SIST EN 60601-2-54:2009
(Main)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)
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)
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.
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)
La CEI 60601-2-54:2009 s'applique à la sécurité de base et aux performances essentielles des appareils electromédicaux et des systèmes electromédicaux destinés à la radiographie de projection et à la radioscopie. Les exigences de sécurité minimales spécifiées dans la présente norme particulière sont estimées assurer un degré de sécurité réalisable dans le cadre du fonctionnement des appareils EM utilisés pour la radiographie et la radioscopie. Des dispositions supplémentaires concernant les procédures d'intervention applicables aux appareils EM sont spécifiées dans la CEI 60601-2-43. La CEI 60601-2-54:2009 a été élaborée en vue d'une utilisation avec la troisième édition de la CEI 60601-1 (2005) et ses normes collatérales.
Medicinska električna oprema - 2-54. del: Posebne zahteve za osnovno varnost in bistvene lastnosti rentgenske opreme za radiografijo in radioskopijo (IEC 60601-2-54:2009)
General Information
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Standards Content (Sample)
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 measureme
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