IEC 60601-2-66:2019

IEC 60601-2-66 ®
Edition 3.0 2019-10
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-66: Particular requirements for the basic safety and essential
performance of hearing instruments aids and hearing instrument aids systems

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IEC 60601-2-66 ®
Edition 3.0 2019-10
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –

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

performance of hearing instruments aids and hearing instrument aids systems

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.180.15; 17.140.50 ISBN 978-2-8322-7543-6

– 2 – IEC 60601-2-66:2019 RLV © IEC 2019
CONTENTS
FOREWORD . 4
INTRODUCTION . 2
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 11
201.4 General requirements . 13
201.5 General requirements for testing ME EQUIPMENT . 14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 15
201.7 ME EQUIPMENT identification, marking and documents . 16
201.8 * Protection against electrical HAZARDS from ME EQUIPMENT . 21
201.9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 24
201.10 * Protection against unwanted and excessive radiation HAZARDS . 26
201.11 * Protection against excessive temperatures and other HAZARDS . 26
201.12 * Accuracy of controls and instruments and protection against hazardous
outputs. 28
201.13 * HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 29
201.14 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 32
201.15 * Construction of ME EQUIPMENT . 32
201.16 * ME SYSTEMS . 34
201.17 * Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 35
Annexes . 36
Annex E (informative) Examples of the connection of the measuring device (MD) for
measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT . 37
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 38
Annex H (informative) PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and
documentation . 39
Annex I (informative) ME SYSTEMS aspects . 40
Annex J (informative) Survey of insulation paths . 41
Annex K (informative) Simplified PATIENT LEAKAGE CURRENT diagrams . 42
Annex L (normative) Insulated winding wires for use without interleaved insulation . 43
Annex AA (informative) Particular guidance and rationale . 44
Annex BB (informative) Abbreviations . 50
Annex CC (informative) Essential performance . 51
Annex DD (informative) Electromagnetic compatibility of ME EQUIPMENT . 52
Bibliography . 54
Index of defined terms used in this particular standard . 56

Figure 201.101 – Measuring circuit for LEAKAGE CURRENT (see 201.8.7.4.7) . 23

Table 201.101 – MECHANICAL HAZARDS to be considered . 25
Table AA.101 – Summary of the approach of this document . 45

Table DD.101 – Example of applicable standards for HEARING AID specific setting for
RF radiated emissions . 52
Table DD.102 – Example of applicable tests . 53

– 4 – IEC 60601-2-66:2019 RLV © IEC 2019
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

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

FOREWORD
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International Standard IEC 60601-2-66 has been prepared by IEC technical committee 29:
Electroacoustics.
This third edition 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.
The text of this International Standard is based on the following documents:
FDIS Report on voting
29/1023/FDIS 29/1030/RVD
Full information on the voting for the approval of this International Standard can be found in the
report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, the following print types are used:
– 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 document, the term
– "clause" means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this document are preceded by the term "Clause" followed by the
clause number. References to subclauses within this particular standard are by number only.
In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance with
this document;
– "should" means that compliance with a requirement or a test is recommended but is not
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