EN 60601-2-63:2015
(Main)Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
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 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. 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 extra-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 extra-oral x-ray equipment. Components and their functions are addressed as far as necessary. 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.
Medizinische elektrische Geräte - Teil 2-63: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von extraoralen zahnärztlichen Röntgeneinrichtungen
Appareils électromédicaux - Partie 2-63: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X dentaires extra-oraux
La CEI 60601-2-63:2012 s'applique à la sécurité de base et aux performances essentielles des appareils à rayonnement X dentaires extra-oraux, également désignés ci-après par appareils EM. Le domaine d'application inclut les systèmes EM contenant de tels appareils EM. 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 extra-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 extra-oraux. Les composants et leurs fonctions sont mentionnés dans la mesure où cela est nécessaire. 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; et - les relations géométriques entre la source de rayonnement X, l'objet anatomique soumis à l'imagerie chez le patient et le récepteur radiologique sont préréglées au niveau de la conception et ne peuvent pas être modifiées de façon arbitraire par l'opérateur pendant l'utilisation prévue.
Medicinska električna oprema - 2-63. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za ekstraoralni zobni rentgen
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2015
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWL]DHNVWUDRUDOQL]REQLUHQWJHQ
Medical electrical equipment - Part 2-63: Particular requirements for basic safety and
essential performance of dental extra-oral x-ray equipment
Medizinische elektrische Geräte - Teil 2-63: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von extraoralen zahnärztlichen
Röntgeneinrichtungen
Appareils électromédicaux - Partie 2-63: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils à rayonnement x dentaires extra-oraux
Ta slovenski standard je istoveten z: EN 60601-2-63:2015
ICS:
11.040.50 Radiografska oprema Radiographic equipment
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 60601-2-63
NORME EUROPÉENNE
EUROPÄISCHE NORM May 2015
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)
Appareils électromédicaux - Medizinische elektrische Geräte - Teil 2-63: Besondere
Partie 2-63: Exigences particulières pour la sécurité Festlegungen für die Sicherheit einschließlich der
de base et les performances essentielles des appareils w esentlichen Leistungsmerkmale von extraoralen
à rayonnement X dentaires extra-oraux zahnärztlichen Röntgeneinrichtungen
(IEC 60601-2-63:2012) (IEC 60601-2-63:2012)
This European Standard w as approved by CENELEC on 2012-10-24. CENELEC members are bound to comply w ith the CEN/CENELEC
Internal Regulations w hich stipulate the conditions for giving this European Standard the status of a national standard w ithout 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 ow n 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, Norw ay, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sw eden, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved w orldw ide for CENELEC Members.
Ref. No. EN 60601-2-63:2015 E
Foreword
The text of document 62B/888/FDIS, future edition 1 of IEC 60601-2-63, 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.
The following dates are fixed:
• latest date by which the document has (dop) 2015-11-29
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-05-29
• latest date by which the national
standards conflicting with the
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 [and/or CEN] 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.
For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part
of this document.
Endorsement notice
The text of the International Standard IEC 60601-2-63:2012 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 Harm onised 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 60601-2-65:2012 NOTE Harmonised as EN 60601-2-65:2013 (not modified).
1)
Superseded by EN 60601-2-54:2009 (IEC 60601-2-54:2009) and partially by EN 60601-2-65:2013
(IEC 60601-2-65:2012).
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 1 When 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
Publication Year Title EN/HD Year
Annex ZA of EN 60601-1:2006 applies except as follows:
Replacement:
1)
IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
1)
(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
Addition:
IEC 60336 - Medical electrical equipment - X-ray tube EN 60336 -
assemblies for medical diagnosis -
Characteristics of focal spots
IEC 60601-2-29 2008 Medical electrical equipment - EN 60601-2-29 2008
Part 2-29: Particular requirements for the + A11 2011
basic safety and essential performance of
radiotherapy simulators
IEC 60601-2-54 2009 Medical electrical equipment - EN 60601-2-54 2009
Part 2-54: 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
1)
Superseded by EN 60601-1-2:2014 (IEC 60601-1-2:2014): DOW = 2018-12-31.
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.
IEC 60601-2-63 ®
Edition 1.0 2012-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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
PRICE CODE
INTERNATIONALE
X
CODE PRIX
ICS 11.040.50 ISBN 978-2-83220-382-8
– 2 – 60601-2-63 © IEC:2012
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 11
201.4 General requirements . 12
201.5 General requirements for testing of ME EQUIPMENT . 13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 16
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 17
201.10 Protection against unwanted and excessive radiation HAZARDS . 18
201.11 Protection against excessive temperatures and other HAZARDS . 18
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 18
201.13 HAZARDOUS SITUATIONS and fault conditions . 18
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 18
201.15 Construction of ME EQUIPMENT . 18
201.16 ME SYSTEMS . 18
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 19
202 Electromagnetic compatibility – Requirements and tests . 19
203 Radiation protection in diagnostic X-ray equipment . 19
Annexes . 31
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 32
Annex AA (informative) Particular guidance and rationale . 33
Bibliography . 39
Index of defined terms used in this particular standard . 42
Figure 203.101 – Zone of EXTRA-FOCAL RADIATION . 28
Figure AA.1 – PANORAMIC X-RAY EQUIPMENT . 33
Figure AA.2 – AIR KERMA during IRRADIATION with direct current X-RAY GENERATOR . 35
Figure AA.3 – AIR KERMA during IRRADIATION with ONE-PEAK X-RAY GENERATOR . 36
Figure AA.4 – Example – series of (numerous) pulsed IRRADIATIONS for a CBCT (cone
beam computed tomography) IRRADIATION event, with CONSTANT POTENTIAL HIGH-
VOLTAGE GENERATOR and time-width modulation . 37
Figure AA.5 – Example – series of two irradiations for PANORAMIC-like views of right
and left TMJ (temporo-mandibolar joint) in the same image, with ONE-PEAK HIGH-
VOLTAGE GENERATOR . 37
60601-2-63 © IEC:2012 – 3 –
Table 201.101 – List of potential ESSENTIAL PERFORMANCE to be considered by
MANUFACTURER in the RISK MANAGEMENT PROCESS . 13
Table 201.C.101 – Marking on the outside of ME EQUIPMENT or its parts . 32
Table 201.C.102 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS . 32
– 4 – 60601-2-63 © IEC:2012
INTERNATIONAL ELECTROTECHNICAL COMMISSION
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MEDICAL ELECTRICAL EQUIPMENT –
Part 2-63: Part
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