EN 60601-2-65:2013

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.

Medizinische elektrische Geräte - Teil 2-65: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von intraoralen zahnärztlichen Röntgeneinrichtungen

Appareils électromédicaux - 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.

Medicinska električna oprema - 2-65. del: Posebne zahteve za osnovno varnost in bistvene zahteve za intraoralni zobni rentgen

Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI INTRAORALNEGA ZOBNEGA RENTGENA in njegovih glavnih sestavnih delov, v nadaljevanju: MEDICINSKA ELEKTRIČNA OPREMA. Področje uporabe tega standarda je omejeno na OPREMO ZA RENTGEN, kjer SESTAV RENTGENSKE CEVI vsebuje VISOKONAPETOSTNI SESTAV TRANSFORMATORJA. EKSTRAORALNI ZOBNI RENTGENI so izključeni s področja uporabe tega standarda. MEDICINSKA ELEKTRIČNA OPREMA in MEDICINSKI ELEKTRIČNI SISTEMI na področju uporabe standardov IEC 60601-2-63, IEC 60601-2-44, IEC 60601-2-54, IEC 60601-2-45 ali IEC 60601-2-43 so izključeni s področja uporabe tega standarda. Področje uporabe tega mednarodnega standarda izključuje tudi RADIOTERAPEVTSKE SIMULATORJE in opremo za denzitometrijo absorpcije kosti ali tkiva. Ta standard tudi ne vključuje MEDICINSKE ELEKTRIČNE OPREME, ki je namenjena ZOBNI RADIOSKOPIJI. Na določenem področju uporabe imajo členi tega standarda prednost in nadomeščajo tiste iz standarda IEC 60601-2-7, Medicinska električna oprema – Posebne zahteve za varnost visokonapetostnih generatorjev diagnostičnih rentgenskih generatorjev, in standarda IEC 60601-2-32, Medicinska električna oprema - Posebne zahteve za varnost opreme, ki je povezana z rentgensko opremo. Vse zahteve glede integrirane SESTAVE RENTGENSKIH CEVI so opredeljene v okviru tega standarda. Torej IEC 60601-2-28 ne velja za MEDICINSKO ELEKTRIČNO OPREMO na področju tega mednarodnega standarda.

General Information

• Status: Published
• Publication Date: 10-Jan-2013
• Withdrawal Date: 23-Oct-2015
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 11-Jan-2013
• Completion Date: 11-Jan-2013
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-2-65:2013 - Medical electrical equipment - Part 2-65: Particular requirements for basic safety and essential performance of dental intra-oral x-ray equipment

Relations

• Replaces: EN 60601-2-32:1994 - Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment
• Effective Date: 29-Jan-2023
• Replaces: EN 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: 28-Jan-2023
• Amended By: EN 60601-2-65:2013/A1:2020 - Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
• Effective Date: 26-Jan-2023
• Amended By: EN 60601-2-65:2013/A2:2021 - Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
• Effective Date: 12-Mar-2019

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2013
1DGRPHãþD
SIST EN 60601-2-32:1995
SIST EN 60601-2-7:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQH]DKWHYH]DLQWUDRUDOQL]REQLUHQWJHQ
Medical electrical equipment - Part 2-65: Particular requirements for basic safety and
essential performance of dental intra-oral x-ray equipment
Medizinische elektrische Geräte - Teil 2-65: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von intraoralen zahnärztlichen
Röntgeneinrichtungen
Appareils électromédicaux - Partie 2-65: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils à rayonnement x dentaires intra-oraux
Ta slovenski standard je istoveten z: EN 60601-2-65:2013
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
13.280 Varstvo pred sevanjem Radiation protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60601-2-65
NORME EUROPÉENNE
January 2013
EUROPÄISCHE NORM
ICS 11.040.50 Supersedes EN 60601-2-7:1998 (partially), EN 60601-2-32:1994 (partially)

English version
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)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-65: Exigences particulières Teil 2-65: Besondere Festlegungen für die
pour la sécurité de base Sicherheit einschließlich der wesentlichen
et les performances essentielles Leistungsmerkmale von intraoralen
des appareils à rayonnement X dentaires zahnärztlichen Röntgeneinrichtungen
intra-oraux (IEC 60601-2-65:2012)
(CEI 60601-2-65:2012)
This European Standard was approved by CENELEC on 2012-10-24. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the CEN-CENELEC Management Centre or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the CEN-CENELEC Management Centre has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus,
the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels

© 2013 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-65:2013 E
Foreword
The text of document 62B/889/FDIS, future edition 1 of IEC 60601-2-65, prepared by IEC/SC 62B
"Diagnostic imaging equipment" of IEC/TC 62 "Electrical equipment in medical practice" was
submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-65:2013.
The following dates are fixed:
(dop) 2013-07-24
• latest date by which the document has
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2015-10-24
• latest date by which the national
standards conflicting with the
document have to be withdrawn
This document supersedes EN 60601-2-7:1998 (PART) and EN 60601-2-32:1994 (PART).

EN 60601-2-7:1998 and EN 60601-2-32:1994:
Within its specific scope, the clauses of EN 60601-2-65:2012 supersede and replace those of
EN 60601-2-7:1998 and EN 60601-2-32:1994.

This standard is to be read in conjunction with EN 60601-1:2006.

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.

- 3 - EN 60601-2-65:2013
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.

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
Endorsement notice
The text of the International Standard IEC 60601-2-65:2012 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:

1)
IEC 60601-2-7:1998 NOTE Harmonised as EN 60601-2-7:1998 (not modified).
IEC 60601-2-28:2010 NOTE Harmonised as EN 60601-2-28:2010 (not modified).
1)
IEC 60601-2-32:1994 NOTE Harmonised as EN 60601-2-32:1994 (not modified).
IEC 60601-2-43:2010 NOTE Harmonised as EN 60601-2-43:2010 (not modified).
IEC 60601-2-44:2009 NOTE Harmonised as EN 60601-2-44:2009 (not modified).
IEC 60601-2-45:2011 NOTE Harmonised as EN 60601-2-45:2011 (not modified).
IEC 60601-2-54:2009 NOTE Harmonised as EN 60601-2-54:2009 (not modified).
IEC 60601-2-63 NOTE Harmonised as EN 60601-2-63.

1)
Superseded by EN 60601-2-54:2009 (IEC 60601-2-54:2009, not modified).

Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Annex ZA of EN 60601-1:2006 applies, except as follows:

Publication Year Title EN/HD Year
In Annex ZA of EN 60601-1:2006 replace IEC 60601-1-2 and IEC 60601-1-3 by:
IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
(mod) Part 1-2: General requirements for basic + corr. March 2010
safety and essential performance -
Collateral standard: Electromagnetic
compatibility - Requirements and tests

IEC 60601-1-3 2008 Medical electrical equipment - EN 60601-1-3 2008
Part 1-3: General requirements for basic + corr. March 2010
safety and essential performance - Collateral
Standard: Radiation protection in diagnostic
X-ray equipment
Add to Annex ZA of EN 60601-1:2006 the following new references:
IEC 60336 - Medical electrical equipment - X-ray tube EN 60336 -
assemblies for medical diagnosis -
Characteristics of focal spots

IEC/TR 60788 2004 Medical electrical equipment - Glossary - -
of defined terms
IEC 62220-1 2003 Medical electrical equipment - EN 62220-1 2004
Characteristics of digital X-ray imaging
devices -
Part 1: Determination of the detective
quantum efficiency
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
...