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)

This International Standard applies to RADIATION DOSE STRUCTURED REPORTS (RDSR) produced
by X-RAY EQUIPMENT that falls within the scope of IEC 60601-2-43:2010 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 regulations 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 data 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 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.
NOTE 6 A public structure facilitates data analysis by any appropriate individual or organization.

Medizinische elektrische Geräte - Dokumentation der Strahlungsdosis - Teil 1: Strukturierte Strahlungsdosis-Berichte für die Radiographie und Radioskopie (IEC 61910-1:2014)

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

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: 23-Mar-2015
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 08-Dec-2014
• Due Date: 12-Feb-2015
• Completion Date: 24-Mar-2015
• Ref Project: EN 61910-1:2014 - Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 61910-1:2015
01-maj-2015
0HGLFLQVNDHOHNWULþQDRSUHPD'RNXPHQWDFLMDRGR]LREVHYDQMDGHO
6WUXNWXULUDQDSRURþLODRVWRSQMLVHYDQMD]DUDGLRJUDILMRLQUDGLRVNRSLMR,(&

Medical Electric Equipment - Radiation dose documentation - Part 1: Radiation dose
structured reports for radiography and radioscopy (IEC 61910-1:2014)
0HGL]LQLVFKHHOHNWULVFKH*HUlWH'RNXPHQWDWLRQGHU6WUDKOXQJVGRVLV7HLO
6WUXNWXULHUWH6WUDKOXQJVGRVLV%HULFKWHIUGLH5DGLRJUDSKLHXQG5DGLRVNRSLH
,(&
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
SIST EN 61910-1:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 61910-1:2015

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SIST EN 61910-1:2015


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

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SIST EN 61910-1:2015
EN 61910-1:2014 - 2 -
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.

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SIST EN 61910-1:2015
- 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

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SIST EN 61910-1:2015

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SIST EN 61910-1:2015



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



Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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SIST EN 61910-1:2015
– 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

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SIST EN 61910-1:2015
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

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SIST EN 61910-1:2015
– 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. 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 itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
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.
This International Standard has been 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 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. A general update to the revised contents of the
DICOM RDSR definition has occurred.

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SIST EN 61910-1:2015
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 indicated 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 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 numbered 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 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 A.
The committee has decided that the contents of this publication will remain unchanged until
the stability 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.

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SIST EN 61910-1:2015
– 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 risk 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 interventional 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 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 documentation 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 the 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 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 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 resulting 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 the 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 individual 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.

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SIST EN 61910-1:2015
IEC 61910-1:2014 © 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 60601-2-43:2010 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 regulations 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 data 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 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.
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 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 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 essential performance of X-ray equipment for interventional procedures

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SIST EN 61910-1:2015
– 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 TR 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 60601-2-54:2009, 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 equipment’s
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 resulting from an IRRADIATION-EVENT can be stored in the X-RAY
EQUIPMENT or image archive or not.
1
Note 3 to entry: Corresponding statement in the DICOM standard [1] PS 3.16, Annex D: An IRRADIATION-EVENT is
the occurrence of radiation being applied to a patient in a single continuous time-frame between the start (release)
and the stop (cease) of the irradiation. Any on-off switching of the irradiation source during the event shall not be
treated as separate events, rather the event includes the time between start and stop of irradiation as triggered by
the user. E.g., a pulsed fluoro X-ray acquisition shall be treated as a single IRRADIATION-EVENT.
Note 4 to entry: LOADING TIME is defined in IEC 60601-1-3:2008, 3.37, and described in IEC 60601-2-54:2009,
203.4.101.3.
3.2
ACTOR
information system or component of information system that produces, manages, or acts on
categories of information required by operational activities in the RESPONSIBLE ORGANIZATION
Note 1 to entry: Details on IHE terms are provided in Clauses B.2 and B.3
Note 2 to entry: See IHE Radiology Technical Framework:2011 [2], Volume 1, Section 1.6.1.
3.3
RADIATION DOSE STRUCTURED REPORT
RDSR
structured digital record of RADIATION dose delivered to a PATIENT during a RADIOLOGICAL
procedure, encoded as DICOM dose structured report object
3.4
* RDSR STREAMING TRANSMISSION
process of sending the current partial RDSR after completion of each IRRADIATION-EVENT
3.5
RDSR END OF PROCEDURE TRANSMISSION
process of sending a final RDSR after completion or discontinuation of a RADIOLOGICAL
procedure
Note 1 to entry: Resetting the dose indicators defines the end of the previous RADIOLOGICAL procedure.
____________
1
 Numbers in square brackets refer to the Bibliography.

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SIST EN 61910-1:2015
IEC 61910-1:2014 © IEC 2014 – 9 –
4 Units and their DICOM storage formats
The numerical values of all quantities shall be stored in a format such that storage rounding
introduces less than 1,0 % total additional uncertainty.
5 General requirements
5.1 * Conformance levels
5.1.1 General
The RDSR shall conform to one of the following levels: basic dose documentation or extended
dose documentation.
NOTE 1 The bas
...