IEC PAS 61910-1:2007

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

This Publicly Available Specification (PAS) applies to medical electrical equipment and medical electrical systems. The scope of this document encompasses all forms of projection radiographic equipment incorporating means for measuring or calculating dose related quantities and capable of producing DICOM compatible images and/or reports. This document provides specific units and quantities. It does not apply for: - dental radiography and radioscopy; - mammography; - computed tomography.

General Information

• Status: Replaced
• Publication Date: 10-Jul-2007
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 24-Sep-2014

Relations

• Replaced By: IEC 61910-1:2014 - Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
• Effective Date: 05-Sep-2023

Standards Content (Sample)

PUBLICLY
IEC
AVAILABLE
PAS 61910-1
SPECIFICATION
First edition
Pre-Standard
2007-07
Medical electrical equipment –
Radiation dose documentation –
Part 1:
Equipment for radiography
and radioscopy
Reference number
IEC/PAS 61910-1:2007(E)
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PUBLICLY
IEC
AVAILABLE
PAS 61910-1
SPECIFICATION
First edition
Pre-Standard
2007-07
Medical electrical equipment –
Radiation dose documentation –
Part 1:
Equipment for radiography
and radioscopy
PRICE CODE
Commission Electrotechnique Internationale T

International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
For price, see current catalogue

– 2 – PAS 61910-1 © IEC:2007(E)
CONTENTS
FOREWORD.3
INTRODUCTION.5

1 Scope, object and related standards.6
1.1 Scope.6
1.2 Object .6
2 Normative references .6
3 Terms and definitions .7
4 Units and their DICOM storage formats .8
5 General requirements .8
5.1 DICOM elements and conformance levels .8
5.1.1 Level 0 limited conformance .8
5.1.2 Level 1 limited dose monitoring .9
5.1.3 Level 2 general dose monitoring .9
5.1.4 Level 3 RESERVED.9
5.2 Data flow.9
5.2.1 General .9
5.2.2 IRRADIATION-EVENT by IRRADIATION-EVENT transmission .10
5.2.3 End of procedure transmission .10
5.2.4 Storage of RDSRs in the imaging equipment .10
5.3 Data to be recorded and stored .10
5.4 Data to be displayed by the equipment.11

Annex A (informative) General guidance and rationale.12
Annex B (informative) Notes and explanations .14
Annex C (normative) Levels of compliance .15
Annex D (informative) Biological background .21

Bibliography.22

Index of defined terms .23

PAS 61910-1 © IEC:2007(E) – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
RADIATION DOSE DOCUMENTATION –

Part 1: Equipment 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, 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 provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
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.
A PAS is a technical specification not fulfilling the requirements for a standard, but made
available to the public.
IEC-PAS 61910-1 has been prepared by maintenance team 38 of IEC subcommittee 62B of
IEC technical committee 62: Electrical equipment in medical practice.
The text of this PAS is based on the This PAS was approved for
following document: publication by the P-members of the
committee concerned as indicated in
the following document
Draft PAS Report on voting
62B/645/PAS 62B/653/RVN
Following publication of this PAS, which is a pre-standard publication, the technical committee
or subcommittee concerned will transform it into an International Standard. Its structure will
then be adapted to the IEC rules.

– 4 – PAS 61910-1 © IEC:2007(E)
This PAS shall remain valid for an initial maximum period of three years starting from
2007-07. The validity may be extended for a single three-year period, following which it shall
be revised to become another type of normative document or shall be withdrawn.
In this publicly available specification, 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 PAS OR AS NOTED: SMALL
CAPITALS.
In referring to the structure of this document, 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 PAS are preceded by the term “Clause” followed by the
clause number. References to subclauses within this collateral standard are by number only.
In this document, 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 document conform to usage described in Annex H of the
ISO/IEC Directives, Part 2. For the purposes of this PAS, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this PAS;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this PAS;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
Clauses, subclauses and definitions for which a rationale is provided in informative Annex A
are marked with an asterisk (*).

PAS 61910-1 © IEC:2007(E) – 5 –
INTRODUCTION
Documentation of the amount of radiation used during an imaging 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
deterministic injuries.
The transition of imaging from film to stored digital images opened the possibility of
automatically recording dose and other data with the images. The DICOM structure
traditionally provides some relevant facilities for doing this in image headers. This system 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 data was stored if
the images were not stored.
Improving dose documentation was addressed jointly by the International Electrotechnical
Commission (IEC) and the DICOM Committee. The supplement 94 to the DICOM standard
was approved in 2005. This supplement provides the technical format needed to store the
entire description of the dose used to perform a single imaging procedure. The companion
IEC publicly available specification defines the relevant radiation quantities and establishes
equipment compliance levels. These represent a combination of increasing patient risk and an
increasing interest in quality assurance. Compliance level one is intended for equipment that
produces dose levels below significant deterministic thresholds for all intended uses.
Compliance level two is intended for equipment used for procedures that could cause
significant deterministic injuries. Compliance level three, while not described in this document,
will eventually contain specifications for advanced dose modelling on individual patients.
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
PACS system, in a medical informatics system, in a freestanding dose management
workstation, or in the imaging equipment itself. The data structure permits the transfer of
entire studies at once or the streaming of individual irradiations.
At present, the scope of DICOM DOSE is limited to aspects of projection radiography and
radioscopy. Expansion of DICOM DOSE to all X-ray imaging modalities is planned.

– 6 – PAS 61910-1 © IEC:2007(E)
MEDICAL ELECTRICA
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