SIST EN 60601-2-54:2009

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische elektrische Geräte - Teil 2-54: Besondere Festlegungen für die Sicherheit und die wesentlichen Leistungsmerkmale von Röntgeneinrichtungen für Radiographie und Radioskopie (IEC 60601-2-54:2009)Appareils électromédicaux - Partie 2-54: Exigences particulières relatives à la sécurité de base et aux performances essentielles des appareils à rayonnement X utilisés pour la radiographie et la radioscopie (CEI 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)11.040.50Radiografska opremaRadiographic equipmentICS:Ta slovenski standard je istoveten z:EN 60601-2-54:2009SIST EN 60601-2-54:2009en,fr01-november-2009SIST EN 60601-2-54:2009SLOVENSKI
STANDARD
EUROPEAN STANDARD EN 60601-2-54 NORME EUROPÉENNE
EUROPÄISCHE NORM September 2009
CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: Avenue Marnix 17, B - 1000 Brussels
© 2009 CENELEC -
All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-54:2009 E
ICS 11.040.50 Supersedes EN 60601-2-7:1998, EN 60601-2-28:1993 (partially) and EN 60601-2-32:1994
English version
Medical electrical equipment -
Part 2-54: Particular requirements
for the basic safety and essential performance of X-ray equipment
for radiography and radioscopy (IEC 60601-2-54:2009)
Appareils électromédicaux -
Partie 2-54: Exigences particulières
pour la sécurité de base
et les performances essentielles
des appareils à rayonnement X utilisés pour la radiographie et la radioscopie (CEI 60601-2-54:2009)
Medizinische elektrische Geräte -
Teil 2-54: Besondere Festlegungen
für die Sicherheit und die wesentlichen Leistungsmerkmale
von Röntgeneinrichtungen
für Radiographie und Radioskopie (IEC 60601-2-54:2009)
This European Standard was approved by CENELEC on 2009-08-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard 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 Central Secretariat 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 own language and notified to the Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.
Foreword The text of document 62B/735/FDIS, future edition 1 of IEC 60601-2-54, 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 was approved by CENELEC as EN 60601-2-54 on 2009-08-01. EN 60601-2-54 was developed for use with EN 60601-1:2006.
This European Standard supersedes EN 60601-2-7:1998, EN 60601-2-32:1994 and EN 60601-2-28:1993 (partially). The following dates were fixed: – latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement
(dop)
2010-05-01 – latest date by which the national standards conflicting
with the EN have to be withdrawn
(dow)
2012-08-01 This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive MDD (93/42/EEC). See Annex ZZ. In this standard, the following print types are used: – Requirements and definitions: roman type. – Test specifications: italic type. – Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term – “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this particular standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: − “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; − “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; − “may” is used to describe a permissible way to achieve compliance with a requirement or test. SIST EN 60601-2-54:2009

- 3 - EN 60601-2-54:2009 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA. Annexes ZA and ZZ have been added by CENELEC. __________ Endorsement notice The text of the International Standard IEC 60601-2-54:2009 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 60627 NOTE
Harmonized as EN 60627:2001 (not modified). [2] IEC 61267 NOTE
Harmonized as EN 61267:2006 (not modified). [3] ISO 4090 NOTE
Harmonized as EN ISO 4090:2004 (not modified). [10] IEC 60601-2-7 NOTE
Harmonized as EN 60601-2-7:1998 (not modified). [11] IEC 60601-2-28 NOTE
Harmonized as EN 60601-2-28:1993 (not modified). [12] IEC 60601-2-32 NOTE
Harmonized as EN 60601-2-32:1994 (not modified). [13] IEC 60601-1-8 NOTE
Harmonized as EN 60601-1-8:2007 (not modified). [14] IEC 60601-1-10 NOTE
Harmonized as EN 60601-1-10:2008 (not modified). [15] IEC 60601-2-43 NOTE
Harmonized as EN 60601-2-43:2000 (not modified). __________
Annex ZA (normative)
Normative references to international publications with their corresponding European publications
The following referenced documents are indispensable for the application 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
When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies.
Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Replace the reference to IEC 60601-1-2 by:
IEC 60601-1-2 (mod) 2007 Medical electrical equipment -
Part 1-2: General requirements for basic
safety and essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 2007
Replace the reference to IEC 60601-1-3 by:
IEC 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 EN 60601-1-3 2008
Addition:
IEC 60336 -1) Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots EN 60336 20052)
IEC 60580 2000 Medical electrical equipment - Dose area product meters EN 60580 2000
IEC/TR 60788 2004 Medical electrical equipment - Glossary of defined terms – –
IEC 60806 -1) Determination of the maximum symmetrical radiation field from a rotating anode X-ray tube for medical diagnosis EN 60806 20042)
IEC 62220-1 2003 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency EN 62220-1 2004
1) Undated reference. 2) Valid edition at date of issue. SIST EN 60601-2-54:2009

- 5 - EN 60601-2-54:2009 Annex ZZ (informative)
Coverage of Essential Requirements of EC 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 as given in Annex I of the EC Directive 93/42/EEC. Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard. ___________
IEC 60601-2-54Edition 1.0 2009-06INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment –
Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
Appareils électromédicaux –
Partie 2-54: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X utilisés pour la radiographie et la radioscopie
INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XBICS 11.040.50 PRICE CODECODE PRIXISBN 2-8318-1047-5
– 2 – 60601-2-54 © IEC:2009 CONTENTS FOREWORD.4 INTRODUCTION.6 201.1 Scope, object and related standards.7 201.2 Normative references.8 201.3 Terms and definitions.9 201.4 General requirements.10 201.5 General requirements for testing of ME EQUIPMENT.11 201.6 Classification of ME EQUIPMENT and ME SYSTEMS.11 201.7 ME EQUIPMENT identification, marking and documents.11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT.14 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS.17 201.10 Protection against unwanted and excessive radiation HAZARDS.21 201.11 Protection against excessive temperatures and other HAZARDS.21 201.12 Accuracy of controls and instruments and protection against hazardous outputs.22 201.13 HAZARDOUS SITUATIONS and fault conditions.22 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).22 201.15 Construction of ME EQUIPMENT.22 201.16 ME SYSTEMS.22 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS.22 202 Electromagnetic compatibility – Requirements and tests.22 203 Radiation protection in diagnostic X-ray equipment.23 Annexes.58 Annex C (informative)
Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS.59 Annex AA (informative)
Particular guidance and rationale.61 Bibliography.64 Index of defined terms used in this particular standard.65
Figure 203.101 – Zone of EXTRA-FOCAL RADIATION.41 Figure 203.102 – Discrepancies in covering the IMAGE RECEPTION AREA.43 Figure 203.103 – Discrepancies in visual indication of the X-RAY FIELD.47 Figure 203.104 – Testing for STRAY RADIATION (X-RAY BEAM horizontal with X-RAY SOURCE ASSEMBLY below the PATIENT SUPPORT).55 Figure 203.105 – Testing for STRAY RADIATION (X-RAY BEAM vertical with X-RAY SOURCE ASSEMBLY below the PATIENT SUPPORT).55 Figure 203.106 – Testing for STRAY RADIATION (X-RAY BEAM horizontal with X-RAY SOURCE ASSEMBLY above the PATIENT SUPPORT).56 Figure 203.107 – Testing for STRAY RADIATION (X-RAY BEAM vertical with X-RAY SOURCE ASSEMBLY above the PATIENT SUPPORT).57
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements.10 Table 203.101 – Tests for verifying reproducibility and linearity.29 SIST EN 60601-2-54:2009

60601-2-54 © IEC:2009 – 3 – Table 203.102 – Loadings for testing AUTOMATIC EXPOSURE CONTROLS.31 Table 203.103 – ATTENUATION for the measurement of AIR KERMA.33 Table 203.104 – ATTENUATION EQUIVALENT of items in the X-RAY BEAM.49 Table 203.105 – Application categories.51 Table 203.106 – Requirements for PRIMARY PROTECTIVE SHIELDING.51 Table 203.107 – STRAY RADIATION in SIGNIFICANT ZONES OF OCCUPANCY.53 Table 201.C.101 – Marking on the outside of ME EQUIPMENT or its parts.59 Table 201.C.102 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS.59
– 4 – 60601-2-54 © IEC:2009 INTERNATIONAL ELECTROTECHNICAL COMMISSION _____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with an IEC Publication. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. International standard IEC 60601-2-54 has been prepared by IEC subcommittee 62B: Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice. IEC 60601-2-54 has been developed for use with the third edition of IEC 60601-1 (2005). It replaces and supersedes IEC 60601-2-7 and IEC 60601-2-32, as well as IEC 60601-2-28:1993 (currently under revision), all of which were developed to amend earlier editions of IEC 60601-1 and consequently no longer apply to this particular standard.
The text of this particular standard is based on the following documents: FDIS Report on voting 62B/735/FDIS 62B/750/RVD
Full information on the voting for the approval of this particular standard can be found in the report on voting indicated in the above table. SIST EN 60601-2-54:2009

60601-2-54 © IEC:2009 – 5 – This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard, the following print types are used:
– Requirements and definitions: roman type. – Test specifications: italic type. – Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term – “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this particular standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: – “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; – “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; – “may” is used to describe a permissible way to achieve compliance with a requirement or test. An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA. A list of all parts of the IEC 60601 series, published under the general title Medical electrical equipment, can be found on the IEC website. The committee has decided that the contents of this publication will remain unchanged until the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in the data related to the specific publication. At this date, the publication will be
• reconfirmed, • withdrawn, • replaced by a revised edition, or • amended.
– 6 – 60601-2-54 © IEC:2009 INTRODUCTION This particular standard has been prepared to provide, based on IEC 60601-1:2005 (third edition) and its collaterals, a complete set of safety requirements for ME EQUIPMENT for RADIOGRAPHY and RADIOSCOPY. While the previously existing standards for such equipment were dedicated to components and subsystems, this particular standard addresses the system level of X-RAY EQUIPMENT, which consists of a combination of an X-RAY GENERATOR, ASSOCIATED EQUIPMENT and ACCESSORIES. Component functions are addressed as far as necessary.
The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of ME EQUIPMENT for RADIOGRAPHY and RADIOSCOPY. Requirements for additional provisions for ME EQUIPMENT for interventional applications are covered by IEC 60601-2-43. SIST EN 60601-2-54:2009

60601-2-54 © IEC:2009 – 7 – MEDICAL ELECTRICAL EQUIPMENT –
Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
201.1 Scope, object and related standards Clause 1 of the general standard1) applies, except as follows: 201.1.1 Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and RADIOSCOPY. IEC 60601-2-43 applies to ME EQUIPMENT and ME SYSTEMS intended to be used for interventional applications and refers to applicable requirements in this particular standard. ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption densitometry, computed tomography, mammography or dental applications are excluded from the scope of this International Standard. The scope of this International Standard also excludes radiotherapy simulators. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. NOTE Taking into account economic and social factors, the scope of this particular standard includes ME EQUIPMENT intended to be used for DIRECT RADIOSCOPY. In some countries examinations performed with DIRECT RADIOSCOPY are prohibited. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for ME EQUIPMENT and ME SYSTEMS for RADIOGRAPHY and RADIOSCOPY. 201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard. IEC 60601-1-2 and IEC 60601-1-3 apply as modified in Clauses 202 and 203 respectively. IEC 60601-1-8 and IEC 60601-1-10 do not apply. All other published collateral standards in the IEC 60601-1 series apply as published. ————————— 1) The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance SIST EN 60601-2-54:2009

– 8 – 60601-2-54 © IEC:2009 NOTE OPERATORS of X-RAY EQUIPMENT are used to audible signals as required in this particular standard rather than to the concepts of IEC 60601-1-8. Therefore IEC 60601-1-8 does not apply. 201.1.4 Particular standards Replacement: In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements. A requirement of a particular standard takes priority over the general standard. For brevity, IEC 60601-1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number. The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words: “Replacement” means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard. “Addition” means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard. “Amendment” means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard. Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201.101. However due to the fact that definitions in the general standard are numbered 3.1 through 3.139, additional definitions in this standard are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for IEC 60601-1-3, etc. The term “this standard” is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together. Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard. 201.2 Normative references NOTE Informative references are listed in the bibliography on page 64. SIST EN 60601-2-54:2009

60601-2-54 © IEC:2009 – 9 – Clause 2 of the general standard applies, except as follows: Addition: IEC 60336, Medical electrical equipment – X-ray tube assemblies for medical diagnosis – Characteristics of focal spots IEC 60580:2000, Medical electrical equipment – Dose area product meters IEC/TR 60788:2004, Medical electrical equipment – Glossary of defined terms IEC 60806, Determination of the maximum symmetrical radiation field from a rotating anode X-ray tube for medical diagnosis
IEC 62220-1:2003, Medical electrical equipment – Characteristics of digital X-ray imaging devices – Part 1: Determination of the detective quantum efficiency Amendment: IEC 60601-1-2:2007 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance– Collateral standard: Electromagnetic compatibility – Requirements and tests IEC 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 201.3 Terms and definitions For the purposes of this document, the terms and definitions given in IEC 60601-1:2005, applicable collateral standards and IEC 60788:2004 apply, except as follows: NOTE An index of defined terms is found beginning on page 65. Addition: 201.3.201 DIRECT RADIOGRAPHY RADIOGRAPHY in which the permanent recording is effected at an IMAGE RECEPTION AREA Example: film-screen or film radiography.
201.3.202 DIRECT RADIOSCOPY RADIOSCOPY in which the visible images are presented at the IMAGE RECEPTION AREA, or close to it, in the RADIATION BEAM
201.3.203 DOSE AREA PRODUCT product of the area of the cross-section of an X-RAY BEAM and the averaged AIR KERMA over that cross-section. The unit is the gray square metre (Gy⋅m2)
201.3.204 ENTRANCE FIELD SIZE dimensions of the field in the entrance plane of an X-RAY IMAGE RECEPTOR that can be used for the transmission of an X-RAY PATTERN under specific conditions
– 10 – 60601-2-54 © IEC:2009 201.3.205 INDIRECT RADIOGRAPHY RADIOGRAPHY in which the permanent recording is effected after TRANSFER of the information obtained at an IMAGE RECEPTION AREA
Examples: CR systems, digital detector systems, image intensifier systems. 201.3.206 INDIRECT RADIOSCOPY RADIOSCOPY in which the images are presented at a location outside the RADIATION BEAM after TRANSFER of the information
201.3.207 INTERLOCK
means preventing the start or the continued operation of ME EQUIPMENT unless certain predetermined conditions prevail
201.3.208 NOMINAL SHORTEST IRRADIATION TIME shortest LOADING TIME for which a required constancy of the controlled RADIATION QUANTIY is maintained
NOTE The IRRADIATION TIME is controlled by a HIGH-VOLTAGE GENERATOR with AUTOMATIC CONTROL SYSTEMS. 201.3.209 SERIAL RADIOGRAPHY RADIOGRAPHY in which the information is obtained and recorded in a regular or irregular series of LOADINGS with equal or unequal LOADING FACTORS 201.4 General requirements Clause 4 of the general standard applies, except as follows
201.4.3 ESSENTIAL PERFORMANCE Additional subclause: 201.4.3.101 * Additional ESSENTIAL PERFORMANCE requirements Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in Table 201.101. Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements Requirement Subclause Accuracy of LOADING FACTORS 203.6.4.3.104
Reproducibility of the RADIATION output 203.6.3.2 AUTOMATIC CONTROL SYSTEM 203.6.5 Imaging performance 203.6.7
201.4.10.2 Supply mains for ME EQUIPMENT and ME SYSTEMS Addition: SIST EN 60601-2-54:2009

60601-2-54 © IEC:2009 – 11 – The internal impedance of a SUPPLY MAINS is to be considered sufficiently low for the operation of X-RAY EQUIPMENT for RADIOGRAPHY and RADIOSCOPY if the value of the APPARENT RESISTANCE OF SUPPLY MAINS does not exceed the value specified in the ACCOMPANYING DOCUMENTS. Either the APPARENT RESISTANCE OF SUPPLY MAINS or other appropriate SUPPLY MAINS specifications used in a facility shall be specified in the ACCOMPANYING DOCUMENTS. NOTE If a NOMINAL voltage is claimed for a mains power supply system, it is assumed that there is no voltage of a higher value between any of the conductors of the system or between any of these conductors and earth. An alternating voltage is considered in practice to be sinusoidal if any instantaneous value of the waveform concerned differs from the instantaneous value of the ideal waveform at the same moment by no more than ± 2 % of the peak value of the ideal waveform. A three-phase SUPPLY MAINS is considered to have a practical symmetry if it delivers symmetrical voltages and produces, when loaded symmetrically, symmetrical currents. The requirements of this standard are based upon the assumption that three-phase systems have a symmetrical configuration of the MAINS VOLTAGE with respect to earth. Single-phase systems may be derived from such three-phase systems. Where the supply system is not earthed at the source it is assumed that adequate measures have been provided to detect, limit and remedy any disturbance of symmetry within a reasonably short time. X-RAY EQUIPMENT is considered to comply with the requirements of this standard only if its specified NOMINAL ELECTRIC POWER can be demonstrated at an APPARENT RESISTANCE OF SUPPLY MAINS having a value not less than the APPARENT RESISTANCE OF SUPPLY MAINS specified by the MANUFACTURER in the ACCOMPANYING DOCUMENTS. Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS. 201.5 General requirements for testing of ME EQUIPMENT Clause 5 of the general standard applies.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS Clause 6 of the general standard applies. 201.7 ME EQUIPMENT identification, marking and documents Clause 7 of the general standard applies, except as follows: 201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts 201.7.2.7 Electrical input power from the SUPPLY MAINS Addition: For ME EQUIPMENT that is specified to be PERMANENTLY INSTALLED, the information may be stated in the ACCOMPANYING DOCUMENTS only.
The information on the input power shall be specified in terms of combinations of
a) the RATED MAINS VOLTAGE of the ME EQUIPMENT in volts; see 7.2.1 and 7.2.6 of the general standard, b) the number of phases; see 7.2.1 and 7.2.6 of the general standard, c) the frequency, in hertz; see 7.2.1 and 7.2.6 of the general standard, d) the maximum permissible value for APPARENT RESISTANCE OF SUPPLY MAINS, in ohms; e) the characteristics of OVER-CURRENT RELEASES required in the SUPPLY MAINS. NOTE These requirements are adapted from 6.1j) of IEC 60601-2-7:1998. SIST EN 60601-2-54:2009

– 12 – 60601-2-54 © IEC:2009 201.7.2.15 Cooling conditions Addition: If cooling is necessary for safe operation of ME EQUIPMENT, or a subassembly thereof, the cooling requirements shall be indicated in the ACCOMPANYING DOCUMENT, including as appropriate: – the maximum heat dissipation into the surrounding air, given separately for each subassembly that dissipates more than 100 W and might be separately located on installation; – the maximum heat dissipation into forced air cooling devices, and the corresponding flow rate and temperature rise of the forced air stream; – the maximum heat dissipation into a cooling medium utility and the permissible input temperature range, minimum flow rate and pressure requirements for the utility. NOTE These requirements are adapted from 6.1t) of IEC 60601-2-7:1998. Additional subclause: 201.7.2.101 Beam limiting device BEAM LIMITING DEVICES shall be provided with the following markings: – those required in subclause 7.2.2 of the general standard; – serial designation or individual identification; – TOTAL FILTRATION in terms of QUALITY EQUIVALENT FILTRATION. NOTE These requirements are adapted from 6.1 of IEC 60601-2-28:1993. 201.7.8.1 Colours of indicator lights Addition: The indication of X-RAY related states shall be excluded from subclause 7.8 in the general standard. Subclauses 203.6.4.2 and 203.6.4.101 shall apply instead. 201.7.9 ACCOMPANYING DOCUMENTS 201.7.9.1 General Addition: The ACCOMPANYING DOCUMENTS shall contain quality control procedures to be performed on the X-RAY EQUIPMENT by the RESPONSIBLE ORGANISATION. These shall include acceptance criteria and frequency for the tests. Additionally for X-RAY EQUIPMENT provided with an integrated digital X-RAY IMAGE RECEPTOR, the ACCOMPANYING DOCUMENTS shall contain: – a description of image processing applied to ORIGINAL DATA including the revision number or how to determine it and identification of the version if applicable; – a description of the file transfer format of the images acquired with this unit and of any data associated with these images;
The performance of means required to present the images for diagnostic purpose shall be stated according to the INTENDED USE. Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS. SIST EN 60601-2-54:2009

60601-2-54 © IEC:2009 – 13 – 201.7.9.2 Instructions for use 201.7.9.2.1 General Addition: 201.7.9.2.1.101 LOADING FACTORS In the instructions for use the LOADING FACTORS shall be stated as described below. The following combinations and data shall be stated: a) The corresponding NOMINAL X-RAY TUBE VOLTAGE for RADIOSCOPY and RADIOGRAPHY
together with the highest X-RAY TUBE CURRENT obtainable from the ME EQUIPMENT when operated at that X-RAY TUBE VOLTAGE. b) The corresponding highest X-RAY TUBE CURRENT for RADIOSCOPY and RADIOGRAPHY together with the highest X-RAY TUBE VOLTAGE obtainable from the ME EQUIPMENT when operating at that X-RAY TUBE CURRENT. c) The corresponding combination of X-RAY TUBE VOLTAGE for RADIOSCOPY and RADIOGRAPHY, and X-RAY TUBE CURRENT which results in the highest electric power in the high-voltage circuit (see 203.4.101). d) The NOMINAL ELECTRIC POWER given as the highest constant electric power in kilowatts which the ME EQUIPMENT can produce/generate, for a LOADING TIME of 0,1 s at an X-RAY TUBE VOLTAGE of 100 kV or, if these values are not selectable, with nearest parameters (see 203.4.101). The NOMINAL ELECTRIC POWER shall be given together with the combination of X-RAY TUBE VOLTAGE and X-RAY TUBE CURRENT and the LOADING TIME. e) For ME EQUIPMENT indicating precalculated or measured CURRENT TIME PRODUCT, the lowest CURRENT TIME PRODUCT or the combinations of LOADING FACTORS resulting in the lowest CURRENT TIME PRODUCT. If the value of the lowest CURRENT TIME PRODUCT depends upon the X-RAY TUBE VOLTAGE or upon certain combinations of values of LOADING FACTORS, the lowest CURRENT TIME PRODUCT may be given as a table or curve showing the dependence. f) The NOMINAL SHORTEST IRRADIATION TIME used in AUTOMATIC EXPOSURE CONTROL systems of ME EQUIPMENT. If the NOMINAL SHORTEST IRRADIATION TIME depends upon LOADING FACTORS such as X-RAY TUBE VOLTAGE and X-RAY TUBE CURRENT, the ranges of these LOADING FACTORS for which the NOMINAL SHORTEST IRRADIATION TIME is valid shall be stated. The maximum possible range of the X-RAY TUBE VOLTAGE and/or the X-RAY TUBE CURRENT during IRRADIATIONS, controlled with the AUTOMATIC EXPOSURE CONTROL SYSTEMS, shall be stated in the instructions for use. NOTE These requirements are adapted from 6.8.2 a) of IEC 60601-2-7:1998. 201.7.9.2.1.102 X-RAY SOURCE ASSEMBLY The instructions for use shall state the maximum symmetrical RADIATION FIELD of the integrated X-RAY SOURCE ASSEMBLY determined according to IEC 60806.
NOTE This requirement is adapted from
6.8.2 (dd) of IEC 60601-2-28:1993. 201.7.9.2.1.103 Integrated X-RAY IMAGE RECEPTOR For X-RAY EQUIPMENT provided with an integrated X-RAY IMAGE RECEPTOR, the instructions for use shall contain a description of the particular handling and maintenance of the X-RAY IMAGE RECEPTOR. Compliance is checked by inspection of the instructions for use. SIST EN 60601-2-54:2009

– 14 – 60601-2-54 © IEC:2009 201.7.9.3 Technical description Additional subclause: 201.7.9.3.101 X-RAY SOURCE ASSEMBLY
The technical description of the integrated X-RAY SOURCE ASSEMBLIES shall specify the following, in addition to the data required to be marked according to subclause 7.2 of the general standard: a) specification of the REFERENCE AXIS to which the TARGET ANGLE(s) and the FOCAL SPOT characteristics of the X-RAY SOURCE ASSEMBLY refer: b) TARGET ANGLE(s) with respect to the specified REFERENCE AXIS; c) position of the FOCAL SPOT and its tolerances on the REFERENCE AXIS; d) NOMINAL FOCAL SPOT VALUE(s) determined according to IEC 60336 for the specified REFERENCE AXIS. NOTE These requirements are adapted from 6.8.3 dd) of IEC 60601-2-28:1993. Additional subclause: 201.7.9.101 Additional statements in ACCOMPANYING DOCUMENTS Additional requirements for statements in ACCOMPANYING DOCUMENTS (which include instructions for use and technical description) are found in the subclauses listed in Table 201.C.102 of Annex C. 201.8 Protection against electrical HAZARDS from ME EQUIPMENT Clause 8 of the general standard applies, except as follows: 201.8.4 Limitation of voltage, current or energy
201.8.4.3 ME EQUIPMENT intended to be connected to a power source by a plug
Addition: 201.8.4.3.101 HIGH-VOLTAGE CABLE CONNECTIONS Detachable HIGH-VOLTAGE CABLE CONNECTIONS shall either be designed so that the use of TOOLS is required to disconnect them or they shall be provided with INTERLOCKS so that at all times when protective covers or HIGH-VOLTAGE CONNECTIONS are removed: – the ME EQUIPMENT is disconnected from its power supply, and – capacitances in the high-voltage circuit are discharged within the minimum time necessary to gain access to the high-voltage circuit, and – the discharged state is maintained. Compliance is checked by inspection and by measurement. NOTE These requirements are adapted from Clause 15, item aa) of IEC 60601-2-7:1998. Additional subclause: 201.8.4.101 Limitation of X-RAY TUBE VOLTAGE ME EQUIPMENT shall be designed so as not to deliver in INTENDED USE, to any connected X-RAY TUBE ASSEMBLY, a voltage greater than the NOMINAL X-RAY TUBE VOLTAGE for the X-RAY TUBE SIST EN 60601-2-54:2009

60601-2-54 © IEC:2009 – 15 – concerned or greater than the NOMINAL X-RAY TUBE VOLTAGE the X-RAY TUBE ASSEMBLY is designed for, whichever is the lower voltage. NOTE This requirement is adapted from 3.1 of IEC 60601-2-7:1998. 201.8.5 Separation of parts 201.8.5.1 MEANS OF PROTECTION (MOP) Additional subclause: 201.8.5.1.101 Additional limitation of voltage, current or energy Provision shall be made to prevent the appearance of an unacceptably high voltage in the MAINS PART or in any other low-voltage circuit. NOTE This may be achieved for example –
by provision of a winding layer or a conductive screen connected to the PROTECTIVE EARTH TERMINAL between high-voltage and low-voltage circuits; –
by provision of a voltage limiting device across terminals to which external devices are connected and between which an excessive voltage might arise if the external path becomes discontinuous. Compliance is checked by inspection of design data and construction. NOTE These requirements are adapted from 15bb) of IEC 60601-2-7:1998. 201.8.5.4 WORKING VOLTAGE Addition: 201.8.5.4.101 Stator and stator circuit dielectric strength testing The test voltage for the dielectric strength testing of stator and stator circuit used for the operation of the rotating anode of the X-RAY TUBE is to be referred to the voltage existing after reduction of the stator supply voltage to its steady state operating value. NOTE This requirement is adapted from 20.4 l) of IEC 60601-2-7:1998. 201.8.6 Protective earthing, functional earthing and potential equalization of ME EQUIPMENT 201.8.6.4 Impedance and current-carrying capability Addition: The flexible conductive screen is not to be recognized as satisfying a requirement for a PROTECTIVE EARTH CONNECTION between the devices connected by the cable. Additional subclause: 201.8.6.101 X-RAY TUBE ASSEMBLY a) Accessible high-voltage cables connecting x-RAY TUBE ASSEMBLIES to their associated HIGH-VOLTAGE GENERATOR shall incorporate a flexible conductive screen, having a resistance per unit length not exceeding 1 Ω m-1, and covered with a non-conductive material capable of protecting the screen against mecha
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