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STANDARD
SIST EN 60601-2-54:2009
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.
SIST EN 60601-2-54:2009
EN 60601-2-54:2009 - 2 -
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). __________
SIST EN 60601-2-54:2009
EN 60601-2-54:2009 - 4 -
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. ___________
SIST EN 60601-2-54:2009
SIST EN 60601-2-54:2009
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
Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale SIST EN 60601-2-54:2009
– 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
SIST EN 60601-2-54:2009
– 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.
SIST EN 60601-2-54:2009
– 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
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