1、 IEC 61910-1 Edition 1.0 2014-09 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Radiation dose documentation Part 1: Radiation dose structured reports for radiography and radioscopy Appareils lectromdicaux Documentation sur la dose de rayonnement Partie 1: Rapports structur
2、s sur la dose de rayonnement pour la radiographie et la radioscopie IEC 61910-1:2014-09(en-fr) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2014 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by
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20、 electrical equipment Radiation dose documentation Part 1: Radiation dose structured reports for radiography and radioscopy Appareils lectromdicaux Documentation sur la dose de rayonnement Partie 1: Rapports structurs sur la dose de rayonnement pour la radiographie et la radioscopie INTERNATIONAL EL
21、ECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE V ICS 11.040.50 PRICE CODE CODE PRIX ISBN 978-2-8322-1869-3 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale Warning! Make sure that you obtained th
22、is publication from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. 2 IEC 61910-1:2014 IEC 2014 CONTENTS FOREWORD . 4 INTRODUCTION . 6 1 Scope 7 2 Normative references 7 3 Terms and definitions 8 4 Units and their DICOM stor
23、age 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 5.2.1 General . 12 5.2.2 RDSR STREAMING TRANSMISSION 12 5.2.3 RDSR END OF PROCEDURE TRANSMISSION 12 Annex A (informative) G
24、eneral 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 outline . 16 B.1 DICOM objects 16 B.2 IHE profiles . 17 B.3 IHE Radiation Exposure Monitoring Profile 17 Annex C (informa
25、tive) 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 location and orientation . 24 D.4 Single procedure step patient dose estimates . 24 D.5 Multiple procedure step patient dos
26、e 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 primary and secondary angles 26 E.3 PATIENT SUPPORT positions 28 E.4 Projection imaging geometries 29 Bibliography 30 Index of
27、 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 primary angle for patient position “recumbent head first supine” 27 Figure E.3 Positioner secondary angle for patient posi
28、tion “recumbent head first supine” 27 IEC 61910-1:2014 IEC 2014 3 Figure E.4 Positioner primary angle for patient position “recumbent head first prone” . 28 Figure E.5 Positioner secondary angle for patient position “recumbent feet first supine” 28 Figure E.6 Position vectors defining the position o
29、f 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 Table C.1 DICOM data elements 19 4 IEC 61910-1:2014 IEC 2014 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT RADIATION
30、 DOSE DOCUMENTATION Part 1: Radiation dose structured reports 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 IE
31、C 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)
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40、ensable 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. This International Standard has be
41、en prepared by subcommittee 62B: Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice. This first edition cancels and replaces IEC/PAS 61910-1, published in 2007. It constitutes a technical revision. This edition includes the following significant tec
42、hnical changes with respect to IEC/PAS 61910-1:2007: The previously defined three conformance levels have been restructured to two. The mapping between DICOM and IEC terms is explicitly described in an annex and is decoupled from the conformance level content requirements. A general update to the re
43、vised contents of the DICOM RDSR definition has occurred. IEC 61910-1:2014 IEC 2014 5 The text of this standard is based on the following documents: FDIS Report on voting 62B/948/FDIS 62B/952/RVD Full information on the voting for the approval of this standard can be found in the report on voting in
44、dicated in the above table. 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
45、 notes, examples and references: smaller type. Normative text of tables is also in a smaller type. TERMS DEFINED IN CLAUSE 3 OF THIS STANDARD OR IN OTHER IEC PUBLICATIONS REFERENCED IN THIS STANDARD: SMALL CAPITALS. In referring to the structure of this standard, the term “clause” means one of the n
46、umbered divisions within the table of contents, inclusive of all subdivisions (e.g., Clause 5 includes subclauses 5.1, 5.2, etc.); “subclause” means a numbered subdivision of a clause (e.g., 5.1, 5.2 and 5.2.1 are all subclauses of Clause 5). References to clauses within this standard are preceded b
47、y 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 stan
48、dard 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
49、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 A. The committee has decided that the contents of this pub
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