FprEN ISO 12052

SLOVENSKI STANDARD
01-junij-2025
Zdravstvena informatika - Digitalno slikanje in komunikacija v medicini (DICOM),
vključno z upravljanjem poteka dela in podatkov (ISO/DIS 12052:2025)
Health informatics - Digital imaging and communication in medicine (DICOM) including
workflow and data management (ISO/DIS 12052:2025)
Medizinische Informatik - Digitale Bildverarbeitung und Kommunikation in der Medizin
(DICOM) inklusive Workflow und Datenmanagement (ISO/DIS 12052:2025)
Informatique de santé - Imagerie numérique et communication en médecine (DICOM)
incluant le déroulement des opérations et la gestion des données (ISO/DIS 12052:2025)
Ta slovenski standard je istoveten z: prEN ISO 12052
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 12052
ISO/TC 215
Health informatics — Digital
Secretariat: ANSI
imaging and communication
Voting begins on:
in medicine (DICOM) including
2025-03-27
workflow and data management
Voting terminates on:
2025-06-19
Informatique de santé — Imagerie numérique et communication
en médecine (DICOM) incluant le déroulement des opérations et
la gestion des données
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 12052:2025(en)
DRAFT
ISO/DIS 12052:2025(en)
International
Standard
ISO/DIS 12052
ISO/TC 215
Health informatics — Digital
Secretariat: ANSI
imaging and communication
Voting begins on:
in medicine (DICOM) including
workflow and data management
Voting terminates on:
Informatique de santé — Imagerie numérique et communication
en médecine (DICOM) incluant le déroulement des opérations et
la gestion des données
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 12052:2025(en)
ii
ISO/DIS 12052:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Symbols (and abbreviated terms) . 3
5 Requirements . 4
5.1 Conformance .4
6 Overview of the content of the DICOM standard . 4
6.1 Document structure .4
6.2 PS3.2: Conformance .5
6.3 PS3.3: Information Object Definitions .7
6.4 PS3.4: Service Class Specifications .7
6.5 PS3.5: Data Structure and Semantics .8
6.6 PS3.6: Data Dictionary .8
6.7 PS3.7: Message Exchange .8
6.8 PS3.8: Network Communication Support For Message Exchange .9
6.9 PS3.9: Retired (formerly Point-to-point Communication Support For Message Exchange) .9
6.10 PS3.10 Media Storage and File Format for Media Interchange .9
6.11 PS3.11: Media Storage Application Profiles .10
6.12 PS3.12: Storage Functions and Media Formats For Data Interchange .11
6.13 PS3.13: Retired (formerly Print Management Point-to-point Communication Support) .11
6.14 PS3.14: Grayscale Standard Display Function .11
6.15 PS3.15: Security and System Management Profiles . 12
6.16 PS3.16: Content Mapping Resource . 12
6.17 PS3.17: Explanatory Information . 12
6.18 PS3.18: Web Services . 12
6.19 PS3.19: Application Hosting . 12
6.20 PS3.20: Imaging Reports using HL7 Clinical Document Architecture . 13
6.21 PS3.21: Transformations between DICOM and other Representations .14
6.22 PS3.22: Real-Time Communication (DICOM-RTV) .14
7 Referencing The DICOM Standard . 14
Bibliography .16

iii
ISO/DIS 12052:2025(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO [had/had not] received notice of
(a) patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
This third edition cancels and replaces the second edition (ISO 12052:2017), which has been technically
revised.
The main changes are as follows:
— updates to clause 3 to add several terms;
— updates to clause 6.10 to clarify the relationship of DICOM media interchange to data set specifications
in Figure 3;
— updates to clause 6.21 to describe and reference PS3.21 for transformation between DICOM and NCI AIM;
— updates to clause 6.22 to describe and reference PS3.22 for real-time communication of DICOM content; and,
— updates to clause 7 to clarify references to units of conformance are not acceptable in lieu of a conformance
statement document for a product.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
ISO/DIS 12052:2025(en)
Introduction
Digital Imaging and Communications in Medicine (DICOM) is the standard for the communication and
management of medical imaging information and related data.
0.1  History
With the introduction of computed tomography (CT) followed by other digital diagnostic imaging modalities
in the 1970's, and the increasing use of computers in clinical applications, the American College of Radiology
(ACR) and the National Electrical Manufacturers Association (NEMA) recognized the emerging need for a
standard method for transferring images and associated information between devices manufactured by
various vendors. These devices produce a variety of digital image formats.
The American College of Radiology (ACR) and the National Electrical Manufacturers Association (NEMA)
formed a joint committee in 1983 to develop a standard to:
— Promote communication of digital image information, regardless of device manufacturer
— Facilitate the development and expansion of picture archiving and communication systems (PACS) that
can also interface with other systems of hospital information
— Allow the creation of diagnostic information data bases that can be interrogated by a wide variety of
devices distributed geographically.
ACR-NEMA Standards Publication No. 300-1985, published in 1985 was designated version 1.0. The Standard
was followed by two revisions: No. 1, dated October 1986 and No. 2, dated January 1988. These Standards
Publications specified a hardware interface, a minimum set of software commands, and a consistent set of
data formats.
ACR-NEMA Standards Publication No. 300-1988, published in 1988 was designated version 2.0. It included
version 1.0, the published revisions, and additional revisions. It also included new material to provide
command support for display devices, to introduce a new hierarchy scheme to identify an image, and to add
data elements for increased specificity when describing an image.
In 1993, ACR-NEMA Standard 300 was substantially revised and replaced by this Standard, designated
Digital Imaging and Communications in Medicine (DICOM). It embodies a number of major enhancements to
previous versions of the ACR-NEMA Standard:
— It is applicable to a networked environment. The ACR-NEMA Standard was applicable in a point-to-
point environment only; for operation in a networked environment a Network Interface Unit (NIU)
was required. DICOM supports operation in a networked environment using the industry standard
networking protocol TCP/IP.
— It is applicable to off-line media exchange. The ACR-NEMA Standard did not specify a file format or choice
of physical media or logical filesystem. DICOM supports operation in an off-line media environment using
industry standard media such as CD-R, DVD-R and USB and common file systems.
— It is a service oriented protocol, specifying the semantics of commands and associated data, and how
devices claiming conformance to the DICOM standard react to commands and data being exchanged.
Specified services include support for management of the workflow of an imaging department. The ACR-
NEMA Standard was confined to the transfer of data with only implicit service requirements.
— It specifies levels of conformance. The ACR-NEMA Standard specified a minimum level of conformance.
DICOM explicitly describes how an implementor must structure a Conformance Statement to select
specific options.
In 1995, with the addition of DICOM capabilities for cardiology imaging supported by the American College
of Cardiology, the ACR-NEMA Joint Committee was reorganized as the DICOM Standards Committee, a broad
collaboration of stakeholders across all medical imaging specialties.
0.2  Principles
v
ISO/DIS 12052:2025(en)
0.2.1  Global Applicability and Localization
DICOM is a world-wide standard that can be used in every locale. It provides mechanisms to handle data that
support cultural requirements, such as different writing systems, character sets, languages, and structures
for addresses and person names. It supports the variety of workflows, processes and policies used for
biomedical imaging in different geographic regions, medical specialties and local practices.
Localization to meet the requirements of national or local health and workflow policies can be done without
deviating from the DICOM standard. Such localization may include specifying code sets (e.g., procedure
codes), or profiling data element usage (both specifying locally allowed values, and making elements that
are optional in the DICOM standard mandatory for local use).
Localization and profiling can be specified in a number of mechanisms outside the purview of the DICOM
Standard. One such mechanism is Integration Profiles from the Integrating the Healthcare Enterprise (IHE)
organization. It is important that Profiling adhere to the concept of non-contradiction. A Profile can add
requirements but not contradict DICOM requirements, as that would make it impossible to comply with both
DICOM and the Profile.
0.2.2  Continuous Maintenance
The DICOM Standard is an evolving standard and it is maintained in accordance with the Procedures of
the DICOM Standards Committee. Proposals for enhancements are welcome from all users of the DICOM
standard, and may be submitted to the Secretariat. Supplements and corrections to the DICOM standard are
balloted and approved several times a year. When approved as Final Text, each change becomes official, is
published separately, and goes into effect immediately. At intervals, all of the approved Final Text changes
are consolidated and published in an updated edition of the DICOM standard. Once changes are consolidated
into an updated edition of the DICOM standard, the individual change documents are not maintained;
readers are directed to use the consolidated edition of the DICOM standard.
A requirement in updating the DICOM standard is to maintain effective compatibility with previous editions.
The maintenance process may involve retirement of sections of the DICOM standard.
Retirement does not imply that these features cannot be used. However, the DICOM Standards Committee
will not maintain the documentation of retired features. The reader is referred to earlier editions of the
DICOM standard.
The use of the retired features is discouraged for new implementations, in favor of those alternatives
remaining in the DICOM standard.
0.2.3  Information Objects and Unique Object Identification
Many DICOM services involve the exchange of persistent information objects, such as images. An instance of
such an information object may be exchanged across many systems and many organizational contexts, and
over time. While minor changes may be made to the attributes of an instance to facilitate its handling within
a particular organization (e.g., by coercing a Patient ID to the value used in a local context), the semantic
content of an instance does not change.
Each instance is identified by a globally unique object identifier, which persists with the instance across all
exchanges. Changes to the semantic content of an instance are defined to create a new instance, which is
assigned a new globally unique object identifier.
0.2.4  Conformance
Conformance to the DICOM standard is stated in terms of Service-Object Pair (SOP) Classes, which represent
Services (such as Storage using network, media, or web) operating on types of Information Objects (such as
CT or MR images).
SOP Class specifications in the DICOM standard are only changed in a manner that is intended to be
forward and backward compatible for all editions of the DICOM standard. Conformance requirements and
conformance claims are therefore referenced to the identifier of the SOP Class, and never referenced to an
edition of the DICOM standard.

vi
ISO/DIS 12052:2025(en)
Each implementation is required to provide a Conformance Statement, in accordance with a consistent pro
forma structure, facilitating comparison of products for interoperability.
0.2.5  Consistency of Information Model
A large number of information objects defined in the DICOM standard follow a common composite
information model with information entities representing Patient, Study, Series, Equipment, Frame of
Reference, and the specific instance data type. This information model is a simplification of the real world
concepts and activities of medical imaging; for acquisition modalities, a Study is approximately equivalent
to an ordered procedure, and a Series is approximately equivalent to a performed data acquisition protocol
element. In other domains, such as Radiotherapy, the Study and Series are less clearly related to real
world entities or activities, but are still required for consistency. This simplified model is sufficient for the
pragmatic needs of managing imaging and related data collected in routine practice.
New information objects defined in DICOM will typically conform to this existing common information
model, allowing reuse of implementations with minimal changes to support the new objects.

vii
DRAFT International Standard ISO/DIS 12052:2025(en)
Health informatics — Digital imaging and communication in
medicine (DICOM) including workflow and data management
1 Scope
Within the field of health informatics the DICOM standard addresses the exchange of digital images, and
information related to the production and management of those images, between both medical imaging
equipment and systems concerned with the management and communication of that information.
The DICOM standard facilitates interoperability of medical imaging equipment by specifying:
— For network communications, a set of protocols to be followed by devices claiming conformance to the
DICOM standard;
— The syntax and semantics of Commands and associated information which can be exchanged using these
protocols;
— For media communication, a set of media storage services to be followed by devices claiming conformance
to the Standard, as well as a File Format and a medical directory structure to facilitate access to the
images and related information stored on interchange media;
— Information that must be supplied with an implementation for which conformance to the DICOM standard
is claimed.
The DICOM standard does not specify:
— The implementation details of any features of the DICOM standard on a device claiming conformance;
— The overall set of features and functions to be expected from a system implemented by integrating a
group of devices each claiming conformance to the DICOM standard;
— A testing/validation procedure to assess an implementation's conformance to the DICOM standard.
The DICOM standard pertains to the field of Medical Informatics. Within that field, it addresses the exchange
of digital information between medical imaging equipment and other systems. Because such equipment
may interoperate with other medical devices and information systems, the scope of this Standard needs to
overlap with other areas of medical informatics. However, this International Standard does not address the
full breadth of this field.
The DICOM standard has been developed with an emphasis on diagnostic medical imaging as practiced
in radiology, cardiology, pathology, dentistry, ophthalmology and related disciplines, and image-based
therapies such as interventional radiology, radiotherapy and surgery. However, it is also applicable to a wide
range of image and non-image related information exchanged in clinical, research, veterinary, and other
medical environments.
The DICOM standard facilitates interoperability of systems claiming conformance in a multi-vendor
environment, but does not, by itself, guarantee interoperability.
2 Normative references
There are no normative references in this document.

ISO/DIS 12052:2025(en)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
attribute
property of an information object (3.10)
Note 1 to entry: An attribute has a name and a value which are independent of any encoding scheme
3.2
command
request to operate on information across a network
3.3
command element
encoding of a parameter of a command (3.2) which conveys this parameter's value
3.4
command stream
result of encoding a set of DICOM command elements (3.3) using the DICOM encoding scheme
3.5
conformance statement
formal statement that describes a specific implementation of the DICOM standard
Note 1 to entry: It specifies the service classes (3.1.5) , information objects (3.10), communication protocols, security
profiles, and media storage application profiles supported by the implementation.
3.6
data dictionary
registry of DICOM data elements which assigns a unique tag, a name, value characteristics, and semantics to
each data element (3.7)
3.7
data element
unit of information as defined by a single entry in the data dictionary (3.6)
3.8
data set
exchanged information consisting of a structured set of attributes (3.1)
Note 1 to entry: The value of each attribute (3.1) in a data set is expressed as a data element (3.7).
3.9
data stream
result of encoding a data set (3.8) using the DICOM encoding scheme (Data Element Numbers and
representations as specified by the data dictionary (3.6)).
3.10
information object
abstraction of a real information entity (e.g., CT Image, Structured Report, etc.) which is acted upon by one
or more DICOM commands (3.2)
Note 1 to entry: Information object is also referred to in the DICOM standard as an information object definition.

ISO/DIS 12052:2025(en)
Note 2 to entry: This term is primarily used in DICOM PS3.1, with a few references in DICOM PS3.3. It is an informal
term corresponding to a formal term that is introduced in DICOM PS3.3. In all other parts (3.14) of the DICOM standard
this formal term is known as an Information Object Definition.
3.11
information object class
formal description of an information object (3.10) which includes a description of its purpose and the
attributes (3.1) it posseses.
Note 1 to entry: It does not include values for these attributes (3.1). Also referred to in the DICOM standard as a SOP
Class or Service-Object Pair Class.
Note 2 to entry: This term is only used in DICOM PS3.1. It is an informal term corresponding to a formal term that is
introduced in DICOM PS3.4. This formal term is known as a service-object pair class (3.16) or more commonly as a SOP Class.
3.12
information object instance
representation of an occurance of a real world entity, which includes values for the attributes (3.1) of the
information object class (3.11) to which the entity belongs
Note 1 to entry: Information object instance is also referred to in the DICOM Standard as a SOP Instance.
Note 2 to entry: This term is only used in DICOM PS3.1. It is an informal term corresponding to a formal term that is
introduced in DICOM PS3.4. This formal term is known as a service-object pair instance or more commonly as a SOP
Instance.
3.13
message
data unit of the message exchange protocol exchanged between two cooperating DICOM applications
Note 1 to entry: A message is composed of a command stream (3.4) followed by an optional data stream (3.9).
3.14
part
subdivision of the DICOM standard that covers related subject material
3.15
service class
structured description of a service which is supported by cooperating DICOM applications using specific
DICOM commands (3.2) acting on a specific class of information object (3.10)
3.16
service-object pair class
SOP class
pair of an
...