Digital Imaging and Communications in Medicine (DICOM) Part 11: Media Storage Application Profiles

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1 Digital Imaging and Communications in Medicine (DICOM) Part 11: Media Storage Application Profiles Published by National Electrical Manufacturers Association 1300 N. 17th Street Rosslyn, Virginia USA Copyright 2011 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 Literacy and Artistic Works, and the International and Pan American Copyright Conventions.

2 Page 2 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. 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 independently test, evaluate, or verify the accuracy or completeness of any information or the soundness 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, whether special, indirect, consequential, or compensatory, directly or indirectly resulting from the publication, use of, application, or reliance on this document. NEMA disclaims and makes no guaranty or warranty, expressed or implied, as to the accuracy or completeness of any information published herein, and disclaims and makes no warranty that the information in this document will fulfill any of your particular purposes or needs. NEMA does not undertake to guarantee the performance of any individual manufacturer or seller s products or services by virtue of this standard or guide. In publishing and making this document available, NEMA is not undertaking to render professional or other services for or on behalf of any person or entity, nor is NEMA undertaking to perform any duty owed by any person or entity to someone else. Anyone using this document should rely on his or her own independent judgment or, as appropriate, seek the advice of a competent professional in determining the exercise of reasonable care in any given circumstances. Information and other standards on the topic covered by this publication may be available from other sources, which the user may wish to consult for additional views or information not covered by this publication. NEMA has no power, nor does it undertake to police or enforce compliance with the contents of this document. NEMA does not certify, test, or inspect products, designs, or installations for safety or health purposes. Any certification or other statement of compliance with any health or safety related information in this document shall not be attributable to NEMA and is solely the responsibility of the certifier or maker of the statement.

3 Page 3 CONTENTS NOTICE AND DISCLAIMER... 2 CONTENTS... 3 FOREWORD Scope and field of application Normative References Definitions REFERENCE MODEL DEFINITIONS DICOM INTRODUCTION AND OVERVIEW DEFINITIONS DICOM CONFORMANCE DICOM INFORMATION OBJECT DEFINITIONS DICOM DATA STRUCTURE AND ENCODING DEFINITIONS DICOM MESSAGE EXCHANGE DEFINITIONS DICOM MEDIA STORAGE AND FILE FORMAT DEFINITIONS MEDIA STORAGE APPLICATION PROFILES Application Profile Class Symbols and abbreviations Conventions Purpose of an Application Profile requirements Structure of application profile CLASS AND PROFILE IDENTIFICATION - SECTION X CLINICAL CONTEXT - SECTION X ROLES AND SERVICE CLASS OPTIONS SECTION X GENERAL CLASS PROFILE - SECTION X SOP CLASSES AND TRANSFER SYNTAXES - SECTION X PHYSICAL MEDIA AND MEDIA FORMATS - SECTION X DIRECTORY INFORMATION IN DICOMDIR - SECTION X OTHER PARAMETERS - SECTION X SPECIFIC APPLICATION PROFILES - SECTION X.4 AND FOLLOWING SECURITY PARAMETERS - SECTION X Annex A Basic Cardiac X-ray Angiographic Application Profile (Normative) A.1 CLASS AND PROFILE IDENTIFICATION A.2 CLINICAL CONTEXT A Roles and service class options A FILE SET CREATOR A FILE SET READER A FILE SET UPDATER A.3 STD-XABC-CD BASIC CARDIAC PROFILE A SOP classes and transfer syntaxes... 18

4 Page 4 A Physical media and media formats A Directory information in DICOMDIR A ADDITIONAL KEYS A ICON IMAGES A Other parameters A IMAGE ATTRIBUTE VALUES A ATTRIBUTE VALUE PRECEDENCE Annex B (Normative) X-ray Angiographic Application Profile B.1 CLASS AND PROFILE IDENTIFICATION B.2 CLINICAL CONTEXT B Roles and Service Class Options B File Set Creator B File Set Reader B File Set Updater B.3 STD-XA1K APPLICATION PROFILE CLASS REQUIREMENTS B SOP Classes and Transfer Syntaxes B Physical Media And Media Formats B Directory Information in DICOMDIR B Additional Keys B Icon Images B Other Parameters B Image Attribute Values B Multiframe JPEG Format B Attribute Value Precedence Annex C Ultrasound Application Profile (Normative) C.1 CLASS AND PROFILE IDENTIFICATION C.2 CLINICAL CONTEXT C Roles C FILE SET CREATOR C FILE SET READER C FILE SET UPDATER C.3 GENERAL CLASS PROFILE C Abstract and Transfer Syntaxes C Ultrasound Single and Multi-frame Pixel Formats Supported C Physical Media And Media Formats C DICOMDIR...31 C Additional Keys C File Component lds C.4 SPATIAL CALIBRATION (SC) CLASS REQUIREMENTS C.5 COMBINED CALIBRATION (CC) CLASS REQUIREMENTS Annex D (Normative) - General Purpose CD-R, DVD and BD Interchange Profiles D.1 PROFILE IDENTIFICATION D.2 CLINICAL CONTEXT D Roles and Service Class Options D File Set Creator D File Set Reader D File Set Updater D.3 STD-GEN PROFILE CLASS D SOP Classes and Transfer Syntaxes D Physical Medium And Medium Format D Directory Information in DICOMDIR... 36

5 Page 5 D Additional Keys D Attribute value precedence D Other Parameters D Security Parameters Annex E (Normative) - CT and MR Image Application Profiles E.1 PROFILE IDENTIFICATION E.2 CLINICAL CONTEXT E Roles and Service Class Options E File Set Creator E File Set Reader E File Set Updater E.3 STD-CTMR PROFILES E SOP Classes and Transfer Syntaxes E Physical Medium And Medium Format E Directory Information in DICOMDIR E Additional Keys E Localizer Related Attributes E Icon Images E Other Parameters E Image Attribute Values E Attribute Value Precedence Annex F (Normative) - Waveform Diskette Interchange Profile Annex G (Normative) - General Purpose MIME Interchange Profile G.1 PROFILE IDENTIFICATION G.2 CLINICAL CONTEXT G ROLES AND SERVICE CLASS OPTIONS G File Set Creator G File Set Reader G.3 STD-GEN-MIME PROFILE G SOP Classes and Transfer Syntaxes G Physical Medium and Medium Format G Directory Information in DICOMDIR G Additional Keys Annex H (Normative) - General Purpose DVD with Compression Interchange Profiles H.1 PROFILE IDENTIFICATION H.2 CLINICAL CONTEXT H Roles and Service Class Options H File Set Creator H File Set Reader H File Set Updater H.3 STD-GEN-DVD AND STD-GEN-SEC-DVD PROFILE CLASSES H SOP Classes and Transfer Syntaxes H Physical Medium And Medium Format H Directory Information in DICOMDIR H Additional Keys H Other Parameters H Multiframe JPEG Format H Security Parameters Annex I (Normative) - DVD MPEG2 Interchange Profiles I.1 PROFILE IDENTIFICATION... 55

6 Page 6 I.2 CLINICAL CONTEXT I Roles and Service Class Options I File Set Creator I File Set Reader I File Set Updater I.3 STD-DVD-MPEG2-MPML AND STD-DVD-SEC-MPEG2-MPML PROFILE CLASSES I SOP Classes and Transfer Syntaxes I Physical Medium And Medium Format I Directory Information in DICOMDIR I Additional Keys I Security Parameters I Dual-format (Informative) Annex J (Normative) - General Purpose USB and Flash Memory with Compression Interchange Profiles59 J.1 PROFILE IDENTIFICATION J.2 CLINICAL CONTEXT J Roles and Service Class Options J File Set Creator J File Set Reader J File Set Updater J.3 STD-GEN-USB, STD-GEN-SEC-USB, STD-GEN-MMC, STD-GEN-SEC-MMC, STD-GEN- CF, STD-GEN-SEC-CF, STD-GEN-SD AND STD-GEN-SEC-SD PROFILE CLASSES J SOP Classes and Transfer Syntaxes J Physical Medium And Medium Format J Directory Information in DICOMDIR J Additional Keys J Other Parameters J Multiframe JPEG Format J Security Parameters Annex K Dental Application Profile (Normative) K.1 CLASS AND PROFILE IDENTIFICATION K.2 CLINICAL CONTEXT K Roles K FILE SET CREATOR K FILE SET READER K FILE SET UPDATER K.3 GENERAL CLASS PROFILE K SOP Classes and Transfer Syntaxes K Physical media and media formats K Directory information in DICOMDIR K Other Parameters K IMAGE ATTRIBUTE VALUES K IMAGE ATTRIBUTE SPECIALIZATION Annex L (Normative) ZIP File over Interchange Profiles L.1 PROFILE IDENTIFICATION L.2 CLINICAL CONTEXT L Roles L File Set Creator L File Set Reader L File Set Updater L.3 GENERAL CLASS PROFILE L STD-GEN-ZIP-MAIL and STD-GEN-SEC-ZIP-MAIL Abstract and Transfer Syntaxes... 71

7 Page 7 L Medium Format L Directory Information in DICOMDIR L Additional Keys L Secure Transport L.4 DENTAL CLASS PROFILE L STD-DTL-SEC-ZIP-MAIL Abstract and Transfer Syntaxes L Medium Format L Directory Information in DICOMDIR L Additional Keys L Specific Image Requirements for STD-DTL-SEC-ZIP-MAIL L Secure Transport Annex M (Normative) - General Purpose BD with compression Interchange Profiles M.1 PROFILE IDENTIFICATION M.2 CLINICAL CONTEXT M Roles and Service Class Options M File Set Creator M File Set Reader M File Set Updater M.3 STD-GEN-BD AND STD-GEN-SEC-BD PROFILE CLASSES M SOP Classes and Transfer Syntaxes M Physical Medium And Medium Format M Directory Information in DICOMDIR M Additional Keys M Other Parameters M Multiframe JPEG Format M Security Parameters... 79

8 Page 8 FOREWORD This DICOM Standard was developed according to the procedures of the DICOM Standards Committee. The DICOM Standard is structured as a multi-part document using the guidelines established in the following document: ISO/IEC Directives, 1989 part 3 - Drafting and Presentation of International Standards. PS 3.1 should be used as the base reference for the current parts of this Standard.

9 Page 9 1 Scope and field of application This part of the DICOM Standard specifies application specific subsets of the DICOM Standard to which an implementation may claim conformance. Such a conformance statement applies to the interoperable interchange of medical images and related information on storage media for specific clinical uses. It follows the framework, defined in PS 3.10, for the interchange of various types of information on storage media. This part is related to other parts of the DICOM Standard in that: - PS 3.2,, specifies the general rules for assuring interoperability, which are applied for media interchange through the Application Profiles of this part - PS 3.3, Information Object Definitions, specifies a number of Information Object Definitions (e.g., various types of images) that may be used in conjunction with this part. It also defines a medical Directory structure to facilitate access to the objects stored on media - PS 3.4, Service Class Specifications, specifies the Media Storage Service Class upon which Application Profiles are built - PS 3.5, Data Structure and Encoding, addresses the encoding rules necessary to construct a Data Set that is encapsulated in a file as specified in PS PS 3.6, Data Dictionary, contains an index by Tag of all Data Elements related to the Attributes of Information Objects defined in PS3.3. This index includes the Value Representation and Value Multiplicity for each Data Element - PS 3.10, Media Storage and File Formats for Media Interchange, standardizes the overall open Storage Media architecture used by this part, including the definition of a generic File Format, a Basic File Service and a Directory concept - PS 3.12, Media Formats and Physical Media, defines a number of standard Physical Media and corresponding Media Formats. These Media Formats and Physical Media selections are referenced by one or more of the Application Profiles of this part. PS 3.12 is intended to be extended as the technologies related to Physical Medium evolve - PS 3.15, Security Profiles defines a number of profiles for use with Secure DICOM Media Storage Application Profiles. The Media Storage Security Profiles specify the cryptographic techniques to be used for each Secure DICOM File in a Secure Media Storage Application Profile. 2 Normative References The following standards contain provisions that, through reference in this text, constitute provisions of this Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this Standard are encouraged to investigate the possibilities of applying the most recent editions of the standards indicated below. ISO/IEC Directives, 1989 part 3 - Drafting and presentation of international standards. ISO , Information Processing Systems - Open Systems Interconnection - Basic Reference Model. ISO , Information processing systems - Open Systems Interconnection - Basic reference Model - Part 2: Security Architecture

10 Page 10 ISO 8859, Information Processing - 8-bit single-byte coded graphic character sets - part 1: Latin Alphabet No. 1. RFC-2630, Cryptographic Message Syntax, June Definitions For the purposes of this standard the following definitions apply. 3.1 REFERENCE MODEL DEFINITIONS This part of the Standard is based on the concepts developed in ISO and makes use of the following terms defined in it: a) Application Entity b) Service or Layer Service c) Transfer Syntax This Part of the Standard makes use of the following terms defined in ISO : a. Data Confidentiality The definition is the property that information is not made available or disclosed to unauthorized individuals, entities or processes. b. Data Origin Authentication The definition is the corroboration that the source of data received is as claimed. c. Data Integrity The definition is the property that data has not been altered or destroyed in an unauthorized manner. d. Key Management The definition is the generation, storage, distribution, deletion, archiving and application of keys in accordance with a security policy. 3.2 DICOM INTRODUCTION AND OVERVIEW DEFINITIONS This part of the Standard makes use of the following terms defined in PS 3.1 of the DICOM Standard: - Attribute 3.3 DICOM CONFORMANCE This part of the Standard makes use of the following terms defined in PS 3.2 of the DICOM Standard: a)

11 Page 11 b) Standard SOP Class c) Standard Extended SOP Class d) Specialized SOP Class e) Private SOP Class f) Standard Application Profile g) Augmented Application Profile h) Private Application Profile 3.4 DICOM INFORMATION OBJECT DEFINITIONS This part of the Standard makes use of the following terms defined in PS 3.3 of the DICOM Standard: a) Information Object Definition b) Basic Directory IOD c) Basic Directory Information Model 3.5 DICOM DATA STRUCTURE AND ENCODING DEFINITIONS This part of the standard makes use of the following terms defined in PS 3.5 of the DICOM Standard: a) Data Element b) Data Set 3.6 DICOM MESSAGE EXCHANGE DEFINITIONS This part of the Standard makes use of the following terms defined in PS 3.7 of the DICOM Standard: a) Service Object Pair (SOP) Class b) Service Object Pair (SOP) Instance c) Implementation Class UID 3.7 DICOM MEDIA STORAGE AND FILE FORMAT DEFINITIONS This part of the standard makes use of the following terms defined in PS 3.10 of the DICOM Standard: a) Application Profile b) DICOM File Format c) DICOM File Service d) DICOM File e) DICOMDIR File f) File g) File ID h) File Meta Information i) File-set j) Media Storage Model k) Secure DICOM File l) Secure Media Storage Application Profile

12 Page MEDIA STORAGE APPLICATION PROFILES This part of the DICOM Standard uses the following definitions: Application Profile Class A group of related Application Profiles defined in a single annex to this part. 4 Symbols and abbreviations The following symbols and abbreviations are used in this part of the standard. ACC ACR AP ASCII AE ANSI BD CEN TC 251 American College of Cardiology American College of Radiology Application Profile American Standard Code for Information Interchange Application Entity American National Standards Institute Blu-ray Disc TM (that is a trademark of Blu-ray Disc TM Association) Comite Europeen de Normalisation - Technical Committee Medical Informatics CF Compact Flash card DICOM Digital Imaging and Communications in Medicine DVD A trademark of the DVD Forum that is not an abbreviation FSC File-set Creator FSR File-set Reader FSU File-set Updater HL7 Health Level 7 IEEE Institute of Electrical and Electronics Engineers IETF Internet Engineering Taskforce IS&C Image Save and Carry ISO International Standards Organization ID Identifier IOD Information Object Definition JIRA Japan Industries Association of Radiological Systems MIME Multipurpose Internet Mail Extension MMC Multimedia Card NEMA National Electrical Manufacturers Association OSI Open Systems Interconnection RFC Request for Comments SD Secure Digital card SMTP Simple Mail Transfer Protocol SOP Service-Object Pair TCP/IP Transmission Control Protocol/Internet Protocol UDF Universal Disk Format

13 Page 13 UID Unique Identifier USB Universal Serial Bus VR Value Representation 5 Conventions Words are capitalized in this document to help the reader understand that these words have been previously defined in Section 3 of this document and are to be interpreted with that meaning. 6 Purpose of an Application Profile An Application Profile is a mechanism for selecting an appropriate set of choices from the parts of DICOM for the support of a particular media interchange application. Application Profiles for commonly used interchange scenarios, such as inter-institutional exchange of x-ray cardiac angiographic examinations, or printing ultrasound studies from recordable media, are meant to use the flexibility offered by DICOM without resulting in so many media and format choices that interchange is compromised. Media interchange applications claim conformance to one or more Media Storage Application Profiles. Two implementations that conform to identical Application Profiles and support complementary File-set roles (e.g. an FSC interchanging media with an FSR) are able to exchange SOP Instances (pieces of DICOM information) on recorded media within the context of those Application Profiles. A DICOM Application Profile specifies: a. which SOP Classes and options must be supported, including any required extensions, specializations, or privatizations b. for each SOP Class, which Transfer Syntaxes may be used c. what information should be included in the Basic Directory IOD d. which Media Storage Service Class options may be utilized e. which roles an application may take: File-set Creator, File-set Reader, and/or File-set Updater f. which physical media and corresponding media formats must be supported g. whether or not the DICOM Files in the File-set shall be Secure DICOM Files h. which Media Storage Security Profile must be used for the creation of Secure DICOM Files and any additional conformance requirements. The result of making the necessary choices means that the Application Profile can be thought of as a vertical path through the various parts of DICOM that begins with choices of information to be exchanged and ends at the physical medium. Figure 6-1 shows the relationship between the concepts used in an Application Profile and the parts of DICOM.

14 Page 14 requirements PS 3.2 PS 3.3 PS 3.4 PS 3.5 PS 3.10 PS 3.12 PS 3.15 Information Object Definitions Service Classes Transfer Syntax File Format, Directory Medium Format, Physical Medium Security Profile Parts of DICOM PS 3.11: Application Profile Figure 6-1 RELATIONSHIP BETWEEN AN APPLICATION PROFILE AND PARTS OF DICOM An Application Profile is organized into the following major parts: a. The name of the Application Profile, or the list of Application Profiles grouped in a related class b. A description of the clinical context of the Application Profile c. The definition of the Media Storage Service Class with the device Roles for the Application Profile and associated options d. Informative section describing the operational requirements of the Application Profile e. Specification of the SOP Classes and associated IODs supported and the Transfer Syntaxes to be used f. The selection of Media Format and Physical Media to be used g. If the Directory Information Module is used, the description of the minimum subset of the Information Model required h. Other parameters that need to be specified to ensure interoperable media interchange i. Security parameters that select the cryptographic techniques to be used with Secure Media Storage Application Profiles The structure of DICOM and the design of the Application Profile mechanism is such that extension to additional SOP Classes and new exchange media is straightforward. 7 requirements Implementations may claim conformance to one or more PS 3.11 Application Profiles in a as outlined in PS 3.2. NOTE : Additional specific conformance requirements for an Application Profile may be listed in the Application Profile definition.

15 Page 15 8 Structure of application profile Application Profiles specific to various clinical areas are defined in the annexes to this part. Each Annex defines an Application Profile Class related to a single area of medical practice, e.g., cardiology, or to a single functional context, e.g., image transfer to a printer system. Several specific Application Profiles may be defined in each Application Profile class, and an identification scheme is established to label each specific Application Profile. An example of an Application Profile structure is provided in below. The section identifier "X" should be replaced by the identifier of the annex. CLASS AND PROFILE IDENTIFICATION - SECTION X.1 Section X.1 of the Application Profile defines the class and specific Application Profiles in that class. This section assigns an identifier to each Application Profile of the form ttt-x...x-y...y, where ttt indicates the type of Application Profile, "x...x" is an abbreviation of a significant term for the clinical context and "y...y" is a significant term for a distinguishing feature of the specific Application Profile. The ttt type term shall be one of STD, AUG, or PRI, indicating whether the Application Profile is a Standard, Augmented, or Private Application Profile respectively (see PS 3.2). Identifiers shall be written such that they may be encoded with LO (Long String) Value Representation (see PS 3.5). s may use the earlier prefix of APL, which is equivalent to STD. This use is deprecated and may be retired in future versions of the standard. CLINICAL CONTEXT - SECTION X.2 Section X.2 of the Application Profile shall describe the clinical need for the interchange of medical images and related information on storage media, and its context of application. This section shall not require any specific functionality of the Application Entities exchanging information using media interchange beyond their capabilities in the roles of File-set Creator, File-set Reader, and File-set Updater. NOTE : This Section does not, for example, place any graphical presentation or performance requirements on workstations that read DICOM interchange media. Such requirements are beyond the scope of a DICOM Media Storage Application Profile. The requirements that fall within the scope of an Application Profile are the specific functional storage media interchange capabilities associated with the defined roles. ROLES AND SERVICE CLASS OPTIONS SECTION X.2.1 Section X.2.1 describes the Service Class Options used and the contextual application of the roles of File-set Creator, File-set Reader, and File-set Updater. GENERAL CLASS PROFILE - SECTION X.3 Section X.3 defines characteristics of the Application Profile Class that are constant across all specific Application Profiles in the class. SOP CLASSES AND TRANSFER SYNTAXES - SECTION X.3.1 Section X.3.1 lists the SOP Classes and Transfer Syntaxes common to all specific Application Profiles in the class, if any. This section specifies which SOP Classes are mandatory and optional for the roles of FSC, FSR, and FSU, including any required groupings or SOP options.

16 Page 16 PHYSICAL MEDIA AND MEDIA FORMATS - SECTION X.3.2 Section X.3.2 defines the physical media and corresponding media formats common to all specific Application Profiles in the class, if any. This section also specifies any file service functionality beyond the DICOM File Service required by the clinical application to be supplied by the Media Format Layer. DIRECTORY INFORMATION IN DICOMDIR - SECTION X.3.3 Section X.3.3 specifies the type of Directory Records that shall be supported and any additional associated keys. It also defines any extensions to or specializations of the Basic Directory Information Object Definition, if any. OTHER PARAMETERS - SECTION X.3.4 Section X.3.4 is optional; if present, it should define any other parameters common to all specific Application Profiles in the class, which may need to be specified in order to ensure interoperable media interchange. SPECIFIC APPLICATION PROFILES - SECTION X.4 AND FOLLOWING Sections X.4.and following, each define the unique characteristics of a specific Application Profile. If there are any Application Profile specific changes to IODs, Transfer Syntax, DICOMDIR, or other general class requirements, they should be described for each Application Profile that specifies such changes. SECURITY PARAMETERS - SECTION X.3.5 Section X.3.5 is optional; if absent, the Application Profile is unsecure and the Secure DICOM File Format shall not be used for any DICOM File in the File-set. If present, this section defines the Media Storage Security Profile to be used for encapsulating all DICOM Files in the File-set, including the DICOM Directory. If this section is present, the Application Profile is called Secure Media Storage Application Profile.

17 Page 17 Annex A Basic Cardiac X-ray Angiographic Application Profile (Normative) A.1 CLASS AND PROFILE IDENTIFICATION This Annex defines an Application Profile Class for Basic Cardiac X-ray Angiographic clinical applications. The identifier for this class shall be STD-XABC. This annex is concerned only with cardiac angiography. The specific Application Profile in this class is shown in the Table A.1-1. NOTE: This table contains only a single Application Profile. It is expected that additional Application Profiles may be added to PS Table A.1-1 BASIC CARDIAC XA PROFILE Application Profile Identifier Description Basic Cardiac X-Ray Angiographic Studies on CD-R Media STD-XABC-CD It handles single frame or multi-frame digital images up to 512x512x8 bits; biplane acquisitions are encoded as two single plane information objects. A.2 CLINICAL CONTEXT This Application Profile Class facilitates the interchange of primary digital X-ray cine runs, typically acquired as part of cardiac catheterization procedures. Typical media interchanges would be from in-lab acquisition equipment to either a display workstation or to a data archive system, or between a display workstation and a data archive system (in both directions). This context is shown in figure A.2-1 below. X-Ray Angiographic LAB X-Ray Angiographic LAB Removable Media Review Removable Media Domain of DICOM Media Data Interchange Removable Media Review Removable Media Possible Network for DICOM Network Interchange Removable Media Removable Media Archive Archive Figure A.2-1 CLINICAL CONTEXT DIAGRAM

18 Page 18 The operational use of media interchange is potentially both intra-institutional and inter-institutional. A.2.1 Roles and service class options This Application Profile Class uses the Media Storage Service Class defined in PS 3.4. The Application Entity shall support one or more of the roles of File-set Creator, File-set Reader, and Fileset Updater, defined in PS A FILE SET CREATOR The Application entity acting as a File-Set Creator generates a File Set under the STD-XABC Application Profile Class. Typical entities using this role would include X-ray angiographic lab equipment, and archive systems that generate a patient record for transfer to another institution. File Set Creators shall be able to generate the Basic Directory SOP Class in the DICOMDIR File with all types of Directory Records related to the SOP Classes stored in the File-set. FSC shall offer the ability to either finalize the disc at the completion of the most recent write session (no additional information can be subsequently added to the disc) or to allow multi-session (additional information may be subsequently added to the disk). NOTE : A multiple volume (a logical volume that can cross multiple physical media) is not supported by this Application Profile Class. If a set of Files, e.g., a Study, cannot be written entirely on one CD-R, the FSC will create multiple independent DICOM File-sets such that each File-set can reside on a single CD-R media controlled by its individual DICOMDIR file. The user of the FSC can opt to use written labels on the discs to indicate that there is more than one disc for this set of files (e.g., a study). A FILE SET READER The role of File Set Reader is used by Application Entities that receive a transferred File Set. Typical entities using this role would include display workstations, and archive systems that receive a patient record transferred from another institution. File Set Readers shall be able to read all the SOP Classes defined for the specific Application Profile for which a is made, using all the defined Transfer Syntaxes. A FILE SET UPDATER The role of File Set Updater is used by Application Entities that receive a transferred File Set and update it by the addition of information. Typical entities using this role would include analytic workstations, which, for instance, may add to the File-set an information object containing a processed (e.g., edge-enhanced) image. Stations that update patient information objects would also use this role. File-set Updaters do not have to read the images. File-set Updaters shall be able to generate one or more of the SOP Instances defined for the specific Application Profile for which a conformance statement is made, and to read and update the DICOMDIR file. FSU shall offer the ability to either finalize the disc at the completion of the most recent write session (no additional information can be subsequently added to the disc) or to allow multi-session (additional information may be subsequently added to the disk). NOTE : If the disc has not been closed out, the File-set Updater shall be able to update information assuming there is enough space on the disc to write a new DICOMDIR file, the information, and the fundamental CD-R control structures. CD-R control structures are the structures that are inherent to the CD-R standards, see PS A.3 STD-XABC-CD BASIC CARDIAC PROFILE A.3.1 SOP classes and transfer syntaxes This Application Profile is based on the Media Storage Service Class (see PS 3.4).

19 Page 19 SOP Classes and corresponding Transfer Syntaxes supported by this Application Profile are specified in the Table A.3-1. Information Object Definition Table A.3-1 STD-XABC-CD SOP CLASSES AND TRANSFER SYNTAXES Service Object Pair Class UID Basic Directory X-Ray Angiographic Image Transfer Syntax and UID Explicit VR Little Endian Uncompressed JPEG Lossless Process 14 (selection value 1) FSC Requirement FSR Requirement FSU Requirement Mandatory Mandatory Mandatory Mandatory Mandatory Optional Notes: 1. This application profile does not allow the use of the X-Ray Angiographic Bi-Plane Image Object. Biplane acquisitions must therefore be transferred as two single plane SOP instances. A future Application Profile that permits X-Ray Angiographic Bi-Plane Image Object transfer is under development. 2. This Applicaton Profile includes only the XA Image SOP Instances. It does not include Standalone Curve, Modality LUT, VOI LUT, or Overlay SOP Instances. A.3.2 Physical media and media formats Basic Cardiac Application Profiles in the STD-XABC class require the 120 mm CD-R physical media with the ISO/IEC 9660 Media Format, as defined in PS A.3.3 Directory information in DICOMDIR Conformant Application Entities shall include in the DICOMDIR File a Basic Directory IOD containing Directory Records at the Patient and subsidiary levels appropriate to the SOP Classes in the File-set. DICOMDIRs with no directory information are not allowed by this Application Profile. A ADDITIONAL KEYS Table A.3-2 specifies the type of Directory Records that shall be supported and the additional associated keys. Refer to the Basic Directory IOD in PS 3.3.

20 Page 20 Table A.3-2 STD-XABC-CD ADDITIONAL DICOMDIR KEYS Key Attribute Tag Directory Record Type Type Patient s Birth Date (0010,0030) PATIENT 2 Patient s Sex (0010,0040) PATIENT 2 Institution Name (0008,0080) SERIES 2 Institution Address (0008,0081) SERIES 2 Performing Physicians Name Icon Image Sequence (0008,1050) SERIES 2 (0088,0200) IMAGE 1 Image Type (0008,0008) IMAGE 1 Calibration Image (0050,0004) IMAGE 2 Referenced Image Sequence >Referenced SOP Class UID >Referenced SOP Instance UID Notes (0008,1140) IMAGE 1C Required if the SOP Instance referenced by the Directory Record has an Image Type (0008,0008) of BIPLANE A or BIPLANE B. (0008,1150) IMAGE 1C Required if Referenced Image Sequence (0008,1140) is present (0008,1155) IMAGE 1C Required if Referenced Image Sequence (0008,1140) is present A ICON IMAGES Directory Records of type IMAGE shall include Icon Images. The icon pixel data shall be supported with Bits Allocated (0028,0100) equal to 8 and Row (0028,0010) and Column (0028,0011) attribute values of 128. Notes: 1. This icon size is larger than that recommended in PS 3.10 because the 64x64 icon would not be clinically useful for identifying and selecting x-ray angiographic images. 2. For multi-frame images, it is recommended that the icon image be derived from the frame identified in the Representative Frame Number attribute (0028,6010), if defined for the image SOP Instance. If the Representative Frame Number is not present, a frame approximately one-third of the way through the multi-frame image should be selected. The process to reduce a 512x512 image to a 128x128 image is beyond the scope of this standard. A.3.4 Other parameters This section defines other parameters common to all specific Application Profiles in the STD-XABC class that need to be specified in order to ensure interoperable media interchange. A IMAGE ATTRIBUTE VALUES The attributes listed in Table A.3-3 used within the X-Ray Angiographic Image files shall take the values specified.

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