IEC 60601-2-65:2012

Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment

IEC 60601-2-65:2012 applies to the basic safety and essential performance of dental intra-oral X-ray equipment and its main components. The scope of this standard is restricted to X-ray equipment where the X-ray tube assembly contains the high-voltage transformer assembly. Dental extra-oral X-ray equipment is excluded from the scope of this standard. This particular standard has been prepared to provide, based on IEC 60601-1:2005 and its collaterals, a complete set of basic safety and essential performance requirements for dental intra-oral X-ray equipment. While the previously existing standards for such equipment were dedicated to components and subsystems, this particular standard addresses the system level of dental intra-oral X-ray equipment. Components and their functions are addressed as far as necessary.

Appareils élecromédicaux - Partie 2-65: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X dentaires intra-oraux

La CEI 60601-2-65:2012 s'applique à la sécurité de base et aux performances essentielles des appareils à rayonnement X dentaires intra-oraux et à ses composants principaux. Le domaine d'application de la présente norme est limité aux appareils à rayonnement X dans lesquels la gaine équipée contient l'ensemble transformateur haute tension. Les appareils à rayonnement X dentaires extra-oraux sont exclus du domaine d'application de la présente norme. La présente norme particulière a été préparée pour fournir, sur la base de la CEI 60601-1:2005 et de ses normes collatérales, un ensemble complet d'exigences de sécurité de base et de performances essentielles pour les appareils à rayonnement X dentaires intra-oraux. Alors que les normes antérieures pour de tels appareils étaient consacrées aux composants et aux sous-systèmes, la présente norme particulière concerne le niveau système des appareils à rayonnement X dentaires intra-oraux. Les composants et leurs fonctions sont mentionnés dans la mesure où cela est nécessaire.

General Information

• Status: Published
• Publication Date: 18-Sep-2012
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.50 - Radiographic equipment
• ICS: 31.100 - Electronic tubes
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Drafting Committee: WG 46 - TC 62/SC 62B/WG 46
• Current Stage: PPUB - Publication issued
• Start Date: 31-Oct-2012
• Completion Date: 19-Sep-2012

Relations

• Replaces: IEC 60601-2-7:1998 - Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
• Effective Date: 05-Sep-2023
• Amended By: IEC 60601-2-65:2012/AMD2:2021 - Amendment 2 - Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
• Effective Date: 05-Sep-2023
• Amended By: IEC 60601-2-65:2012/AMD1:2017 - Amendment 1 - Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-65 ®
Edition 1.2 2021-05
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-65: Particular requirements for the basic safety and essential performance
of dental intra-oral X-ray equipment

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

IEC Central Office Tel.: [phone]
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Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

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IEC 60601-2-65 ®
Edition 1.2 2021-05
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –

Part 2-65: Particular requirements for the basic safety and essential

performance of dental intra-oral X-ray equipment

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.50 ISBN 978-2-8322-9774-2

IEC 60601-2-65 ®
Edition 1.2 2021-05
CONSOLIDATED VERSION
REDLINE VERSION
colour
inside
Medical electrical equipment –
Part 2-65: Particular requirements for the basic safety and essential performance
of dental intra-oral X-ray equipment

– 2 – IEC 60601-2-65:2012+AMD1:2017
+AMD2:2021 CSV  IEC 2021
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
INTRODUCTION TO AMENDMENT 1 . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 10
201.4 General requirements . 11
201.5 General requirements for testing of ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 15
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 . 16
201.13 HAZARDOUS SITUATIONS and fault conditions . 16
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 16
201.15 Construction of ME EQUIPMENT. 16
201.16 ME SYSTEMS . 16
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 17
202 Electromagnetic compatibility – Requirements and tests . 17
203 Radiation protection in diagnostic X-ray equipment . 17
Annexes . 29
Annex C (informative) Guide to marking and labeling requirements for ME EQUIPMENT
and ME SYSTEMS . 30
Annex AA (informative) Particular guidance and rationale . 31
Annex BB (informative) Identification of parts of dental X-RAY INTRA-ORAL SYSTEMS in
relation to defined terms in this standard . 38
Bibliography . 40
Index of defined terms used in this particular standard . 43

Figure AA.1 – AIR KERMA during IRRADIATION with direct current X-RAY GENERATOR . 32
Figure AA.2 – AIR KERMA during IRRADIATION with ONE-PEAK X-RAY GENERATOR. 34
Figure AA.3 – Waveform of long IRRADIATION TIME X-RADIATION from a
ONE-PEAK X-RAY GENERATOR . 35
Figure BB.1 – Structure of DENTAL INTRA-ORAL X-RAY EQUIPMENT . 38
Figure BB.2 – Parts of DENTAL INTRA-ORAL X-RAY EQUIPMENT . 39

Table 201.101 – List of potential ESSENTIAL PERFORMANCE to be considered by
MANUFACTURER in the RISK MANAGEMENT PROCESS . 11
Table 201.C.101 – Marking on the outside of ME EQUIPMENT or its parts . 30
Table 201.C.102 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS . 30

+AMD2:2021 CSV  IEC 2021
INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-65: Particular requirements for the basic safety
and essential performance of dental intra-oral X-ray equipment

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
This consolidated version of the official IEC Standard and its amendments has been
prepared for user convenience.
IEC 60601-2-65 edition 1.2 contains the first edition (2012-09) [documents 62B/889/FDIS
and 62B/897/RVD], its amendment 1 (2017-05) [documents 62B/1006/CDV and
62B/1039/RVC] and its amendment 2 (2021-05) [documents 62B/1233/FDIS and
62B/1238/RVD].
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendment 1. Additions are in green text, deletions are in strikethrough
red text. A separate Final version with all changes accepted is available in this
publication.
– 4 – IEC 60601-2-65:2012+AMD1:2017
+AMD2:2021 CSV  IEC 2021
International Standard IEC 60601-2-65 has been prepared by IEC subcommittee 62B:
Diagnostic Imaging Equipment, of IEC technical committee 62: Electrical equipment in
medical practice.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
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 number. References to subclauses within this particular standard are by number only.
In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.

+AMD2:2021 CSV 
...

IEC 60601-2-65 ®
Edition 1.0 2012-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-65: Particular requirements for the basic safety and essential performance
of dental intra-oral X-ray equipment

Appareils électromédicaux –
Partie 2-65: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à rayonnement X dentaires intra-oraux

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester.
If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,
please contact the address below or your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni
utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie et les
microfilms, sans l'accord écrit de la CEI ou du Comité national de la CEI du pays du demandeur.
Si vous avez des questions sur le copyright de la CEI ou si vous désirez obtenir des droits supplémentaires sur cette
publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.

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About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.

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by a variety of criteria (reference number, text, technical electrical terms containing more than 30 000 terms and
committee,…). definitions in English and French, with equivalent terms in
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withdrawn publications. Electrotechnical Vocabulary (IEV) on-line.

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IEC 60601-2-65 ®
Edition 1.0 2012-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 2-65: Particular requirements for the basic safety and essential performance

of dental intra-oral X-ray equipment

Appareils électromédicaux –
Partie 2-65: Exigences particulières pour la sécurité de base et les performances

essentielles des appareils à rayonnement X dentaires intra-oraux

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX X
ICS 11.040.50 ISBN 978-2-83220-383-5

– 2 – 60601-2-65  IEC:2012
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 of ME EQUIPMENT . 10
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 10
201.7 ME EQUIPMENT identification, marking and documents . 11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 13
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14
201.10 Protection against unwanted and excessive radiation HAZARDS . 14
201.11 Protection against excessive temperatures and other HAZARDS . 14
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 15
201.13 HAZARDOUS SITUATIONS and fault conditions . 15
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 15
201.15 Construction of ME EQUIPMENT . 15
201.16 ME SYSTEMS . 15
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 15
202 Electromagnetic compatibility – Requirements and tests . 15
203 Radiation protection in diagnostic X-ray equipment . 16
Annexes . 26
Annex C (informative) Guide to marking and labeling requirements for ME EQUIPMENT
and ME SYSTEMS . 27
Annex AA (informative) Particular guidance and rationale . 28
Annex BB (informative) Identification of parts of dental X-RAY INTRA-ORAL SYSTEMS in
relation to defined terms in this standard . 35
Bibliography . 37
Index of defined terms used in this particular standard . 40

Figure AA.1 – AIR KERMA during IRRADIATION with direct current X-RAY GENERATOR . 29
Figure AA.2 – AIR KERMA during IRRADIATION with ONE-PEAK X-RAY GENERATOR. 31
Figure AA.3 – Waveform of long IRRADIATION TIME X-RADIATION from a
ONE-PEAK X-RAY GENERATOR . 32
Figure BB.1 – Structure of DENTAL INTRA-ORAL X-RAY EQUIPMENT . 35
Figure BB.2 – Parts of DENTAL INTRA-ORAL X-RAY EQUIPMENT . 36

Table 201.101 – List of potential ESSENTIAL PERFORMANCE to be considered by
MANUFACTURER in the RISK MANAGEMENT PROCESS . 10
Table 201.C.101 – Marking on the outside of ME EQUIPMENT or its parts . 27
Table 201.C.102 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS . 27

60601-2-65  IEC:2012 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-65: Particular requirements for the basic safety
and essential performance of dental intra-oral X-ray equipment

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-65 has been prepared by IEC subcommittee 62B:
Diagnostic Imaging Equipment, of IEC technical committee 62: Electrical equipment in
medical practice.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62B/889/FDIS 62B/897/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.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

– 4 – 60601-2-65  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, I
...

IEC 60601-2-65 ®
Edition 1.2 2021-05
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-65: Particular requirements for the basic safety and essential performance
of dental intra-oral X-ray equipment
Appareils électromédicaux –
Partie 2-65: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à rayonnement X dentaires intra-oraux
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.

IEC Central Office Tel.: [phone]
3, rue de Varembé [e-mail]
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.

IEC publications search - webstore.iec.ch/advsearchform IEC online collection - oc.iec.ch
The advanced search enables to find IEC publications by a Discover our powerful search engine and read freely all the
variety of criteria (reference number, text, technical publications previews. With a subscription you will always
committee, …). It also gives information on projects, replaced have access to up to date content tailored to your needs.
and withdrawn publications.
Electropedia - www.electropedia.org
IEC Just Published - webstore.iec.ch/justpublished
The world's leading online dictionary on electrotechnology,
Stay up to date on all new IEC publications. Just Published
containing more than 22 000 terminological entries in English
details all new publications released. Available online and
and French, with equivalent terms in 18 additional languages.
once a month by email.
Also known as the International Electrotechnical Vocabulary

(IEV) online.
IEC Customer Service Centre - webstore.iec.ch/csc
If you wish to give us your feedback on this publication or
need further assistance, please contact the Customer Service
Centre: [e-mail].
A propos de l'IEC
La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications IEC
Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la
plus récente, un corrigendum ou amendement peut avoir été publié.

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IEC 60601-2-65 ®
Edition 1.2 2021-05
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-65: Particular requirements for the basic safety and essential
performance of dental intra-oral X-ray equipment
Appareils électromédicaux –
Partie 2-65: Exigences particulières pour la sécurité de base et les
performances essentielles des appareils à rayonnement X dentaires intra-oraux
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-4311-4

IEC 60601-2-65 ®
Edition 1.2 2021-05
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 2-65: Particular requirements for the basic safety and essential performance
of dental intra-oral X-ray equipment
Appareils électromédicaux –
Partie 2-65: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à rayonnement X dentaires intra-oraux
– 2 – IEC 60601-2-65:2012+AMD1:2017
+AMD2:2021 CSV  IEC 2021
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
INTRODUCTION TO AMENDMENT 1 . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 11
201.4 General requirements . 12
201.5 General requirements for testing of ME EQUIPMENT . 13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 15
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 16
201.10 Protection against unwanted and excessive radiation HAZARDS . 17
201.11 Protection against excessive temperatures and other HAZARDS . 17
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 17
201.13 HAZARDOUS SITUATIONS and fault conditions . 17
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 17
201.15 Construction of ME EQUIPMENT. 17
201.16 ME SYSTEMS . 17
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 18
202 Electromagnetic compatibility – Requirements and tests . 18
203 Radiation protection in diagnostic X-ray equipment . 18
Annexes . 31
Annex C (informative) Guide to marking and labeling requirements for ME EQUIPMENT
and ME SYSTEMS . 32
Annex AA (informative) Particular guidance and rationale . 33
Annex BB (informative) Identification of parts of dental X-RAY INTRA-ORAL SYSTEMS in
relation to defined terms in this standard . 40
Bibliography . 42
Index of defined terms used in this particular standard . 45

Figure AA.1 – AIR KERMA during IRRADIATION with direct current X-RAY GENERATOR . 34
Figure AA.2 – AIR KERMA during IRRADIATION with ONE-PEAK X-RAY GENERATOR. 36
Figure AA.3 – Waveform of long IRRADIATION TIME X-RADIATION from a
ONE-PEAK X-RAY GENERATOR . 37
Figure BB.1 – Structure of DENTAL INTRA-ORAL X-RAY EQUIPMENT . 40
Figure BB.2 – Parts of DENTAL INTRA-ORAL X-RAY EQUIPMENT . 41

Table 201.101 – List of potential ESSENTIAL PERFORMANCE to be considered by
MANUFACTURER in the RISK MANAGEMENT PROCESS . 12

+AMD2:2021 CSV  IEC 2021
Table 201.C.101 – Marking on the outside of ME EQUIPMENT or its parts . 32
Table 201.C.102 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS . 32

– 4 – IEC 60601-2-65:2012+AMD1:2017
+AMD2:2021 CSV  IEC 2021
INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-65: Particular requirements for the basic safety
and essential performance of dental intra-oral X-ray equipment

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
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Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of th
...

IEC 60601-2-65 ®
Edition 1.1 2017-05
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-65: Particular requirements for the basic safety and essential performance
of dental intra-oral X-ray equipment

Appareils électromédicaux –
Partie 2-65: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à rayonnement X dentaires intra-oraux

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IEC 60601-2-65 ®
Edition 1.1 2017-05
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 2-65: Particular requirements for the basic safety and essential

performance of dental intra-oral X-ray equipment

Appareils électromédicaux –
Partie 2-65: Exigences particulières pour la sécurité de base et les

performances essentielles des appareils à rayonnement X dentaires intra-oraux

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-4396-1

IEC 60601-2-65 ®
Edition 1.1 2017-05
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 2-65: Particular requirements for the basic safety and essential performance
of dental intra-oral X-ray equipment

Appareils électromédicaux –
Partie 2-65: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à rayonnement X dentaires intra-oraux

– 2 – IEC 60601-2-65:2012+AMD1:2017 CSV
 IEC 2017
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
INTRODUCTION TO AMENDMENT 1 . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements . 11
201.5 General requirements for testing of ME EQUIPMENT . 11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 15
201.10 Protection against unwanted and excessive radiation HAZARDS . 15
201.11 Protection against excessive temperatures and other HAZARDS . 16
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 16
201.13 HAZARDOUS SITUATIONS and fault conditions . 16
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 16
201.15 Construction of ME EQUIPMENT. 16
201.16 ME SYSTEMS . 16
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 16
202 Electromagnetic compatibility – Requirements and tests . 16
203 Radiation protection in diagnostic X-ray equipment . 17
Annexes . 27
Annex C (informative) Guide to marking and labeling requirements for ME EQUIPMENT
and ME SYSTEMS . 28
Annex AA (informative) Particular guidance and rationale . 29
Annex BB (informative) Identification of parts of dental X-RAY INTRA-ORAL SYSTEMS in
relation to defined terms in this standard . 36
Bibliography . 38
Index of defined terms used in this particular standard . 41

Figure AA.1 – AIR KERMA during IRRADIATION with direct current X-RAY GENERATOR . 30
Figure AA.2 – AIR KERMA during IRRADIATION with ONE-PEAK X-RAY GENERATOR. 32
Figure AA.3 – Waveform of long IRRADIATION TIME X-RADIATION from a
ONE-PEAK X-RAY GENERATOR . 33
Figure BB.1 – Structure of DENTAL INTRA-ORAL X-RAY EQUIPMENT . 36
Figure BB.2 – Parts of DENTAL INTRA-ORAL X-RAY EQUIPMENT . 37

Table 201.101 – List of potential ESSENTIAL PERFORMANCE to be considered by
MANUFACTURER in the RISK MANAGEMENT PROCESS . 11
Table 201.C.101 – Marking on the outside of ME EQUIPMENT or its parts . 28
Table 201.C.102 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS . 28

 IEC 2017
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-65: Particular requirements for the basic safety
and essential performance of dental intra-oral X-ray equipment
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall
...