1、DRAFT FOR DEVELOPMENTDD CEN/TS 15127-1:2005Health informatics Testing of physiological measurement software Part 1: GeneralICS 35.080; 35.240.80g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g3
2、7g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58DD CEN/TS 15127-1:2005This Draft for Development was published under the authority of the Standards Policy and Strategy Committee on 31 March 2008 BSI 2008ISBN 978 0 580 53198 9National forewordThis Draft for Development is the UK implementation of CEN/TS
3、15127-1:2005.This publication is not to be regarded as a British Standard.It is being issued in the Draft for Development series of publications and is of a provisional nature. It should be applied on this provisional basis, so that information and experience of its practical application can be obta
4、ined.Comments arising from the use of this Draft for Development are requested so that UK experience can be reported to the European organization responsible for its conversion to a European standard. A review of this publication will be initiated not later than three years after its publication by
5、the European organization so that a decision can be taken on its status. Notification of the start of the review period will be made in an announcement in the appropriate issue of Update Standards.According to the replies received by the end of the review period, the responsible BSI Committee will d
6、ecide whether to support the conversion into a European Standard, to extend the life of the Technical Specification or to withdraw it. Comments should be sent to the Secretary of the responsible BSI Technical Committee at British Standards House, 389 Chiswick High Road, London W4 4AL.The UK particip
7、ation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible fo
8、r its correct application.Amendments/corrigenda issued since publicationDate CommentsTECHNICAL SPECIFICATIONSPCIFICATION TECHNIQUETECHNISCHE SPEZIFIKATIONCEN/TS 15127-1July 2005ICS 35.080; 35.240.80English versionHealth informatics - Testing of physiological measurementsoftware - Part 1: GeneralBewe
9、rtung von physiologischen AnalysesystemenThis Technical Specification (CEN/TS) was approved by CEN on 24 April 2005 for provisional application.The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit theircomments, par
10、ticularly on the question whether the CEN/TS can be converted into a European Standard.CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS availablepromptly at national level in an appropriate form. It is permissible to keep conflicti
11、ng national standards in force (in parallel to the CEN/TS)until the final decision about the possible conversion of the CEN/TS into an EN is reached.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary,
12、Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart,
13、 36 B-1050 Brussels 2005 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. CEN/TS 15127-1:2005: E2 Contents Page Foreword 3 Introduction4 1 Scope .6 2 Normative references .6 3 Terms, definitions and abbreviations6 4 Purpose and nature of
14、 test data sets 10 5 Structure of the documentation of test data sets.11 6 Original acquired patient data arrays and converted acquired patient data arrays 14 Annex A (informative) Historical background and review.15 Bibliography.16 CEN/TS 15127-1:20053 Foreword This document (CEN/TS 15127-1:2005) h
15、as been prepared by Technical Committee CEN/TC 251 “Health informatics”, the secretariat of which is held by NEN. This Technical Specification was first produced by a project team funded by the British Standards Institute as a contribution to the work of CEN/TC251/WGIV. It is a contribution towards
16、work item WI050 “Evaluation of Physiological Analysis Systems”. The work item identified two priority medical areas: Nuclear Medicine Analysis Systems and ElectroCardioGram Analysis Systems. Much background work has been done on Nuclear Medicine Systems and was used by the team in production of this
17、 document. This technical specification is intended to be a generic base technical specification, which can be adapted to be specific to particular medical areas. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to announce
18、this CEN Technical Specification: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kin
19、gdom. CEN/TS 15127-1:20054 Introduction Motivation - nature of test data Many Diagnostic Healthcare Procedures that involve the acquisition of patient data by means of one or more Medical Devices produce results in the form of an Acquired Patient Data Array. Examples are a time series of Medical Ima
20、ge data stored in a 3-dimensional array, and a set of ECG waveform data stored in a 2-dimensional array. It is often the case that such data arrays are subjected to computer processing in order to derive data in a more simple form as an aid to clinical diagnosis. Ideally, the same diagnostic test pe
21、rformed on the same patient using different equipment should produce the same final result. In practice, however, reproducibility problems can arise due to differences in - the data acquisition protocol (e.g. patient position, image data acquisition frame rate), or differences in the means of data p
22、rocessing. This latter step is amenable to evaluation by the use of standard test data, which can be employed by users of different data processing systems to compare their results against those obtained in other centres. In principle, various types of test data can be used to assess the validity of
23、 results produced by a medical software application that produces quantitative results. In general, such test data may comprise real clinical data, simulated (synthetic) data, or a combination of the two (hybrid data). In the case of real clinical data, the input to the data processing step will be
24、the primary output from a Medical Device (e.g. raw image data). The software referred to in this technical specification should thus be considered as being associated with the second stage of a two-stage process: data acquisition followed by data processing. This CEN Technical Specification describe
25、s a framework for specifying a set of test data to be submitted to a medical software application. The framework allows for the production of a medical application specific technical specification, which allows a number of medical device/processing system users to obtain results using the same test
26、data set comprising one or more Acquired Patient Data Arrays, plus associated descriptive data. The descriptive data will include firstly descriptions of the way in which the test data was created to enable appropriate processing to be performed and secondly to specify the results that shall be obta
27、ined by the application. For historical background and review of previous work, see Annex A. This CEN Technical Specification specifies the components that must be included in the set of test data intended to test the performance of software designed to process data in the form of one or more Acquir
28、ed Patient Data Arrays and possible associated data, such as Region of Interest (ROI) data. Relevant bodies In order to ensure quality and consistency in the application of test data sets, three bodies may be identified: The first is a test data creation/approval body with the responsibility of appr
29、oving the test data as appropriate for the test described. The second is a testing body (that performs the testing) which might be an independent testing laboratory or a user. Lastly, a body that evaluates the test results obtained by testing bodies, potentially for certification. NOTE the creating
30、and evaluating functions may be performed by the same body. The evaluating body may issue formal certification Test data set This could comprise for example: one or more Acquired Patient Data Arrays which could be submitted for processing; essential details concerning how the test data arrays were o
31、btained (eg. array size, dimension details, etc); the names of the parameters to be derived by the processing; and finally the expected values for the derived parameters. The test data set is specified in Clause 4. CEN/TS 15127-1:20055 Descriptive data sections These sections could be for example: T
32、itle of document; Name of diagnostic procedure for which the test data set is relevant; Description of diagnostic procedure; How the test data set should be used in practice, and its results; Expected value(s) for the derived parameter(s) which may or may not be supplied to Testing Bodies (e.g. user
33、s). The results of tests may be used for audit or certification purposes. The descriptive data sections are specified in Clause 5. CEN/TS 15127-1:20056 1 Scope 1.1 In scope The means to specify test data sets, documenting the creation of the test data, and the use of the test data for the testing, p
34、ossibly for certification purposes, of medical software which is designed to process data in the form of one or more arrays of acquired patient and associated data. 1.2 Out of scope The means by which medical software is certified or produced. The nomination of bodies to perform functions related to
35、 the creation and use of Test Data Sets. The working practices of bodies responsible for the creation or use of test data sets or bodies responsible for the evaluation of the test results. The means by which the test data are created 2 Normative references The following referenced documents are indi
36、spensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN ISO/IEC 17025, General requirements for the competence of testing and calibration laborat
37、ories (ISO/IEC 17025:2005) ISO 9126, Information Technology Software product evaluation Quality characteristics and guidelines for their use 3 Terms, definitions and abbreviations 3.1 Abbreviations ECG Electrocardiogram LUT Look-Up Table ROI Region of Interest TDS Test data set 3.2 Terms and definit
38、ions 3.2.1 acquired patient data array healthcare procedure product in the form of a data array of one or more dimensions obtained from a process of measurement involving the body of a patient CEN/TS 15127-1:20057 3.2.2 cine loop mode of display for a Medical Image Series that simulates the display
39、produced by running a continuous loop of film though a cine-projector NOTE The duration of the display of each image (i.e. the displayed frame rate) should be selectable by the operator over a suitable range. 3.2.3 composite rendered healthcare procedure product logical data structure which specifie
40、s two or more rendered healthcare procedure products and the alignment between them in time or space, such as a Medical Image and a graphic entity to be superimposed on it or two or more medical image series which are to be displayed synchronised in cine loop mode 3.2.4 curve healthcare procedure pr
41、oduct that may be presented in the form of a rectilinear graph as might be plotted on graph paper 3.2.5 digital image visual representation of digital image data 3.2.6 digital image data set of numerical values which may be meaningfully rendered as a visible image NOTE Such data might be constructed
42、 by computer and therefore does not correspond to a physical image. 3.2.7 digital image rendering data data required to enable digital image data values to be rendered NOTE It may include image size and position (Zoom and Pan) within the display area and LUT data and window (threshold) information.
43、3.2.8 healthcare procedure systematic activity directed at, or performed on, an individual patient with the object of disease screening, monitoring, prevention, diagnosis, treatment or rehabilitation 3.2.9 healthcare procedure product entity produced when a healthcare procedure is performed NOTE It
44、may be an Information Item Procedure Product such as a measured value, Curve, Image or section of text or a physical sample or specimen taken from a patient. 3.2.10 healthcare procedure product rendering data logical data structure which specifies a set of rendering parameters for a healthcare proce
45、dure product 3.2.11 healthcare procedure step identified part of a healthcare procedure NOTE 1 It may be performed during a single department visit by the patient (or visit to the patient in the case of the use of a mobile data acquisition unit). For compatibility with DICOM study component, it shou
46、ld be performed using not more than one piece of Medical Image data creating equipment for data acquisition or processing). CEN/TS 15127-1:20058 NOTE 2 In general a Healthcare Procedure will be performed in a number of steps some of which will yield Healthcare Procedure Products. 3.2.12 healthcare p
47、rocedure type name of a healthcare procedure which may be performed on a patient (e.g., in-vivo healthcare diagnostic procedure such as a diagnostic imaging procedure) NOTE A directory of Healthcare Procedure Types is maintained by a Healthcare Service department to show Healthcare Procedures for wh
48、ich Healthcare Service Requests can be accepted. 3.2.13 healthcare service service provided with the intention of directly or indirectly improving the health of the people, populations or animals to whom it is provided 3.2.14 healthcare service report set of one or more information item procedure pr
49、oducts 3.2.15 healthcare service request request, made by an identifiable person, for one or more healthcare procedures to be performed for a specified patient NOTE 1 The Healthcare Procedure type(s) may or may not be specified depending on the local rules of the Institution. NOTE 2 A Healthcare Service Report is usually a deliverable arising from a Healthcare Service Request. 3.2.16 healthcare service requester medically qualified healthcare professional who submits a healthcare service request 3.2.17 imaging modality technique or apparatus for the acq
