EN 61910-1:2014

Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy

IEC 61910-1:2014 applies to radiation dose structured reports produced by X ray equipment that falls within the scope of IEC 60601-2-43:2010 or IEC 60601-2-54:2009. This document does not impose specific requirements on the accuracy of the reported or displayed data. Existing standards or regulations can have applicable requirements for accuracy and precision. This standard provides specific units and quantities and prescribes data storage formats. 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 with the production of projection radiological images. This first edition cancels and replaces IEC/PAS 61910-1, published in 2007. It constitutes a technical revision which includes the following significant technical 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; - and a general update to the revised contents of the DICOM RDSR definition has occurred.

Medizinische elektrische Geräte - Dokumentation der Strahlungsdosis - Teil 1: Strukturierte Strahlungsdosis-Berichte für die Radiographie und Radioskopie

Appareils électromédicaux - Documentation sur la dose de rayonnement - Partie 1: Rapports structurés sur la dose de rayonnement pour la radiographie et la radioscopie

L'IEC 61910-1:2014 s'applique aux rapports structures sur la dose de rayonnement générés par l'appareil a rayonnement X entrant dans le domaine d'application de l'IEC 60601-2-43:2010 ou de l'IEC 60601-2-54:2009. Le présent document n'impose aucune exigence particulière quant à l'exactitude des données consignées ou affichées. Les normes et règlements existants peuvent comporter des exigences applicables en matière d'exactitude et de précision. La présente norme indique les unités et grandeurs spécifiques et précise des formats de stockage de données. Le présent document ne présente aucune exigence quant à l'affichage des informations sur la dose aux opérateurs ou à d'autres individus. La présente Norme internationale a pour objet de spécifier l'ensemble de données minimal à utiliser pour consigner les informations dosimétriques et connexes associées à la production d'images radiologiques de projection. Cette première édition annule et remplace l'IEC/PAS 61910-1, parue en 2007. Cette édition constitue une révision technique qui inclut les modifications techniques majeures suivantes par rapport à l'IEC/PAS 61910-1:2007: - les trois niveaux de conformité définis précédemment ont été restructurés en deux niveaux; - la correspondance entre les termes DICOM et IEC est décrite explicitement dans une annexe et est dissociée des exigences relatives au contenu des niveaux de conformité; et le contenu révisé de la définition du RDSR selon la DICOM a été mis à jour de manière générale.

Medicinska električna oprema - Dokumentacija o dozi obsevanja - 1. del: Strukturirana poročila o stopnji sevanja za radiografijo in radioskopijo (IEC 61910-1:2014)

Ta mednarodni standard se uporablja za STRUKTURIRANA POROČILA O STOPNJI SEVANJA (RDSR), ki jih ustvari RENTGENSKA OPREMA, ki spada na področje uporabe standarda IEC 60601-2-43:2010 ali IEC 60601-2-54:2009.
OPOMBA 1: Namen je razviti in objaviti podobne dokumente za druge modalitete rentgenskega slikanja, ki lahko ustvarjajo sporočila RDSR.
OPOMBA 2: Ta dokument ne predpisuje posebnih zahtev glede natančnosti posredovanih ali prikazanih podatkov.
Obstoječi standardi ali predpisi lahko vključujejo veljavne zahteve glede natančnosti in točnosti. Ta standard podaja specifične enote in količine ter predpisuje oblike za shranjevanje podatkov. OPOMBA 3: Podatkovne oblike so določene tako, da bo številčna negotovost v zvezi z obliko najverjetneje majhna glede na druge podatkovne negotovosti.
OPOMBA 4: Ta dokument ne predpisuje nobenih zahtev glede načina prikaza informacij o odmerkih za OPERATERJE ali druge osebe.
Cilj tega mednarodnega standarda je določiti najmanjši nabor podatkov, ki se uporablja za sporočanje dozimetričnih in povezanih informacij glede izdelave projekcijskih RADIOLOŠKIH SLIK.
OPOMBA 5: Podatkovna polja in struktura poročil so namenjeni za lažje zbiranje dozimetričnih podatkov, uporabnih za upravljanje postopkov dovajanja pomembnega odmerka, programe za kakovost opreme, določitev referenčnih ravni in izobraževanje.
OPOMBA 6: Javna struktura omogoča lažjo analizo podatkov za katero koli ustrezno osebo ali organizacijo.

General Information

• Status: Published
• Publication Date: 13-Nov-2014
• Withdrawal Date: 28-Oct-2017
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 14-Nov-2014
• Completion Date: 14-Nov-2014
• Ref Project: SIST EN 61910-1:2015 - Medical Electric Equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy (IEC 61910-1:2014)

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2015
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6WUXNWXULUDQDSRURþLODRVWRSQMLVHYDQMD]DUDGLRJUDILMRLQUDGLRVNRSLMR,(&

Medical Electric Equipment - Radiation dose documentation - Part 1: Radiation dose
structured reports for radiography and radioscopy (IEC 61910-1:2014)
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6WUXNWXULHUWH6WUDKOXQJVGRVLV%HULFKWHIUGLH5DGLRJUDSKLHXQG5DGLRVNRSLH
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Appareils électromédicaux - Documentation sur la dose de rayonnement - Partie 1 :
Rapports structurés sur la dose de rayonnement pour la radiographie et la (IEC 61910-
1:2014)radioscopie
Ta slovenski standard je istoveten z: EN 61910-1:2014
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 61910-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2014
ICS 11.040.50
English Version
Medical electrical equipment - Radiation dose documentation -
Part 1: Radiation dose structured reports for radiography and
radioscopy
(IEC 61910-1:2014)
Appareils électromédicaux - Documentation sur la dose de Medizinische elektrische Geräte - Dokumentation der
rayonnement - Partie 1: Rapports structurés sur la dose de Strahlungsdosis - Teil 1: Strukturierte Strahlungsdosis-
rayonnement pour la radiographie et la radioscopie Berichte für die Radiographie und Radioskopie
(CEI 61910-1:2014) (IEC 61910-1:2014)
This European Standard was approved by CENELEC on 2014-10-29. 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 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-CENELEC 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, Iceland, 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
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für 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
Foreword
The 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:
(dop) 2015-07-29
• latest date by which the document has to be
implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2017-10-29
standards conflicting with the
document have to be withdrawn
Attention is drawn to the possibility 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 without any modification.

- 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 its 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 applies.
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 - EN 60601-1 2006
Part 1: General requirements for basic + corr. Mars 2010
safety and essential performance +A11 2011
+A1 2012  +A1 2013
+A1/corr. July 2014
+A12 2014
IEC 60601-1-3 2008 Medical electrical equipment - EN 60601-1-3 2008
Part 1-3: General requirements + corr. Mars 2010
for basic safety and essential performance
- Collateral Standard: Radiation protection
in diagnostic X-ray equipment
+A1 2013  +A1 2013
+A1/corr. May 2014
IEC 60601-2-43 2010 Medical electrical equipment - EN 60601-2-43 2010
Part 2-43: Particular requirements for the + corr. July 2014
basic safety and essential performance of
X ray equipment for interventional
procedures
IEC 60601-2-54 2009 Medical electrical equipment - EN 60601-2-54 2009
Part 2-54: Particular requirements for the
basic safety and essential performance of
X-ray equipment for radiography and
radioscopy
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
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 électromédicaux – Documentation sur la dose de rayonnement –

Partie 1: Rapports structurés sur la dose de rayonnement pour la radiographie

et la radioscopie
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX V
ICS 11.040.50 ISBN 978-2-8322-1869-3

– 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 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
5.2.1 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 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 location 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 primary 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 primary angle for patient position “recumbent − head
first − supine” . 27
Figure E.3 − Positioner secondary angle for patient position “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 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

Table C.1 – DICOM data elements . 19

– 4 – IEC 61910-1:2014 © IEC 2014

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
RADIATION 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 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. IE
...