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

1、BSENISO15193:2009ICS11.100.10NOCOPYINGWITHOUTBSIPERMISSIONEXCEPTASPERMITTEDBYCOPYRIGHTLAWBRITISHSTANDARDInvitrodiagnosticmedicaldevicesMeasurementofquantitiesinsamplesofbiologicaloriginR equirementsforcontentandpresentationofreferencemeasurementprocedures(ISO15193:2009)BS EN ISO 15193:2009Incorporat

2、ing corrigendum January 2016EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORMEN ISO 15193 May 2009 ICS 11.100.10 Supersedes EN 12286:1998English Version In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of refe

3、rence measurement procedures (ISO 15193:2009) Dispositifs mdicaux de diagnostic in vitro - Mesurage desgrandeurs dans des chantillons dorigine biologique - Exigences relatives au contenu et la prsentation desprocdures de mesure de rfrence (ISO 15193:2009) In-vitro-Diagnostika - Messung von Gren in P

4、roben biologischen Ursprungs - Anforderungen an den Inhalt und die Darstellung von Referenzmessverfahren (ISO15193:2009) 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 thi

5、s European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (E

6、nglish, 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.CEN members are the national standards bodies of Austria, Belgium, Bulgar

7、ia, 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, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATI

8、ON COMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 15193:2009: EBS EN ISO 15193:2009ISBN 978 0 580 92899 4Amend

9、ments/corrigenda issued since publicationDate Comments31 January 2016 Implementation of CEN Correction Notice 12 August 2009: Supersession information updatedThis British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2009 The British Standards In

10、stitution 2016. Published by BSI Standards Limited 2016National forewordThis British Standard is the UK implementation of EN ISO 15193:2009. It supersedes BS EN 12286:1999 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs.A list of organizat

11、ions 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.Compliance with a British Standard cannot confer immunity from legal obligations.E

12、UROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15193 May 2009 ICS 11.100.10 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

13、 (ISO 15193:2009) Dispositifs mdicaux de diagnostic in vitro - Mesurage des grandeurs 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 Ursprun

14、gs - Anforderungen an den Inhalt und die Darstellung von Referenzmessverfahren (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

15、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 CEN member. This European Standard exists in three official versions (English, French, German

16、). 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. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Rep

17、ublic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN D

18、E 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 Members. Ref. No. EN ISO 15193:2009: EEN ISO 15193:2009 (E) 3 Foreword This document (EN ISO 15193:

19、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 laboratory testing and in vitro diagnostic test systems“. This European Standard shall be given the

20、 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 2009. This document supersedes EN 12286:1998. Attention is drawn to the possibility that some

21、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 European Commission and the European Free Trade Association, and s

22、upports 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 national standards organizations of the following countries are bound to implement this Eur

23、opean 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the Unite

24、d Kingdom. iiBS EN ISO 15193:2009EN ISO 15193:2009 (E)EN ISO 15193:2009 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 98/79 This European Standard has been prepared under a mandate given to CEN by the European Commission and t

25、he 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 has been implemented as a national standard in at least one Member S

26、tate, 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 regulations. WARNING: Other requirements and other EU Directives may

27、be applicable to the products falling within the scope of this standard. iiiBS EN ISO 15193:2009EN ISO 15193:2009 (E)BS EN ISO 15193:2009ISO 15193:2009(E) ISO 2009 All rights reserved iiiContents PageForeword ivIntroduction v1Scope . 12Normative references. 13Terms and definitions. 24Presentation of

28、 a reference measurement procedure 44.1 Elements of a reference measurement procedure 44.2 Warning and safety precautions. 44.3 Introduction. 54.4 Scope. 54.5 Terms, definitions, symbols and abbreviated terms. 54.6 Measurement principle and measurement method. 64.7 Check list. 64.8 Reagents and mate

29、rials. 74.9 Apparatus 94.10 Sampling and sample. 94.11 Preparation of measuring system and analytical portion 94.12 Operation of measuring system 114.13 Data processing 114.14 Analytical reliability 124.15 Special cases 154.16 Validation of a reference measurement procedure. 154.17 Reporting.154.18

30、Quality assurance. 164.19 Bibliography 164.20 Dates of authorization and revision 16Annex A (informative) Reference procedures for properties other than differential and rational quantities. 17Bibliography. 18BS EN ISO 15193:2009ISO 15193:2009(E) ISO 2009 All rights reservedivvviBS EN ISO 15193:2009

31、ISO 15193:2009(E)iv 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 out through ISO technical committees. Each m

32、ember 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 collaborates closelywith the International Ele

33、ctrotechnical 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 Standards. Draft International Standardsadopte

34、d by the technical committees are circulated to the member bodies for voting. Publication 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 of this document may be the subject of patent

35、 rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 15193 was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 140, In vitro diagnostic medical devices, in collaboration with Technical Committee ISO/TC 212,Clinical labo

36、ratory 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 15193:2002),which has been technicallyrevised.BS EN ISO 15193:2009ISO 15193:2009(E) ISO

37、 2009 All rights reserved vBS EN ISO 15193:2009ISO 15193:2009(E) ISO 2009 All rights reserved vIntroduction Reference measurement systems are needed to produce useful and reliable measurement results,whether in science, technology or routine service, so asto be comparable and ultimately metrological

38、ly traceable tomeasurement units and/or measurement standards and/or measurement procedures of the highestmetrological level. Reference measurement procedures play a crucial role in this metrological system because they can be used for the following: a) in assessing performance properties ofmeasurin

39、g systems comprising measuring instruments, auxiliaryequipment as well as reagents,b) in demonstrating if there is a functional interchangeability of different routine measurement procedurespurporting to measure the same quantity,c) in assigning quantityvalues to reference materials that are then us

40、ed for purposes of calibration ortrueness control of routine measurement procedures, and d) in detecting analytical influence quantities in patient samples.For medical laboratory measurements, in particular,it is vitally important to both patient careand health screening that the measurement results

41、 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, namelywhen it is related to technical requirements: that are specified in standards, technical spec

42、ifications, or technical regulations, etc., for which quantityvalues 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 standard are listed in ISO/IEC Guide 15. In Clause 3 of this International Standard, c

43、oncepts are indicated by italicized text. BS EN ISO 15193:2009ISO 15193:2009(E) ISO 2009 All rights reservedviBS EN ISO 15193:2009INTERNATIONAL STANDARD ISO 15193:2009(E) ISO 2009 All rights reserved 1In vitro diagnostic medical devices Measurement ofquantities in samples of biological origin Requir

44、ements for content and presentation of reference measurement procedures1 Scope This International Standard specifies requirements for the content of a reference measurement procedure forin vitro diagnostic medical devices and medical laboratories. NOTE 1It is intended that an experienced laboratoryw

45、orker who follows a measurement procedure written inaccordance with this International Standard can be expected to produce measurement results with a measurementuncertainty not exceeding the stipulated interval. This International Standard applies to reference measurement procedures providing values

46、 of differential orrational quantities.Annex A provides information on nominal properties and ordinal quantities.This International Standard is valid for any person, body or institution involved in one of the various branches of laboratory medicine whose intention is to write a document to serve as

47、a reference measurement procedure. Full descriptions of measurement methods are usually published in scientific literature, inwhich methods aredescribed in sufficient detail that they can be used as the basis of a documented measurement procedure. NOTE 2In this International Standard, “international

48、 measurement standard” designates a materialstandard. The term“international standard” is used by WHO for reference materials. 2 NormativereferencesThe following referenced documents are indispensable for the application of this document. For datedreferences, only the edition cited applies. For unda

49、ted references, the latest edition of the referenceddocument (including any amendments) applies.ISO 15194, In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentationISO/IEC Guide 98-3:2008, Guide to the expression of uncertainty in measurement (GUM:1995)ISO/IEC Guide 99:2007, Internationalvocabulary of metrology Basic and general concepts and associatedterms (VIM)ISO 15193:2009(E)BS EN ISO