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)
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
- 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
Relations
- Effective Date
- 10-May-2016
Overview
The SIST EN 60601-2-63:2015/A1:2019 standard specifies particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment. This amendment to EN 60601-2-63:2015 introduces updates aligned with IEC 60601-1:2005 and its Amendment 1:2012, ensuring compliance with the latest medical electrical equipment safety protocols. Published by CLC in October 2019, this European Standard harmonizes diagnostic imaging safety with international guidelines, targeting dental radiographic devices used outside the oral cavity.
This standard is critical for manufacturers, regulators, and healthcare providers, as it addresses safety, radiation protection, electromagnetic compatibility, and performance accuracy to minimize risks in dental X-ray diagnostics. Adoption of this standard supports compliance with EU regulations and facilitates market access across members of the European Committee for Electrotechnical Standardization (CENELEC).
Key Topics
Basic Safety Requirements
SIST EN 60601-2-63:2015/A1:2019 outlines electrical safety measures to protect patients and operators from hazards such as electric shock, overheating, and mechanical failures.Essential Performance Criteria
Ensures the X-ray system reliably produces accurate diagnostic images, maintaining correct X-ray tube voltage, current, and irradiation time within defined tolerances. Performance under normal and fault conditions is tested to safeguard diagnostic integrity.Radiation Protection
Includes provisions for minimizing patient and operator exposure based on IEC 60601-1-3:2008 and its Amendment 1:2013, focusing on shielding, controlled emission, and monitoring of radiation dose.Electromagnetic Compatibility (EMC)
Specifies immunity to electromagnetic interference in the clinical environment per IEC 60601-1-2, ensuring consistent device functioning without disruption from external or internal sources.Risk Management
Encourages a documented risk management process per IEC 60601-1:2005/AMD1:2012, enabling manufacturers to minimize potential hazards through design and testing controls.Terminology Harmonization
Consolidates definitions with general standards for terms like essential performance, hazard, single fault condition, and patient to unify understanding across related medical electrical equipment standards.
Applications
SIST EN 60601-2-63:2015/A1:2019 is intended for manufacturers, designers, and testers of dental extra-oral X-ray equipment, including panoramic and cephalometric imaging systems. It applies to equipment used in:
- Dental clinics and hospitals for diagnostic imaging
- Dental radiology departments specializing in extra-oral radiography
- Equipment intended for use by dental professionals to support treatment planning and patient monitoring
Compliance with this standard improves patient safety, enhances diagnostic reliability, and aligns product development with regulatory requirements applicable within the EU and internationally. It also assists healthcare facilities in selecting devices that meet recognized safety and performance benchmarks.
Related Standards
This standard works in conjunction with several key IEC and EN standards, including:
- IEC 60601-1:2005 / AMD1:2012 - General requirements for basic safety and essential performance of medical electrical equipment
- IEC 60601-1-2:2014 - Collateral standard for electromagnetic compatibility of medical equipment
- IEC 60601-1-3:2008 / AMD1:2013 - Collateral standard on radiation protection in diagnostic X-ray equipment
- IEC 60601-2-29:2008 - Requirements for radiotherapy simulators
- IEC 60601-2-54:2009 - Requirements for X-ray equipment for radiography and radioscopy
- IEC/TR 60788:2004 - Glossary of defined terms in medical electrical equipment
- IEC 60601-1-10, -1-11, -1-12 - Collateral standards on physiological controllers, home healthcare, and emergency medical services equipment
Adherence to these complementary standards creates a robust compliance framework covering the safety, performance, and specific technical requirements vital for dental extra-oral X-ray devices.
By implementing SIST EN 60601-2-63:2015/A1:2019, stakeholders enhance patient safety, radiation protection, and operational reliability in dental radiographic diagnostics, ensuring continuous alignment with evolving international medical device standards.
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 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.
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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
...
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