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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12287:1999 The Euro
2、pean Standard EN 12287:1999 has the status of a British Standard ICS 07.100.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Description of reference materials Licensed Copy: sheffi
3、eldun sheffieldun, na, Sat Oct 28 05:28:14 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 under the authority of the Standards Committee and comes into effect on 15 October 1999
4、BSI 10-1999 ISBN 0 580 32699 3 BS EN 12287:1999 Amendments issued since publication Amd. No.DateComments National foreword This British Standard is the English language version of EN 12287:1999. The UK participation in its preparation was entrusted to Technical Committee CH/69, In vitro diagnostic s
5、ystems, which has the responsibility to: aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them i
6、n the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitl
7、ed International Standards Correspondence Index, or by using the Find facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance wi
8、th a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 12, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when
9、the document was last issued. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:14 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Bru
10、ssels 1999 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12287:1999 E EUROPEAN STANDARDEN 12287 NORME EUROPE ENNE EUROPA ISCHE NORM June 1999 ICS 11.100 English version In vitro diagnostic medical devices Measurement of quantitie
11、s in samples of biological origin Description of reference materials Dispositifs me dicaux de diagnostic in vitro Mesure des grandeurs dans les e chantillons dorigine biologique Description des mate riaux de re fe rence In-vitro-Diagnostika Messung von Gro en in Proben biologischen Ursprungs Beschre
12、ibung von Referenzmaterialien This European Standard was approved by CEN on 1 April 1999. 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 li
13、sts 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 version in any other language made by translation under the resp
14、onsibility 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, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Ne
15、therlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:14 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 2 EN 12287:1999 BSI 10-1999 Foreword This European Standard has been prepared by Technical Committee CEN/TC 140,
16、 In vitro diagnostic medical devices, the Secretariat of which is held by DIN. The International Federation of Clinical Chemistry (IFCC) and the European Confederation of Laboratory Medicine (ECLM) have contributed to its preparation. This European Standard shall be given the status of a national st
17、andard, either by publication of an identical text or by endorsement, at the latest by December 1999, and conflicting national standards shall be withdrawn at the latest by December 1999. This European Standard has been prepared under a mandate given to CEN by the European Commission and the Europea
18、n Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this standard. This European Standard is based on ISO Guide 31 Contents of certificates of reference materials. The future E
19、uropean Standard Measurement of quantities in samples of biological origin Presentation of reference measurement procedures presents requirements to ensure that values assigned to reference materials by such procedures are reliable and stated in a useful way. Annexes A, B and ZA are for information
20、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, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norwa
21、y, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword2 Introduction3 1Scope3 2Normative references3 3Terms and definitions3 4Classification and naming of reference materials4 5Description of a reference material5 6Label10 7Certificate10 8Package insert10 Annex A (inf
22、ormative) Materials with properties other than quantities11 Annex B (informative) Bibliography11 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives12 Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:14 GMT+00:00
23、 2006, Uncontrolled Copy, (c) BSI Page 3 EN 12287:1999 BSI 10-1999 Introduction To produce useful and reliable results of measurement, whether in science, technology, or routine service, it is necessary that they are supported by a reference measurement system so as to be comparable and ultimately t
24、raceable to measurement standards of the highest metrological level. The substances which are used to obtain this traceability, both through time, distances, and different measurement procedures, are the reference materials. A given reference material is supported by documentation containing descrip
25、tions, measurement results, instructions for use, stability data, and storage conditions. The present European Standard specifies the content and format of such supporting documentation. Reference materials are used for one of three main purposes: a) calibration of values indicated by a measuring sy
26、stem or of another reference material; b) validation or control of trueness of measured values in a given laboratory, or in a group of laboratories; c) evaluation of the performance of a new measurement procedure. The maximum acceptable uncertainty of measurement of the assigned value of the referen
27、ce material depends on the requirements of the results of the measurement procedure. 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 (written) standards available are listed in
28、 ISO/IEC Guide 15. 1 Scope This European Standard specifies requirements and formats for the description of reference materials. It is applicable to reference materials of higher metrological order, classifiable as primary measurement standards and secondary measurement standards that function eithe
29、r as calibrators or control materials for reference measurement procedures. This standard does not apply to reference materials that are parts of an in vitro diagnostic measuring system. This European Standard also provides instructions on how to collect basic data for value determination and how to
30、 present the assigned value. The standard also specifies the format for a certificate. This European Standard is not applicable to the production of the reference materials. 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other publications.
31、These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For un
32、dated references the latest edition of the publications referred to applies. EN 375:1992, In vitro diagnostic systems Requirements for labelling of in vitro diagnostic reagents for professional use. ISO 31:1992, Quantities and units. 3 Terms and definitions For the purposes of this standard, the ter
33、ms and definitions given in the International vocabulary of basic and general terms in metrology apply (3.1 and 3.2 are quotes from VIM) together with the following. 3.1 primary measurement standard standard that is designated or widely acknowledged as having the highest metrological qualities and w
34、hose value is accepted without reference to other standards of the same quantity 6.4 of VIM NOTE 1The concept of primary standard is equally valid for base quantities and derived quantities. NOTE 2The word measurement has been included in the term here for consistency. NOTE 3Measurement standards in
35、clude reference materials. 3.2 secondary measurement standard standard whose value is assigned by comparison with a primary standard of the same quantity 6.5 of VIM NOTE 1The word measurement has been included in the term here for consistency. NOTE 2Measurement standards include reference materials.
36、 3.3 matrix (of a material system) all components of a material system except the analyte 3.4 matrix effect influence of a property of the sample, independent of the presence of the analyte, on the measurement and thereby on the value of the measurable quantity NOTE 1A specified cause of a matrix ef
37、fect is an influence quantity. NOTE 2A matrix effect depends on the detailed steps of the measurement as described in the measurement procedure. EXAMPLE The measurement of the amount-of-substance concentration of sodium ion in plasma by flame emission spectrometry may be influenced by the viscosity
38、of the sample. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:14 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 12287:1999 BSI 10-1999 3.5 commutability of a material ability of a material to yield the same numerical relationships between results of measurements by a given set of
39、 measurement procedures, purporting to measure the same quantity, as those between the expectations of the relationships obtained when the same procedures are applied to other relevant types of material NOTEFor reference materials used to calibrate measurement procedures intended for biological samp
40、les, other relevant types of material include a large number of samples from healthy and relevantly diseased individuals. 3.6 report document giving detailed information on a reference material, supplementary to that contained in a certificate or package insert NOTEThe information may comprise the p
41、reparation of the reference material, methods of measurement, factors affecting trueness, statistical treatment of results, and the way in which traceability was established. 4 Classification and naming of reference materials 4.1 Description of the properties of reference materials A reference mater
42、ial has properties, each of which shall be described according to the following format: a) system (i.e. the material itself); b) any relevant component(s); and c) kind-of-quantity (quantity in a general sense). If the property is a measurable quantity, it shall have a value that is equal to: d) a nu
43、merical value multiplied by; e) a unit of measurement. EXAMPLE Certified reference material (BCR; CRM 303)Calcium(II); amount-of-substance concentration (reconstituted) c = 2,472 mmol/l (U = 0,019 mmol/l; k = 2) where U is the expanded uncertainty of measurement using the coverage factor k. 4.2 Syst
44、em 4.2.1 Function The reference material shall be capable of functioning as one of the following: a) calibration material (calibrator): to determine the calibration function of a given measurement procedure (which may then also be used to calibrate another reference material); or b) control material
45、: to assess the analytical trueness or uncertainty of measurement of an established or new measurement procedure in a given laboratory or in a group of laboratories. Within a given measuring system in a given laboratory, a reference material shall perform only one of the functions, and which one sha
46、ll be specified by the term calibration material (calibrator) or control material. 4.2.2 Application and authorities The application and authorities of the system shall consist of the following: a) geographical scope; e.g. international, regional, national, local; b) responsible body, e.g. authority
47、, institution, company, or laboratory; c) certification of properties where applicable. NOTEExamples of the responsible bodies of item b) include the World Health Organization (WHO), the Standards, Measurements and Testing Programme of the European Commission, national reference institution, manufac
48、turer of separately available reference materials or a specialized hospital laboratory. In item c) some values may have to be certified, e.g. by the Standards, Measurements and Testing Programme of the European Commission or by the National Institute of Standards and Technology (NIST) of the USA. Ot
49、her values may be given for information only. 4.2.3 Hierarchical position of reference materials of higher order in the reference measurement system Measurement standards of higher order shall be classified according to their positions in the reference measurement system for a given quantity as follows: a) primary measurement standard (see 3.1); b) secondary measurement standard (see 3.2). 4.2.4 Identification code(s) An identification code shall be assigned to the reference material. A lot identification shall be included when av
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