Digital Imaging and Communications in Medicine (DICOM)

Supplement 208: DICOM Encapsulation of Additional Models for 3D Manufacturing

Prepared by:

DICOM Standards Committee, Working Group 17

1300 N. 17th Street Suite 1752

Rosslyn, Virginia 22209 USA

VERSION: DRAFT-5 March 18, 2018

This is a draft document. Do not circulate, quote, or reproduce it except with the approval of NEMA.

Developed pursuant to DICOM Work Item 2017-04-E Supplement 205 - Encapsulation of Additional Models for 3D Manufacturing Page 2

Table of Contents

Scope and Field of Application ...... 4 Changes to NEMA Standards Publication PS 3.2-2018x...... 6 Changes to NEMA Standards Publication PS 3.3-2018x...... 7 5 Changes to NEMA Standards Publication PS 3.3-2018x...... 7 A.X.Y1 Encapsulated 3MF Information Object Definition ...... 9 A.X.Y1.1 Encapsulated 3MF IOD Description ...... 9 A.X.Y1.2 Encapsulated 3MF Entity-Relationship Model ...... 9 A.X.Y1.3 Encapsulated 3MF IOD Module Table ...... 9 10 A.X1.3.4 Encapsulated 3MF IOD Content Constraints ...... 9 A.X.Y2 Encapsulated Information Object Definition ...... 10 A.X.Y2.1 Encapsulated X3D IOD Description ...... 10 A.X.Y2.2 Encapsulated X3D Entity-Relationship Model ...... 10 A.X.Y2.3 Encapsulated X3D IOD Module Table ...... 10 15 A.X.Y2.4 Encapsulated X3D IOD Content Constraints ...... 10 A.X.Y3 Encapsulated VRML Information Object Definition ...... 10 A.X.Y3.1 Encapsulated VRML IOD Description ...... 10 A.X.Y3.2 Encapsulated VRML Entity-Relationship Model ...... 11 A.X.Y3.3 Encapsulated VRML IOD Module Table ...... 11 20 A.X.Y3.4 Encapsulated VRML IOD Content Constraints ...... 11 A.X.Y4 Encapsulated OBJ Information Object Definition ...... 11 A.X.Y4.1 Encapsulated OBJ IOD Description ...... 11 A.X.Y4.2 Encapsulated OBJ Entity-Relationship Model ...... 11 A.X.Y4.3 Encapsulated OBJ IOD Module Table ...... 12 25 A.X.Y4.4 Encapsulated OBJ IOD Content Constraints ...... 12 C.24.2 Encapsulated Document Module ...... 12 C.24.2.1 Attribute Requirements for Encapsulated CDA Document ...... 15 C.24.2.X1 Encoding of Multipart Encapsulated Documents ...... 15 C.24.2.X2 Attribute Requirements for Multipart 3D Manufacturing 30 Documents 16 C.24.Y Manufacturing 3D Model Module ...... 17 Changes to NEMA Standards Publication PS 3.4-2018x...... 19 B.5 STANDARD SOP CLASSES ...... 19 Changes to NEMA Standards Publication PS 3.6-2018x...... 20 35 Annex A Registry of DICOM unique identifiers (UID) (Normative) ...... 20 Changes to NEMA Standards Publication PS 3.16-2018x ...... 22 CID 7XX1 MODEL DOCUMENT TITLES ...... 22 CID 7XX2 PURPOSE OF REFERENCE TO PREDECESSOR 3D MODEL ...... 22 Table CID 7XX2. Purpose of Reference to Predecessor 3D Model ...... 22 40 CID 7XX3 MODEL SCALE UNITS ...... 23 Table CID 7XX3. 3D Model Scale Units ...... 23 D DICOM CONTROLLED TERMINOLOGY DEFINITIONS (NORMATIVE)...... 23 Changes to NEMA Standards Publication PS 3.17-2018x ...... 25 HHHH Encapsulated 3D (Informative) ...... 25

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45

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Scope and Field of Application

This supplement adds a new DICOM IOD to encapsulate additional 3D files to facilitate 3D manufacturing. 50 The supplement will address the encapsulation of 4 different 3D modalities:

1) Extensible 3D Graphics (X3D) and The Virtual Reality Modeling Language (VRML) 3D model file formats.

X3D/VRML have distinct differences to the STL . These file formats have the capability of storing color information; the information is either coded to a vertex or face of a polygon or as a texture map that is 55 wrapped around the 3D model. The texture maps can be one of many common 2D image file formats: JPEG, PNG, GIF, SVG, , or TIF. X3D is also specifically developed utilizing the XML file-scheme to Commented [jr1]: Find normative references enhance human-readability and extensibility. Both file formats were developed and curated by the Web3D consortium, X3D is the successor of the VRML format.

In the interest of simplicity and minimizing SOP Instance size and promoting long-term interoperability, 60 only iterations of X3D Specification 3.0 (all profiles are accepted) and greater as well as VRML2.0 (also Commented [jr2]: To WG06: one SOP class per version? known as VRML97) is supported for DICOM encapsulation. Commented [jr3]: There is no VRML 2.0+, Web3D Consortium moved to X3D. For simplicity of this document, future references to the file formats will only reference X3D; VRML will be implied unless otherwise noted. Commented [SE4]: Does this mean only VRML 2.0, or 2.0 and greater? 2) Object Files (OBJ) and Material Library Files (MTL)

65 Similar to X3D, the OBJ file format has the capability of storing color information via the companion MTL file. In turn, the MTL file format references texture files of the same file formats as X3D. OBJ, while not a binary file format, is not designed for human readability.

3) 3D Manufacturing File (3MF)

The 3MF file format is the newest common-use 3D file format with growing widespread adoption. The 70 format has the capability of storing color information via references to texture files; the texture files can only be JPG or PNG. The file format was designed specifically for (X3D and OBJ were originally designed for 3D visualization).

The four new IODs allow 3D manufacturing models to be exchanged between various types of equipment using DICOM messages. This adds the ability to store, query and retrieve 3D models as DICOM objects. 75 Updates are addressed by storing new instances, with reference back to earlier instances similar to the IOD for STL encapsulation (supplement 205).

The 3D model files are a type of document that contains geometric instructions on how an object could be created by a 3D printer, milling machine, or other type of device capable of manufacturing a physical object. File types 1 and 3 also have the added option of additional metadata for specialized print 80 instructions such as material options.

OPEN ISSUES TABLE # Question Comments

5 Are there additional attributes for multi-part 3D Waiting on public comments. The only added models that are needed that weren’t addressed attribute was regarding the inclusion of color. in Sup 205?

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CLOSED ISSUES TABLE # Question Comments

85

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Changes to NEMA Standards Publication PS 3.2-2018x

Digital Imaging and Communications in Medicine Part 2: Conformance

90

Item: Add to table A.1-2 categorizing SOP Classes:

The SOP Classes are categorized as follows:

Table A.1-2 95 UID VALUES UID Value UID NAME Category … … …

1.2.840.10008.5.1.4.1.1.xxx2 Encapsulated X3D Transfer Commented [jr5]: 3.0 and above or 1 class per version? Storage SOP Class 1.2.840.10008.5.1.4.1.1.xxx3 Encapsulated VRML Transfer Storage SOP Class 1.2.840.10008.5.1.4.1.1.xxx4 Encapsulated OBJ Transfer Storage SOP Class 1.2.840.10008.5.1.4.1.1.xxx5 Encapsulated 3MF Transfer Storage SOP Class … … …

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Changes to NEMA Standards Publication PS 3.3-2018x

Digital Imaging and Communications in Medicine (DICOM) 2 Normative References

100

Item: Add normative reference

2.6 Other References

105 3MF: 3MF Consortium. 2017. 3D Manufacturing Format: Core Specification & Reference Guide version 1.2.

MTL: …

JPG

GIF

110 …

OBJ: Wavefront Technologies. 1992. Object Files (.obj), Advanced Visualizer. Commented [jr6]: Reason for removing MTL? Does MTL need IANA registration? VRML: Information technology — Computer graphics, image processing and environmental representation — Extensible 3D (X3D), Web3D Consortium, 2008.

X3D: Information technology -- Computer graphics and image processing -- The Virtual Reality Modeling 115 Language (VRML), Web3D Consortium, 1997.

Changes to NEMA Standards Publication PS 3.3-2018x

Digital Imaging and Communications in Medicine (DICOM) Part 3: Information Object Definitions

Modify Section A.1.4 Overview of the Composite IOD Module Content – Insert 4 new IODs

120 Table A.1-3 COMPOSITE INFORMATION OBJECT MODULES OVERVIEW – MORE NON-IMAGES IODs … Enc Enc Enc Enc … Modules 3MF X3D VRML OBJ

Patient M M M M

Patient Summary

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Clinical Trial Subject U U U U

General Study M M M M

Patient Study U U U U

Clinical Trial Study U U U U

Study Content

Encapsulated Document Series M M M M

Clinical Trial Series U U U U

General Equip. M M M M

Enhanced General Equip. M M M M

Encapsulated Document M M M M

SOP Common M M M M

Manufacturing 3D Model M M M M

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Modify Annex A.X – Insert new section for Encapsulated 3D IODs after A.X.1 (STL)

A.X.Y1 Encapsulated 3MF Information Object Definition 125 A.X.Y1.1 Encapsulated 3MF IOD Description The Encapsulated 3MF Information Object Definition (IOD) describes a 3D model (including supporting 2D texture map files) in 3MF Document format that has been encapsulated within a DICOM information object.

A.X.Y1.2 Encapsulated 3MF Entity-Relationship Model 130 This IOD uses the E-R Model in Section A.1.2, with only the Encapsulated Document IE below the Series IE.

A.X.Y1.3 Encapsulated 3MF IOD Module Table Table A.X.Y1-1 specifies the Encapsulated 3MF IOD Modules.

Table A.X.Y1-1 135 Encapsulated 3MF IOD MODULES IE Module Reference Usage Patient Patient C.7.1.1 M Specimen Identification C.7.1.2 U Clinical Trial Subject C.7.1.3 U Study General Study C.7.2.1 M Patient Study C.7.2.2 U Clinical Trial Study C.7.2.3 U Series Encapsulated Document C.24.1 M Series Clinical Trial Series C.7.3.2 U Frame of Reference Frame of Reference C.7.4.1 M Equipment General Equipment C.7.5.1 M Enhanced General C.7.5.2 M Equipment Image Common Instance C.12.2 C - Required if other instances are Reference referenced Encapsulated Encapsulated Document C.24.2 M Document Manufacturing 3D Model C.24.Y M SOP Common C.12.1 M

A.X1.3.4 Encapsulated 3MF IOD Content Constraints The Encapsulated Document (0042,0011) attribute shall contain a 3MF Document [3MF] stream.

The MIME Type of Encapsulated Document (0042,0012) value shall be ‘model/3mf’.

140 The value of the Modality (0008,0060) shall be “MODEL”.

NOTE: In the Predecessor Documents Sequence Attribute, if the document is a modified version of one or more earlier 3D models, then only the most direct predecessors should be referenced.

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A.X.Y2 Encapsulated X3D Information Object Definition A.X.Y2.1 Encapsulated X3D IOD Description 145 The Encapsulated X3D Information Object Definition (IOD) describes a 3D model in X3D format, and supporting 2D texture map files that have been encapsulated within a DICOM information object.

A.X.Y2.2 Encapsulated X3D Entity-Relationship Model This IOD uses the E-R Model in Section A.1.2, with only the Encapsulated Document IE below the Series IE.

150 A.X.Y2.3 Encapsulated X3D IOD Module Table Table A.X.Y2-1 specifies the Encapsulated X3D IOD Modules.

Table A.X.Y2-1 Encapsulated X3D IOD MODULES IE Module Reference Usage Patient Patient C.7.1.1 M Specimen Identification C.7.1.2 U Clinical Trial Subject C.7.1.3 U Study General Study C.7.2.1 M Patient Study C.7.2.2 U Clinical Trial Study C.7.2.3 U Series Encapsulated Document C.24.1 M Series Clinical Trial Series C.7.3.2 U Frame of Reference Frame of Reference C.7.4.1 M Equipment General Equipment C.7.5.1 M Enhanced General C.7.5.2 M Equipment Image Common Instance C.12.2 C - Required if other instances are Reference referenced Encapsulated Encapsulated Document C.24.2 M Document Manufacturing 3D Model C.24.Y M SOP Common C.12.1 M

155 A.X.Y2.4 Encapsulated X3D IOD Content Constraints The Encapsulated Document (0042,0011) attribute shall contain a multipart MIME stream. (See C.24.2.X1 and C.24.2.X2.)

The value of the Modality (0008,0060) shall be “MODEL”.

NOTE: In the Predecessor Documents Sequence Attribute, if the document is a modified version of one or more 160 earlier 3D models, then only the most direct predecessors should be referenced.

A.X.Y3 Encapsulated VRML Information Object Definition A.X.Y3.1 Encapsulated VRML IOD Description The Encapsulated VRML Information Object Definition (IOD) describes a 3D model in VRML format, and 165 supporting 2D texture map files that have been encapsulated within a DICOM information object.

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A.X.Y3.2 Encapsulated VRML Entity-Relationship Model This IOD uses the E-R Model in Section A.1.2, with only the Encapsulated Document IE below the Series IE.

A.X.Y3.3 Encapsulated VRML IOD Module Table 170 Table A.X.Y3-1 specifies the Encapsulated VRML IOD Modules.

Table A.X.Y3-1 Encapsulated VRML IOD MODULES IE Module Reference Usage Patient Patient C.7.1.1 M Specimen Identification C.7.1.2 U Clinical Trial Subject C.7.1.3 U Study General Study C.7.2.1 M Patient Study C.7.2.2 U Clinical Trial Study C.7.2.3 U Series Encapsulated Document C.24.1 M Series Clinical Trial Series C.7.3.2 U Frame of Reference Frame of Reference C.7.4.1 M Equipment General Equipment C.7.5.1 M Enhanced General C.7.5.2 M Equipment Image Common Instance C.12.2 C - Required if other instances are Reference referenced Encapsulated Encapsulated Document C.24.2 M Document Manufacturing 3D Model C.24.Y M SOP Common C.12.1 M

A.X.Y3.4 Encapsulated VRML IOD Content Constraints 175 The Encapsulated Document (0042,0011) attribute shall contain a multipart MIME stream. (See C.24.2.X1 and C.24.2.X2.)

The value of the Modality (0008,0060) shall be “MODEL”.

NOTE: In the Predecessor Documents Sequence Attribute, if the document is a modified version of one or more earlier 3D models, then only the most direct predecessors should be referenced. 180 A.X.Y4 Encapsulated OBJ Information Object Definition A.X.Y4.1 Encapsulated OBJ IOD Description The Encapsulated OBJ Information Object Definition (IOD) describes a 3D model in OBJ format, supporting material library file (MTL), and supporting 2D texture map files that have been encapsulated 185 within a DICOM information object.

A.X.Y4.2 Encapsulated OBJ Entity-Relationship Model This IOD uses the E-R Model in Section A.1.2, with only the Encapsulated Document IE below the Series IE.

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A.X.Y4.3 Encapsulated OBJ IOD Module Table 190 Table A.X.Y4-1 specifies the Encapsulated OBJ IOD Modules.

Table A.X.Y4-1 Encapsulated OBJ IOD MODULES IE Module Reference Usage Patient Patient C.7.1.1 M Specimen Identification C.7.1.2 U Clinical Trial Subject C.7.1.3 U Study General Study C.7.2.1 M Patient Study C.7.2.2 U Clinical Trial Study C.7.2.3 U Series Encapsulated Document C.24.1 M Series Clinical Trial Series C.7.3.2 U Frame of Reference Frame of Reference C.7.4.1 M Equipment General Equipment C.7.5.1 M Enhanced General C.7.5.2 M Equipment Image Common Instance C.12.2 C - Required if other instances are Reference referenced Encapsulated Encapsulated Document C.24.2 M Document Manufacturing 3D Model C.24.Y M SOP Common C.12.1 M

A.X.Y4.4 Encapsulated OBJ IOD Content Constraints 195 The Encapsulated Document (0042,0011) attribute shall contain a multipart MIME stream. (See C.24.2.X1 and C.24.2.X2.)

The value of the Modality (0008,0060) shall be “MODEL”.

NOTE: In the Predecessor Documents Sequence Attribute, if the document is a modified version of one or more earlier 3D models, then only the most direct predecessors should be referenced. 200

Modify Annex C.24 – Clarifications for Encapsulated STL 3D Manufacturing 3D Model

C.24.2 Encapsulated Document Module Table C.24-2 defines the Encapsulated Document Attributes.

Table C.24-2 205 Encapsulated Document Module Attributes Attribute Name Tag Type Attribute Description Instance Number (0020,0013) 1 A number that identifies this SOP Instance. The value shall be unique within a series. Content Date (0008,0023) 2 The date the document content creation was started.

Content Time (0008,0033) 2 The time the document content creation was started.

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Acquisition DateTime (0008,002A) 2 The date and time that the original generation of the data in the document started. Image Laterality (0020,0062) 3 Laterality of the (possibly paired) body part that is the subject of the encapsulated document. Enumerated Values: R right L left U unpaired B both left and right

If the IOD is an encapsulated STL 3D manufacturing Commented [SE7]: Confirm if we should use current text, model, then values for the laterality attribute shall refer to the “encapsulated 3D manufacturing model” (all lower case), or intended placement of the created object regardless of how it explicitly list the IODs. was generated (see also Model Mirroring, C.24.Y.2). Commented [jr8]: Who do I confirm with? WG06?

Burned In Annotation (0028,0301) 1 Indicates whether or not the encapsulated document contains sufficient burned in annotation to identify the patient and date the data was acquired. Enumerated Values: YES NO Identification of patient and date as text in an encapsulated document (e.g., in an XML attribute or element) is equivalent to "burned in annotation". A de-identified document may use the value NO. If the document is a 3D manufacturing model, the presence of identifying information embossed or engraved on any part of the model shall be indicated by a value of YES. Recognizable Visual (0028,0302) 3 Indicates whether or not the instance contains sufficiently Features recognizable visual features to allow the instance or a reconstruction from a set of instances to identify the patient. Enumerated Values: YES NO If this Attribute is absent, then the instance may or may not contain recognizable visual features. Source Instance (0042,0013) 1C A sequence that identifies some or all of the Instances that Sequence were used to derive the encapsulated document. One or more Items shall be included in this Sequence. Instances may be drawn from different studies. Required if derived from one or more DICOM Instances (e.g. 3D models derived from image series). May be present otherwise. >Include Table 10-11 “SOP Instance Reference Macro Attributes” >Purpose of Reference (0040,A170) 3 Code Sequence Describes the purpose for which the reference is made, that is what role the source instances played in the derivation of this encapsulated document Only a single Item is permitted in this Sequence. >>Include Table 8.8-1 Defined CID 7013 “Source Instance Purposes of Reference”.

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“Code Sequence Macro Attributes” Document Title (0042,0010) 2 The title of the document.

Note In the case of a PDF encapsulated document, this may be the value of the "Title" entry in the "Document Information Directory" as encoded in the PDF data. Concept Name Code (0040,A043) 2 Sequence A coded representation of the document title. Zero or one Item shall be included in this Sequence.

>Include Table 8.8-1 “Code Sequence Macro For Encapsulated STL IODs 3D Manufacturing Models, the Commented [SE9]: See comment above Attributes” Baseline CID is 7xx1 “3D Model Document Titles”. For all other Encapsulated documents use the Baseline CID 7020 “Document Titles”. Document Class Code (0040,E008) 3 Sequence Additional classifications of the document, beyond the title represented in Concept Name Code Sequence. May be equivalent to HL7 v2.x TXA-2. One or more Items are permitted in this Sequence. >Include Table 8.8-1 “Code Sequence Macro No Baseline CID is defined. Attributes” Verification Flag (0040,A493) 3 Indicates whether the Encapsulated Document is Verified. Enumerated Values: UNVERIFIED Not attested by a legally accountable person. VERIFIED Attested to (signed) by a Verifying Observer or Legal Authenticator named in the document, who is accountable for its content. HL7 Instance Identifier (0040,E001) 1C Instance Identifier of the encapsulated HL7 Structured Document, encoded as a UID (OID or UUID), concatenated with a caret ("^") and Extension value (if Extension is present in Instance Identifier). Required if encapsulated document is a CDA document. Predecessor Documents (0040,A360) 3 References to SOP Instances whose content has been Sequence Attribute wholly or partially included in this document with or without modification. One or more Items are permitted in this sequence. >Include Table C.17-3 'Hierarchical SOP Instance Defined CID for the Purpose of Reference Code Sequence in Reference Macro' the Hierarchical SOP Instance Reference Macro is: For an Encapsulated STL IOD, CID 7xx2 “Purpose of Reference to Predecessor 3D Model”; Otherwise, CID 7009 “Purpose of Reference to Predecessor Report”. Identical Documents (0040,A525) 3 Duplicates of this document, stored with different SOP Sequence Instance UIDs. One or more Items are permitted in this sequence. See Section C.17.2.2 for further explanation. >Include Table C.17-3 “Hierarchical SOP Instance Reference Macro Attributes” MIME Type of (0042,0012) 1 The type of the encapsulated document stream described Encapsulated Document using the MIME Media Type (see RFC 2046). Media type parameters should not be included.

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Extended MIME Type of (ggg1,eee1) 1C The type of the encapsulated document stream Encapsulated described using the MIME Media Type (see RFC 2046). Document Media type parameters may be included. If present, the media type (with media type parameters removed) shall match MIME Type of Encapsulated Document (0042,0012). Required if MIME Type of Encapsulated Document (0042,0012) is a multipart type (see Section C.24.2.X1). May be present otherwise. Commented [SE10]: A full multipart content type can look List of MIME Types (0042,0014) 1C MIME Types of subcomponents of the encapsulated like: Content-Type: document. Multipart/Related;boundary=MIME_boundary; Required if the encapsulated document incorporates type="application/xop+"; subcomponents with MIME types different than the primary start=""; MIME Type of the encapsulated document. startinfo="application/soap+xml; action=\"ProcessData\"" Encapsulated Document (0042,0011) 1 Encapsulated Document stream, containing a document This allows us to put “Multipart/Related in the existing tag encoded according to the MIME Type. (which is limited to 64 characters), and the full specification here. Note I considered allowing other content headers, including 1. One could distinguish four stages in the creation of the Encapsulated Document Object, identified by the Content-Encoding (which can specify zip), but do not have a following Attributes: compelling argument for why to allow them.

1. Measurement and/or data collection, identified by Acquisition DateTime (0008,002A) in the I also considered expressly prohibiting content type parameters that specify character set, etc. These obviously 210 Encapsulated Document Module. could contradict the current character set, which would cause problems, but I’m skeptical that we’ll see the issue in practice. 2. Creation of the original documentation of the data collection, identified by Content Date (0008,0023) and Content Time (0008,0033).

3. Rendering of the original documentation into the format that will be encapsulated, e.g., a PDF document. The rendering time is not captured by any DICOM Attribute, but may be encoded in the 215 rendering.

4. Encapsulation of the rendering into a DICOM Object, identified by Instance Creation Date (0008,0012) and Instance Creation Time (0008,0013) in the SOP Common Module.

2. DICOM does not specify requirements for consistency between DICOM attribute values and data in the encapsulated document. It is expected that applications will ensure consistency in a manner appropriate 220 to the application. For example, the Patient ID in an encapsulated CDA document may be that of a different institution, which originated the document, and it may be appropriate for the DICOM attribute value to be different.

C.24.2.1 Attribute Requirements for Encapsulated CDA Document 225 For an Encapsulated CDA Document, Document Title (0042,0010) shall have the value of the CDA Document Title, if one is present in the encapsulated document.

Concept Name Code Sequence (0040,A043) shall have the value of the CDA Document Type Code, with transcoding as necessary for converting the HL7 CE Data Type to the DICOM Code Sequence item.

Enumerated Values for MIME Type of Encapsulated Document (0042,0012):

230 text/XML

Add after Annex C.24.2.1 – Attribute Requirements for Encapsulated CDA Document

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C.24.2.X1 Encoding of Multipart Encapsulated Documents 235 Multiple octet streams can be included in a single Encapsulated Document (0042,0011) stream, similar to an email including multiple attachments. Each component octet stream is a part. The parts, separated by delimiters and headers, are serialized into a combined multipart stream which forms the content of the encapsulated document. A multipart stream can have one or more parts.

The MIME Type of Encapsulated Document (0042,0012) attribute for a multipart document shall have a 240 value of a multipart content type (e.g., multipart/related, multipart/mixed).

The List of MIME Types (0042,0014) attribute shall list the content type of each of the parts. Commented [SE11]: Consistent with what is said for Encapsulated CDA, this is fairly loose language – no ordering, The Extended MIME Type of Encapsulated Document (ggg1,eee1) attribute for a multipart document shall no comment about repeated content types, etc. have a value that specifies a multipart content type and shall include a boundary parameter. If the content is Multipart/Related, then the start and type parameters, which identify the root (“main”) part and its MIME 245 type, shall be included.

The Encapsulated Document (0042,0011) attribute for a multipart document shall contain only the message body, as defined in [RFC2046]. Commented [SE12]: Do we need to specify the character set? I think the header portion of each part is required to be Notes US-ASCII.

1. The message body is separated into parts by boundary delimiters. Each part includes a Do we need to specify no prologue or epilog content. 250 Content-type header specifying the MIME type of that part, and can include other content headers, for example to specify binary or base64 encoding, or filenames. 2. [RFC2387] indicates that use of Content-Disposition part headers (which allows specification of filenames) are to be ignored in Multipart/Related content. It also indicates that this header Commented [SE13]: may have value for Multipart/Related content for some applications. DICOM permits s Commented [SE14]: https://tools.ietf.org/html/rfc2387 255 3. HTTP headers are not case sensitive, and are in the US-ASCII character set, Therefore, section 5 multipart/mixed

C.24.2.X2 Attribute Requirements for Multipart 3D Manufacturing Documents Commented [SE15]: should treat “Attachment” and ATTACHMENT and attachment all the same.. MIME types Encapsulated X3D, Encapsulated VRML, and Encapsulated OBJ Documents are conveyed using may use different case than specified in tble. multipart/mixed content for the encapsulated document. This encapsulated document parts contain the May need to quote header field values 260 model file, and IOD-specific support files such as 2D image texture maps.

Extended MIME Type of Encapsulated Document (gggg,eee1) shall specify a content type of multipart/mixed and shall include a boundary parameter.

The List of MIME Types (0042,0014) attribute shall list the content types of each of the parts. Commented [SE16]: Consistent with what is said for Encapsulated CDA, this is fairly loose language – no ordering, The Encapsulated Document (0042,0011) attribute shall contain a multipart/mixed body as defined in no comment about repeated content types, etc.

265 RFC2045] and [RFC2046].The permitted content types for the parts depend on the IOD as specified in Table C.24-3. A single model file shall be included. The model file shall be conveyed in the first part.

Table C.24-3 Multipart Encapsulated Document Content Types IOD Content Type Usage Encapsulated X3D Manufacturing Model model/x3d+xml M image/png U image/jpeg U image/gif U image/jpeg U image/gif U image/svg+xml U

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Encapsulated VRML Manufacturing model/vrml M Model image/png U image/jpeg U image/gif U image/svg+xml U image/tiff U image/bmp U Encapsulated OBJ Manufacturing Model model/x3d+xml M image/png U image/jpeg U

270 Each part shall include a Content-Type header field with a value of the content type of that part. Commented [SE17]: Convert to a table?

Each part shall include a Content-Disposition header field [RFC2183] with the value “inline”. The Content Add content-length? Disposition header shall include a filename parameter. The filename* header parameter is not permitted. Commented [SE18]: Need a statement requiring the filenames to match how they are referenced in the model, etc.. Each part may include a Content-Encoding header field with the value gzip. Need a statement limiting characters that can be in a file name? and/or a comment that a system is permitted to use Each part may include a Content-Transfer-Encoding header field with a value of 8bit, binary, or base64. other filenames, but needs to maintain the linkages

Note that use of multipart/related without filenames is 275 Each part may include a Content-Description header field. consistent with what we did for STL.

Commented [SE19]: Or deflate? Do we need to support more than one? Are either patent or license encumbered? Commented [SE20]: Needed? Modify PS3.3 Annex C.24 to insert definition of a new 3D Manufacturing module and associated defined terms.

C.24.Y Manufacturing 3D Model Module 280 Table C.24.Y-1 defines attributes specific to models used in medical 3D manufacturing.

Table C.24.Y-1 Manufacturing 3D Model Module Attributes Attribute Name Tag Type Attribute Description Processing Function (0018,5020). 3 Description of processing functions applied to the source data and/or prior model to produce this instance Measurement Units (0040,08EA) 1 Units of distance for the coordinate system for the Code Sequence encapsulated STL 3D Manufacturing Model file Only a single Item shall be included in this Sequence. STL, OBJ, and 3MF will have a default value of mm; X3D will have a default value of m. X3D and 3MF may have specific metadata further defining unit scale; software reading these files are encouraged to prioritize the in- file unit scale over the this tag if the two conflict. >Include Table 8.8-1 “Code Sequence Macro Defined CID 7xx3 “Model Scale Units”. Attributes”

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Model Modification (aaa1,bbb1) 3 Specifies whether a modification of the observed anatomy (other than mirroring) was used to create the model (e.g. simulating an expected surgical result). In the negative, the model follows the observed patient anatomy in the source data. Enumerated Values: YES NO

Model Mirroring (aaa1,bbb2) 3 Specifies whether mirroring of anatomy from the other side of the patient was used to create the model Enumerated Values: YES NO

Model Usage (aaa1,bbb3) 3 Specifies the use for which the manufactured object is intended. See Section C.24.Y.1 for Defined Terms Color Usage (aaa1,bbb4) Specifies the use for which the color in the 3D manufactured object is intended. See Section C.24.Y.2 for Defined Terms Icon Image Sequence (0088,0200) 3 A preview image representing the rendered model. See Section C.7.6.1.1.6 for further explanation

285

C.24.Y.2 Color Usage

Color Usage (aaa1,bbb4) is used to distinguish similar-appearing models by providing the original intent of the designer. The model may be used for other purposes.

Defined Terms:

290 NO COLOR Modeled object is contains no color information

CONSTRUCTED COLOR Modeled object is contains color information constructed by a user. This term includes colors assigned purposefully or arbitrarily by a user.

INFORMED COLOR Modeled object is contains color information informed by the underlying image set. E.g., color information correlates to Hounsfield unit or MRI 295 intensity values or color information correlates to pressure gradients.

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300 Changes to NEMA Standards Publication PS 3.4-2018x

Digital Imaging and Communications in Medicine (DICOM) Part 4: Service Class Specifications

Modify Annex B.5 Standard SOP Classes – add new item.

305 B.5 STANDARD SOP CLASSES Table B.5-1 STANDARD SOP CLASSES Commented [jr21]: Add STL to table? SOP Class Name SOP Class UID IOD (See PS 3.3) … Encapsulated 3MF Storage 1.2.840.10008.5.1.4.1.1.xxx1 Encapsulated 3MF IOD Encapsulated X3D Storage 1.2.840.10008.5.1.4.1.1.xxx2 Encapsulated X3D IOD Encapsulated VRML Storage 1.2.840.10008.5.1.4.1.1.xxx3 Encapsulated VRML IOD Encapsulated OBJ Storage 1.2.840.10008.5.1.4.1.1.xxx4 Encapsulated OBJ IOD …

310

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Changes to NEMA Standards Publication PS 3.6-2018x

Digital Imaging and Communications in Medicine (DICOM) Part 6: Data Dictionary

315

Modify PS3.6 Table 6-1. Registry of DICOM Data Elements to add the following elements in the correct order.

Table 6-1. Registry of DICOM Data Elements

Tag Name Keyword VR VM

… … … … …

(gggg,eee1) Extended MIME Type of ExtendedMIMETypeOfEncapsulatedDocument ST 1 Encapsulated Document

(aaa1,bbb4) Color Usage ColorUsage CS 1

… 320

Modify PS3.6 Annex A Registry of DICOM unique identifiers (UID) – add new item.

Annex A Registry of DICOM unique identifiers (UID) (Normative)

Table A-1 lists the UID values that are registered and used throughout the Parts of the DICOM Standard. 325 This central registry ensures that when additional UIDs are assigned, non-duplicate values are assigned.

Table A-1 UID VALUES Commented [jr22]: Add STL to table? UID Value UID NAME UID TYPE Part

1.2.840.10008.5.1.4.1.1.xxx1 Encapsulated 3MF Storage SOP Class PS 3.4

1.2.840.10008.5.1.4.1.1.xxx2 Encapsulated X3D Storage SOP Class PS 3.4

1.2.840.10008.5.1.4.1.1.xxx3 Encapsulated VRML Storage SOP Class PS 3.4

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1.2.840.10008.5.1.4.1.1.xxx4 Encapsulated OBJ Storage SOP Class PS 3.4

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Changes to NEMA Standards Publication PS 3.16-2018x Commented [jr23]: Remove?

330 Digital Imaging and Communications in Medicine Part 16: Content Mapping Resource

Addition to PS3.16 Content Mapping Resource – Modify CID 29 Acquisition Modality to include MODEL in the correct location.

Addition to PS3.16 Content Mapping Resource – Add 3 new CIDs.

335 CID 7XX1 MODEL DOCUMENT TITLES Type: Extensible Version: YYYYMMDD UID: 1.2.840.10008.6.1.xx1

340 Context Group ID 7xx1 comprises all 3D printed model document names of the LOINC coding scheme (i.e., terms with Component:"3D printed model" and Scale:"Doc"). The Coding Scheme Designator shall be LN. These values of the Context Group are reproduced here for reference only, and might not constitute the current complete set; see the LOINC coding scheme.

Note 345 The LOINC coding scheme can be found at https://loinc.org. The current value set for this Context Group may be obtained by the following query: https://search.loinc.org/searchLOINC/search.zul?query=Component%3A%223D+printed+model%22+Scale%3AD oc.

350 Table CID 7XX1. MODEL DOCUMENT TITLES

Coding Scheme Code Value Code Meaning Designator LN 85041-2 MR Unspecified body region 3D printed model LN 85040-4 CT Unspecified body region 3D printed model

CID 7XX2 PURPOSE OF REFERENCE TO PREDECESSOR 3D MODEL

355 Type: Extensible Version: YYYYMMDD UID: 1.2.840.10008.6.1.xx2

Context Group ID 7xx2 comprises all reasons that a prior 3D model may be referenced by a later instance.

360 Table CID 7XX2. Purpose of Reference to Predecessor 3D Model Coding Scheme Designator Code Value Code Meaning

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DCM abcdefg01 Version prior to further segmentation DCM abcdefg02 Version prior to post- processing DCM abcdefg03 Version prior to alternate segmentation DCM abcdefg04 contributor to fusion DCM abcdefg05 Version prior to other modification

CID 7XX3 MODEL SCALE UNITS Type: Extensible Version: YYYYMMDD 365 UID: 1.2.840.10008.6.1.xx3

Context Group ID 7xx3 comprises all valid scale units that may be used in a 3D model.

Table CID 7XX3. 3D Model Scale Units Coding Scheme Designator Code Value Code Meaning UCUM m meter UCUM cm centimeter UCUM mm millimeter UCUM um micrometer

370

Addition to PS3.16 Content Mapping Resource – Appendix D, Add new DICOM controlled terminology definitions introduced in CID 7XX2 above

D DICOM CONTROLLED TERMINOLOGY DEFINITIONS (NORMATIVE) This Annex specifies the meanings of codes defined in DICOM, either explicitly or by reference to another 375 part of DICOM or an external reference document or standard.

The contents of this table are available in OWL format at ftp://medical.nema.org/medical/dicom/resources/ontology/dcm/dcm.owl and in Bioportal.

Table D-1. DICOM Controlled Terminology Definitions (Coding Scheme Designator "DCM" Coding Scheme Version "01")

Code Value Code Meaning Definition Notes … abcdefg01 Further Segmentation Additional segmentation, refining earlier approach, was performed abcdefg02 Post-Processing Post-processing (other than

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segmentation) was done in order to prepare model for specific uses (e.g. instrument, implant, prosthetic, etc.) or manufacturing methods (e.g. built-in supports, print surface adhesion, etc.) abcdefg03 Alternate Segmentation Anatomical structures of the earlier model were identified using fundamentally different segmentation approach (e.g. pathway, algorithm, or threshold selection)” abcdefg04 Fusion of Multiple Models Earlier models contributed to the creation of fused model … 380

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Changes to NEMA Standards Publication PS 3.17-2018x

Digital Imaging and Communications in Medicine Part 17: Informative

385 Addition to PS3.17 Append new Annex containing informative information on the creation of encapsulated STL objects

HHHH Encapsulated 3D (Informative)

The goal of encapsulating a 3D manufacturing model file inside a DICOM instance rather than transforming the data into a different representation is to facilitate preservation of the 3D file in the exact 390 form that it is used with extant manufacturing devices, while at the same time unambiguously associating it with the patient for whose care the model was created and the images from which the model was derived.

HHHH.1 Example Encoding

Below are tables showing example excerpts for encoding of STL files and associated preview bitmap images (the latter being optional) for two patients. 395 Example A: Patient A will shortly be undergoing a complex partial nephrectomy to remove lesions on a kidney. A 3D manufacturing model (encoded in binary X3D) was created to manufacture a surgical planning aid representing the patient’s unique anatomy. 400 A model was constructed from a CT (CT1) dataset. The model was created on July 16, 2017 at 1:04:34 PM. The model was initially created as a colorless STL file. Clinicians requested that the lesions be colored; an X3D file was generated. The model is expressed as a single X3D file with two (2) texture maps encoded as PNG. 405

A preview image was created showing the rendered 3D object.

In this example, the creator of the model inscribed the patient’s medical record number on a side of the model, to avoid the possibility of a wrong patient error.

410 Table HHHH.2 Commented [jr24]: Not complete yet. Encapsulated STL Example A (Encapsulated Document Series and Document Values) Attribute Tag Example Value Comments Name Modality (0008,0060) MODEL

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Attribute Tag Example Value Comments Name … Series (0008,103E) 3DP Models Description … Content Date (0008,0023) 20170716 Content Time (0008,0033) 13:00:34 Acquisition (0008,002A) 20170716 13:00:34 DateTime Image (0020,0062) U Laterality Burned In (0028,0301) YES Annotation Recognizable (0028,0302) NO Visual Features Source (0042,0013) A sequence referencing CT1 source Images from 2 studies are Instance images and MR1 source images included because they both Sequence provided source data. %item >Referenced (0008,1150) 1.2.840.10008.5.1.4.1.1.2.1 Referenced object is an SOP Class UID Enhanced CT Image Storage >Referenced (0008,1155) 2.999.89235.5951.35894.153 The multi-frame CT image SOP Instance from study CT1 UID %enditem Document Title (0042,0010) Cardiac Model 2 Concept Name (0040,A043) Code Sequence %item (85041-2, LN, “MR XXX 3D model”) From CID 7xx1. LOINC code for MR derived 3D model %enditem Predecessor (0040,A360) A sequence referencing the UID of the The earlier encapsulated Documents earlier encapsulated STL STL is included so that end Sequence users can understand how this model relates to %item >Include Table C.17-3 'Hierarchical SOP Instance Reference Macro' > Study (0020,000D) 2.999.1241.1515.15151.515.62 Instance UID > Reference (0008,1115) Series Sequence %item >> Series (0020,000E) 2.999.89235.5951.35894.151

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Attribute Tag Example Value Comments Name Instance UID >> Referenced (0008,1199) SOP Sequence %item >>> (0008,1150) 1.2.840.10008.5.1.4.1.1.xxxx Encapsulated STL SOP Referenced Class SOP Class UID >>> (0008,1155) 2.999.1241.1515.15151.515.68 Referenced SOP Instance UID %enditem %enditem %item >>Purpose of (0040,A170) Reference Code Sequence %item (abcdefg01, DCM, “Version prior to From CID 7xx2. This model further segmentation”) modified the earlier one to achieve more fine-grained segmentation %enditem %enditem %enditem MIME Type of (0040,0012) model/x3d+xml Encapsulated Document Encapsulated (0042,0011) Byte stream representing the binary STL Note that ASCII STL files Document file. are not supported. Icon Image (0088,0200) Sequence containing an image The pre-rendered preview Sequence image

Table HHHH.3 415 Encapsulated STL Example A (3DM Module Values) Attribute Name Tag Example Value Comments Model Modification (aaa1,bbb1) NO

Model Mirroring (aaa1,bbb2) NO Model Usage (aaa1,bbb1) PLANNING Units of measurement (0040,08EA)

%item (mm, UCUM, "mm")

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Attribute Name Tag Example Value Comments %enditem

Example B: OBJ + MTL + 4 texture maps JPG

420 Flexible, color print

Example C: 3MF + 6 texture maps 425 Color helmet for dysmorophic head

Example D: 430 4 STL files for different bones in the arm

No color