SIST EN 60601-2-63:2015/A1:2019
(Amendment)Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment (IEC 60601-2-63:2012/A1:2017)
General Information
- Abstract
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL EXTRA-ORAL X-RAY EQUIPMENT, hereafter also called ME EQUIPMENT. The scope includes ME SYSTEMS containing such ME EQUIPMENT.
NOTE 1 This includes PANORAMIC equipment, CEPHALOMETRIC equipment, and equipment for dental volumetric reconstruction (hereafter DVR) as defined in 201.3.203 below.
NOTE 2 DVR includes dental CBCT (cone beam computed tomography), which is also known with other names in certain parts of the world, e.g. DVT (digital volumetric tomography); DVR also includes tomosynthesis.
NOTE 3 This may include the imaging of other anatomical parts (e.g. the hand) as long as required for dental treatment (e.g. orthodontic treatment).
NOTE 4 This may include anatomical objects of interest to the ENT (ear, nose, and throat) specialist.
The scope of this standard is restricted to X-RAY EQUIPMENT where:
• the X-RAY TUBE ASSEMBLY contains the HIGH-VOLTAGE TRANSFORMER ASSEMBLY and
• the geometrical relations between the X-RAY SOURCE, the anatomical object being imaged
in the PATIENT, and the X-RAY IMAGE RECEPTOR, are preset in the design and cannot be arbitrarily altered by the OPERATOR during INTENDED USE.
NOTE 5 DENTAL INTRA-ORAL X-RAY EQUIPMENT is excluded from the scope of this standard.
NOTE 6 FOCAL SPOT TO IMAGE RECEPTOR DISTANCE and FOCAL SPOT to object distance are preset in the design of DENTAL EXTRA-ORAL X-RAY EQUIPMENT.
NOTE 7 For DENTAL X-RAY EQUIPMENT not in the scope of this document because of the restriction above, applicable clauses of IEC 60601-2-54 may be used with this document. ME EQUIPMENT and ME SYSTEMS in the scope of IEC 60601-2-44, IEC 60601-2-54, IEC 60601-2-45, IEC 60601-2-65 or IEC 60601-2-43 are excluded from the scope of this particular standard. The scope of this International Standard also excludes RADIOTHERAPY SIMULATORS and equipment for bone or tissue absorption densitometry. Excluded from the scope is also ME EQUIPMENT intended to be used for DENTAL RADIOSCOPY. Within its specific scope, the clauses of this particular standard supersede and replace those of IEC 60601-2-7, Medical electrical equipment – Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators and of IEC 60601-2-32, Medical electrical equipment – Particular requirements for the safety of associated equipment of X-ray equipment. IEC 60601-2-7 and IEC 60601-2-32, have been included in either IEC 60601-1:2005 (Ed3) or this particular standard. Therefore IEC 60601-2-7 and IEC 60601-2-32 are not part of the IEC 60601-1 3rd edition scheme for DENTAL EXTRA-ORAL X-RAY EQUIPMENT.
All requirements addressing integrated X-RAY TUBE ASSEMBLIES are covered by this particular standard. Therefore IEC 60601-2-28 does not apply to ME EQUIPMENT in the scope of this International Standard with the exception of X-RAY TUBE ASSEMBLIES that are replaceable in the field.
NOTE 9 Requirements particular to DENTAL X-RAY-EQUIPMENT which were included in previous editions of the collateral standard IEC 60601-1-3 or the particular standard IEC 60601-2-28 have been extracted and moved into this particular standard.
NOTE 10 For X-RAY EQUIPMENT in the scope of this particular standard X-RAY TUBE ASSEMBLIES are X-RAY MONOBLOCK ASSEMBLIES.
- Status
- Published
- Publication Date
- 04-Nov-2019
- Technical Committee
- IEMO - Electrical equipment in medical practice
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 23-Oct-2019
- Due Date
- 28-Dec-2019
- Completion Date
- 05-Nov-2019
- Directive
- 93/42/EEC - Medical devices
Overview
SIST EN 60601-2-63:2015/A1:2019 is a European standard developed by CLC (CEN-CENELEC) that specifies the particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment. This amendment, harmonized with IEC 60601-2-63:2012/A1:2017, enhances and updates the original 2015 edition. It is integral for manufacturers, regulatory bodies, and dental professionals focused on the safety, quality, and compliance of radiographic dental equipment used outside the oral cavity.
The standard establishes requirements for the design and performance of extra-oral dental X-ray apparatus, addressing critical factors such as accuracy of exposure parameters, electromagnetic compatibility, radiation protection, and risk management. EN 60601-2-63 serves as a companion to the general safety standard EN 60601-1, providing specialized guidance for dental imaging equipment.
Key Topics
Basic Safety and Essential Performance
Ensures that dental extra-oral X-ray equipment is safe for both patients and operators, complying with general and specific safety requirements.Accuracy of Exposure Parameters
Sets tolerances for X-ray tube voltage (±10%), tube current (±20%), and irradiation time (±5% + 50 ms) to ensure diagnostic image quality and patient safety.Radiation Protection
Requires adherence to standards for minimizing exposure, including compliance with EN 60601-1-3 and its amendments, focusing on safety in diagnostic X-ray environments.Electromagnetic Compatibility (EMC)
Details requirements for immunity and emissions, demanding practical EMC testing under risk management processes to ensure operation is not disrupted by electromagnetic disturbances.Terminology and Risk Management
Aligns terminology and requirements with the latest definitions in EN 60601-1 and its amendments, emphasizing comprehensive risk management throughout equipment lifecycle.
Applications
The standard is applied throughout the design, manufacturing, testing, and certification of dental extra-oral X-ray devices, such as panoramic and cephalometric X-ray machines. Key practical applications include:
Regulatory Compliance
Assists manufacturers in demonstrating compliance with European safety directives and legal requirements, facilitating market access and CE marking for dental radiographic devices.Quality Assurance
Provides benchmarks for functional performance, enabling ongoing equipment maintenance, calibration, and quality control in dental clinics and radiography centers.Radiation Safety
Supports healthcare providers in implementing robust radiation protection protocols, reducing risk to both patients and practitioners during diagnostic procedures.Procurement Specifications
Serves as a technical reference for dental professionals and purchasing bodies when specifying and acquiring compliant extra-oral X-ray systems.
Related Standards
SIST EN 60601-2-63:2015/A1:2019 is part of a wider framework of standards for medical electrical equipment. Key related standards include:
EN 60601-1:2006/A11:2011, A12:2014
General requirements for basic safety and essential performance for all medical electrical equipmentEN 60601-1-3:2008/A11:2016
Collateral standard focusing on radiation protection in diagnostic X-ray equipmentEN 60601-2-54:2009
Requirements for X-ray equipment for radiography and radioscopyIEC/TR 60788:2004
Glossary of defined medical imaging equipment terms
Adhering to these standards ensures dental X-ray systems are aligned with best practices in safety, electromagnetic compatibility, and performance, supporting high-quality patient care in dental imaging.
Keywords: dental X-ray standard, EN 60601-2-63, extra-oral X-ray, medical electrical equipment, dental radiography, radiation safety, essential performance, European standards for dental equipment, IEC 60601-2-63 compliance, dental imaging equipment safety
Relations
- Effective Date
- 09-Feb-2026
- Effective Date
- 03-Feb-2026
- Effective Date
- 03-Feb-2026
- Effective Date
- 03-Feb-2026
- Effective Date
- 03-Feb-2026
- Effective Date
- 03-Feb-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 10-May-2016
Get Certified
Connect with accredited certification bodies for this standard
BSI Group
BSI (British Standards Institution) is the business standards company that helps organizations make excellence a habit.
TÜV Rheinland
TÜV Rheinland is a leading international provider of technical services.
TÜV SÜD
TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions.
Sponsored listings
Frequently Asked Questions
SIST EN 60601-2-63:2015/A1:2019 is a amendment published by the Slovenian Institute for Standardization (SIST). Its full title is "Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment (IEC 60601-2-63:2012/A1:2017)". This standard covers: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL EXTRA-ORAL X-RAY EQUIPMENT, hereafter also called ME EQUIPMENT. The scope includes ME SYSTEMS containing such ME EQUIPMENT. NOTE 1 This includes PANORAMIC equipment, CEPHALOMETRIC equipment, and equipment for dental volumetric reconstruction (hereafter DVR) as defined in 201.3.203 below. NOTE 2 DVR includes dental CBCT (cone beam computed tomography), which is also known with other names in certain parts of the world, e.g. DVT (digital volumetric tomography); DVR also includes tomosynthesis. NOTE 3 This may include the imaging of other anatomical parts (e.g. the hand) as long as required for dental treatment (e.g. orthodontic treatment). NOTE 4 This may include anatomical objects of interest to the ENT (ear, nose, and throat) specialist. The scope of this standard is restricted to X-RAY EQUIPMENT where: • the X-RAY TUBE ASSEMBLY contains the HIGH-VOLTAGE TRANSFORMER ASSEMBLY and • the geometrical relations between the X-RAY SOURCE, the anatomical object being imaged in the PATIENT, and the X-RAY IMAGE RECEPTOR, are preset in the design and cannot be arbitrarily altered by the OPERATOR during INTENDED USE. NOTE 5 DENTAL INTRA-ORAL X-RAY EQUIPMENT is excluded from the scope of this standard. NOTE 6 FOCAL SPOT TO IMAGE RECEPTOR DISTANCE and FOCAL SPOT to object distance are preset in the design of DENTAL EXTRA-ORAL X-RAY EQUIPMENT. NOTE 7 For DENTAL X-RAY EQUIPMENT not in the scope of this document because of the restriction above, applicable clauses of IEC 60601-2-54 may be used with this document. ME EQUIPMENT and ME SYSTEMS in the scope of IEC 60601-2-44, IEC 60601-2-54, IEC 60601-2-45, IEC 60601-2-65 or IEC 60601-2-43 are excluded from the scope of this particular standard. The scope of this International Standard also excludes RADIOTHERAPY SIMULATORS and equipment for bone or tissue absorption densitometry. Excluded from the scope is also ME EQUIPMENT intended to be used for DENTAL RADIOSCOPY. Within its specific scope, the clauses of this particular standard supersede and replace those of IEC 60601-2-7, Medical electrical equipment – Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators and of IEC 60601-2-32, Medical electrical equipment – Particular requirements for the safety of associated equipment of X-ray equipment. IEC 60601-2-7 and IEC 60601-2-32, have been included in either IEC 60601-1:2005 (Ed3) or this particular standard. Therefore IEC 60601-2-7 and IEC 60601-2-32 are not part of the IEC 60601-1 3rd edition scheme for DENTAL EXTRA-ORAL X-RAY EQUIPMENT. All requirements addressing integrated X-RAY TUBE ASSEMBLIES are covered by this particular standard. Therefore IEC 60601-2-28 does not apply to ME EQUIPMENT in the scope of this International Standard with the exception of X-RAY TUBE ASSEMBLIES that are replaceable in the field. NOTE 9 Requirements particular to DENTAL X-RAY-EQUIPMENT which were included in previous editions of the collateral standard IEC 60601-1-3 or the particular standard IEC 60601-2-28 have been extracted and moved into this particular standard. NOTE 10 For X-RAY EQUIPMENT in the scope of this particular standard X-RAY TUBE ASSEMBLIES are X-RAY MONOBLOCK ASSEMBLIES.
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL EXTRA-ORAL X-RAY EQUIPMENT, hereafter also called ME EQUIPMENT. The scope includes ME SYSTEMS containing such ME EQUIPMENT. NOTE 1 This includes PANORAMIC equipment, CEPHALOMETRIC equipment, and equipment for dental volumetric reconstruction (hereafter DVR) as defined in 201.3.203 below. NOTE 2 DVR includes dental CBCT (cone beam computed tomography), which is also known with other names in certain parts of the world, e.g. DVT (digital volumetric tomography); DVR also includes tomosynthesis. NOTE 3 This may include the imaging of other anatomical parts (e.g. the hand) as long as required for dental treatment (e.g. orthodontic treatment). NOTE 4 This may include anatomical objects of interest to the ENT (ear, nose, and throat) specialist. The scope of this standard is restricted to X-RAY EQUIPMENT where: • the X-RAY TUBE ASSEMBLY contains the HIGH-VOLTAGE TRANSFORMER ASSEMBLY and • the geometrical relations between the X-RAY SOURCE, the anatomical object being imaged in the PATIENT, and the X-RAY IMAGE RECEPTOR, are preset in the design and cannot be arbitrarily altered by the OPERATOR during INTENDED USE. NOTE 5 DENTAL INTRA-ORAL X-RAY EQUIPMENT is excluded from the scope of this standard. NOTE 6 FOCAL SPOT TO IMAGE RECEPTOR DISTANCE and FOCAL SPOT to object distance are preset in the design of DENTAL EXTRA-ORAL X-RAY EQUIPMENT. NOTE 7 For DENTAL X-RAY EQUIPMENT not in the scope of this document because of the restriction above, applicable clauses of IEC 60601-2-54 may be used with this document. ME EQUIPMENT and ME SYSTEMS in the scope of IEC 60601-2-44, IEC 60601-2-54, IEC 60601-2-45, IEC 60601-2-65 or IEC 60601-2-43 are excluded from the scope of this particular standard. The scope of this International Standard also excludes RADIOTHERAPY SIMULATORS and equipment for bone or tissue absorption densitometry. Excluded from the scope is also ME EQUIPMENT intended to be used for DENTAL RADIOSCOPY. Within its specific scope, the clauses of this particular standard supersede and replace those of IEC 60601-2-7, Medical electrical equipment – Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators and of IEC 60601-2-32, Medical electrical equipment – Particular requirements for the safety of associated equipment of X-ray equipment. IEC 60601-2-7 and IEC 60601-2-32, have been included in either IEC 60601-1:2005 (Ed3) or this particular standard. Therefore IEC 60601-2-7 and IEC 60601-2-32 are not part of the IEC 60601-1 3rd edition scheme for DENTAL EXTRA-ORAL X-RAY EQUIPMENT. All requirements addressing integrated X-RAY TUBE ASSEMBLIES are covered by this particular standard. Therefore IEC 60601-2-28 does not apply to ME EQUIPMENT in the scope of this International Standard with the exception of X-RAY TUBE ASSEMBLIES that are replaceable in the field. NOTE 9 Requirements particular to DENTAL X-RAY-EQUIPMENT which were included in previous editions of the collateral standard IEC 60601-1-3 or the particular standard IEC 60601-2-28 have been extracted and moved into this particular standard. NOTE 10 For X-RAY EQUIPMENT in the scope of this particular standard X-RAY TUBE ASSEMBLIES are X-RAY MONOBLOCK ASSEMBLIES.
SIST EN 60601-2-63:2015/A1:2019 is classified under the following ICS (International Classification for Standards) categories: 11.040.50 - Radiographic equipment; 11.060.20 - Dental equipment; 13.280 - Radiation protection. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 60601-2-63:2015/A1:2019 has the following relationships with other standards: It is inter standard links to SIST EN 13698-1:2003, SIST EN 60601-1-3:2008, SIST EN 60601-1:2007, SIST EN 60601-2-54:2009, SIST EN IEC 60336:2021, SIST EN 60601-2-29:2009, SIST EN 13718-1:2008, SIST EN 1789:2007+A1:2010, SIST EN 1789:2007+A2:2015, SIST EN 60601-2-63:2015. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 60601-2-63:2015/A1:2019 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/295. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
SIST EN 60601-2-63:2015/A1:2019 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2019
Medicinska električna oprema - 2-63. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti za ekstraoralni zobni rentgen - Dopolnilo A1 (IEC 60601-2-
63:2012/A1:2017)
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and
essential performance of dental extra-oral X-ray equipment (IEC 60601-2-
63:2012/A1:2017)
Medizinische elektrische Geräte - Teil 2-63: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von extraoralen zahnärztlichen
Röntgeneinrichtungen (IEC 60601-2-63:2012/A1:2017)
Appareils électromédicaux - Partie 2-63: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils à rayonnement X dentaires extra-oraux
(IEC 60601-2-63:2012/A1:2017)
Ta slovenski standard je istoveten z: EN 60601-2-63:2015/A1:2019
ICS:
11.040.50 Radiografska oprema Radiographic equipment
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 60601-2-63:2015/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2019
ICS 11.040.50
English Version
Medical electrical equipment - Part 2-63: Particular requirements
for the basic safety and essential performance of dental extra-
oral X-ray equipment
(IEC 60601-2-63:2012/A1:2017)
Appareils électromédicaux - Partie 2-63: Exigences Medizinische elektrische Geräte - Teil 2-63: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils à rayonnement X dentaires extra- wesentlichen Leistungsmerkmale von extraoralen
oraux zahnärztlichen Röntgeneinrichtungen
(IEC 60601-2-63:2012/A1:2017) (IEC 60601-2-63:2012/A1:2017)
This amendment A1 modifies the European Standard EN 60601-2-63:2015; it was approved by CENELEC on 2019-08-07. 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
© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-63:2015/A1:2019 E
European foreword
The text of document 62B/1049/FDIS, future IEC 60601-2-63/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 60601-2-63:2015/A1:2019.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-04-11
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2022-10-11
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.
Endorsement notice
The text of the International Standard IEC 60601-2-63:2012/A1:2017 was approved by CENELEC as
a European Standard without any modification.
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
Addition
IEC 60336 - Medical electrical equipment - X-ray tubeE N 60336 -
assemblies for medical diagnosis -
Characteristics of focal spots
IEC 60601-1 2005 Medical electrical equipment - Part 1: GeneralE N 60601-1 2006
requirements for basic safety and essential
performance
+A12 2014
+EN 60601-2010
1:2006/corrigendum
Mar. 2010
+AC 2014
+A11 2011
IEC 60601-2-29 2008 Medical electrical equipment - Part 2-29:E N 60601-2-29 2008
Particular requirements for the basic safety and
essential performance of radiotherapy simulators
+A11 2011
IEC 60601-2-54 2009 Medical electrical equipment - Part 2-54:E N 60601-2-54 2009
Particular requirements for the basic safety and
essential performance of X-ray equipment for
radiography and radioscopy
IEC/TR 60788 2004 Medical electrical equipment - Glossary of- -
defined terms
IEC/PAS 61910-1 2007 Medical electrical equipment - Radiation dose- -
documentation -- Part 1: Equipment for
radiography and radioscopy
Replacement
IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: General EN 60601-1-3 2008
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
IEC 60601-2-63 ®
Edition 1.0 2017-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –
Part 2-63: Particular requirements for the basic safety and essential performance
of dental extra-oral X-ray equipment
Appareils électromédicaux –
Partie 2-63: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à rayonnement X dentaires extra-oraux
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
...