DIN EN ISO 15194-2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the conte.pdf

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1、October 2009DEUTSCHE NORM English price group 13No 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-j“1551071

2、www.din.deDDIN EN ISO 15194In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content ofsupporting documentation (ISO 15194:2009)English version of DIN EN ISO 15194:2009-10In-vitro-Diagnostika Messung v

3、on Gren in Proben biologischen Ursprungs Anforderungen an zertifizierte Referenzmaterialien und an den Inhalt derBegleitdokumentation (ISO 15194:2009)Englische Fassung DIN EN ISO 15194:2009-10SupersedesDIN EN 12287:1999-08www.beuth.deDocument comprises 25 pagesDIN EN ISO 15194:2009-10 2 National for

4、eword 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 tech

5、nical cooperation between ISO and CEN (Vienna Agreement) and was developed as a result of the need to revise ISO 15194:2002 and EN 12287:1999. The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Technical Committee NA 063-03-02 AA Re

6、ferenzsysteme. 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 2

7、and in the bibliography of the EN are as follows: ISO 5725-2 DIN ISO 5725-2 ISO 13485 DIN EN ISO 13485 ISO 14971 DIN EN ISO 14971 ISO 15193 DIN EN ISO 15193 ISO 15195 DIN EN ISO 15195 ISO 17511 DIN EN ISO 17511 ISO 18113-2 E DIN EN ISO 18113-2 ISO 18153 DIN EN ISO 18153 ISO/IEC 17025 DIN EN ISO/IEC

8、17025 ISO/IEC Guide 51 DIN 820-120 Amendments This standard differs from DIN EN 12287:1999-08 as follows: a) Clause 6 “Content of supporting documentation” has been added. b) Requirements on how to collect data and how to present values and their measurement uncertainty have been included. c) Requir

9、ements for properties, production, and characterization of certified reference material have been included. d) New terms and definitions have been included. e) The standard has been brought in line with the state of the art. f) The standard has been editorially revised. Previous editions DIN EN 1228

10、7: 1999-08 DIN EN ISO 15194:2009-10 3 National Annex NA (informative) Bibliography DIN 820-120, Standardization Part 120: Guidelines for the inclusion of safety aspects in standards DIN EN ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes DIN EN ISO 14971, Me

11、dical devices Application of risk management to medical devices DIN EN ISO 15193, In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements, content, and format of reference measurement procedures DIN EN ISO 15195, Laboratory medicine Requirements for

12、 reference measurement laboratories 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 E DIN EN ISO 18113-2, Clinical laboratory testing and in vitro diagnostic medica

13、l systems Information supplied by the manufacturer (labelling) Part 2: In vitro diagnostic reagents for professional use DIN EN ISO 18153, In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values for catalytic concentration of enzymes as

14、signed to calibrators and control materials DIN EN ISO/IEC 17025, Allgemeine Anforderungen an die Kompetenz von Prf- und Kalibrierlaboratorien DIN ISO 5725-2, Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproduc

15、ibility of a standard measurement method DIN EN ISO 15194:2009-10 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15194 May 2009 ICS 11.100.10 Supersedes EN 12287:1999English Version In vitro diagnostic medical devices - Measurement of quantities in sample

16、s of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009) Dispositifs mdicaux de diagnostic in vitro - Mesurage des grandeurs dans les chantillons dorigine biologique - Exigences relatives aux matriaux de rfrence certifis et

17、au contenu de la documentation associe (ISO 15194:2009) In-vitro-Diagnostika - Messung von Gren in Proben biologischen Ursprungs - Anforderungen an zertifizierte Referenzmaterialien und an den Inhalt der Begleitdokumentation (ISO 15194:2009) This European Standard was approved by CEN on 16 April 200

18、9. 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 bibliographical references concerning such national standards may be obtained o

19、n 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 of a CEN member into its own language and notified to the CEN Management C

20、entre 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, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Po

21、land, 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 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by

22、 any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15194:2009: EContents Page Foreword .3 Introduction.4 1 Scope5 2 Normative references5 3 Terms and definitions .6 4 Systematic format of properties in the supporting documentation of a certified reference material.8 4.1 Format o

23、f properties .8 4.2 Construction of systematic designations.9 4.3 Trivial names9 5 Properties, production, and characterization of a certified reference material9 5.1 Hierarchical position.9 5.2 Properties.9 5.3 Production and characterization .10 6 Content of supporting documentation10 6.1 Supporti

24、ng documentation 10 6.2 Label .10 6.3 Certificate .10 6.4 Certification report 11 Annex A (informative) Certified reference materials with nominal properties or ordinal quantities .19 Bibliography20 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of

25、EU Directive 98/7921 2 DIN EN ISO 15194:2009-10 EN ISO 15194:2009 (E) Foreword This document (EN ISO 15194:2009) 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 “C

26、linical 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

27、 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

28、 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 organ

29、izations 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, Ro

30、mania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. 3 EN ISO 15194:2009 (E) DIN EN ISO 15194:2009-10 This document supersedes EN 12287:1999 Introduction Reference measurement systems are needed to produce useful and reliable measurement results, whether in science, technolo

31、gy or routine service, so as to be comparable and ultimately metrologically traceable to measurement standards and/or measurement procedures of the highest metrological level. Substances or devices that are used to obtain this metrological traceability, through time, distances and different measurem

32、ent procedures, are reference materials. Certified reference materials are needed at the higher metrological levels of a calibration hierarchy. A given certified reference material is supported by documentation containing sources of material, descriptions, measurement results, metrological traceabil

33、ity, instructions for use, stability data and storage conditions, as well as health and safety warnings. This International Standard specifies the quality requirements for such materials and the content of their supporting documentation. Reference materials are used for one of three main purposes: a

34、) calibration of quantity values indicated by a measuring system or assigned to another reference material; b) validation or control of trueness of measured values in a given laboratory, or in a group of laboratories; NOTE In ISO terminology “trueness” is related to “bias”, “systematic effect” and “

35、systematic error”, whereas “accuracy” is related both to “trueness” (with its relations) and “precision”, where the latter is related to “standard deviation”, “coefficient of variation ”, “random effect” and “random error”. c) evaluation of the performance of a new measurement procedure. The maximum

36、 acceptable measurement uncertainty of the assigned value of a reference material depends on the requirements of the measured quantity values obtained by a measurement procedure involving the reference material. As the proper use of a reference material depends on its description, it is important to

37、 apply rules for the documentation of reference materials. The advantages of having standards available are listed in ISO/IEC Guide 15. In Clause 3 of this International Standard, concepts are indicated by italicized text. 4 DIN EN ISO 15194:2009-10 EN ISO 15194:2009 (E) 1 Scope This International S

38、tandard specifies requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511. It is applicable to certified reference materials classifiable as primary measurement stan

39、dards, secondary measurement standards and international conventional calibrators that function either as calibrators or trueness control materials. This International Standard also provides requirements on how to collect data for value determination and how to present the assigned value and its mea

40、surement uncertainty. This International Standard applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities. This International Standard does not apply to reference materials that ar

41、e parts of an in vitro diagnostic measuring system, although it is possible that many elements are helpful. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references,

42、the latest edition of the referenced document (including any amendments) applies. ISO 31 (all parts)1), Quantities and units ISO 5725-2, Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard

43、measurement method ISO 17511:2003, In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials ISO 18153, In vitro diagnostic medical devices Measurement of quantities in biological samples Metr

44、ological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials ISO Guide 31, Reference materials Contents of certificates and labels ISO Guide 34, General requirements for the competence of reference material producers ISO Guide 35, Reference materi

45、als General and statistical principles for certification 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 associated terms (VIM) 1) The ISO 31 series is currently bein

46、g replaced progressively by the ISO 80000 series and the IEC 80000 series. 5 EN ISO 15194:2009 (E) DIN EN ISO 15194:2009-10 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO/IEC Guide 99 and the following apply. 3.1 primary measurement standard primary

47、 standard measurement standard whose quantity value and measurement uncertainty are established using a primary measurement procedure EXAMPLE Primary measurement standard of amount-of-substance concentration prepared by dissolving a known amount of substance of a chemical component to a known volume

48、 of solution. NOTE 1 Adapted from ISO/IEC Guide 99:2007, 5.4. NOTE 2 The concept of “primary measurement standard” is equally valid for base quantities and derived quantities. NOTE 3 Further explanation of the role of primary measurement standards within a calibration hierarchy can be found in ISO 1

49、7511 and ISO 18153. 3.2 secondary measurement standard secondary standard measurement standard whose quantity value and measurement uncertainty are assigned through calibration with respect to a primary measurement standard for a quantity of the same kind NOTE 1 The relation can be obtained directly between the primary measurement standard and the secondary measurement standard, or involve an intermediate measuring system calibrated by the primary standard and assigning a measurement result to the secondary standard.