EN 61910-1-2014 en Medical electrical equipment - Radiation dose documentation - Part 1 Radiation dose structured reports for radiography and radioscopy.pdf

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1、BSI Standards PublicationMedical electrical equipment Radiation dose documentationPart 1: Radiation dose structured reports for radiography and radioscopyBS EN 61910-1:2014National forewordThis British Standard is the UK implementation of EN 61910-1:2014. It isidentical to IEC 61910-1:2014.The UK pa

2、rticipation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee CH/62/2, Diagnostic imaging equipment.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport

3、to include all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 77966 4ICS 11.040.50Compliance with a British Standard cannot confer immunity fromlegal obligations.Th

4、is British Standard was published under the authority of theStandards Policy and Strategy Committee on 28 February 2015.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 61910-1:2014EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 61910-1 November 2014 ICS 11.

5、040.50 English Version Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy (IEC 61910-1:2014) Appareils lectromdicaux - Documentation sur la dose de rayonnement - Partie 1: Rapports structurs sur la dose de rayonnemen

6、t pour la radiographie et la radioscopie (CEI 61910-1:2014) Medizinische elektrische Gerte - Dokumentation der Strahlungsdosis - Teil 1: Strukturierte Strahlungsdosis-Berichte fr die Radiographie und Radioskopie (IEC 61910-1:2014) This European Standard was approved by CENELEC on 2014-10-29. CENELEC

7、 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 appl

8、ication 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 own language and notified to the CEN-CE

9、NELEC 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, I

10、celand, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Eur

11、opisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 61910-1:2014 E BS EN 61910-1:2014EN 61910-1:2014 - 2 - Foreword The

12、text of document 62B/948/FDIS, future edition 1 of IEC 61910-1, 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 61910-1:2014. The following dates are fixed: latest d

13、ate by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2015-07-29 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2017-10-29 Attention is drawn to the possibility

14、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. Endorsement notice The text of the International Standard IEC 61910-1:2014 was approved by CENELEC as a European Standard wi

15、thout any modification. BS EN 61910-1:2014- 3 - EN 61910-1:2014 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 i

16、ts 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 a

17、pplies. 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 IEC 60601-1 2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 6

18、0601-1 + corr. Mars +A11 2006 2010 2011 +A1 2012 +A1 +A1/corr. July 2013 2014 +A12 2014 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 +

19、 corr. Mars 2008 2010 +A1 2013 +A1 2013 +A1/corr. May 2014 IEC 60601-2-43 2010 Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X ray equipment for interventional procedures EN 60601-2-43 + corr. July 2010 2014 IEC 60601-2-54 2009 Me

20、dical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy EN 60601-2-54 2009 IEC/TR 60788 2004 Medical electrical equipment - Glossary of defined terms - - BS EN 61910-1:2014 2 IEC 61910-1:2014 IEC

21、 2014 CONTENTS INTRODUCTION . 6 1 Scope 7 2 Normative references 7 3 Terms and definitions 8 4 Units and their DICOM storage formats . 9 5 General requirements 9 5.1 * Conformance levels 9 5.1.1 General . 9 5.1.2 Basic dose documentation . 9 5.1.3 Extended dose documentation . 10 5.2 Data flow 12 5.

22、2.1 General . 12 5.2.2 RDSR STREAMING TRANSMISSION 12 5.2.3 RDSR END OF PROCEDURE TRANSMISSION 12 Annex A (informative) General guidance and rationale . 13 A.1 General guidance 13 A.2 Rationale for specific clauses and subclauses 13 A.3 Biological background . 14 Annex B (informative) DICOM and IHE

23、outline . 16 B.1 DICOM objects 16 B.2 IHE profiles . 17 B.3 IHE Radiation Exposure Monitoring Profile 17 Annex C (informative) Glossary of DICOM data elements 19 Annex D (informative) Coordinate systems and their applications 23 D.1 General . 23 D.2 Equipment-specific information . 23 D.3 Patient lo

24、cation and orientation . 24 D.4 Single procedure step patient dose estimates . 24 D.5 Multiple procedure step patient dose estimates . 24 D.6 Numeric and geometric expression of uncertainty . 25 Annex E (informative) Geometry and positions in DICOM. 26 E.1 Patient positions . 26 E.2 Positioner prima

25、ry and secondary angles 26 E.3 PATIENT SUPPORT positions 28 E.4 Projection imaging geometries 29 Bibliography 30 Index of defined terms used in this particular standard 31 Figure E.1 PATIENT positions for X-RAY EQUIPMENT with PATIENT SUPPORT such as in X-ray angiography. . 26 Figure E.2 Positioner p

26、rimary angle for patient position “recumbent head first supine” 27 Figure E.3 Positioner secondary angle for patient position “recumbent head first supine” 27 BS EN 61910-1:2014IEC 61910-1:2014 IEC 2014 3 Figure E.4 Positioner primary angle for patient position “recumbent head first prone” . 28 Figu

27、re E.5 Positioner secondary angle for patient position “recumbent feet first supine” 28 Figure E.6 Position vectors defining the position of the PATIENT SUPPORT . 29 Figure E.7 Distance-related DICOM attributes for X-RAY EQUIPMENT with C-arm and PATIENT SUPPORT such as in X-ray angiography . 29 Tabl

28、e C.1 DICOM data elements 19 BS EN 61910-1:2014 6 IEC 61910-1:2014 IEC 2014 INTRODUCTION Documentation of the amount of IONIZING RADIATION used during a RADIOLOGICAL procedure is valuable for several reasons. For all procedures dose documentation provides information needed to estimate radiogenic ri

29、sk to the population. It also plays a role in general institutional quality assurance by providing data for performance validation against established RADIATION dose reference levels. Detailed documentation makes a significant contribution to clinical management of PATIENTS following those intervent

30、ional procedures that might induce tissue reactions. The transition from imaging on film to digital imaging opened the possibility of automatically recording dose and other data with the images. The Digital Imaging and Communications in Medicine (DICOM) protocol traditionally provides some relevant

31、facilities for doing this in image headers. This has had several limitations. The most obvious of these is the lack of a means for storing dose data without storing images. Thus, radioscopic data was seldom stored; and no dose data was stored if the images were not stored. Improving dose documentati

32、on was addressed jointly by the International Electrotechnical Commission (IEC) and the DICOM Standards Committee. Supplement 94 to the DICOM standard was approved in 2005 and incorporated since the 2006 edition of the standard. The DICOM standard now provides the technical format needed to store th

33、e entire description of the dose used to perform a single imaging procedure. This first edition of IEC 61910-1 replaces the Publicly Available Specification (PAS) and can become a companion document to IEC 60601-2-43 and IEC 60601-2-54. It defines the reporting of relevant RADIATION dose information

34、 and establishes conformance levels for dose documentation, to be referred to by requirements in the aforementioned equipment standards. The conformance levels represent a combination of increasing PATIENT risk and an increasing interest in quality assurance. The basic dose documentation conformance

35、 level is intended for X-RAY EQUIPMENT that produces dose levels below significant deterministic thresholds for all INTENDED USES. The extended dose documentation conformance level is intended for X-RAY EQUIPMENT used for procedures that could cause significant tissue reactions. The process resultin

36、g from this work is summarized as follows. Information is gathered into a radiation dose structured report (RDSR). This new object is designed to be stored in a picture archiving and communication system (PACS), in a medical informatics system, in a freestanding dose management workstation, or in th

37、e X-RAY EQUIPMENT itself. A performed procedure step (resulting in a single RDSR) is related to the RADIATION applied to a single PATIENT by a single piece of X-RAY EQUIPMENT in one session. The data structure permits the transfer of entire studies at once or the streaming of information per individ

38、ual IRRADIATION-EVENT. The Integrating the Healthcare Enterprise (IHE) Radiation Exposure Monitoring (REM) Profile describes an IT architecture for the creation, storage, analysis and distribution (including submission to centralized registries) of DICOM RDSR objects. BS EN 61910-1:2014IEC 61910-1:2

39、014 IEC 2014 7 MEDICAL ELECTRICAL EQUIPMENT RADIATION DOSE DOCUMENTATION Part 1: Radiation dose structured reports for radiography and radioscopy 1 Scope This International Standard applies to RADIATION DOSE STRUCTURED REPORTS (RDSR) produced by X-RAY EQUIPMENT that falls within the scope of IEC 606

40、01-2-43:2010 or IEC 60601-2-54:2009. NOTE 1 The intent is to develop and publish similar documents for other X-ray imaging modalities capable of producing RDSRs. NOTE 2 This document does not impose specific requirements on the accuracy of the reported or displayed data. Existing standards or regula

41、tions can have applicable requirements for accuracy and precision. This standard provides specific units and quantities and prescribes data storage formats. NOTE 3 The data formats are specified such that the numerical uncertainty attributable to the format is likely to be small compared to other da

42、ta uncertainties. NOTE 4 This document does not present any requirements on the form of display of dose information to OPERATORS or other individuals. The objective of this International Standard is to specify the minimum dataset to be used for reporting dosimetric and related information associated

43、 with the production of projection RADIOLOGICAL IMAGES. NOTE 5 The data fields and report structure are intended to facilitate the collection of dosimetric data useful for: management of procedures delivering significant dose, facility quality programs, establishment of reference levels, education.

44、NOTE 6 A public structure facilitates data analysis by any appropriate individual or organization. 2 Normative references 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

45、applies. For undated references, the latest edition of the referenced document (including any amendments) applies. IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005/AMD1:2012 IEC 60601-1-3:2008, Medical electrical

46、equipment Part 1-3: General requirements for basic safety and essential performance Collateral Standard: Radiation protection in diagnostic X-ray equipment IEC 60601-1-3:2008/AMD1:2013 IEC 60601-2-43:2010, Medical electrical equipment Part 2-43: Particular requirements for the basic safety and essen

47、tial performance of X-ray equipment for interventional procedures BS EN 61910-1:2014 8 IEC 61910-1:2014 IEC 2014 IEC 60601-2-54:2009, Medical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy IEC T

48、R 60788:2004, Medical electrical equipment Glossary of defined terms 3 Terms and definitions For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012, IEC 60601-1-3:2008 + IEC 60601-1-3:2008/AMD1:2013, IEC 60601-2-43:2010, IEC 60601-2-54:200

49、9, IEC TR 60788:2004 and the following apply. 3.1 * IRRADIATION-EVENT LOADING of X-RAY EQUIPMENT caused by a single continuous actuation of the equipments IRRADIATION SWITCH, from the start of the LOADING TIME of the first pulse until the LOADING TIME trailing edge of the final pulse Note 1 to entry: An IRRADIATION-EVENT can produce a single image (e.g. chest-radiograph) or a series of images (e.g. RADIOSCOPY, Cine or DSA acquisition). Note 2 to entry: The RADIOLOGICAL IMAGES resultin