SIST EN 60601-2-63:2015/A1:2019

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 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.

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)

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)

Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI EKSTRAORALNEGA ZOBNEGA RENTGENA, v nadaljevanju: ELEKTROMEDICINSKA OPREMA. Področje uporabe vključuje ELEKTROMEDICINSKE SISTEME, ki vključujejo tako ELEKTROMEDICINSKO OPREMO.
OPOMBA 1 Sem spada PANORAMSKA oprema, oprema za KEFALOMETRIJO in oprema za zobno volumetrično rekonstitucija (v nadaljevanju: DVR), kot je opredeljena v točki 201.3.203 spodaj.
OPOMBA 2 DVR vključuje zobni CBCT (računalniška tomografija s konusnim snopom), poznana tudi pod drugimi imeni v določenih delih sveta, npr. DVT (digitalna volumetrična tomografija); DVR vključuje tudi tomosintezo.
OPOMBA 3 Sem lahko spada slikanje drugih anatomskih delov (npr. roke), če je to potrebno za zobno zdravljenje.
OPOMBA 4 Sem lahko spadajo anatomski deli, ki so zanimivi za specialista ENT (uho, nos in grlo).
Področje uporabe tega standarda je omejeno na RENTGENSKO OPREMO, pri kateri:
• SESTAV RENTGENSKIH CEVI vsebuje VISOKONAPETOSTNI SESTAV TRANSFORMATORJEV in
• je geometrično razmerje med RENTGENSKIM VIROM, slikanim anatomskim delom
PACIENTA in RENTGENSKIM SLIKOVNIM SPREJEMNIKOM prednastavljeno v sami zasnovi in ga OPERATER ne more poljubno spremeniti med NAMERAVANO UPORABO.
OPOMBA 5 INTRAORALNI ZOBNI RENTGENI so izključeni s področja uporabe tega standarda.
OPOMBA 6 RAZDALJA MED GORIŠČEM IN SLIKOVNIM SPREJEMNIKOM ter GORIŠČEM in delom sta prednastavljeni v zasnovi EKSTRAORALNEGA ZOBNEGA RENTGENA.
OPOMBA 7 Za ZOBNI RENTGEN, ki ni v področju uporabe tega dokumenta zaradi zgornjih omejitev, se lahko s tem dokumentom uporabljajo ustrezne točke standarda IEC 60601-2-54. MEDICINSKA ELEKTRIČNA OPREMA in MEDICINSKI ELEKTRIČNI SISTEMI na področju uporabe standardov IEC 60601-2-44, IEC 60601-2-54, IEC 60601-2-45, IEC 60601-2-65 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 točke 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. Standarda IEC 60601-2-7 in IEC 60601-2-32 sta vključena ali v standard IEC 60601-1:2005 (3 različica) ali ta standard. Standarda IEC 60601-2-7 in IEC 60601-2-32 tako nista del sheme tretje različice standarda IEC 60601-1 za ZOBNI RENTGEN.
Vse zahteve glede integrirane SESTAVE RENTGENSKIH CEVI so opredeljene v okviru tega standarda. Standard IEC 60601-2-28 se tako ne uporablja za ELEKTROMEDICINSKO OPREMO, ki spada v področje uporabe tega mednarodnega standarda, razen SESTAVOV RENTGENSKIH CEVI, ki so zamenljive na kraju samem.
OPOMBA 9 Zahteve za ZOBNI RENTGEN, ki so bile vključene v prejšnje različice spremljevalnega standarda IEC 60601-1-3 ali standarda IEC 60601-2-28, so bile premaknjene v ta standard.
OPOMBA 10 SESTAVI RENTGENSKIH CEVI so RENTGENSKI SESTAVI MONOBLOKOV v okviru RENTGENA, ki spada v področje uporabe tega standarda.

General Information

• Status: Published
• Publication Date: 04-Nov-2019
• ICS: 11.040.50 - Radiographic equipment
• ICS: 11.060.20 - Dental equipment
• ICS: 13.280 - Radiation protection
• 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: Not Harmonized93/42/EEC - Medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN 60601-2-63:2015/A1:2019 - Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment

Relations

• Refers: SIST 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: SIST 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: SIST EN 60601-1:2007 - Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
• Effective Date: 03-Feb-2026
• Refers: SIST EN 60601-2-54:2009 - Medical electrical equipment - Part 2-54: Particular requirements for basic safety and essential performance of X-ray equipment for radiography and radioscopy (IEC 60601-2-54:2009)
• Effective Date: 03-Feb-2026
• Refers: SIST EN IEC 60336:2021 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics (IEC 60336:2020)
• Effective Date: 03-Feb-2026
• Refers: SIST EN 60601-2-29:2009 - Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators (IEC 60601-2-29:2008)
• Effective Date: 03-Feb-2026
• Referred By: SIST EN 13718-1:2008 - Medical vehicles and their equipment - Air Ambulances - Part 1: Requirements of medical devices used in air ambulances
• Effective Date: 09-Feb-2026
• Referred By: SIST EN 1789:2007+A1:2010 - Medical vehicles and their equipment - Road ambulances
• Effective Date: 09-Feb-2026
• Referred By: SIST EN 1789:2007+A2:2015 - Medical vehicles and their equipment - Road ambulances
• Effective Date: 09-Feb-2026
• Amends: SIST EN 60601-2-63:2015 - Medical electrical equipment - Part 2-63: Particular requirements for basic safety and essential performance of dental extra-oral x-ray equipment
• Effective Date: 10-May-2016

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 equipment

• EN 60601-1-3:2008/A11:2016
  Collateral standard focusing on radiation protection in diagnostic X-ray equipment

• EN 60601-2-54:2009
  Requirements for X-ray equipment for radiography and radioscopy

• IEC/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.

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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

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
...