IEC 80601-2-60:2019

IEC 80601-2-60
Edition 2.0 2019-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-60: Particular requirements for the basic safety and essential performance
of dental equipment
Appareils électromédicaux –
Partie 2-60: Exigences particulières pour la sécurité de base et les performances
essentielles des équipements dentaires

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IEC 80601-2-60
Edition 2.0 2019-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –

Part 2-60: Particular requirements for the basic safety and essential performance

of dental equipment
Appareils électromédicaux –
Partie 2-60: Exigences particulières pour la sécurité de base et les performances

essentielles des équipements dentaires

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-7049-3

– 2 – IEC 80601-2-60:2019 © IEC 2019
CONTENTS
FOREWORD . 3
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 of ME EQUIPMENT . 10
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 10
201.7 ME EQUIPMENT identification, marking and documents . 10
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 11
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 16
201.10 Protection against unwanted and excessive radiation HAZARDS . 19
201.11 Protection against excessive temperatures and other HAZARDS . 19
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 23
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 23
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 24
201.15 Construction of ME EQUIPMENT . 24
201.16 ME SYSTEMS . 25
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 25
201.101 Cordless HAND-HELD and foot-operated control devices . 25
Annexes . 26
Annex AA (informative) Particular guidance and rationale . 27
Bibliography . 39
Index of defined terms used in this document . 40

Figure AA.1 – Example of APPLIED PARTS for DENTAL EQUIPMENT . 28
Figure AA.2 – Calculation of LEAKAGE CURRENT . 29
Figure AA.3 – Insulation problem of commutator DENTAL ELECTRICAL MOTOR . 31
Figure AA.4 – Loading fan construction . 37
Figure AA.5 – Load diagram with loading fan . 37

Table 201.101 – Test voltages for solid insulation for SECONDARY CIRCUITS according to
201.8.9.1.12 . 12
Table 201.102 – Determination of TENSILE SAFETY FACTOR . 18
Table 201.103 – Mass distribution. 19
Table 201.104 – Allowable maximum temperatures for the OPERATOR SIDE of DENTAL
HANDPIECES . 20
Table AA.1 – RATED impulse voltage for equipment energized directly from the low-
voltage mains . 32

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-60: Particular requirements for the basic safety
and essential performance of dental equipment

FOREWORD
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International standard IEC 80601-2-60 has been prepared by a Joint Working Group of
subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical
equipment in medical practice, and subcommittee 6: Dental equipment, of ISO technical
committee 106: Dentistry.
This second edition cancels and replaces the first edition published in 2012. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.

– 4 – IEC 80601-2-60:2019 © IEC 2019
The text of this International Standard is based on the following documents:
FDIS Report on voting
62D/1683/FDIS 62D/1691/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 Directive
...