XR 25

NEMA XR 25
COMPUTED
TOMOGRAPHY
DOSE CHECK
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Copyright National Electrical Manufacturers Association

Provided by IHS under license with NEMA
No reproduction or networking permitted without license from IHS Not for Resale
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NEMA Standards Publication XR 25-2010
Computed Tomography Dose Check
Published by:
National Electrical Manufacturers Association

1300 North 17th Street, Suite 1752
Rosslyn, Virginia 22209
www.nema.org
www.medicalimaging.org
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© Copyright 2010 by the National Electrical Manufacturers Association. All rights, including translation
into other languages, reserved under the Universal Copyright Convention, the Berne Convention for the
Protection of Literary and Artistic Works, and the International and Pan American Copyright Conventions.

NOTICE AND DISCLAIMER
The information in this publication was considered technically sound by the consensus of persons
engaged in the development and approval of the document at the time it was developed. Consensus
does not necessarily mean that there is unanimous agreement among every person participating in the
development of this document.
National Electrical Manufacturers Association (NEMA) standards and guideline publications, of which the
document contained herein is one, are developed through a voluntary consensus standards development
process. This process brings together volunteers and/or seeks out the views of persons who have an
interest in the topic covered by this publication. While NEMA administers the process and establishes
rules to promote fairness in the development of consensus, it does not write the document and it does not
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of any judgments contained in its standards and guideline publications.
NEMA disclaims liability for any personal injury, property, or other damages of any nature whatsoever,
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additional views or information not covered by this publication.
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of the statement.
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XR 25-2010
Page i
CONTENTS
Foreword..................................................................................................................................................ii
Member Company List ...........................................................................................................................iii
History.....................................................................................................................................................iv
Section 1 OVERVIEW.................................................................................................................................. 1
1.1 Scope......................................................................................................................................... 1
1.2 Rationale.................................................................................................................................... 1
1.3 References ................................................................................................................................ 1
1.3.1 Normative References .................................................................................................. 1
1.4 Definitions .................................................................................................................................. 2
1.5 Abbreviations............................................................................................................................. 2
Section 2 DOSE NOTIFICATIONS AND DOSE ALERTS .......................................................................... 3
2.1 Dose Notifications...................................................................................................................... 3
2.1.1 Configuration ................................................................................................................. 3
2.1.2 Checking Prior to SCANNING ...................................................................................... 3
2.1.3 Audit Capability for PROTOCOLS and PROTOCOL ELEMENTS ............................... 3
2.1.4 Dose Notification Format............................................................................................... 4
2.2 Dose Alerts ................................................................................................................................ 4
2.2.1 Configuration ................................................................................................................. 4
2.2.2 Checking Prior to SCANNING ...................................................................................... 4
2.2.3 Checking Prior to Saving PROTOCOLS and Audit Capability ..................................... 5
2.2.4 Dose Alert Format ......................................................................................................... 5
ANNEX A (Informative) ............................................................................................................................... 6
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© Copyright 2010 by the National Electrical Manufacturers Association.

XR 25-2010
Page ii
Foreword
This standard is intended to be used by medical imaging device manufacturers in the design and
manufacture of CT scanner equipment.
This standard was developed by the CT Group of the X-Ray Imaging Section of the Medical Imaging &
Technology Alliance (MITA), a division of NEMA. Inquiries, comments, and proposed or recommended
revisions should be submitted to the X-Ray Imaging Section by contacting:
Executive Director
MITA
1300 North 17th Street
Suite 1752
Rosslyn, Virginia 22209
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XR 25-2010
Page iii
Member Company List
At the time of the approval of the standard, the CT Group was composed of the following members:
GE Healthcare
Hitachi Medical Systems America, Inc.
Philips Healthcare
Siemens Medical Solutions USA, Inc.
Toshiba America Medical Systems
At the time of the approval of the standard, the X-Ray Imaging Section was composed of the following
members:
Advanced Instrument Development, Inc.

Agfa Healthcare
Bioptics, Inc.
Biospace Med
Capintec, Inc.
Carestream Health, Inc.
CIRS
Eizo Nanao Corporation
Fujifilm Medical Systems, U.S.A., Inc.
Gamma Medica Ideas, Inc.
GE Healthcare
Hitachi Medical Systems America, Inc.
Hologic, Inc.
Konica Minolta Medial Imaging USA, Inc.
Medtronic Navigation
Philips Healthcare
Sectra North America
Shimadzu Medical Systems
Siemens Medical Solutions USA, Inc.
Stryker Communications
The Phantom Laboratory
Toshiba America Medical Systems, Inc.
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XR 25-2010
Page iv
History
This is the first edition of this standard.

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XR 25-2010
Page 1
Section 1
OVERVIEW
1.1 SCOPE
This standard applies to particular dose-related notification and alert messages appearing on the
operating consoles of CT scanners.
This standard is not intended to define all notification, alert, or other messages resident on any CT
scanner.
1.2 RATIONALE
This standard intends to notify and alert the operating personnel, generally technologists, that prepare
and set the SCAN PARAMETERS—prior to starting a SCAN—whether the estimated dose index is above
the value defined and set by the operating group, practice, or organization (hereafter referred to as
“institution”) to warrant notification to the operator.
In order to accommodate a range of different operational and QA-related features adapted from a variety
of technological advances in current and prospective scanner models, dose messages to the operator
are not limited to those specified in this standard.
The IEC 60601-2-44 Ed. 2.1 and Ed. 3 (Particular requirements for the basic safety and essential
performance of X-ray equipment for computed tomography) standard currently does not contain these
dose notifications and alerts. This NEMA standard supplements the IEC standard until 60601-2-44 is
updated to include a version of the features herein specified.
1.3 REFERENCES
1.3.1 Normative References
The following normative documents contain provisions, which through reference in this text, constitute
provisions of this Standards Publication. By reference herein these publications are adopted, in whole or
in part as indicated, in this Standards Publication.
International Electrotechnical Commission

3, rue de Varembé
Case postale 131
CH-1211 Geneva 20
Switzerland
IEC 60601-2-44 Ed. 2.1 and Ed. 3 Particular requirements for the basic safety and essential performance
of X-ray equipment for computed tomography
International Organization for Standardization (ISO)

1, rue de Varembé
Case postale 56
CH-1211 Geneva 20
Switzerland
ISO 12052 Health informatics – Digital imaging and communication in medicine (DICOM) including
workflow and data management

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XR 25-2010
Page 2
1.4 DEFINITIONS
SCAN or SCANNING:
As used in this standard, SCAN or SCANNING denotes the complete process of irradiating a person or
an object while collecting x-ray transmission data to produce a tomographic image or to produce a
tomographic data set that could be applied for analytical or density-conversion purposes. Data may be
collected simultaneously during a single SCAN for the production of one or more tomographic images or
tomographic data sets.
SCANNING PARAMETER:
A SCANNING PARAMETER is the individual building block of an acquisition, for example, tube voltage,
tube current, rotation time, etc. These are each individual SCANNING PARAMETERS. Multiple
SCANNING PARAMETERS are grouped together to form a PROTOCOL ELEMENT.
PROTOCOL ELEMENT:
A PROTOCOL ELEMENT is a set consisting of all the SCANNING PARAMETERS necessary to perform
a single SCAN (tube voltage, tube current, rotation time, spatial location, etc.).
NOTE—Various CT systems may use terms corresponding to the term “PROTOCOL ELEMENT” that are consistent with the rest of
their user interfaces and documentation, e.g., “scan,” “scan group,” “scan series,” etc.
PROTOCOL ELEMENT GROUP:

A PROTOCOL ELEMENT GROUP is one or more PROTOCOL ELEMENTS grouped together and
executed by the system based on a single press of the Confirm/Go/Load software button on the user
interface. The SCANNING for this group may occur from one or more activations of the “X-ray on”
hardware button.
PROTOCOL:
A group of PROTOCOL ELEMENTS predefined for a certain CT examination.
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EXAMINATION:
A group of PROTOCOLS used for the entire CT procedure for the current patient.
NOTIFICATION VALUE:
A value of CTDIvol (in units of mGy) or of DLP (in units of mGy·cm) that is set by the operating institution
to trigger a notification to the operator prior to SCANNING when exceeded by a corresponding dose
index value expected for the selected PROTOCOL ELEMENT.
NOTE—A NOTIFICATION VALUE represents a value above which a dose index value would be above the institution’s established
range for the PROTOCOL ELEMENT.
ALERT VALUE:
A value of CTDIvol (in units of mGy) or of DLP (in units of mGy·cm) that is set by the operating institution
to trigger an alert to the operator prior to SCANNING within an ongoing EXAMINATION if it would be
exceeded by an accumulated dose index, on acquisition of the next confirmed PROTOCOL ELEMENT
GROUP.
NOTE—An ALERT VALUE represents a value above which the accumulated dose index value would be well above the institution’s
established range for the EXAMINATION that warrants more stringent review and consideration before proceeding.
1.5 ABBREVIATIONS
CTDIvol: Volume Computed Tomography Dose Index (as defined in IEC 60601-2-44)
DLP: Dose Length Product (as defined in IEC 60601-2-44)

XR 25-2010
Page 3
Section 2
DOSE NOTIFICATIONS AND DOSE ALERTS
2.1 DOSE NOTIFICATIONS

2.1.1 Configuration
Manufacturers shall provide a means for users to enter, save, and modify NOTIFICATION VALUES.
The system shall permit a NOTIFICATION VALUE in terms of CTDIvol, DLP, or both for each of the
PROTOCOL ELEMENTS making up each PROTOCOL. The system is not required to support
NOTIFICATION VALUES for scan projection radiography.
The system may permit the user to choose not to set NOTIFICATION VALUES for some or all
PROTOCOL ELEMENTS in some or all PROTOCOLS.
2.1.2 Checking Prior to SCANNING

The NOTIFICATION VALUE(S) for the current PROTOCOL ELEMENT(S) shall be visible to the operator
prior to confirmation of the PROTOCOL ELEMENT GROUP.
When a PROTOCOL ELEMENT GROUP is confirmed, the system shall display a notification (see 2.1.4)
on the operator’s console if the estimated CTDIvol or DLP exceeds the corresponding NOTIFICATION
VALUE(S). The notification shall be displayed prior to the start of the SCAN, and shall never interrupt the
SCAN.
Some PROTOCOL ELEMENTS, such as bolus tracking or interventional, may not have a predefined
number of rotations but may have other pre-programmed limits on the number of exposures or exposure
time. When estimating the CTDIvol and DLP for these types of PROTOCOL ELEMENTS, the estimate
shall assume that the SCAN proceeds to those limits for PROTOCOL ELEMENTS such as bolus tracking;
however, for interventional type PROTOCOL ELEMENTS, alternate means may be used such as values
in mGy/s. If there are no preprogrammed limits, checking is not required.
The system is not required to display a notification if no corresponding NOTIFICATION VALUES have
been set.
To exceed a NOTIFICATION VALUE, the system shall require the operator to reconfirm the chosen
PROTOCOL ELEMENTS before proceeding to the SCAN. The system shall permit the operator to enter a
diagnostic reason (of up to 64 characters) at the operator’s discretion. The system does not have to
require the input of such reason(s) in order to proceed.
When a SCAN is performed that exceeds a NOTIFICATION VALUE, the system shall record the date and
time, a unique study identifier, the NOTIFICATION VALUE(S) that were exceeded, and the corresponding
dose index value(s) that triggered the notification and any diagnostic reason provided for proceeding after
receiving a notification. This record shall be available for site review and audit.
2.1.3 Audit Capability for PROTOCOLS and PROTOCOL ELEMENTS

The system shall be able to generate a list of all PROTOCOLS and PROTOCOL ELEMENTS with their
corresponding NOTIFICATION VALUES. If the NOTIFICATION VALUE is not set for a particular
PROTOCOL ELEMENT, the list will indicate this status. The system shall generate the list on request of
the user.
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XR 25-2010
Page 4
2.1.4 Dose Notification Format

The notification shall include at least three elements: a title, a body, and operator interactions (including a
field to enter diagnostic reason(s)).
The title of the notification shall be the text in the following box:
DOSE NOTIFICATION
The body of the notification message shall identify the NOTIFICATION VALUE(S) that would be
exceeded, and the corresponding estimated dose index value(s), and may provide additional information
for clarity.
The interactions shall allow the operator to:
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(1) Enter diagnostic reason (optional) then confirm to proceed, or
(2) Go back and adjust SCANNING PARAMETERS
2.2 DOSE ALERTS

2.2.1 Configuration
Manufacturers shall provide a means for users to enter, save, and modify ALERT VALUE(S) in terms of
CTDIvol, DLP, or both.
2.2.2 Checking Prior to SCANNING

For each EXAMINATION, at each position on the z-axis in the DICOM patient coordinate system, the
system shall accumulate values for the total CTDIvol and shall accumulate the total DLP as the
EXAMINATION proceeds. The system shall reset the accumulated values to zero when an
EXAMINATION is closed. The system may set the accumulated total CTDIvol to zero when the DICOM
patient coordinate system shifts, e.g., when the patient changes position on the table. The system is not
required to accumulate values for scan projection radiography.
When a PROTOCOL ELEMENT GROUP is confirmed, the system shall display an alert (see 2.2.4) on the
operator’s console if the accumulated CTDIvol or the accumulated DLP, plus the estimated values for the
confirmed PROTOCOL ELEMENT GROUP, exceeds the corresponding ALERT VALUE. The alert shall
be displayed prior to the start of the SCAN, and shall never interrupt the SCAN.
Some PROTOCOL ELEMENTS, such as bolus tracking or interventional, may not have a predefined
number of rotations but may have other pre-programmed limits on the number of exposures or exposure
time. When estimating the CTDIvol and DLP for these types of PROTOCOL ELEMENTS, the estimate
shall assume that the SCAN proceeds to those limits for PROTOCOL ELEMENTS such as bolus tracking;
however, for interventional type PROTOCOL ELEMENTS, alternate means may be used such as values
in mGy/s. If there are no preprogrammed limits, checking is not required.
The system is not required to display an alert if a corresponding ALERT VALUE has not been set.
To proceed with SCANNING when an ALERT VALUE has been exceeded, the system shall require the
operator to enter his/her name and reconfirm the chosen PROTOCOL ELEMENTS before proceeding to
the SCAN. The system shall also provide password-protection capability that prevents execution of the
SCAN unless the correct password is entered. The activation of the password-protection capability may
be configurable. The system shall permit the operator to enter a diagnostic reason (of up to 64
characters) at the operator’s discretion. The system does not have to require the input of such reason(s)
in order to proceed.

XR 25-2010
Page 5
When a SCAN is performed that exceeds an ALERT VALUE, the system shall record the date and time,
the operator’s name, unique study identifier, the ALERT VALUE(S) that were exceeded, and the
corresponding dose index value(s) that triggered the alert and any diagnostic reason provided for
proceeding after receiving an alert. This record shall be available for site review and audit.
2.2.3 Checking Prior to Saving PROTOCOLS and Audit Capability

When a PROTOCOL is saved, the system shall display an alert (see 2.2.4) on the operator’s console if
the estimated CTDIvol or DLP exceeds the corresponding ALERT VALUE.
The system shall be able to generate a list of ALERT VALUES. If any ALERT VALUE has not been set,
the list will indicate this status. The system shall generate the list on request of the user.
2.2.4 Dose Alert Format

The alert shall include at least three elements: a title, a body, and operator interactions (including a field
to enter diagnostic reason(s)).
The title of the alert shall be the text in the following box:
DOSE ALERT
A dose alert value will be exceeded!
The body of the alert message shall identify the ALERT VALUE(S) that would be exceeded, the
corresponding estimated dose value(s), and may provide additional information for clarity.
The interactions shall allow the operator to:
(1) Enter diagnostic reason (optional) and enter the user’s name and password (if so configured) then
confirm to proceed, or
(2) Go back and adjust SCANNING PARAMETERS

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XR 25-2010
Page 6
ANNEX A
(Informative)
This example does not intend to represent any particular scanner model or brand of equipment and is
intended only to assist the reader interpreting the terms used throughout this document.
Consider a typical CT procedure with contrast administration. It typically consists of four parts:
Part 1: Scan projection radiograph, to define the SCAN location
Part 2: Bolus Locator—axial SCAN to define slice of patient to track
Part 3: Tracking—Multiple axial SCANS, monitoring the Bolus Locator slice after contrast has been
administered
Part 4: Helical scan—SCAN of patient, with contrast in the bloodstream
Each of the above parts (1, 2, 3, 4) are separate PROTOCOL ELEMENTS. PROTOCOL ELEMENTS
have their own SCAN PARAMETERS such as kVp, mA, rotation time, etc.
PROTOCOL ELEMENT GROUP is defined by the Confirm/Go/Load software button:

Part 1 above is a PROTOCOL ELEMENT GROUP
Part 2 above is a PROTOCOL ELEMENT GROUP
Parts 3 and 4 above together form a PROTOCOL ELEMENT GROUP
Note—NOTIFICATION VALUE for Part 1 above is not required by this standard.
PROTOCOL is associated with a diagnostic task, e.g., tri-phased liver, head with/without contrast.
All four of the PROTOCOL ELEMENTS above together make up a PROTOCOL.
EXAMINATION is associated with a patient; e.g., trauma examination consisting of head and pelvis
protocols. In this example, the PROTOCOL also represents the complete EXAMINATION.
Parts 1 and 2 are each initiated by the technologist, by selecting “Confirm/Go/Load” on the user interface,
and then pressing the “X-ray on” button.
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Part 3 is initiated by a “Confirm/Go/Load” on the user interface, and then pressing the “X-ray on” button or
in conjunction with the Contrast hookup.
Part 4 is automatically initiated (no need for “Confirm/Go/Load”) by the tracking scan, when the contrast is
detected in the Bolus Locator slice.
The dose NOTIFICATION VALUES and ALERT VALUES are checked each time “Confirm/Go/Load” is
pressed.
The key issue for comparisons is the combination of selecting “Confirm/Go/Load” on the user interface,
and then pressing the “X-ray on” button. In our simple example listed above, Part 2 will be compared to
its individual NOTIFICATION VALUE.
Parts 3 and 4 together comprise a single PROTOCOL ELEMENT GROUP. This is because of the
automatic transition between parts 3 and 4. Upon pressing “Confirm/Go/Load,” the system will compare
the dose index for the Part 3 tracking scans against the corresponding NOTIFICATION VALUE.
Additionally, the system will compare the dose index for Part 4, the helical scan, with the corresponding

XR 25-2010
Page 7
NOTIFICATION VALUE. Finally, the system will compare the accumulated dose index (Part 2 already
acquired and estimates for Parts 3 and 4) against the ALERT VALUE.
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NEMA XR 25

Copyright National Electrical Manufacturers Association

Copyright National Electrical Manufacturers Association

Computed Tomography Dose Check

National Electrical Manufacturers Association

Copyright National Electrical Manufacturers Association

Copyright National Electrical Manufacturers Association

© Copyright 2010 by the National Electrical Manufacturers Association.

© Copyright 2010 by the National Electrical Manufacturers Association.

Member Company List

Advanced Instrument Development, Inc.

© Copyright 2010 by the National Electrical Manufacturers Association.

This is the first edition of this standard.

© Copyright 2010 by the National Electrical Manufacturers Association.

International Electrotechnical Commission

International Organization for Standardization (ISO)

© Copyright 2010 by the National Electrical Manufacturers Association.

Copyright National Electrical Manufacturers Association

PROTOCOL ELEMENT GROUP:

© Copyright 2010 by the National Electrical Manufacturers Association.

2.1 DOSE NOTIFICATIONS

2.1.2 Checking Prior to SCANNING

2.1.3 Audit Capability for PROTOCOLS and PROTOCOL ELEMENTS

2.1.4 Dose Notification Format

The interactions shall allow the operator to:

(2) Go back and adjust SCANNING PARAMETERS

2.2 DOSE ALERTS

2.2.2 Checking Prior to SCANNING

© Copyright 2010 by the National Electrical Manufacturers Association.

2.2.3 Checking Prior to Saving PROTOCOLS and Audit Capability

2.2.4 Dose Alert Format

The interactions shall allow the operator to:

(2) Go back and adjust SCANNING PARAMETERS

© Copyright 2010 by the National Electrical Manufacturers Association.

PROTOCOL ELEMENT GROUP is defined by the Confirm/Go/Load software button:

Note—NOTIFICATION VALUE for Part 1 above is not required by this standard.

All four of the PROTOCOL ELEMENTS above together make up a PROTOCOL.

© Copyright 2010 by the National Electrical Manufacturers Association.

© Copyright 2010 by the National Electrical Manufacturers Association.

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