SIST EN IEC 80601-2-60:2020/oprA1:2025

SLOVENSKI STANDARD
01-maj-2025
Medicinska električna oprema - 2-60. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti zobozdravstvene opreme - Dopolnilo A1
Amendment 1 - Medical electrical equipment - Part 2-60: Particular requirements for the
basic safety and essential performance of dental equipment
Medizinische elektrische Geräte - Teil 2-60: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Dental-Geräten
Appareils électromédicaux - Partie 2-60: Exigences particulères pour la sécurité de base
et les performances essentielles des équipements dentaires
Ta slovenski standard je istoveten z: EN IEC 80601-2-60:2020/prA1:2025
ICS:
11.060.20 Zobotehnična oprema Dental equipment
SIST EN IEC 80601-2- en
60:2020/oprA1:2025
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

62D/2209/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 80601-2-60/AMD1 ED2
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2025-03-21 2025-06-13
SUPERSEDES DOCUMENTS:
62D/2150/CD, 62D/2206/CC
IEC SC 62D : PARTICULAR MEDICAL EQUIPMENT, SOFTWARE, AND SYSTEMS
SECRETARIAT: SECRETARY:
United States of America Ms Ladan Bulookbashi
OF INTEREST TO THE FOLLOWING COMMITTEES: HORIZONTAL FUNCTION(S):

ASPECTS CONCERNED:
SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
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clauses. (SEE AC/22/2007 OR NEW GUIDANCE DOC).

TITLE:
Amendment 1 - Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and
essential performance of dental equipment

PROPOSED STABILITY DATE: 2030
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62D/2209/CDV 2 IEC 80601-2-60/AMD1 ED2 © IEC 2025
1 INTERNATIONAL ELECTROTECHNICAL COMMISSION
2 ____________
4 MEDICAL ELECTRICAL EQUIPMENT –
6 Part 2-60: Particular requirements for the basic safety
7 and essential performance of dental equipment
9 AMENDMENT 1
11 FOREWORD
12 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
13 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
14 co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
15 in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
16 Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC Publication(s)"). Their
17 preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
18 may participate in this preparatory work. International, governmental and non-governmental organizations liaising
19 with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
20 Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
21 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
22 consensus of opinion on the relevant subjects since each technical committee has representation from all
23 interested IEC National Committees.
24 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
25 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
26 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
27 misinterpretation by any end user.
28 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
29 transparently to the maximum extent possible in their national and regional publications. Any divergence between
30 any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
31 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
32 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
33 services carried out by independent certification bodies.
34 6) All users should ensure that they have the latest edition of this publication.
35 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
36 members of its technical committees and IEC National Committees for any personal injury, property damage or
37 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
38 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
39 Publications.
40 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
41 indispensable for the correct application of this publication.
42 9) Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
43 rights. IEC shall not be held responsible for identifying any or all such patent rights.
44 International standard IEC 80601-2-60 has been prepared by a Joint Working Group of
45 subcommittee 62D: Particular medical equipment, software, and systems, of IEC technical
46 committee 62: Medical equipment, software, and systems, and subcommittee 6: Dental
47 equipment, of ISO technical committee 106: Dentistry.
48 This document amends IEC 80601-2-60:2019.
49 The text of this Amendment is based on the following documents:
Draft Report on voting
62D/XX/XXXX 62D/XX/XXX
51 Full information on the voting for its approval can be found in the report on voting indicated in
52 the above table.
IEC 80601-2-60/AMD1 ED2 © IEC 2025 3 62D/2209/CDV
53 The language used for the development of this Amendment is English.
54 This publication is published as a double logo standard.
55 In this document, the following print types are used:
56 – requirements and definitions: roman type;
57 – test specifications: italic type;
58 – informative material appearing outside of tables, such as notes, examples and references: in smaller type.
59 Normative text of tables is also in a smaller type;
60 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
61 NOTED: SMALL CAPITALS.
62 In referring to the structure of this document, the term
63 – “clause” means one of the seventeen numbered divisions within the table of contents,
64 inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
65 – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
66 subclauses of Clause 7).
67 References to clauses within this document are preceded by the term “Clause” followed by the
68 clause number. References to subclauses within this particular standard are by number only.
69 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
70 combination of the conditions is true.
71 The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC
72 Directives, Part 2. For the purposes of this document, the auxiliary verb:
73 – “shall” means that compliance with a requirement or a test is mandatory for compliance with
74 this document;
75 – “should” means that compliance with a requirement or a test is recommended but is not
76 mandatory for compliance with this document;
77 – “may” is used to describe a permissible way to achieve compliance with a requirement or
78 test.
79 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
80 indicates that there is guidance or rationale related to that item in Annex AA.
81 A list of all parts of the IEC 60601 series, published under the general title: Medical electrical
82 equipment, can be found on the IEC website.
83 The committee has decided that the contents of this document will remain unchanged until the
84 stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
85 the specific document. At this date, the document will be
86 • reconfirmed,
87 • withdrawn,
88 • replaced by a revised edition, or
89 • amended.
62D/2209/CDV 4 IEC 80601-2-60/AMD1 ED2 © IEC 2025
91 MEDICAL ELECTRICAL EQUIPMENT –
93 Part 2-60: Particular requirements for the basic safety
94 and essential performance of dental equipment
96 AMENDMENT 1
100 201.1.4 Particular standards
101 Replace the third paragraph with the following:
102 For brevity, IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, and IEC 60601-
103 1:2005/AMD2:2020 are referred to in this particular standard as the general standard. Collateral
104 standards are referred to by their document number.
106 201.2 Normative references
107 Delete normative reference:
108 IEC 60825-1:2014, Safety of laser products – Part 1: Equipment classification and requirements
109 IEC 60601-2-22:2007, Medical electrical equipment – Part 2-22: Particular requirements for
110 basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser
111 equipment
112 IEC 60601-2-22:2007/AMD1:2012
113 Change the existing dated references with the following:
114 ISO 7494-1:2018, Dentistry — Stationary dental units and dental patient chairs — Part 1:
115 General requirements
116 In Clause 201.2 normative References, change the following dated references
117 IEC 60601-2-2:2017/AMD1:2023, Medical electrical equipment – Part 2-2: Particular
118 requirements for the basic safety and essential performance of high frequency surgical
119 equipment and high frequency surgical accessories
120 IEC 60664-1:2020, Insulation coordination for equipment within low-voltage systems – Part 1:
121 Principles, requirements and tests
122 IEC 61810-1:2015/AMD1:2019, Electromechanical elementary relays – Part 1: General and
123 safety requirements
124 ISO 1942, Dentistry – Vocabulary
IEC 80601-2-60/AMD1 ED2 © IEC 2025 5 62D/2209/CDV
127 201.3.201 DENTAL ELECTRICAL MOTOR
128 Replace with the following:
129 HAND-HELD part of the DENTAL HANDPIECE electrically powered by the DENTAL UNIT or internally.
130 201.3.202 DENTAL EQUIPMENT
131 Replace with the following:
132 ME EQUIPMENT with any combination of DENTAL HANDPIECES, DENTAL UNITS,
133 DENTAL PATIENT CHAIRS, DENTAL OPERATING LIGHTS and intraoral sensors.
134 Note 1 to entry: Devices like dental x-ray sensors and apex locators are DENTAL EQUIPMENT
135 201.3.203 DENTAL HANDPIECE
136 Replace with the following:
137 HAND-HELD instrument used in dentistry for use in PATIENT treatment, connected to the
138 DENTAL UNIT or internally powered.
139 201.3.208 PATIENT SIDE OF DENTAL HANDPIECE
140 Replace with the following:
141 part of DENTAL HANDPIECE which is designed to be introduced into the oral cavity where all parts
142 of the DENTAL HANDPIECE within 80 mm of the tip are considered as an APPLIED PART
143 Note 1 to entry: This dimension relates to reprocessing classification.
144 201.4.3 ESSENTIAL PERFORMANCE
145 Replace the existing text with the following:
146 Addition:
147 DENTAL EQUIPMENT does not have ESSENTIAL PERFORMANCE, unless specified by the
148 MANUFACTURER.
149 201.7.2.11 Mode of operation
150 Replace the text with the following:
151 Addition:
152 For DENTAL HANDPIECES, marking is not required.
153 For DENTAL ELECTRICAL MOTORS, marking is not required.
62D/2209/CDV 6 IEC 80601-2-60/AMD1 ED2 © IEC 2025
*
155 201.7.4.1 Power switches
156 Add this new subclause with the following new text:
157 Marking is not required for switches used to activate or control DENTAL HANDPIECES and DENTAL
158 ELECTRICAL MOTORS.
159 201.8.5.1.101 * APPLIED PARTS that form one single APPLIED PART
160 Replace the existing test of this subclause with the following:
161 In DENTAL EQUIPMENT the DENTAL HANDPIECES may be considered as multiple functions of one
162 APPLIED PART or PATIENT CONNECTIONS of one APPLIED PART.
163 The combination of several APPLIED PARTS to form one single APPLIED PART is only permitted if
164 no HAZARDOUS SITUATION occurs when individually applying any of the several APPLIED PARTS or
165 when concurrently applying any combination of the several APPLIED PARTS. Requirements for
166 patient leakage current and insulation according to the General Standard apply.
167 EXAMPLE 1: For a dual motor controller system with two dental motors or dental handpieces,
168 consideration shall be given to a potential HAZARDOUS SITUATION in which an OPERATOR is using
169 one handpiece and the assistant is changing the bur in the other handpiece.
170 EXAMPLE 2: For an apex locator system, consideration shall be given to a potential HAZARDOUS
171 SITUATION in wh
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