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1、BRITISH STANDARD BS 8440-2:2005 Health informatics Medical digital imaging Profiles format Part 2: Particular requirements for metadata profiles ICS 35.240.80 ? Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 00:58:22 GMT+00:00 2006, Uncontrolled Copy, (c) BSI B
2、S 8440-2:2005 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 26 August 2005 BSI 26 August 2005 The following BSI references relate to the work on this standard: Committee reference IST/35 Draft for Development 03/107679 DC ISBN 0 580 46550 0
3、 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee IST/35, Health informatics, upon which the following bodies were represented: Association of Anaesthetists of Great Britain and Ireland British Computer Society British Ins
4、titute of Radiology British Medical Association BUPA Health Level Seven (HL7) Institute of Physics and Engineering in Medicine NHS Connecting for Health Royal College of Radiologists Royal Phaarmaceutical Society of Great Britain Amendments issued since publication Amd. No.DateComments Licensed Copy
5、: London South Bank University, London South Bank University, Fri Dec 08 00:58:22 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 8440-2:2005 BSI 26 August 2005 i Contents Page Committees responsibleInside front cover Forewordii Introduction1 1Scope 1 2Terms and definitions 1 3Abbreviations 2 4Positio
6、n within the taxonomy 2 5Scenario 2 6Profile specification 2 7Conformance clause 3 Annex A (normative) Layout of MDI metadata profile table 4 Annex B (normative) Layout of additional requirements and clarification tables 5 Bibliography 6 Licensed Copy: London South Bank University, London South Bank
7、 University, Fri Dec 08 00:58:22 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 8440-2:2005 ii BSI 26 August 2005 Foreword This British Standard has been prepared by Technical Committee IST/35. BS 8440 is intended for use in drafting profiles of medical digital imaging standards. Many applications in
8、 medical digital imaging are based on de facto standards and specifications, as well as national and international standards. BS 8440, Health informatics Medical digital imaging Profiles format consists of two parts: Part 1: General principles; Part 2: Particular requirements for metadata profiles.
9、Subsequent parts are anticipated, which will specify particular requirements for specific standards and specifications. A part might be produced to deal with medical digital image data communication profiles. This British Standard does not purport to include all the necessary provisions of a contrac
10、t. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i to ii, pages 1 to 6, an inside back cover and a back cover. The B
11、SI copyright notice displayed in this document indicates when the document was last issued. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 00:58:22 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 8440-2:2005 BSI 26 August 2005 1 Introduction The domain of medical
12、 digital imaging (MDI) profile standards is reviewed in BS 8440-1. BS 8440-2 recognizes a need for metadata profiles of certain standards and specifications. Digital image array data that are communicated electronically always have an associated set of digital image array descriptive data elements t
13、hat are usually stored together in a so called header section of the communicated data. These descriptive data include data concerning: a) the characteristics of the digital image array itself, such as the array dimensions and number format; b) administrative data, such as the type and identificatio
14、n of the imaging procedure that produced the digital image array data; c) technical data, such as type and identity of the medical imaging equipment used, data acquisition parameters and date of last QA procedure; and d) clinically relevant data, such as patient orientation, laterality and frame of
15、reference. These descriptive data are usually referred to as “metadata” in generic MDI standards. The standard that specifies the image data array format also specifies the data structure to be used to record the metadata. The data structure specification enables an application to read and identify
16、each recorded item. A data element is either identified by means of a tag (e.g. Interfile, TIFF, XML) or on the basis of the position of the recorded data element within a set of items (e.g. BIIF, HL7). A data element might be of a simple data type such as an integer or a string or might be of a com
17、plex data type made up of a set of data elements having simple or complex data type. MDI profile standards that are based on tag or fixed length item paradigms specify a unique name for each data element. This British Standard specifies the means to record MDI metadata as a printed or electronic tab
18、le. The content of the profile table constitutes a metadata MDI profile. Such profiles are designed to enable a particular task to be performed. The table content can be compared with an equivalent table showing the data elements supported by a given application (product) to test conformance with th
19、e MDI profile standard. A standard profile table can also be used to construct a record that conforms to the medical imaging standard specification and includes a test digital image array. This record can be submitted to an application to test its ability to perform the specified function. Some MDI
20、profiles are profiles of standards concerned with the communication of information related to the performance of diagnostic imaging procedures, such as patient details and requested procedure type. However, the same table structure can be used to express profiles of these standards as that used for
21、MDI metadata profiles. 1 Scope This part of BS 8440 specifies requirements for the drafting, format and content of Medical Data Imaging (MDI) profile standards. It also specifies the means to express the set of standard digital imaging descriptive data elements and any special requirements associate
22、d with specific data elements in printed and electronic format. 2 Terms and definitions For the purposes of this British Standard, the following terms and definitions apply. 2.1 logical data structure conceptual aspect of data type expressing the nature of values that are composite, i.e. not atoms N
23、OTE An atom is a value that cannot be decomposed. Non-atomic values have constituent parts (which need not themselves be atoms), and the data structure expresses how constituents may be combined to form a compound value or selected from a compound value. 2.2 metadata data item that specifies some in
24、formation relevant to a set of digital image array data Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 00:58:22 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 8440-2:2005 2 BSI 26 August 2005 2.3 metadata MDI profile standard set of data elements that have to be
25、 included when an application, for which conformance with a standardized MDI profile is claimed, communicates metadata 3 Abbreviations 4 Position within the taxonomy The MDI profile standard shall relate the MDI profile it defines to the MDI profile taxonomy (see, for example, BS 8440-1). Specifical
26、ly, the scope shall include the identifier and title of the MDI profile defined within. 5 Scenario The MDI profile standard shall include or reference a scenario or scenarios in its scope, clearly illustrating one or more contexts within which the MDI profile can be used. 6 Profile specification 6.1
27、 General The profile specification shall be recorded as a profile table of alphanumeric text. Each row of the table shall record one item of the metadata MDI profile standard. The items shall be presented in the order in which they appear in the MDI standard. NOTE A data element of simple data type
28、might be a constituent of a group of data elements that is one member of complex data type. Thus a data element might be a member of a sub-group or a sub-sub-group, etc. 6.2 MDI metadata profile table The columns of the MDI metadata profile table shall document the following information in the follo
29、wing order and format, as shown in Annex A. Column 1: Profile item identifier. The metadata MDI profile reference, formed from the first part of the reference given in the title of the metadata profile, followed by ., followed by the item (row) number, e.g. A-IHE4-4.1PR.1 for the first row of the ta
30、ble that specifies the content of the profile with reference A-IHE4-4.1PR in BS 8441-1. Column 2: Standard/ version. The standard and, where applicable, the version of the standard (e.g. a revision) within which the content item is defined. NOTE Some profiles reference more than one version of a sta
31、ndard, but one profile can only reference one standard. Column 3: Container name. The name of the container within which the content item resides. Column 4: Content item name. Name of the content item. NOTE This may be a simple content item or a constituent of a compound content item. Column 5: Cont
32、ent item identifier. An identifier for the content item. Column 6: Length (LEN). The length of the content item in octets. Column 7: Data type (DT). The data type of the content item, expressed as specified in the standard (sub-)clause referenced in Columns 2 and 11. BIIFBasic Image Interchange Form
33、at HL7Health Level 7 TIFFTagged Image File Format XMLExtended Mark-up Language Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 00:58:22 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 8440-2:2005 BSI 26 August 2005 3 Column 8: Cardinality (Card). Expressed as ab w
34、here: a: minimum number of instances allowed. b: maximum number of instances. Column 9: Optionality (Opt). Expressed as: R: Specified as required in the referenced standard RA: Additional requirement that was optional or whose optionality is not specified in the referenced standard, but which is spe
35、cified by as mandatory by the profile RE: required but might be empty (DICOM) C: Conditional requirement. Condition based on value(s) of one or more required fields. Column 10: Example value. For test purposes and illustration. NOTE The examples are written in American English, as is the Scenarios D
36、ocument IHE4. Column 11: Document Clause (Doc. Clause). The relevant clause number in either the revision of the referenced standard (e.g. HL7 2.3.1, as in BS 8441-1) or the scenario (e.g. IHE4, as in BS 8441-2). Column 12: A/C (Additional requirement/Clarification). An entry of A or C or both A and
37、 C in this column indicates that details of any additional constraint beyond that specified by the referenced document or clarification, is given in the Additional requirement or Clarification table. Column 13: Object identifier (OID). Globally unique identifier for this profile row entry item, as d
38、efined in ISO 8824. NOTE The OID avoids the potential for conflict arising from more than one institution choosing the same profile item ID. The OID provides a unique database key. Column 14: Comments. Any additional comments, such as information about the extension of an existing MDI profile. 6.3 A
39、dditional requirements table and clarification table An additional requirements table and a clarification table shall follow the digital image metadata profile table, regardless of whether any additional requirements or clarification are indicated in Column 12 of the profile table. The columns of th
40、e additional requirements table and the clarification table shall document the following information in the following order, as shown in Annex B. Column 1: Profile item identifier. Column 2: Content item name. Column 3: Description of additional requirements (for the additional requirements table) o
41、r Clarification text (for the clarification table). 6.4 Format of electronic record If the contents of the MDI profile table are to be recorded in electronic form, the format shall be tab delimited text file (CSV extension). 7 Conformance clause The conformance clause shall specify how to verify the
42、 conformance of the product with the MDI metadata profile. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 00:58:22 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 8440-2:2005 4 BSI 26 August 2005 Annex A (normative) Layout of MDI metadata profile table Profile it
43、em IDStandard/ Version Container name Content item name Content item ID LENDTCardOptExample value Document clause A/CProfile item OID Comments Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 00:58:22 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 8440-2:2005 BSI
44、26 August 2005 5 Annex B (normative) Layout of additional requirements and clarification tables B.1 Additional requirements table B.2 Clarification table Profile item IDContent item nameDescription of additional requirement Profile item IDContent item nameClarification text Licensed Copy: London Sou
45、th Bank University, London South Bank University, Fri Dec 08 00:58:22 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 8440-2:2005 BSI 26 August 20056 Bibliography Standards ISO 8824 (all parts), Information technology Abstract Syntax Notation One (ASN.1). Other publications 1 OOSTERWIJK, H., KUZMAK, P
46、., DAYHOFF, R. Dr, and SIEGEL, E. Dr. Modality Interface DICOM Conformance Requirements Version: 1.0, Department of Veterans Affairs, 1999. 2 EICHELBERG, M. et al. Interoperability of DICOM implementations can be enhanced significantly by QC approach using validation tools, Proceedings of ACC 1999,
47、abstract 1504-1. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 00:58:22 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 00:58:22 GMT+00:00 2006, Uncontrolled Copy, (c) BSI B
48、S 8440-2:2005 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent national body responsible for preparing British Standards. It presents the UK view on standards in Europe and at the international level. It is incorporated by Royal Charter. Revisions Bri
49、tish Standards are updated by amendment or revision. Users of British Standards should make sure that they possess the latest amendments or editions. It is the constant aim of BSI to improve the quality of our products and services. We would be grateful if anyone finding an inaccuracy or ambiguity while using this British Standard would inform the Secretary of the technical committee responsible, the identity of which can be found on the inside
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