IEC 80601-2-60:2012

IEC 80601-2-60
Edition 1.0 2012-02
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 1.0 2012-02
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
PRICE CODE
INTERNATIONALE
CODE PRIX V
ICS 11.040.01 ISBN 978-2-88912-914-0

– 2 – 80601-2-60 © IEC:2012
CONTENTS
FOREWORD . 3

201.1 Scope, object and related standards. 5

201.2 Normative references . 6

201.3 Terms and definitions . 7

201.4 General requirements . 8

201.5 General requirements for testing of ME EQUIPMENT . 8

201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 9

201.7 ME EQUIPMENT identification, marking and documents . 9
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 10
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14
201.10 Protection against unwanted and excessive radiation HAZARDS . 16
201.11 Protection against excessive temperatures and other HAZARDS . 16
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 20
201.13 HAZARDOUS SITUATIONS and fault conditions . 20
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 21
201.15 Construction of ME EQUIPMENT . 21
201.16 ME SYSTEMS. 21
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 21
201.101 Cordless HAND-HELD and foot-operated control devices . 21
Annexes . 21
Annex AA (informative) Particular guidance and rationale . 22
Bibliography . 31
Index of defined terms used in this particular standard. 32

Figure AA.1 – Example of APPLIED PARTS for DENTAL EQUIPMENT . 23
Figure AA.2 – Calculation of LEAKAGE CURRENT . 24
Figure AA.3 – Insulation problem of commutator DENTAL ELECTRICAL MOTOR . 25
Figure AA.4 – Loading fan construction. 29

Figure AA.5 – Load diagram with loading fan . 30

Table 201.101 – Test voltages for solid insulation for SECONDARY CIRCUITS according to
201.8.5.2 . 10
Table 201.102 – Determination of TENSILE SAFETY FACTOR . 15
Table 201.103 – Mass distribution . 16
Table 201.104 – Allowable maximum temperatures for DENTAL HANDPIECE . 17

80601-2-60 © IEC:2012 – 3 –
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: Electrical equipment in medical practice of IEC technical committee 62:
Electrical equipment in medical practice and subcommittee 6: Dental equipment of ISO
technical committee 106: Dentistry.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/964/FDIS 62D/984/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. In ISO, the standard has been approved by 16
P-members out of 17 having cast a vote.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

– 4 – 80601-2-60 © IEC:2012
In this standard, 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 standard, 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 standard are preceded by the term “Clause” followed by the
clause numb
...