IEC 60601-2-66:2015

IEC 60601-2-66 ®
Edition 2.0 2015-06
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 2.0 2015-06
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
INTERNATIONALE
ICS 11.180.15; 17.140.50 ISBN 978-2-8322-2766-4

– 2 – IEC 60601-2-66:2015 © IEC 2015

CONTENTS
FOREWORD . 3

INTRODUCTION . 5

201.1 Scope, object and related standards . 6

201.2 Normative references . 8

201.3 Terms and definitions . 8

201.4 General requirements . 10

201.5 General requirements for testing ME EQUIPMENT . 10

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 for ME EQUIPMENT . 25
201.14 *PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 28
201.15 *Construction of ME EQUIPMENT . 29
201.16 *ME SYSTEMS . 31
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 . 32
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 LEAKAGE CURRENT . 20

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

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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