DD-CEN-TS-15127-1-2005.pdf
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1、DRAFT FOR DEVELOPMENT DD CEN/TS 15127-1:2005 Health informatics Testing of physiological measurement software Part 1: General ICS 35.080; 35.240.80 ? Licensed CopyChinese University of Hong Kong, 20/10/2008 09:32, Uncontrolled Copy, (c) BSI DD CEN/TS 15127-1:2005 This Draft for Development was publi
2、shed under the authority of the Standards Policy and Strategy Committee on 31 March 2008 BSI 2008 ISBN 978 0 580 53198 9 National foreword This Draft for Development is the UK implementation of CEN/TS 15127-1:2005. This publication is not to be regarded as a British Standard. It is being issued in t
3、he 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 obtained. Comments arising from the use of this Draft for Development are requested so that UK experi
4、ence 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 the European organization so that a decision can be taken on its status. Notification of the sta
5、rt 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 decide whether to support the conversion into a European Standard, to extend the life of the Tec
6、hnical 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 participation in its preparation was entrusted to Technical Committee IST/35, Health informatics. A li
7、st 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 for its correct application. Amendments/corrigenda issued since publication DateComments Licen
8、sed CopyChinese University of Hong Kong, 20/10/2008 09:32, Uncontrolled Copy, (c) BSI TECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN/TS 15127-1 July 2005 ICS 35.080; 35.240.80 English version Health informatics - Testing of physiological measurement software - Part 1: Ge
9、neral Bewertung von physiologischen Analysesystemen This 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 their
10、comments, particularly 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 available promptly at national level in an appropriate form. It is permissible to
11、 keep conflicting 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,
12、 Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management C
13、entre: rue de Stassart, 36 B-1050 Brussels 2005 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN/TS 15127-1:2005: E Licensed CopyChinese University of Hong Kong, 20/10/2008 09:32, Uncontrolled Copy, (c) BSI 2 Contents Page Foreword
14、3 Introduction4 1 Scope.6 2 Normative references .6 3 Terms, definitions and abbreviations6 4 Purpose and nature of 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) Hist
15、orical background and review.15 Bibliography.16 CEN/TS 15127-1:2005 Licensed CopyChinese University of Hong Kong, 20/10/2008 09:32, Uncontrolled Copy, (c) BSI 3 Foreword This document (CEN/TS 15127-1:2005) has been prepared by Technical Committee CEN/TC 251 “Health informatics”, the secretariat of w
16、hich 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 work item WI050 “Evaluation of Physiological Analysis Systems”. The work item identified two
17、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 document. This technical specification is intended to be a generic base technical specificat
18、ion, 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 this CEN Technical Specification: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia,
19、 Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. CEN/TS 15127-1:2005 Licensed CopyChinese University of Hong Kong, 20/10/2008 09:32, Unc
20、ontrolled Copy, (c) BSI 4 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 Imag
21、e 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
22、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
23、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
24、 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
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