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1、BS EN ISO 15194:2009 ICS 11.100.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BRITISH STANDARD In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting docume
2、ntation (ISO 15194:2009) Licensed CopyChinese University of Hong Kong, 13/06/2009 08:00, Uncontrolled Copy, (c) BSI This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2009 BSI 2009 ISBN 978 0 580 57788 8 Amendments/corrigenda issued since
3、 publication DateComments BS EN ISO 15194:2009 National foreword This British Standard is the UK implementation of EN ISO 15194:2009. It supersedes BS EN 12287:1999 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs. A list of organizations
4、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. Lic
5、ensed CopyChinese University of Hong Kong, 13/06/2009 08:00, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15194 May 2009 ICS 11.100.10 English Version In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements
6、 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 au contenu de la documentation associ
7、e (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 2009. CEN members are bound to comply wi
8、th 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 on application to the CEN Management C
9、entre 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 Centre has the same status as the offi
10、cial 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, Poland, Portugal, Romania, Slovakia, Sl
11、ovenia, 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 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN
12、national Members. Ref. No. EN ISO 15194:2009: E Licensed CopyChinese University of Hong Kong, 13/06/2009 08:00, Uncontrolled Copy, (c) BSI BS EN ISO 15194:2009 EN ISO 15194:2009 (E) 3 Foreword This document (EN ISO 15194:2009) has been prepared by Technical Committee CEN/TC 140 “In vitro diagnostic
13、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 status of a national standard, either by publication of an identical text or b
14、y endorsement, at the latest by November 2009, and conflicting national standards shall be withdrawn at the latest 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
15、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 supports essential requirements of EC Directive. For relationship with EC Directive, see informative Annex ZA, which is
16、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 European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,
17、 Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Licensed CopyChinese University of Hong Kong, 13/06/2009 08:00, Uncontrolled Copy, (c) BSI BS EN ISO 15194:2
18、009 EN ISO 15194:2009 (E) 4 Annex ZA (informative) Relationship between this International Standard and the Essential Requirements of EU Directive 98/79 This International Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to pr
19、ovide 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 Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the normativ
20、e 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 be applicable to the products fall
21、ing within the scope of this standard. Licensed CopyChinese University of Hong Kong, 13/06/2009 08:00, Uncontrolled Copy, (c) BSI BS EN ISO 15194:2009 ISO 15194:2009(E) ISO 2009 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references. 1 3 Terms and definit
22、ions. 2 4 Systematic format of properties in the supporting documentation of a certified reference material 4 4.1 Format of properties. 4 4.2 Construction of systematic designations 5 4.3 Trivial names. 5 5 Properties, production, and characterization of a certified reference material . 5 5.1 Hierar
23、chical position 5 5.2 Properties 5 5.3 Production and characterization. 6 6 Content of supporting documentation. 6 6.1 Supporting documentation 6 6.2 Label. 6 6.3 Certificate 6 6.4 Certification report 7 Annex A (informative) Certified reference materials with nominal properties or ordinal quantitie
24、s. 15 Bibliography. 16 Licensed CopyChinese University of Hong Kong, 13/06/2009 08:00, Uncontrolled Copy, (c) BSI BS EN ISO 15194:2009 ISO 15194:2009(E) iv ISO 2009 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards b
25、odies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizati
26、ons, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the
27、 ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of t
28、he 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 rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 15194 was prepared by the European Committee for Standardization
29、 (CEN) Technical Committee CEN/TC 140, In vitro diagnostic medical devices, in collaboration with Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). This s
30、econd edition cancels and replaces the first edition (ISO 15194:2002), which has been technically revised. Licensed CopyChinese University of Hong Kong, 13/06/2009 08:00, Uncontrolled Copy, (c) BSI BS EN ISO 15194:2009 ISO 15194:2009(E) ISO 2009 All rights reserved v Introduction Reference measureme
31、nt systems are needed to produce useful and reliable measurement results, whether in science, technology 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
32、that are used to obtain this metrological traceability, through time, distances and different measurement 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 d
33、ocumentation containing sources of material, descriptions, measurement results, metrological traceability, 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 con
34、tent of their supporting documentation. Reference materials are used for one of three main purposes: a) 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 gro
35、up 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”, where the latter is related to “standard deviation”, “coefficient of variation ”, “random ef
36、fect” and “random error”. c) evaluation of the performance of a new measurement procedure. The maximum 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 refere
37、nce material. As the proper use of a reference material depends on its description, it is important to 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 indic
38、ated by italicized text. Licensed CopyChinese University of Hong Kong, 13/06/2009 08:00, Uncontrolled Copy, (c) BSI BS EN ISO 15194:2009 Licensed CopyChinese University of Hong Kong, 13/06/2009 08:00, Uncontrolled Copy, (c) BSI BS EN ISO 15194:2009 INTERNATIONAL STANDARD ISO 15194:2009(E) ISO 2009 A
39、ll rights reserved 1 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentation 1 Scope This International Standard specifies requirements for certified reference materials a
40、nd 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 standards, secondary measurement standards and international conventio
41、nal 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 measurement uncertainty. This International Standard applies to certi
42、fied 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 are parts of an in vitro diagnostic measuring system, although it is
43、 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, the latest edition of the referenced document (including any amend
44、ments) 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 measurement method ISO 17511:2003, In vitro diagnostic medical dev
45、ices 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 Metrological traceability of values for catalytic concentration of enz
46、ymes 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 materials General and statistical principles for certification ISO/IEC G
47、uide 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 being replaced progressively by the ISO 80000 series and the IEC 80000
48、 series. Licensed CopyChinese University of Hong Kong, 13/06/2009 08:00, Uncontrolled Copy, (c) BSI BS EN ISO 15194:2009 ISO 15194:2009(E) 2 ISO 2009 All rights reserved 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO/IEC Guide 99 and the following a
49、pply. 3.1 primary measurement standard primary 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 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 Fur
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