DIN EN ISO 15193-2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measu.pdf

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1、October 2009DEUTSCHE NORM English price group 14No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.100.10!$Z-|“1551089

2、www.din.deDDIN EN ISO 15193In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for content and presentation of reference measurementprocedures (ISO 15193:2009)English version of DIN EN ISO 15193:2009-10In-vitro-Diagnostika Messung von Gren in Pr

3、oben biologischen Ursprungs Anforderungen an den Inhalt und die Darstellung von Referenzmessverfahren(ISO 15193:2009)Englische Fassung DIN EN ISO 15193:2009-10SupersedesDIN EN 12286:1999-02 and1:2000-11www.beuth.deDIN EN 12286 CorrigendumDocument comprises 28 pagesDIN EN ISO 15193:2009-10 2 National

4、 foreword This standard has been prepared by Technical Committee ISO/TC 212 “Clinical laboratory testing and in vitro diagnostic test systems” in collaboration with Technical Committee CEN/TC 140 “In vitro diagnostic medical devices” (Secretariat: DIN, Germany), in accordance with the Agreement on t

5、echnical cooperation between ISO and CEN (Vienna Agreement) and was developed as a result of the need to revise ISO 15193:2002 and EN 12286:1999. The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Technical Committee NA 063-03-02 AA

6、 Referenzsysteme. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. DIN shall not be held responsible for identifying any or all such patent rights. The DIN Standards corresponding to the International Standard referred to in clause

7、 2 and in the bibliography of the EN are as follows: ISO 3696 DIN ISO 3696 ISO 5725-1 DIN ISO 5725-1 ISO 5725-2 DIN ISO 5725-2 ISO 5725-3 DIN ISO 5725-3 ISO 5725-4 DIN ISO 5725-4 ISO 5725-5 DIN ISO 5725-5 ISO 5725-6 DIN ISO 5725-6 ISO 15194 DIN EN ISO 15194 ISO 17511 DIN EN ISO 17511 ISO 18153 DIN E

8、N ISO 18153 Amendments This standard differs from DIN EN 12286:1999-02 and DIN EN 12286 Corrigendum 1:2000-11 as follows: a) New terms and definitions have been included. b) Subclause 4.14.13 “Intermediate precision standard deviation” has been added. c) Requirements for the statistical analysis of

9、data have been deleted. d) The standard has been brought in line with the state of the art. e) The standard has been editorially revised. Previous editions DIN EN 12286: 1999-02 DIN EN 12286 Corrigendum 1: 2000-11 DIN EN ISO 15193:2009-10 3 National Annex NA (informative) Bibliography DIN ISO 3696,

10、Water for analytical laboratory use Specification and test methods DIN ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results Part 1: General principles and definitions DIN ISO 5725-2, Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method

11、 for the determination of repeatability and reproducibility of a standard measurement method DIN ISO 5725-3, Accuracy (trueness and precision) of measurement methods and results Part 3: Intermediate measures of the precision of a standard measurement method DIN ISO 5725-4, Accuracy (trueness and pre

12、cision) of measurement methods and results Part 4: Basic methods for the determination of the trueness of a standard measurement method DIN ISO 5725-5, Accuracy (trueness and precision) of measurement methods and results Part 5: Alternative methods for the determination of the precision of a standar

13、d measurement method DIN ISO 5725-6, Accuracy (trueness and precision) of measurement methods and results Part 6: Use in practice of accuracy values DIN EN ISO 15194, In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference ma

14、terials and the content of supporting documentation DIN EN ISO 17511, In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials DIN EN ISO 18153, In vitro diagnostic medical devices Measuremen

15、t of quantities in biological samples Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials DIN EN ISO 15193:2009-10 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15193 May 2009 ICS 11.10

16、0.10 Supersedes EN 12286:1998English Version In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009) Dispositifs mdicaux de diagnostic in vitro - Mesurage des gran

17、deurs dans des chantillons dorigine biologique - Exigences relatives au contenu et la prsentation des procdures de mesure de rfrence (ISO 15193:2009) In-vitro-Diagnostika - Messung von Gren in Proben biologischen Ursprungs - Anforderungen an den Inhalt und die Darstellung von Referenzmessverfahren (

18、ISO 15193:2009) This European Standard was approved by CEN on 16 April 2009. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibli

19、ographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility

20、of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ire

21、land, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix

22、17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15193:2009: EContents 2 EN ISO 15193:2009 (E) DIN EN ISO 15193:2009-10 Page Foreword .3 Introduction.4 1 Scope5 2 Normative references5 3 Terms and defini

23、tions .6 4 Presentation of a reference measurement procedure.8 4.1 Elements of a reference measurement procedure.8 4.2 Warning and safety precautions8 4.3 Introduction9 4.4 Scope9 4.5 Terms, definitions, symbols and abbreviated terms .9 4.6 Measurement principle and measurement method .10 4.7 Check

24、list10 4.8 Reagents and materials 11 4.9 Apparatus.13 4.10 Sampling and sample13 4.11 Preparation of measuring system and analytical portion.13 4.12 Operation of measuring system 15 4.13 Data processing.15 4.14 Analytical reliability.16 4.15 Special cases .19 4.16 Validation of a reference measureme

25、nt procedure .19 4.17 Reporting19 4.18 Quality assurance20 4.19 Bibliography.20 4.20 Dates of authorization and revision 20 Annex A (informative) Reference procedures for properties other than differential and rational quantities21 Bibliography22 Annex ZA (informative) Relationship between this Euro

26、pean Standard and the Essential Requirements of EU Directive 98/7924 Foreword This document (EN ISO 15193:2009) has been prepared by Technical Committee CEN/TC 140 “In vitro diagnostic medical devices”, the secretariat of which is held by DIN, in collaboration with Technical Committee ISO/TC 212 “Cl

27、inical laboratory testing and in vitro diagnostic test systems”. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by November 2009, and conflicting national standards shall be withdrawn at the latest

28、by November 2009. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CEN by the

29、European Commission and the European Free Trade Association, and supports essential requirements of EC Directive. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organi

30、zations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Rom

31、ania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. 3 DIN EN ISO 15193:2009-10 EN ISO 15193:2009 (E) This document supersedes EN 12286:1998 Introduction Reference measurement systems are needed to produce useful and reliable measurement results, whether in science, technolog

32、y or routine service, so as to be comparable and ultimately metrologically traceable to measurement units and/or measurement standards and/or measurement procedures of the highest metrological level. Reference measurement procedures play a crucial role in this metrological system because they can be

33、 used for the following: a) in assessing performance properties of measuring systems comprising measuring instruments, auxiliary equipment as well as reagents, b) in demonstrating if there is a functional interchangeability of different routine measurement procedures purporting to measure the same q

34、uantity, c) in assigning quantity values to reference materials that are then used for purposes of calibration or trueness control of routine measurement procedures, and d) in detecting analytical influence quantities in patient samples. For medical laboratory measurements, in particular, it is vita

35、lly important to both patient care and health screening that the measurement results reported to the physicians and patients are adequately comparable, reproducible and accurate. In some cases, it is advisable that a reference measurement procedure be given in the form of a standard, namely when it

36、is related to technical requirements: that are specified in standards, technical specifications, or technical regulations, etc., for which quantity values are to be stated by the supplier, and that have a direct relationship to the performance of a product or process. The advantages of having such a

37、 standard are listed in ISO/IEC Guide 15. In Clause 3 of this International Standard, concepts are indicated by italicized text. 4 EN ISO 15193:2009 (E) DIN EN ISO 15193:2009-10 1 Scope This International Standard specifies requirements for the content of a reference measurement procedure for in vit

38、ro diagnostic medical devices and medical laboratories. NOTE 1 It is intended that an experienced laboratory worker who follows a measurement procedure written in accordance with this International Standard can be expected to produce measurement results with a measurement uncertainty not exceeding t

39、he stipulated interval. This International Standard applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities. This International Standard is valid for any person, body or institution

40、 involved in one of the various branches of laboratory medicine whose intention is to write a document to serve as a reference measurement procedure. Full descriptions of measurement methods are usually published in scientific literature, in which methods are described in sufficient detail that they

41、 can be used as the basis of a documented measurement procedure. NOTE 2 In this International Standard, “international measurement standard” designates a material standard. The term “international standard” is used by WHO for reference materials. 2 Normative references The following referenced docum

42、ents are indispensable 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. ISO 15194, In vitro diagnostic medical devices Measurement of quantities in sam

43、ples of biological origin Requirements for certified reference materials and the content of supporting documentation ISO/IEC Guide 98-3:2008, Guide to the expression of uncertainty in measurement (GUM:1995) ISO/IEC Guide 99:2007, International vocabulary of metrology Basic and general concepts and a

44、ssociated terms (VIM) 5 DIN EN ISO 15193:2009-10 EN ISO 15193:2009 (E) 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO/IEC Guide 99 and ISO/IEC Guide 98-3 and the following apply. 3.1 primary sample collection of one or more parts initially taken fro

45、m a system and intended to provide information about the system, or to serve as a basis for a decision about the system NOTE In some cases, the information provided also applies to a larger system or a set of systems, of which the sampled system is an element. 3.2 laboratory sample primary sample, o

46、r a subsample of it, as prepared for sending to or as received by the laboratory and intended for measurement 3.3 analytical sample sample prepared from the laboratory sample and from which analytical portions can be taken NOTE The analytical sample can be subjected to various treatments before an a

47、nalytical portion is taken. 3.4 analytical portion portion of material taken from the analytical sample and on which the measurement is actually carried out, either directly or following dissolution NOTE The analytical portion is taken directly from the primary sample or laboratory sample if no prep

48、aration of these is required. The analytical portion is sometimes dissolved to give an analytical solution before being exposed to the measuring device. 3.5 analytical solution solution prepared prior to measurement by dissolving an analytical portion in a liquid or solid material, with or without r

49、eaction 3.6 matrix material system components of a material system, except the analyte 3.7 reference measurement procedure measurement procedure accepted as providing measurement results fit for their use in assessing measurement trueness of measured quantity values obtained from other measurement procedures for quantities of the same kind, in calibration, or in characterizing reference materials NOTE 1 Adapted from ISO/IEC Guide 99:2007, 2.7. NOTE 2 The roles of reference measurement procedures are detailed in ISO 175