRENT . 20

Table 201.102 – MECHANICAL HAZARDS to be considered . 21
Table AA.101 – Summary of the approach of this standard . 35

60601-2-66 © IEC:2012 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-66: Particular requirements for the basic safety and essential
performance of hearing instruments and hearing instrument systems

FOREWORD
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International Standard IEC 60601-2-66 has been prepared by IEC technical committee 29:
Electroacoustics.
The text of this particular standard is based on the following documents:
FDIS Report on voting
29/777/FDIS 29/792/RVD
Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:

– 4 – 60601-2-66 © IEC:2012
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions wit
...

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