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

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1、BSENISO15194:2009ICS11.100.10NOCOPYINGWITHOUTBSIPERMISSIONEXCEPTASPERMITTEDBYCOPYRIGHTLAWBRITISHSTANDARDInvitrodiagnosticmedicaldevicesMeasurementofquantitiesinsamplesofbiologicaloriginRequirementsforcertifiedreferencematerialsandthecontentofsupportingdocumentation(ISO15194:2009)Incorporating corrig

2、endumJanuary 2016This British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 31 May 2009BS EN ISO 15194:2009National forewordThis British Standard is the UK implementation of EN ISO 15194:2009.It supersedes BS EN 12287:1999 which is withdrawn.The UK particip

3、ation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct app

4、lication.Compliance with a British Standard cannot confer immunityfrom legal obligations. The British StandardsInstitution 2016. Published byBSI Standards Limited 2016ISBN 978 0 580 92900 7Amendments/corrigenda issued since publicationDate Comments 31 January 2016 Implementation of CEN Correction No

5、tice 12 August2009: Supersession details updatedEUROPEAN 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 samples of biological origin - Requirements for certified r

6、eference 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 au contenu de la documentation associe (ISO 15194:200

7、9) 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 2009. CEN members are bound to comply with the CEN/CENEL

8、EC 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 on application to the CEN Management Centre or to any

9、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 Centre has the same status as the official versions. C

10、EN 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, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, S

11、weden, 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 any means reserved worldwide for CEN national Member

12、s. Ref. No. EN ISO 15194:2009: EEN 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 “Clinical laborato

13、ry 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 by November 200

14、9. This document supersedes EN 12287:1999. 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 man

15、date given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the

16、national standards organizations 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, Norw

17、ay, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN ISO 15194:2009iiEN ISO 15194:2009 (E) Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 98/79 This European Standard has been pr

18、epared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide one means of conforming to Essential Requirements of the New Approach Directive 98/79. Once this standard is cited in the Official Journal of the European Union under that Directive and

19、has been implemented as a national standard in at least one Member State, compliance with the normative clauses of this standard confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA r

20、egulations. WARNING: Other requirements and other EU Directives may be applicable to the products falling within the scope of this standard. BS EN ISO 15194:2009iiiBS EN ISO 15194:2009ISO 15194:2009(E) ISO 2009 All rights reservedivContents PageForeword. vIntroduction. vi1Scope. 12Normative referenc

21、es. 13Terms and definitions. 24Systematic format of propertiesin the supporting documentation of a certified referencematerial 44.1 Format of properties. 44.2 Construction of systematic designations 54.3 Trivial names. 55Properties, production, and characterization of a certified reference material.

22、 55.1 Hierarchical position 55.2 Properties 55.3 Production and characterization. 66Content of supporting documentation. 66.1 Supporting documentation 66.2 Label. 66.3 Certificate 66.4 Certification report 7Annex A (informative) Certified reference materials with nominal properties or ordinal quanti

23、ties. 15Bibliography. 16BS EN ISO 15194:2009ISO 15194:2009(E)v ISO 2009 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried o

24、ut through ISO technical committees. Each member bodyinterested in a subject for which a technical committee has beenestablished has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO col

25、laborates closelywith the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Sta

26、ndards. Draft International Standardsadopted by the technical committees are ci rculated to the member bodies for voting. Public ation as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements

27、of this document may be the subject of patent rights. ISO shall not be held responsible for identifying an y or all such patent rights. ISO 15194 was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 140, In vitro diagnostic medical devices, in collaboration wit

28、h Technical Committee ISO/TC 212,Clinical laboratory testing and in vitro diagnostic test systems, in accordance with the Agreement on technicalcooperation between ISO and CEN (Vienna Agreement).This second edition cancels and replaces the first edition (ISO 15194:2002),which has been technicallyrev

29、ised.BS EN ISO 15194:2009ISO 15194:2009(E) ISO 2009 All rights reservedIntroduction Reference measurement systems are needed to produce useful and reliable measur ement results,whether in science, technology or routine service, so asto be comparable and ultimately metrologically traceable tomeasurem

30、ent standards and/or measurement procedures of the highest metrological level. Substances ordevices that are used to obtain this metrological traceability, through time, distances and different measurement procedures, are reference materials. Certified reference materials are needed at thehigher met

31、rological levels of a calibration hierarchy.A given certified reference m aterial is supported by documentation containing sources of material, descriptions, measurement results, metrological traceability, instructions for use, stability data and storage conditions, as well as health and safety warn

32、ings. This International Standard specifies the qualityrequirements for such materials and the content of their supporting documentation.Reference materials are used for one of three main purposes: a) calibration of quantityvalues indicated by a measuring sys tem or assigned to another reference mat

33、erial; b) validation or control of trueness of measured values in a given labora tory, orin agroup of laboratories;NOTE In ISO terminology “trueness” is related to “bias”, “systematic effect” and “systematic error”, whereas“accuracy” is related both to “trueness” (with its relations) and “precision”

34、, 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 acceptable measurement uncertaintyof the assigned value ofa reference material depends onthe requirements

35、 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 apply rul es for the documentation of reference materials.The advantages of having standards available are l

36、isted in ISO/IEC Guide 15. In Clause 3 of this International Standard, concepts are indicated by italicized text. vi BS EN ISO 15194:2009INTERNATIONAL STANDA RD ISO 15194:2009(E) ISO 2009 All rights reserved 1In vitro diagnostic medical devices Measurement ofquantities in samples of biological origi

37、n Requirements for certified reference materials and the content of supporting documentation1 Scope This International Standard specifies re quirements for certified referenc e materials and the content of theirsupporting documentation, in order for them to be considered of higher metrological order

38、 in accordance withISO 17511. It isapplicable to certified reference materials classifiable as primary measurement s tandards,secondary measurement standards and international conventional calibrators that function either ascalibrators or trueness control materials. This International Standard also

39、provides requirements on how tocollectdata for value determination and how to present the assigned value and itsmeasurement uncertainty. This International Standard applies to certified reference materials with assigned values of differential orrational quantities.Annex A provides information on nom

40、inal properties and ordinal quantities.This International Standard does not apply to reference material s that are parts of an in vitro diagnosticmeasuring system, although it is possible that many elements are helpful. 2 NormativereferencesThe following referenced documents are indispensable for th

41、e application of this document. For datedreferences, only the edition cited applies. For undated references, the latest edition of the referenceddocument (including any amendments) applies.ISO 31 (all parts) 1), Quantities and unitsISO 5725-2 , Accuracy (trueness and precision) of measurement method

42、s an d results Part2: Basic methodfor the determination of repeatability and reproducibility of a standard measurement methodISO 17511:2003, In vitro diagnostic medical devices Measurement of quantitiesin biological samples Metrological traceability of values assigned to calibrators and control mate

43、rialsISO 18153, In vitro diagnostic medical devices Measurement ofquantities in biological samples Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materialsISO Guide 31, Reference materials Contents of certificates and labelsISO Guide 34, G

44、eneral requirements for the competence of reference material producersISO Guide 35, Reference materials General and statistical principles for certificationISO/IEC Guide 98-3:2008, Guide to the expression of uncertainty in measurement (GUM:1995)ISO/IEC Guide 99:2007, Internationalvocabulary of metro

45、logy Basic and general concepts and associatedterms (VIM)1) The ISO 31 series is currently being replaced progressively by the ISO 80000 series and the IEC 80000 series. BS EN ISO 15194:2009ISO 15194:2009(E)2 ISO 2009 All rights reserved3 Terms and definitions For the purposes of this document, the

46、terms and definitions given in ISO/IEC Guide 99 and the following apply. 3.1 primary measurement standardprimary standardmeasurement standardwhose quantityvalue and measurement uncertainty are established using a primary measurement procedure EXAMPLE Primary measurement standard of amount-of-substan

47、ce concentration prepared by dissolving a knownamount of substance of a chemical component to a known volume 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 3Further ex

48、planation of the role of primary measurement standards within a calibration hierarchy can be foundin ISO 17511 and ISO 18153.3.2 secondary measurement standardsecondary standardmeasurement standardwhose quantityvalue and measurement uncertaintyar eassigned through calibrationwith respect to a primar

49、y measurement standard for a quantity of the samekind NOTE 1The relation can be obtaineddirectly between the primary measurement standard and the secondarymeasurement standard, or involve an intermediate measuring system calibrated by the primary standard and assigning ameasurement result to the secondary standard. NOTE 2 Adapted from ISO/IEC Guide 99:2007, 5.5. EXAMPLE NIST Standard Reference Material 1951b, Lipids in Frozen Human Serum is a secondary measurementstandard that is calibrated using NIST Standard Reference Material 1911c,