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An implementation claiming conformance with a Standard Extended SOP Class shall identify in its Conformance Statement the Standard SOP Class being extended, the options, roles, and behavior selected, and describe the Attributes being added with the Standard SOP Class's IOD Model and Modules.
Specialized SOP Classes shall:
a.be completely conformant to relevant Parts of the DICOM Standard;
b.be based on a Standard SOP Class, i.e.:
•contain all the Type 1, 1C, 2, and 2C Attributes of Standard SOP Class on which it is based;
•not change the semantics of any Standard Attribute;
•use a Privately Defined UID for its SOP Class (i.e., shall not be identified with a DICOM Defined UID);
c.be based on the DICOM Information Model in PS3.3 and PS3.4.
Specialized SOP Classes may:
a.contain additional Standard and/or Private Type 1, 1C, 2, or 2C Attributes;
b.add Private and Standard Type 3 Attributes, which may or may not be published in the Conformance Statement.
Note
The usage of any unpublished Attributes may be ignored by other users and providers of the Specialized SOP Class.
c.enumerate the permitted values for Attributes within the set allowed by the Standard SOP Class;
d.enumerate the permitted Templates for Content Items within the set allowed by the Standard SOP Class.
An implementation claiming conformance with a Specialized SOP Class shall include in its Conformance Statement the identity of the Standard SOP Class being specialized, a description of usage of all Standard and Private Type 1, 1C, 2, and 2C Attributes in the Specialized SOP Class, a description of the constraints on Attributes values and Templates, and the associated Privately Defined UID.
Private SOP Classes shall:
a.becompletelyconformanttorelevantPartsoftheDICOMStandardwiththepossibleexceptionthatsupportoftheDICOMDefault Transfer Syntax or a Transfer Syntax mandated by a media storage Application Profile is not required;
b.not change the PS3.6 specification of any Standard Attributes;
c.use a Privately Defined UID for its SOP Class (i.e., shall not be identified with a DICOM Defined UID);
d.not change existing DIMSE Services or create new ones;
e.not change existing DICOM File Services defined in PS3.10 or extend them in a manner that jeopardizes interoperability.
Private SOP Classes may:
a.use or apply DIMSE Services to privately defined or altered IODs (i.e., not necessarily be based on a Standard SOP Class);
b.use or apply Media Storage Operations to privately defined or altered IODs (i.e., not necessarily be based on a Standard SOP Class);
c.designate any Standard Attribute as Type 1, 1C, 2, or 2C regardless of the Type of the Attribute in other IODs;
d.define Private Attributes as Type 1, 1C, 2, or 2C;
e.include Private and Standard Type 3 Attributes, which may or may not be published in the Conformance Statement.
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An implementation claiming conformance with a Private SOP Class shall provide a PS3.3, PS3.4, and PS3.6-like description of the Private SOP Class in the implementation's Conformance Statement, including descriptions of the usage of all Standard and Private Type 1, 1C, 2, or 2C Attributes in the SOP Class, the DICOM Information Model, and the Privately Defined UIDs.
Note
Unpublished SOP Classes (i.e., SOP Classes that are not defined in the DICOM Standard and are not defined in the Con- formance Statement) are permitted in order to allow an implementation to support other abstract syntaxes within the DICOM Application Context. Such unpublished SOP Classes would utilize Privately Defined UIDs. The presence of an unpublished SOP Class does not prevent the implementation from being DICOM conformant but would have no meaning to other imple- mentations and may be ignored.
7.4 Rules Governing Types of Application Profiles
ApplicationProfileusedinaConformanceStatementshallbeofoneofthreebasictypes.EachApplicationProfileinanimplementation claiming conformance to the DICOM Standard shall be handled in accordance with the following rules, as dictated by the type of Ap- plication Profile.
7.4.1 Standard Application Profile
A Standard Application Profile shall:
a.conform to all relevant Parts of DICOM with no changes;
b.support only one of the Physical Media and associated Media Format, as specified by PS3.12.
To claim conformance to a Standard Application Profile, an implementation shall make a declaration of this fact in its Conformance Statement, and identify its selected options, roles, and behavior.
An implementation of a Standard Application Profile may extend Standard SOP Classes of this Standard application profile. Such Standard Extended SOP Classes shall meet the requirements specified in Section 7.3.
7.4.2 Augmented Application Profile
An Augmented Application Profile shall:
a.be a proper super set of the Standard Application Profile. It adds the support of additional Standard or Standard Extended SOP Classes;
b.use the same Physical Media and its associated Media Format specified in the corresponding Standard Application Profile;
c.not include Specialized or Private SOP Classes.
An Augmented Application Profile may:
a.include one or more Standard or Standard Extended SOP Classes in addition to those of the corresponding Standard Application Profile. These additional SOP Classes may be mandatory or optional;
b.include the extensions (e.g., additional required keys, additional directory records) to the Basic Directory Information Object corresponding to the SOP Classes defined in a);
c.add one or more new roles (FSC, FSR, FSU).
ToclaimconformancetoanAugmentedApplicationProfile,animplementationshallmakeadeclarationofthisfactinitsConformance Statement, and shall identify the Standard Application Profile from which it is derived and specify the augmentations. The implement- ation shall also identify its selected options, roles, and behavior.
An implementation of a Augmented Application Profile may:
a.extend Standard SOP Classes of the corresponding Standard application profile. Such Standard Extended SOP Classes shall meet the requirements specified in Section 7.3;
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b.also claim conformance to the Standard Application Profile on which this Augmented Profile is based. In this case, FSC and FSU implementations shall be able to restrict their behavior to the Standard Application Profile (i.e., provide a means to write only the Standard or Standard Extended SOP Classes defined in the corresponding Standard Application Profile).
7.4.3 Private Application Profile
A Private Application Profile:
•conforms to PS3.10 and to the Media Storage Service Class specified in PS3.4;
•support only one of the Physical Media and associated Media Format, as specified by PS3.12;
Note
The intent of these two conditions is to ensure that at least the DICOMDIR is readable by other APs.
•complies with the rules governing SOP Classes in Section 7.3.
To claim conformance to a Private Application Profile, an implementation shall make a declaration of this fact in its Conformance Statement, and shall provide a description of the Application Profile patterned after the descriptions in PS3.11. The implementation shall also identify its selected options, roles, and behavior.
Note
AnimplementationthatdoesnotmeettheprovisionsofSection7,includingthetypesofApplicationProfile,isnotconformant to DICOM and so is outside the scope of DICOM conformance. Such an implementation is not an Application Profile in DICOM terminology. For example, if an implementation chooses to write DICOM files onto media that is not in PS3.12, or use a file system not defined for a specific media type in PS3.12, then that implementation cannot claim that it conforms to the DICOM Standard using that media or file system.
7.5 Conformance of DICOM Media
DICOM does not define conformance of a piece of medium in a generic sense. DICOM conformance of a piece of medium can only be evaluated within the scope of one or more media storage Application Profiles that define specific contexts for interoperability.
Note
One may accept the statement "this is a DICOM CD-R" when pointing to a storage medium. However, one should not state "thisCD-RisDICOMconformant",butrather"thisCD-RconformstotheBasicCardiacX-rayAngiographicDICOMApplication Profile".
7.6 Security Profiles
DICOMspecifiesmethodsforprovidingsecurityatdifferentlevelsoftheISOOSIBasicReferenceModelthroughtheuseofmechanisms specific to a particular layer. The methods for applying these mechanisms are described in the various parts of the DICOM Standard. SomemechanismsandalgorithmsarespecifiedinPS3.15asSecurityProfiles.Animplementation'sConformanceStatementdescribes which Security Profiles can be used by that application.
Note
Forexample,theBasicTLSSecureTransportConnectionProfiledefinesamechanismforauthenticatingentitiesparticipating in the exchange of data, and for protecting the integrity and confidentiality of information during interchange.
An implementation shall list in its Conformance Statement any Security Profiles that it supports, how it selects which Security Profiles it uses, how it uses features of that Security Profile, and any extensions it makes to that Security Profile.
An implementation shall list in its Conformance Statement any additional use of the User Identity association negotiation sub-item that is not specified in a standard Security Profile.
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7.7 Transformation of DICOM SR to CDA
DICOM specifies the transformation of DICOM SR objects to CDA documents in PS3.20.
This transformation is unidirectional (DICOM SR to HL7 CDA). Conformance statements shall at a minimum state conformance to the top level templates used for the SR document and the CDA document.
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A DICOM Conformance Statement Template (Normative)
This Annex is a template that shall be used to generate a DICOM Conformance Statement. The document is hierarchically structured in three different levels:
•A DICOM Conformance Statement Overview, which is typically one page, geared towards people that want to get a quick overview of the functionality and services.
•For Networking and Media, the relationship between the AEs, followed by the information for each AE
•For the services supported as SCU and SCP all the SOP specific details
Annexes are provided to specify the Object descriptions (IODs), with specifics about the field usage as well as the data dictionaries.
Note
The numbering scheme for numbering paragraphs in this document is to be used as a guideline in preparing the outline of the Conformance Statement. Although strongly encouraged, the Conformance Statement is not required to have exactly the sameparagraphnumbersbecauseaparticularConformanceStatementmighthavespecialconsiderations,whichwillcause the outline to differ in certain details from the outline of this document. In addition, a vendor might have internal company guidelinesprescribingaspecificformat.Notehowever,thattheoverallstructure,tables,definitionofvariablesandinformation such as headers, should be strictly followed.
A.0 Cover Page
A DICOM Conformance Statement may have a cover page, which, if present, shall include:
a.Thecommercialnameandversion(s)oftheconcernedproductorproducts(ifapplicabletoseveralproducts)includingalloptional features. The product version shall correspond to the functionality as described in this conformance statement.
b.Date of the document
A.1 Conformance Statement Overview
The Overview consist of typically 5-10 lines describing the network services and media storage capabilities supported by the product in layman's terms (i.e., no DICOM acronyms should be used).
A table of Supported Networking DICOM Service (SOP) Classes is provided with roles (User/Provider), organized in 4 categories:
•Transfer
•Query/Retrieve
•Workflow Management
•Print Management
The first column shall specify the SOP Classes exactly as named in PS3.6., Registry of DICOM Unique Identifiers. The phrase "and specializations" may be added to indicate support of all specializations negotiated through the SOP Class Common Extended Nego- tiation.IftheimplementationsupportsallSOPClassesofaparticularServiceClassthroughSOPClassCommonExtendedNegotiation, the first column shall specify "All services of the <x> Service Class".
Table A.1-1. Network Services
SOP Classes |
User of Service (SCU) |
Provider of Service (SCP) |
Transfer
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