Digital Imaging and Communications in Medicine (DICOM) Supplement 40: DVD Media Using UDF

Transcription

1 Digital Imaging and Communications in Medicine (DICOM) 6 7 Supplement 40: DVD Media Using UDF This is a working draft only. It has not been approved as a Standard and may undergo considerable revision before final approval. This document should not be construed as definitive for the content of a future DICOM standard, nor that a DICOM standard on DVD Media using UDF will be approved. In particular the choices of filesystem revision level (UDF 1.5) and media types (DVD-R and DVD-RAM) are subject to change DICOM Standards Committee, Working Group 5 Interchange Media 1300 N. 17 th Street Rosslyn, Virginia USA VERSION: Draft Version 0.14, 16 September 1999

2 Page ii 29 DOCUMENT HISTORY 30 Document Version Date March 1998 Initial draft Content August 1998 Add requirements for physical media choice Begin specifying UDF restrictions August 1998 Fix incorrect ISO reference September 1998 Incorporate output of last WG1 and 5 meetings on criteria and relative priorities. Replace media comparison table with updated table from Ted Ozeki September 1998 Incorporate WG 5 meeting output: 6 clean up typos 6 remove CD references from comparison table & Annex J 6 use UDF 2.0 only, not add open SCSI command set as requirement - elaborate on open issues October 1998 Correct various typos December 1998 Update media comparison table with feedback from DVD vendors Update Part 12 changes with new references and information from manufacturers December 1998 Rename to "DVD UDF Media" Update media comparison table & remove ASMO/MMVF Correct typos and grammar Reorganize part 12 addition and add more UDF specifics January 1999 Revise forward defining strategy Revise media comparison table January 1999 Public comment proposal for WG 6 review January 1999 Incorporate WG 6 comments January 1999 Public comment version June 1999 Draft after June meeting decision to use R and RAM for trial implementations. Remove reference to ISO 9660/UDF bridge disk. Agree on UDF 1.5 revisit for ballot Agree on DVD-R and RAM only (those are all that are available for testing and meet criteria) revisit for ballot.

3 Page iii September 1999 Working draft for experiments after WG 6 decision not to approve "draft for trial implementation" since significant changes are expected before ballot - no content change since rev

4 Page iv 32 OPEN ISSUES 33 Does WG1 want both R and RAM for trial implementation of cardiac profiles? Does WG12 want both R and RAM for trial implementation of ultrasound profiles? Should we restrict DVD-RAM to single-sided Type 2 cartridges only to promote interoperability and meet the DVD-ROM readability criterion?

5 Page v 34 Contents Contents v Foreword vii Scope and Field of Application...viii FILESYSTEM...VIII CRITERIA FOR CHOICE OF A PHYSICAL MEDIUM...IX STRATEGY FOR CHOICE OF A PHYSICAL MEDIUM...XI FORM OF THIS SUPPLEMENT...XIII 2...Normative References Definitions Symbols and abbreviations...2 Annex B (Normative) X-ray Angiographic Application Profile s...3 B.1 CLASS AND PROFILE IDENTIFICATION...3 B.2 CLINICAL CONTEXT...3 B Roles and Service Class Options...4 B.3 STD-XA1K-CD APPLICATION PROFILE CLASS REQUIREMENTS...5 B Physical Media And Media Formats...5 Annex C Ultrasound Application Profile (Normative)...6 C.1 CLASS AND PROFILE IDENTIFICATION...6 C.2 CLINICAL CONTEXT...6 C Roles...7 C.3 GENERAL CLASS PROFILE...7 C Physical Media And Media Formats...7 Annex D (Normative) - General Purpose CD-R and DVD Image Interchange Profile s...9 D.1 PROFILE IDENTIFICATION...9 D.2 CLINICAL CONTEXT...9 D.2.1 Roles and Service Class Options...10 D.3 STD-GEN-CD PROFILE CLASS...11 D.3.2 Physical Medium And Medium Format...11 Annex E (Normative) - CT and MR Image Application Profiles...12 E.1 PROFILE IDENTIFICATION...12 E.2 CLINICAL CONTEXT...12 E.2.1 Roles and Service Class Options...13 E.3 STD-CTMR PROFILES...14 E.3.2 Physical Medium And Medium Format Normative references Definitions Symbols and abbreviations...16 Annex J UDF on 120 mm DVD-R and DVD-RAM Medium (Normative)...18

6 Page vi J.1 DICOM MAPPING TO MEDIA FORMAT...18 J Media Character Set...18 J DICOM File-set...18 J DICOM File ID Mapping...19 J DICOM File Management Information...19 J.2 FILESYSTEM...19 J UDF File system...19 J.3 MEDIA FORMATS...21 J DVD-R...21 J DVD-RAM...21

7 Page vii Foreword This Supplement has been prepared by the DICOM Working Group 5 (Interchange Media) according to the procedures of the DICOM 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. This document is a Supplement to the DICOM Standard. It is an extension to PS 3.11 and 3.12 of the published DICOM Standard which consists of the following parts: PS Introduction and Overview PS Conformance PS Information Object Definitions PS Service Class Specifications PS Data Structures and Encoding PS Data Dictionary PS Message Exchange PS Network Communication Support for Message Exchange PS Point-to-Point Communication Support for Message Exchange PS Media Storage and File Format for Data Interchange PS Media Storage Application Profiles PS Media Formats and Physical Media for Data Interchange PS Print Management Point-to-Point Communication Support PS Grayscale Standard Display Function These parts are related but independent documents.

8 Page viii 108 Scope and Field of Application New clinical applications have requirements for higher capacity media formats that are becoming available that can potentially be used for image interchange. These include the DVD based writable and rewritable forms that are addressed by this supplement. FILESYSTEM The existing DICOM media make use either of the DOS FAT16 file system, or in the case of CD-R, the ISO 9660 Level 1 file system. The FAT16 file system is limited in the number of clusters (minimum unit of disk space that can be allocated) that it can address in a single partition to This results in very large clusters and wastage of large amounts of space as the size of the media increases. The ISO 9660 file system is only used on CD-ROM, and CD-R media, and is not suitable for frequent incremental updates, since its allocation table is in a fixed location at the beginning of a track. Therefore, a new file system is required to make efficient use of higher capacity media writable and rewritable media. The consumer and computer industries have standardized on UDF, a profile of ECMA 167/ISO 13346, for DVD media. Note: UDF may also be useful for other new media types, such as higher capacity MOD, which may be the subject of future supplements. There are three major versions of UDF: used by DVD-Video (so-called "microudf") - supported (read) by popular operating systems - no incremental writing support adds support for incremental writing (virtual allocation tables) - supported by all existing DVD mastering software for rewritable media adds named streams (to back up this feature in NT and to replace extended attributes) - expected to be supported by all DVD mastering software CD-R media is normally written "disk at once" or "track at once" (effectively requiring the entire volume to be cached on a hard disk in advance). The medical imaging industry has been reluctant to use multisession recording which not only wastes space (due to large lead-in and lead-out areas) but also is perceived to risk destruction of the existing content of the media. Caching an entire volume of the new higher capacity media is undesirable and potentially unnecessary if incrementally writable media and file systems are available. Accordingly, the choice of at least UDF 1.5 over 1.02 is suggested. This strategy is consistent with the consumer and IT industry providers who are using UDF 1.5 or 2.0 for so-called "drive letter" write access to new types of media. The risk of this choice

9 Page ix is that consumer OS vendors will not make 1.5 or 2.0 read capability available natively (i.e. without special drivers). Named Streams that are added in UDF 2.0 allow the feature of the same name in NT to be copied to UDF file systems, in addition to being a more flexible approach to storing other OS specific features (such as Mac finder information and resource forks) that are stored as Extended Attributes in earlier UDF versions. The named streams also provide a place to encode media specific information such as laser power calibration parameters. None of the Named Streams features are directly relevant to the DICOM application, however it is hoped that eventually most drive and software vendors will adopt 2.0 over 1.5 to take advantage of these features for non-dicom applications. For the purposes of this draft for trial implementation, UDF 1.5 has been selected, since that is the only version currently implemented by operating system, software and driver vendors, and UDF 2.0x is undergoing revision. This decision will be revisited before letter ballot text is drafted and may well change. CRITERIA FOR CHOICE OF A PHYSICAL MEDIUM The choice of a file system such as UDF provides a means of supporting new media types in a robust manner, but is only a step towards interoperability of removable media. If a choice of physical medium needs to be made, decision criteria need to be established. Historically, many of the same criteria were considered by the Ad Hoc Committee for the selection of a digital exchange media for X-ray Angiography. In their deliberations, factors such as the choice of disk rather than tape, the physical size (and its ability to be mailed easily), and multiple sources of drive and media do not need to be revisited or are now self apparent. Other criteria such as adherence to information standards, potential for performance improvement and non-obsolescence are redundant (since anyone can make a "standard"), the subject of competing claims which are impossible to verify, or dependent on the vagaries of the marketplace. The original criteria also specified the choice of a transport interface (SCSI-2), but given that there are now several viable transport interfaces in common use (including IDE, ATAPI), this choice should not be specified by DICOM. However, it is essential that proprietary extensions to any standard transport interface command set (such as SCSI) be published and readily available. Many of the original criteria are still applicable, or can be modified in light of the experience gained with CD- R and MOD. Furthermore, the existence of DICOM standard media (where there was none before) creates the need for new criteria, such as some form of backward compatibility. It should be stressed that DICOM is not attempting to standardize an archive medium, only an interchange medium. Though many applications typically write interchange media using the same physical drive and software as is used for writing single archival volumes for shelf management, there is no requirement that the media defined here be of archival longevity. Furthermore, in a large automated archive that maintains multiple platters, there is no suggestion that DICOM media is appropriate or optimized for that application. Indeed, proprietary disk or tape based formats may well be more suitable, since the proposed media, file system and DICOMDIR structure are not optimized for such applications. The input of other working groups that may use new media has been sought. In particular, the Cardiac WG 1 have considered media requirements for their "unit patient record for a single episode of care" that includes multiple image types with a total volume on the order 2.5 to 5 GB. Considering only X-ray angiography, a single session with 1K acquisition will typically occupy several CD-Rs Note: There is no requirement to have a DICOM File-set or file system volume span two sides of a two-sided disk if both sides are required to meet the capacity requirement.

10 Page x The 1K acquisitions also increase (by a factor of four over the 512 profile) the read transfer rates required for real-time playback. Limited read transfer rates proved a significant limitation of the early CD-R drives and caused significant dissatisfaction amongst users. The cardiac group also places a high priority on the ability to read any new medium on a physician's desktop PC without additional hardware, making readability on conventional DVD-ROM drives essential. Notes: 1. Some manufacturers of specific types of writable DVD media may make DVD-ROM drives that read them, but unless most if not all manufacturers of DVD-ROM drives support that media, then "ubiquitous readability" is compromised. 2. First generation DVD-ROM drives could not read CD-R. Most second generation DVD-ROM drives have a dual laser and can read CD-R, and those conforming to the OSTA "Multi-read" specification can read CD-R and CD-RW. Taking into account the suggestions of the cardiac group, as well as input from individual WG 5 participants familiar with other areas of application, the following criteria are suggested in decreasing order of priority. 1. Interoperability, including - the ability to read the media written on other vendors devices - backward read compatibility, i.e. the ability to read DICOM CD-R media Notes: 1. This requirement excludes MOD. 2. No DVD drives can write or update CD-R. 2. Ubiquitous readability - media can be read on common desktop PC hardware and software, e.g. with a conventional DVD-ROM drive, with the media removed from any caddy or cartridge 3. High capacity -specifically, of the order of 2.5 to 5 GB if possible, but essentially as much as possible 4. High performance - sustained read transfer rate of > 2 MB/s - sustained write transfer rate of > 1 MB/s for incremental (packet writing) mode Note: This does not include verification, which may require a separate verification pass. - "reasonable" random access times (TBD) to make skipping to referenced images realistic 5. Durable for transport (without archival longevity) - not likely to be a criteria that distinguishes media choices, since all laminated polycarbonate based media (including all DVD proposals) seem to have similar characteristics (if handled according to the manufacturers recommendations) to CD-R 6. Updateable

11 Page xi media can be removed, reinserted and contents updated or extended (on a different device) Notes: 1. Though a medium may be ablative, if it can be written incrementally, the filesystem can make it appear that files can be updated or deleted, though space is still occupied. 2. Incrementally writing may be associated with significant overhead that reduces the effective capacity of the medium. - this requirement may need to be balanced against performance, capacity, and ubiquitous readability 7. Mass produced component with enduring applications and substantial economies of scale - this is partially a restatement of the historical "non-obsolescence" and "multiple sources" criteria - it also reflects the need for the medical imaging industry to leverage the volume and availability of mass produced hardware and software components as well as out-sourced expertise for a media choice to be realistic 8. Consistency with existing standard - no gratuitous incompatibilities should be introduced at the application level Notes: 1. The efficiency of the DICOMDIR structure may become an issue for very high capacity media containing large numbers of small files, but changing this would cause complete incompatibility. 2. Longer filenames and deeper directories are possible with the proposed UDF filesystem, but may cause application incompatibility. 9. Write once is a low priority since: - even ablative media can be intentionally altered by copying, editing, and recreation - accidental erasure of any medium can be prevented at the software level 10. Security - digital media is subject to higher expectations in terms of confidentiality, authentication and integrity, but despite the higher capacity or "unit record" applications, the current standard for interchange is the paper record which has no security features other than physical security, hence this is a low priority - the difficulty of application level security and the lack of standard drive or file system level security solutions further lowers the priority of this feature STRATEGY FOR CHOICE OF A PHYSICAL MEDIUM A strategy needs to be established to deal with the fact that different proposed media types are not directly compatible with each other. That is, they may not always be read or written in each other s drives, due to differences in physical form and/or recording method. Even within the class of so-called "DVD" media, which share the same 120 mm physical form, differences in recording method make them incompatible. While it is conceivable that a single drive could read multiple media types ( a "multi-read" drive), it is unlikely that a single drive could write multiple media types Note: The term "multi-read" needs to be clarified. OSTA have defined a specification that refers to a DVD-ROM drive that can also read CD-R and CD-RW media. That specification is not directly relevant to this supplement.

12 Page xii Recently OSTA have begun a new initiative, Multi-read 2000, in which the term multi-read is used in the same sense as in this supplement. Alternative proposals for new media make the choice far from simple. Unfortunately, it is anticipated that convergence of the various proposals will be slow, if it occurs at all. If DICOM waits too long to make a choice or suggest a strategy it is likely that medical imaging vendors will need to make their own (potentially incompatible) choices in order to satisfy the expectations of their customers. The following possible standardization strategies are suggested: 1. include in DICOM a "generic UDF profile" that does not specify a physical media: - this allows for use of new media without requiring a choice of media be made - it leaves the choice to the marketplace - it creates the risk of reduced interoperability (especially if DICOM already defines another file system for the same media, e.g. ISO-9660 CD-R or DOS FAT16 MOD) 2. define profiles including UDF and a single physical media choice: - this requires waiting until the consumer industry appears to be converging on a choice - it creates the risk that the choice will fail in the marketplace - it maximizes the probability of read interoperability - it maximizes the probability of write/update interoperability - is consistent with current DICOM media strategy 3. define profiles including UDF and more than one physical media choice: - it reduces the probability of interoperability, the more choices are available - it allows write/update interoperability when the same media is used - is consistent with current DICOM media strategy 4. define profiles including UDF and the ability to READ (not create) a variety of media - this allows so called "multi-read" drives to be specified that can read a variety of physical media - it reduces the risk of making a specific physical media choice for the writer - it creates the risk that multi-read drives will not become available as soon as expected - it maximizes the probability of read interoperability, but sacrifices rewrite/update interoperability - if writers are not also multi-read, then a writer may not conform as a reader It is the opinion of the working group that a generic UDF" strategy would not provide sufficient interoperability to be useful. Neither a single medium only nor a multi-read strategy is viable today, since no single medium is clearly superior, several media satisfy the criteria, and no multi-read specification is yet available.

13 Page xiii Accordingly, the choice has been made to include both currently available media types, DVD-R and DVD- RAM in the standard. For the purposes of this draft for trial implementation, separate profiles for each of DVD-R and DVD-RAM have been selected, since those are the only media and drives available for trial. This decision will be revisited before letter ballot text is drafted and may well change. FORM OF THIS SUPPLEMENT This supplement defines the use of DVD-R and DVD-RAM physical media. It specifies the use of the Universal Disk Format (UDF) 1.5. Media Application Profiles are defined for general purpose and clinically specific applications, including general purpose, 1K angiography, ultrasound and CT/MR. Since this document proposes changes to existing Parts of DICOM, the reader should have a working understanding of the Standard. This proposed Supplement includes a number of Addenda to existing Parts of DICOM : - PS 3.11 Addendum: Media Storage Application Profiles - PS 3.12 Addendum: Media Formats and Physical Media 315

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15 Page Changes to NEMA Standards Publication PS Digital Imaging and Communications in Medicine (DICOM) Part 11: Media Storage Application Profiles

16 Page Normative References Definitions Symbols and abbreviations DVD UDF A trademark of the DVD Forum that is not an abbreviation. Universal Disk Format

17 Page Annex B (Normative) X-ray Angiographic Application Profile s B.1 CLASS AND PROFILE IDENTIFICATION This Annex defines a class of Application Profiles for 1024 X-ray Angiographic clinical applications. The identifier for this class shall be STD-XA1K. It is the intent of this these profile s to be backward compatible with the Basic Cardiac X-ray Angiographic Application Profile (STD-XABC-CD) in PS 3.11 Annex A. The specific Application Profiles in this class are shown in the Table 1. Table X-ray Angiographic Profiles Application Profile Identifier Description 1024 X-Ray Angiographic Studies on CD-R Media 1024 X-Ray Angiographic Studies on DVD-R Media 1024 X-Ray Angiographic Studies on DVD- RAM Media B.2 CLINICAL CONTEXT STD-XA1K-CD STD-XA1K- DVD-R STD-XA1K- DVD-RAM It handles single frame or multiframe X-ray digital images up to 1024x1024x12 bits; biplane acquisitions are encoded as two single plane information objects. Secondary Capture images are supported. It handles single frame or multi-frame X-ray digital images up to 1024x1024x12 bits; biplane acquisitions are encoded as two single plane information objects. Secondary Capture images are supported. It handles single frame or multi-frame X-ray digital images up to 1024x1024x12 bits; biplane acquisitions are encoded as two single plane information objects. Secondary Capture images are supported. This class of Application Profiles facilitates the interchange of primary digital X-ray cine runs, typically acquired as part of angiographic 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).

18 Page Additionally, images derived from or related to primary digital X-ray cine runs, such as quantitative analysis images, reference images, multi-modality images and screen capture images, may be interchanged via this Profile. The operational use of the media interchange is potentially both intra-institutional and inter-institutional Note: An FSC conforming to the Basic 512 Cardiac Angiographic Profile and General Purpose CD-R Profile supporting the SC Image Media Storage SOP Class could, if the restrictions in this profile were observed, create images that were readable by an FSR supporting the profile. Conversely, SC Images written by an FSC conforming to this profile, would be readable by an FSR conforming to the Basic 512 Cardiac Angiographic Profile and the General Purpose CD-R Profile supporting the SC Image Media Storage SOP Class B.2.1 Roles and Service Class Options This Application Profile Class uses the Media Storage Service Class defined in PS 3.4 with the Interchange Option. The Application Entity shall support one or more of the roles of File-set Creator, File-set Reader, and Fileset Updater, defined in PS B File Set Creator The Application entity acting as a File-Set Creator generates a File Set under the STD-XA1K Application Profile Class. Typical entities using this role would include X-ray angiographic lab equipment, and archive systems which 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. An 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 disc) or to allow packet-writing if supported by the media and file system specified in the profile 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 medium, the FSC will create multiple independent DICOM File-set such that each File-set can reside on a single CD-R medium controlled by its individual DICOMDIR file. The user of the FSC can opt to use written labels on the discs to reflect that there is more than one disc for this set of files (e.g., a Study) B File Set Reader The role of File Set Reader shall be used by Application Entities which receive a transferred File Set. Typical entities using this role would include display workstations, and archive systems which receive a patient record transferred from another institution. File Set Readers shall be able to read all the defined SOP Instances files defined for the specific Application Profiles to which a conformance claim is made, using all the defined Transfer Syntaxes. B File Set Updater The role of File Set Updater shall be used by Application Entities which receive a transferred File Set and update it by the addition of processed 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 frame. Stations which update patient information objects would also use this role. File-set Updaters shall be able to read and update the DICOMDIR file. File-set Updaters do not have to read the image information object. File-set Updaters shall be able to generate any of the SOP Instances

19 Page files defined for the specific Application Profiles to which a conformance claim is made, and to read and update the DICOMDIR file. An 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 disc) or to allow packet-writing if supported by the media and file system specified in the profile Note: If the disc has not been finalized, the File-set Updater will 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 volume control structures. CD-R Volume control structures are the structures that are inherent to the CD-R media standards of the physical volume; see PS B.3 STD-XA1K-CD APPLICATION PROFILE CLASS REQUIREMENTS B.3.2 Physical Media And Media Formats The 1024 X-Ray Angiographic Application CD-R Profiles in the STD-XA1K -CDR class require s the 120 mm CD-R physical media with the ISO/IEC 9660 Media Format, as defined in PS3.12. The 1024 X-Ray Angiographic Application DVD profile STD-XA1K-DVD-R requires the 120 mm DVD-R media as defined in PS The 1024 X-Ray Angiographic Application DVD profile STD-XA1K-DVD-RAM requires the 120 mm DVD-RAM media as defined in PS 3.12.

20 Page Annex C Ultrasound Application Profile (Normative) C.1 CLASS AND PROFILE IDENTIFICATION This Annex defines Application Profiles for Ultrasound Media Storage applications. Each Application Profile has a unique identifier used for conformance claims. Due to the variety of clinical applications of storage media in Ultrasound, a family of application profiles are described in this section to best tailor an application choice to the specific needs of the user. The identifier used to describe each profile is broken down into three parts: a prefix, mid-section, and suffix. The prefix describes the overall Application Profile Class and is common for all ultrasound application profiles. The mid section describes the specific clinical application of the profile. The suffix is used to describe the actual media choice the profile will use. The prefix for this class of application profiles is identified with the STD-US identifier. Note: Conformance Statements 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. The midsection is broken down into three subclasses which describes the clinical use of the data. These classes are: Image Display (ID identifier), Spatial Calibration (SC identifier), and Combined Calibration (CC identifier). All three subclasses can be applied to either single frames (SF) images or single and multiframes (MF) images. The SC subclass enhances the ID class by adding the requirement for region specific spatial calibration data with each IOD. The CC subclass enhances the SC subclass by requiring region specific pixel component calibration. The suffix, xxxx, is used to describe the actual media choice used for the conformance claim. Any of the above mentioned classes can be stored onto one of eight pieces of media described in the Table C.3-3. The specific Application Profiles are shown in the following table. Table C.1-1 APPLICATION PROFILE IDENTIFIERS Application Profile Single Frame Single & Multi-Frame Image Display STD-US-ID-SF-xxxx STD-US-ID-MF-xxxx Spatial Calibration STD-US-SC-SF-xxxx STD-US-SC-MF-xxxx Combined Calibration STD-US-CC-SF-xxxx STD-US-CC-MF-xxxx The ID Application Profile Classes are intended to be used for the transfer of ultrasound images for display purposes. The SC Application Profile Classes are intended to be used for the transfer of ultrasound images with spatial calibration data for quantitative purposes (see section C.4). The CC Application Profile Classes are intended to be used for the transfer of ultrasound images with spatial and pixel component calibration data for more advanced quantitative purposes (see section C.5). C.2 CLINICAL CONTEXT...

21 Page C.2.1 Roles C FILE SET CREATOR The role of File Set Creator shall be used by Application Entities which generate a File Set under the STD- US class of Application Profiles. Typical entities using this role would include ultrasound imaging equipment, workstations, and archive systems which generate a patient record for transfer. File Set Creators shall be able to generate the DICOMDIR directory file, single and/or multi frame Ultrasound Information Object files, and depending on the subclass, region specific calibration in the defined Transfer Syntaxes. An 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 disc) or to allow packet-writing if supported by the media and file system specified in the profile. C FILE SET READER The role of File Set Reader shall be used by Application Entities which receive a transferred File Set. Typical entities using this role would include ultrasound systems, display workstations, and archive systems which receive a patient record from a piece of media. File Set Readers shall be able to read the DICOMDIR directory file and all Information Objects defined for the specific Application Profiles, using the defined Transfer Syntaxes. C FILE SET USER The role of File Set Updater shall be used by Application Entities which receive a transferred File Set and updates it by the addition or deletion of objects to the media. Typical entities using this role would include ultrasound systems adding new patient records to the media and workstations which may add an information object containing a processed or modified image. An 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 disc) or to allow packet-writing if supported by the media and file system specified in the profile. C.3 GENERAL CLASS PROFILE... C.3.2 Physical Media And Media Formats An ultrasound application profile class may be supported by any one of the media described in Table C.3-3.

22 Page Media Media Classes Table C.3-3 MEDIA CLASSES Media Format PS MB Floppy Disc FLOP DOS Annex B 128 MB 90 mm MOD MOD128 DOS, unpartitioned (removable media) Annex C 230 MB 90 mm MOD MOD230 DOS, unpartitioned (removable media) Annex G 540 MB 90 mm MOD MOD540 DOS, unpartitioned (removable media) Annex H 650MB 130 mm MOD MOD650 DOS, unpartitioned (removable media) Annex D 1.2GB 130 mm MOD MOD12 DOS, unpartitioned (removable media) Annex E 2.3GB 130 mm MOD MOD23 DOS, unpartitioned (removable media) Annex I CD-R CDR ISO/IEC 9660 Annex F DVD-R DVD-R UDF Annex J DVD-RAM DVD-RAM UDF Annex J

23 Page Annex D (Normative) - General Purpose CD-R and DVD Image Interchange Profile s D.1 PROFILE IDENTIFICATION This Annex defines an Application Profile Class potentially inclusive of all defined Media Storage SOP Classes. This class is intended to be used for the interchange of Composite Image and Standalone SOP Instances via CD-R and DVD media for general purpose applications. Objects from multiple modalities may be included on the same media. A detailed list of the Media Storage SOP Classes that may be supported is defined in PS 3.4. Table D.1-1 STD-GEN-CD Profile s Application Profile Identifier Description General Purpose CD-R Image Interchange General Purpose Image Interchange on DVD-R Media General Purpose Image Interchange on DVD- RAM Media STD-GEN-CD STD-GEN-DVD-R STD-GEN-DVD-RAM Handles interchange of Composite Image SOP Instances and SOP Instances which conform to the model defined for Standalone SOP Classes, such as Curves, Overlays and LUTs. Handles interchange of Composite Image SOP Instances and SOP Instances which conform to the model defined for Stand-alone SOP Classes, such as Curves, Overlays and LUTs. Handles interchange of Composite Image SOP Instances and SOP Instances which conform to the model defined for Stand-alone SOP Classes, such as Curves, Overlays and LUTs. The identifier for this General Purpose Image Exchange profile class shall be STD-GEN-CD. Equipment claiming conformance to this Application Profile shall list the subset of Media Storage SOP Classes that it supports in its Conformance Statement. Note: Since it is not required to support all Media Storage Classes the user should carefully consider the subset of supported Media Storage SOP Classes in the Conformance Statements of such equipment to establish effective object interchange. D.2 CLINICAL CONTEXT This Application Profile facilitates the interchange of images and related data on CD-R and DVD media. Typical interchange would be between acquisition devices, archives and workstations. This Application Profile facilitates the creation of a multi-modality medium for image interchange, useful for clinical, patient record, teaching and research applications, within and between institutions.

24 Page This profile is intended only for general purpose applications. It is not intended as a replacement for specific Application Profiles that may be defined for a particular clinical context. The latter may support compression transfer syntaxes, limitations on the form and content of SOP Class instances, and specific media choices that preclude the use of the General Purpose Interchange Profile. Note: The creation of a CD-R or DVD is considerably more complex than the reading thereof. Therefore the clinical context for this Application profile is likely to be asymmetric, with a sophisticated File Set Creator and relatively simple File Set Readers. D.2.1 Roles and Service Class Options This Application Profile uses the Media Storage Service Class defined in PS3.4 with the Interchange Option. The Application Entity shall support one or more of the roles of File Set Creator (FSC), File Set Reader (FSR), and File Set Updater (FSU), defined in PS D File Set Creator The role of File Set Creator shall be used by Application Entities which generate a File Set under this Image Interchange Class of Application Profiles. File Set Creators shall be able to generate the Basic Directory SOP Class in the DICOMDIR file with all the subsidiary Directory Records related to the Image SOP Classes stored in the File Set. The Application Entity acting as a File Set Creator generates a File Set under the a STD-GEN-CD Application Profile. An 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 disc) or to allow packet-writing if supported by the media and file system specified in the profile. 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 volume, the FSC will create multiple independent DICOM File-set such that each File-set can reside on a single CD-R volume controlled by its individual DICOMDIR file. The user of the FSC can opt to use written labels on the discs to reflect that there is more than one disc for this set of files (e.g., a Study). D File Set Reader The role of File Set Reader shall be used by Application Entities which receive a transferred File Set under the Image Interchange Class of Application Profiles. Typical entities using this role would include image generating systems, display workstations, and archive systems which receive a patient record; e.g. transferred from another institution. File Set Readers shall be able to read the DICOMDIR directory file and all the SOP Instance files defined for this Application Profile, for which a Conformance Statement is made, using the defined Transfer Syntax. D File Set Updater The role of File Set Updater is used by Application Entities which receive a transferred File Set under the Image Exchange Class of Application Profiles and update it by the addition (or deletion) of images or information to (or from) the medium. Typical entities using this role would include image generating systems and workstations which process or modify images.

25 Page File Set Updaters shall be able to generate one or more of the SOP Instances defined for this Application Profile, for which a Conformance Statement is made, and to read and update the DICOMDIR file. An 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 disc) or to allow packet-writing if supported by the media and file system specified in the profile. Note: If the volume has not been finalized, the File Set Updater will be able to update information assuming there is enough space on the volume to write a new DICOMDIR file, the information, and the fundamental volume control structures. Volume control structures are the structures that are inherent to the standards of the physical volume, see PS D.3 STD-GEN-CD PROFILE CLASS... D.3.2 Physical Medium And Medium Format The STD-GEN-CD application profile requires the 120 mm CD-R physical medium with the ISO/IEC 9660 Media Format, as defined in PS3.12. The STD-GEN-DVD-R profile requires the 120 mm DVD-R media as defined in PS The STD-GEN-DVD-RAM profile requires the 120 mm DVD-RAM media as defined in PS 3.12.

26 Page Annex E (Normative) - CT and MR Image Application Profiles E.1 PROFILE IDENTIFICATION This Annex defines Application Profiles for Computed Tomography and Magnetic Resonance Imaging interchange and storage on high capacity rewritable magneto-optical disks (MOD), CD-R, and DVD with lossless compression. 571 Table E.1 - STD-CTMR Profiles Application Profile Identifier Description CT/MR Studies on 650MB MOD STD-CTMR-MOD650 Handles single frame 8, 12 or 16 bit grayscale and 8 bit palette color, uncompressed and lossless compressed images. CT/MR Studies on 1.2GB MOD STD-CTMR-MOD12 Handles single frame 8, 12 or 16 bit grayscale and 8 bit palette color, uncompressed and lossless compressed images. CT/MR Studies on 2.3GB MOD STD-CTMR-MOD23 Handles single frame 8, 12 or 16 bit grayscale and 8 bit palette color, uncompressed and lossless compressed images. CT/MR Studies on CD-R STD-CTMR-CD Handles single frame 8, 12 or 16 bit grayscale and 8 bit palette color, uncompressed and lossless compressed images. CT/MR Studies on DVD-R Media STD-CTMR-DVD-R Handles single frame 8, 12 or 16 bit grayscale and 8 bit palette color, uncompressed and lossless compressed images. CT/MR Studies on DVD- RAM Media STD-CTMR-DVD- RAM Handles single frame 8, 12 or 16 bit grayscale and 8 bit palette color, uncompressed and lossless compressed images E.2 CLINICAL CONTEXT These Application Profiles facilitate the interchange and storage of primary CT and MR images as well as related Secondary Capture Images with certain defined attributes, including grayscale and palette color images. CT, MR and SC images may co-exist within the same File-set.

27 Page Typical interchanges would be between acquisition devices, archives and workstations, within and between institutions. E.2.1 Roles and Service Class Options These Application Profiles uses the Media Storage Service Class defined in PS 3.4 with the Interchange Option. The Application Entity shall support one or more of the roles of File-set Creator, File-set Reader, and Fileset Updater, defined in PS E File Set Creator The Application entity acting as a File-Set Creator generates a File Set under a STD-CTMR Application Profile. Typical entities using this role would include CT or MR equipment, and archive systems which 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. An 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 disc) or to allow packet-writing if supported by the media and file system specified in the profile Note: A multiple volume (a logical volume that can cross multiple physical media) is not supported by this class of Application profile. If a set of Files, e.g., a Study, cannot be written entirely on one physical volume, the FSC will create multiple independent DICOM File-sets such that each File-set can reside on a single physical volume controlled by its individual DICOMDIR file. The user of the FSC can opt to use written labels on the physical volumes to indicate that there is more than one physical volume for this set of files (e.g., a study) E File Set Reader The role of File Set Reader is used by Application Entities which receive a transferred File Set. Typical entities using this role would include display workstations, and archive systems which 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 Conformance Statement is made, using all the defined Transfer Syntaxes. E File Set Updater The role of File Set Updater is used by Application Entities which 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 image. Stations which 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. An 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 disc) or to allow packet-writing if supported by the media and file system specified in the profile.

28 Page Note: The File-set Updater shall be able to update information assuming there is enough space on the volume to write a new DICOMDIR file and the information. Note: If the volume has not been finalized, the File Set Updater will be able to update information assuming there is enough space on the volume to write a new DICOMDIR file, the information, and the fundamental volume control structures. Volume control structures are the structures that are inherent to the standards of the physical volume, see PS E.3 STD-CTMR PROFILES E.3.2 Physical Medium And Medium Format The STD-CTMR-MOD650 application profile requires the 130 mm 650MB R/W MOD physical medium with the PCDOS Media Format, as defined in PS The STD-CTMR-MOD12 application profile requires the 130 mm 1.2GB R/W MOD physical medium with the PCDOS Media Format, as defined in PS The STD-CTMR-MOD23 application profile requires the 130 mm 2.3GB R/W MOD physical medium with the PCDOS Media Format, as defined in PS The STD-CTMR-CD application profile requires the 120 mm CD-R physical medium with the ISO 9660 Media Format, as defined in PS The STD-CTMR-DVD-R profile requires the 120 mm DVD-R media as defined in PS The STD-CTMR-DVD-RAM profile requires the 120 mm DVD-RAM media as defined in PS 3.12.

29 Page Changes to NEMA Standards Publication PS Digital Imaging and Communications in Medicine (DICOM) Part 12: Media Formats and Physical Media for Media Interchange 656

30 Page Normative references ISO 9660: 1988 (E) Information processing - Volume and file structure of CD ROM for information interchange ISO/IEC Information technology - Data interchange on read-only optical discs (CD-ROM), 1989 Part II: CD-WO version 2.0 in Orange Book Note: This reference will be replaced by the corresponding ISO reference when available. System Description CD-ROM XA (extended Architecture) Specification Note: This reference will be replaced by the corresponding ISO reference when available UDF version 1.5, OSTA ISO 13346:1995 ECMA 167 3rd Edition Unicode 2.0 DVD Specifications for Recordable Disc, Version 1.0 ECMA 267 (ISO/IEC DIS 16448) 120 mm DVD Read-Only Disk ECMA 272 (ISO/IEC DIS 16824) 120 mm DVD Rewritable Disk (DVD-RAM) Definitions Symbols and abbreviations 677 The following symbols and abbreviations are used in this part of the standard CD CD-R CD-ROM CD-RW CD-WO DVD DVD-R Compact Disk Compact Disc Recordable Compact Disk - Read Only Compact Disk - Rewritable Compact Disc Write Once A trademark of the DVD Forum that is not an abbreviation DVD-Recordable