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

2020-03-17-JO- BT decision BT164/DG11529/DV to remove the link to the MDD (93/42/EEC)
Publication on hold due to negative assessment

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

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

Medicinska električna oprema - 2-65. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za intraoralni zobni rentgen - Dopolnilo A1 (IEC 60601-2-65:2012/A1:2017)

General Information

• Status: Published
• Publication Date: 02-Apr-2020
• 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: 9093 - Decision to confirm - Review Enquiry
• Start Date: 05-Jan-2026
• Completion Date: 20-Feb-2026
• Directive: Not Harmonized93/42/EEC - 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/A1:2020 - 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/A1:2017)

Relations

• Refers: IEC TR 60788:2004 - Medical electrical equipment - Glossary of defined terms
• Effective Date: 10-Feb-2026
• Refers: EN 13698-1:2003 - Pallet production specification - Part 1: Construction specification for 800 mm x 1200 mm flat wooden pallets
• Effective Date: 09-Feb-2026
• Refers: EN IEC 60336:2021 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics
• Effective Date: 03-Feb-2026
• Refers: EN 60601-1:2006 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 03-Feb-2026
• Refers: EN 60601-1-3:2008 - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
• Effective Date: 03-Feb-2026
• Refers: EN 62220-1:2004 - Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency
• Effective Date: 03-Feb-2026
• Referred By: EN 1789:2007+A2:2014 - Medical vehicles and their equipment - Road ambulances
• Effective Date: 09-Feb-2026
• Referred By: EN 13718-1:2008 - Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
• Effective Date: 09-Feb-2026
• Referred By: EN 1789:2007+A1:2010 - Medical vehicles and their equipment - Road ambulances
• Effective Date: 09-Feb-2026
• Amends: 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
• Effective Date: 26-Jan-2023

Overview

EN 60601-2-65:2013/A1:2020 is a European standard released by the CENELEC (CLC) that specifies the particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment. This amendment, based on IEC 60601-2-65:2012/A1:2017, integrates updates relevant to manufacturers, regulatory bodies, and end users in the dental and medical imaging equipment sector.

The document addresses safety, risk management, and performance for intra-oral dental X-ray devices, ensuring their reliable operation in clinical environments. The standard harmonizes requirements for European conformity and supports critical aspects of medical device safety, electromagnetic compatibility (EMC), and radiation protection.

Key Topics

• Basic Safety & Essential Performance: Clarifies the minimum safety and performance requirements for dental intra-oral X-ray equipment, referencing general standards such as IEC 60601-1 and related amendments.
• Risk Management: Emphasizes the implementation of thorough risk management processes as outlined in IEC 60601-1:2005 and its amendment (AMD1:2012).
• Electromagnetic Compatibility (EMC): Updates requirements for EMC in dental X-ray devices to align with current collateral standards, ensuring devices' reliable operation without interference.
• Radiation Protection: Incorporates collateral standards from IEC 60601-1-3, setting clear guidelines for protecting patients, users, and the environment from unnecessary radiation exposure.
• Terminology and Definitions: Provides harmonized definitions for critical terms such as "essential performance," "risk management," and "single fault condition," referencing the applicable IEC standards.
• Normative References: Ensures all referenced standards are up to date, fostering alignment across European and international regulatory frameworks.

Applications

This standard applies specifically to dental intra-oral X-ray equipment and is essential for:

• Dental Equipment Manufacturers: Ensuring the design and production of X-ray units are compliant with the latest safety and performance standards.
• Dental Practices & Clinics: Assuring selection and use of X-ray equipment that meets recognized European safety norms, thereby protecting both patients and clinical staff.
• Regulatory Authorities & Notified Bodies: Assessing conformity for certification, market approval, and ongoing compliance in the EU and EFTA.
• Quality Assurance Personnel: Implementing consistent procedures for risk management, performance verification, and EMC testing as part of operational protocols.

The standard is central in qualification processes for CE marking of dental X-ray devices, aligning them with EU Directives and providing guidance for integration into healthcare facilities.

Related Standards

EN 60601-2-65:2013/A1:2020 references and relates closely to a suite of standards for medical electrical equipment, including:

• EN 60601-1: General requirements for basic safety and essential performance.
• EN 60601-1-3: Radiation protection in diagnostic X-ray equipment.
• EN 60601-1-10 / -11 / -12: Requirements for physiologic closed-loop controllers, equipment used in home healthcare and emergency medical services environments.
• EN 60336: Characteristics of X-ray tube focal spots.
• EN 62220-1: Determination of detective quantum efficiency for digital X-ray imaging devices.

Upholding these standards helps manufacturers and users maintain high levels of patient safety, equipment reliability, and regulatory compliance in the field of dental radiography.

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Keywords: EN 60601-2-65, dental intra-oral X-ray equipment, dental X-ray safety standard, IEC 60601-2-65, medical electrical equipment, radiation protection, essential performance, risk management, EMC, CENELEC, European medical standards, dental radiography compliance.

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2020
Medicinska električna oprema - 2-65. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti za intraoralni zobni rentgen - Dopolnilo A1 (IEC 60601-2-
65:2012/A1:2017)
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/A1:2017)
Medizinische elektrische Geräte - Teil 2-65: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von intraoralen zahnärztlichen
Röntgeneinrichtungen (IEC 60601-2-65:2012/A1:2017)
Appareils électromédicaux - Partie 2-65: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils à rayonnement X dentaires intra-oraux
(IEC 60601-2-65:2012/A1:2017)
Ta slovenski standard je istoveten z: EN 60601-2-65:2013/A1:2020
ICS:
11.060.20 Zobotehnična oprema 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 60601-2-65:2013/A1

NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2020
ICS 11.040.50
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/A1:2017)
Appareils électromédicaux - Partie 2-65: Exigences Medizinische elektrische Geräte - Teil 2-65: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils à rayonnement X dentaires intra- wesentlichen Leistungsmerkmale von intraoralen
oraux zahnärztlichen Röntgeneinrichtungen
(IEC 60601-2-65:2012/A1:2017) (IEC 60601-2-65:2012/A1:2017)
This amendment A1 modifies the European Standard EN 60601-2-65:2013; it was approved by CENELEC on 2020-01-01. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment 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 amendment 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-65:2013/A1:2020 E

European foreword
The text of document 62B/1006/CDV, future IEC 60601-2-65/A1, prepared by 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/A1:2020.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-10-03
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2023-04-03
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and supports essential requirements of EU
Directive(s).
For the relationship with EU Directive(s), see informative Annex ZZ, included in EN 60601-2-65:2013.
Endorsement notice
The text of the International Standard IEC 60601-2-65:2012/A1:2017 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:
IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10
IEC 60601-1-11 NOTE Harmonized as EN 60601-1-11
IEC 60601-1-12 NOTE Harmonized as EN 60601-1-12

Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1  Where an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu.
The Annex ZA of EN 60601-1:2006 is applicable, except as follows:
Publication Year Title EN/HD Year
Replace
IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: EN 60601-1-3 2008
General requirements for basic safety and
essential performance - Collateral
Standard: Radiation protection in
diagnostic X-ray equipment
+EN 60601-1-2010
3:2008/corrigendum
Mar. 2010
+A11 2016
Addition
IEC 60336 -  Medical electrical equipment - X-ray tube EN 60336 -
assemblies for medical diagnosis -
Characteristics of focal spots
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
+A12 2014
+EN 60601-2010
1:2006/corrigendum
Mar. 2010
+AC 2014
+A11 2011
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/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 60601-2-65 ®
Edition 1.0 2017-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
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
...