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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12286:1999 Incorpor
2、ating Amendment No. 1 The European Standard EN 12286:1998, with the incorporation of amendment A1:2000 has the status of a British Standard ICS 11.100 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW In vitro diagnostic medical devices Measurement of quantities in samples of bi
3、ological origin Presentation of reference measurement procedures Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:30:06 GMT+00:00 2006, Uncontrolled Copy, (c) BSI This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published un
4、der the authority of the Standards Committee and comes into effect on 15 January 2001 BSI 01-2001 ISBN 0 580 30629 1 BS EN 12286:1999 Amendments issued since publication Amd. No.DateText affected 11034January 2001Addition of informative annex ZA National foreword This British Standard is the English
5、 language version of EN 12286:1998, including amendment A1:2000. The UK participation in its preparation was entrusted to Technical Committee CH/69, In vitro diagnostic systems, which has the responsibility to: aid enquirers to understand the text; present to the responsible European committee any e
6、nquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The
7、British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled International Standards Correspondence Index, or by using the Find facility of the BSI Standards Electronic Catalogue. A Britis
8、h Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front
9、cover, an inside front cover, the EN title page, pages 2 to 14, an inside back cover and a back cover. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:30:06 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches
10、 Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1998 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12286:1998 + A1:2000 E EUROPEAN STANDARDEN 12286 NORME EUROPE ENNE November 1998 EUROPA ISCHE NORM
11、+A1 May 2000 ICS 11.100 Descriptors: medicine, bioassay, in vitro diagnostics, sampling, measurements, procedure English version In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Presentation of reference measurement procedures (includes amendment A1:2000)
12、 Dispositifs me dicaux de diagnostic in vitro Mesure des grandeurs dans des e chantillons dorigine biologique Pre sentation des modes ope ratoires de mesure de re fe rence (inclut lamendement A1:2000) In-Vitro-Diagnostika Messung von Gro en in Proben biologischen Ursprungs Darstellung von Referenzme
13、vefahren (entha lt A nderung A1:2000) This European Standard was approved by CEN on 14 October 1998. Amendment A1 was approved by CEN on 9 April 2000. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status
14、 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 Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A ver
15、sion in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, Fra
16、nce, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:30:06 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 2 EN 12286:1998 BSI 01-2001 Foreword This European
17、Standard has been prepared by Technical Committee CEN/TC 140, In vitro diagnostic medical devices, the Secretariat of which is held by DIN. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the European Confederation of Laboratory Medicine (ECLM) have contributed
18、to its preparation. 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 May 1999, and conflicting national standards shall be withdrawn at the latest by May 1999. This European Standard is based on IS
19、O/DIS 78-2 with special consideration of the requirements for biological materials and for reference measurement procedures. prEN 12287 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Description of reference materials specifies requirements of importanc
20、e to the calibration and quality assurance of reference measurement procedures. Annexes A and B are for information only. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium
21、, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Foreword to amendment A1 This amendment EN 12286:1998/A1:2000 to the EN 12286:1998 has been prepared by Technical Commit
22、tee CEN/TC 140, In vitro diagnostic medical devices, the Secretariat of which is held by DIN. This amendment to the European Standard EN 12286:1998 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by November 2000, and conf
23、licting national standards shall be withdrawn at the latest by November 2000. This amendment to the European Standard EN 12286:1998 has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s
24、). For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this standard. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Re
25、public, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword2 Introduction3 1Scope3 2Normative references3 3Definitions3 4Presentation of a reference measurement proced
26、ure4 Annex A (informative) Reference procedures for properties other than quantities12 Annex B (informative) Bibliography13 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives14 Licensed Copy: sheffieldun sheffieldun, na, Sa
27、t Oct 28 05:30:06 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 12286:1998 BSI 01-2001 1) This document has been prepared by a joint working group consisting of experts appointed by: BIPMInternational Bureau of Weights and Measures IECInternational Electrotechnical Commission IFCCInternationa
28、l Federation of Clinical Chemistry and Laboratory Medicine ISOInternational Organization for Standardization IUPACInternational Union of Pure and Applied Chemistry IUPAPInternational Union of Pure and Applied Physics OIMLInternational Organization of Legal Metrology 2) The abbreviation VIM is used i
29、n this standard. Introduction Reference measurement systems are needed for producing useful and reliable results of measurement, whether in science, technology, or routine service so as to be comparable and ultimately traceable to measurement standards of the highest metrological level. Analytical r
30、eference measurement procedures play a crucial role in this metrological system because they can be used in assessing performance characteristics of measuring systems comprising measuring instruments, auxiliary equipment as well as reagents; in demonstrating the functional interchangeability of diff
31、erent routine measurement procedures purporting to measure the same quantity; in assigning values to reference materials that are then used for purposes of calibration or control of routine measurement procedures; and in detecting analytical influence quantities in patient samples. For clinical labo
32、ratory measurements, in particular, it is vitally important to acute and continuous patient care that the results reported to the physicians and patients are adequately comparable, reproducible, and accurate. In some cases, a reference measurement procedure should be given in the form of a (written)
33、 standard, namely when it is related to technical requirements specified in standards, technical specifications, or technical regulations, etc.; for which values are to be stated by the supplier; that have a direct relationship to the performance of a product or process. The advantages of having suc
34、h a standard are listed in the ISO/IEC Guide 15. 1 Scope This European Standard specifies requirements for the drafting of a reference measurement procedure. NOTEIt is intended that an experienced laboratory worker, following a measurement procedure written in accordance with this European Standard
35、can be expected to produce results with an uncertainty of measurement not exceeding the stipulated range. This European Standard is applicable to any person, body, or institution, involved in one of the various branches of laboratory medicine, intending to write a document to serve as a reference me
36、asurement procedure. 2 Normative references This European Standard incorporates by dated or undated reference provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent ame
37、ndments to, or revisions of, any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN ISO 3696, Water for analytical laboratory use Specification and test meth
38、ods. (ISO 3696:1987) ISO 6353-2, Reagents for chemical analysis Part 2: Specifications First series. ISO 6353-3, Reagents for chemical analysis Part 3: Specifications Second series. ISO/IEC Directives Part 2:1992 Methodology for the development of International Standards. International vocabulary of
39、 basic and general terms in metrology (VIM), 2nd edition, Geneva: ISO, 19931)2) Guide to the expression of uncertainty in measurement, 1st edition, Geneva: ISO, 19931) 3 Definitions For the purposes of this European Standard, the definitions given in International Vocabulary of Basic and General Ter
40、ms in Metrology and in Guide to the Expression of Uncertainty in Measurement apply together with the following: 3.1 primary sample collection of one or more parts initially taken from a system and intended to provide information about the system or to serve as a basis for a decision about the system
41、 NOTEIn 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 or a subsample of it as prepared for sending to or as received by the laboratory and intended for measurement Licensed Copy
42、: sheffieldun sheffieldun, na, Sat Oct 28 05:30:06 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 12286:1998 BSI 01-2001 3.3 analytical sample sample prepared from the laboratory sample and from which analytical portions may be taken NOTEThe analytical sample can be subjected to various treatm
43、ents before an analytical portion is taken. 3.4 analytical portion portion of material taken from the analytical sample and on which the measurement or observation is actually carried out NOTEThe analytical portion is taken directly from the primary sample or laboratory sample if no preparation of t
44、hese is required. The analytical portion sometimes is dissolved to give an analytical solution before being exposed to the measuring device. 3.5 analytical solution solution prepared by dissolving, with or without reaction, an analytical portion in a gas, liquid, or solid 3.6 matrix (of a material s
45、ystem) all components of a material system, except the analyte 3.7 reference measurement procedure thoroughly investigated measurement procedure shown to yield values having an uncertainty of measurement commensurate with its intended use, especially in assessing the trueness of other measurement pr
46、ocedures for the same quantity and in characterizing reference materials 3.8 analytical specificity ability of a measurement procedure to determine solely the measurable quantity it purports to measure 3.9 analytical interference systematic error of measurement caused by an influence quantity which
47、does not by itself produce a signal in the measuring system, but which causes an enhancement or depression of the value indicated 3.10 influence quantity quantity that is not the measurand but that affects the result of the measurement 2.7 of VIM 3.11 measurand particular quantity subject to measure
48、ment 2.6 of VIM 4 Presentation of a reference measurement procedure 4.1 Elements of a written reference measurement procedure The presentation of a reference measurement procedure shall comprise at least the elements listed as mandatory (M) in Table 1. The order of the elements listed in Table 1 may
49、 be changed and additional elements, such as an abstract, etc. may be added as appropriate. 4.2 Warning and safety precautions 4.2.1 Attention shall be drawn to any danger associated with a type of sample, reagent, equipment or activity, and all necessary precautions shall be described, including precautions for disposal. Regional, national, and local legislation and regulations may apply. 4.2.2 This information shall be printed in capital letters or in bold type as follows: a) immediately after the tit
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