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1、INTERNATIONAL STANDARD IS0 181 53 First edition 2003-08-1 5 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control mate ri als Dispositifs mdicaux de diagno
2、stic in vitro - Mesurage des grandeurs dans des chantillons dorigine biologique - Traabilit mtrologique des valeurs de concentration catalytique des enzymes attribues aux agents dtalonnage et aux matriaux de contrle Reference number IS0 181 53:2003(E) IS0 2003 Copyright International Organization fo
3、r Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 21:16:14 MDTNo reproduction or networking permitted without license from IHS -,-,- IS0 18153:2003(E) PDF disclaimer This PDF file may contain embedded typefaces. In acco
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8、 Geneva 20 Tel. + 41 22 749 O 1 11 Fax +41 227490947 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii O IS0 2003 -All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not
9、for Resale, 04/19/2007 21:16:14 MDTNo reproduction or networking permitted without license from IHS -,-,- IS0 18153:2003(E) Foreword IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies (IS0 member bodies). The work of preparing Internationa
10、l Standards is normally carried out through IS0 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 organizations, governmental and non-governmental, in liaison with SO, a
11、lso take part in the work. IS0 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 ISO/IEC Directives, Part 2. The main task of technical commit
12、tees 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 the member bodies casting a vote. Attention is drawn to the pos
13、sibility that some of the elements of this document may be the subject of patent rights. IS0 shall not be held responsible for identifying any or all such patent rights. IS0 18153 was prepared by the European Committee for Standardization (CEN) in collaboration with Technical Committee ISOTC 212, Cl
14、inical laboratory testing and in vitro diagnostic test systems, in accordance with the Agreement on technical cooperation between IS0 and CEN (Vienna Agreement). Throughout the text of this document, read “.this European Standard .“ to mean “.this International Standard .“. For the purposes of this
15、International Standard, the CEN annex regarding fulfilment of European Council Directives has been removed. O IS0 2003 -All rights reserved iii Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resal
16、e, 04/19/2007 21:16:14 MDTNo reproduction or networking permitted without license from IHS -,-,- IS0 18153:2003(E) Contents Foreword v Introduction vi 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Metrological traceability chain and calibration hierarchy . 3 4.1 Principles 3 4.2 Str
17、ucture . 4 5 Validation of metrologically traceable calibration 6 5.1 Principles 6 5.2 Analytical specificity of measurement procedures 6 5.3 Commutability of calibrators 7 5.4 Commutability of control materials 7 Annex A (informative) List of IFCC primary reference measurement procedures . 8 Annex
18、B (informative) List of certified reference materials (CRM) . 9 Bibliography 10 iv O IS0 2003 -All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 21:16:14 MDTNo
19、reproduction or networking permitted without license from IHS -,-,- IS0 18153:2003(E) Foreword This document (EN IS0 18153:2003) 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 Committ
20、ee ISO/TC 212 “Clinical laboratory testing and in vitro diagnostic test systems“. This European Standard EN IS0 18153:2003 including the Amendment shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2004, and confl
21、icting national standards shall be withdrawn at the latest by February 2004. 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 EU Directive(s). For relationship with EU Directive(s),
22、 see informative annex ZA, which is an integral part of this document. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), the European Confederation of Laboratory Medicine (ECLM), and the European Diagnostic Manufacturers Association (EDMA) have contributed to its pre
23、paration. This standard includes a Bibliography. Annexes A and B are informative. According to the CENKENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, Franc
24、e, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and the United Kingdom. O IS0 2003 -All rights reserved V Copyright International Organization for Standardization Provided by IHS under license with ISO Licen
25、see=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 21:16:14 MDTNo reproduction or networking permitted without license from IHS -,-,- IS0 18153:2003(E) Introduction The Directive 98/79/EC on in vitro diagnostic medical devices requires that the metrologically traceability of values
26、 assigned to calibrators and control materials be assured through available reference measurement materials and reference measurement procedures of higher order. Following this concept, the European Standard prEN IS0 1751 1 on “traceability“ has been elaborated which describes a hierarchical order o
27、f measurement procedures and calibration materials. The general rules expressed in that standard also apply to quantities involving catalytic activity. Whenever possible, metrological traceability should be demonstrated to the SI unit which forms the top of the calibration hierarchy. For the measure
28、ment of the catalytic activity concentration of enzymes (hereafter called catalytic concentration), a hierarchy of calibrators and measurement procedures is described in the present standard. For enzyme measurements, the definition of the derived coherent SI unit “mole per second cubic metre“, given
29、 the special name “katal per cubic metre“ by the General Conference on Weights and Measures, is the top of the hierarchy followed by a primary reference measurement procedure to which lower level measurement procedures, calibrators, and control materials should be traced whenever possible. Enzymes i
30、n blood or other biological fluids can be measured for diagnostic purposes in terms of their catalytic concentrations. The analytical principle of the measurement of the catalytic rate of conversion of substrate has considerable advantages of speed, low limit of detection, analytical specificity, an
31、d low cost. Results of catalytic concentration measurements are only comparable if the enzyme activities are measured under the same conditions. Therefore, an enzyme measurand cannot be described only by kind-of-quantity (e.g. catalytic concentration), name of enzyme and of system, but requires also
32、 the specified measurement procedure and especially the indicator component of the measured reaction. At the top of the calibration hierarchy, the measurement procedure should be internationally agreed, e.g. creatine kinase measured by the conversion rate of NADH in the IFCC reference measurement pr
33、ocedure. Thus, the primary reference measurement procedure is an integral part of the definition of the measurand and has to be followed in all detail, e.g. as concerns: kind of substrate (where the specificity of the enzyme allows this to be varied) and its concentration, activators and their conce
34、ntrations, direction of catalysed reaction, indicator component, buffer system and pH, temperature, pre-incubation time, material used for starting the reaction, lag time, reaction time. O IS0 2003 -All rights reserved Copyright International Organization for Standardization Provided by IHS under li
35、cense with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 21:16:14 MDTNo reproduction or networking permitted without license from IHS -,-,- IS0 18153:2003(E) The disadvantage of the procedure-dependence of the definition of the enzyme measurand and therefore of the re
36、sults of the measurements are well known: problems are caused in external quality assessment (EQA) and in assessing the transferability of methods; a multiplicity of biological reference intervals exists with the consequent risk of clinical misinterpretation of enzyme results. The standardization of
37、 routine enzyme measurements is important to laboratory medicine, to improve the clinical utility and comparability of results through the elimination of existing differences in biolog ical reference intervals. Two approaches can be considered: a) the exclusive routine use of a recommended or standa
38、rdized procedure for each enzyme; b) calibration of one or more routine procedures by commutable enzyme calibration materials with values assigned by a chosen reference measurement procedure. The “recommended procedure“ approach (a) has been pursued vigorously for more than twenty years. It has had
39、considerable success in improving the quality and comparability of enzyme measurements and in discouraging the use of ana iytica II y unsatisfactory procedures. However, the recommended- proced ure-a pproach to standardization appears to have reached the limits of its usefulness. Its disadvantages i
40、nclude: absence of a consensus of choice among a number of differing recommendations; intentional or unintentional modification of recommended procedures in routine use; unresponsiveness of recommended procedures to analytical and technical improvement; and partly non-adaptability of recommended pro
41、cedures to preferred automation. As a change in routine enzyme procedures, whether recommended or not, inevitably entails a change of biological reference values, it is understandably unwelcome to clinicians. Improvement of the design and analytical performance of enzyme measurements will, and shoul
42、d, continue. However, this should follow the normal practice of development and dissemination of scientific advances. Attempts to develop and promote further standardized procedures for universal use are neither practicable nor desirable. The “reference measurement procedure and calibration material
43、“ approach (b) has, in contrast, received relatively little attention. Among the objections that have been raised are: 1. lack of stable enzyme reference materials in appropriate matrices to serve as calibrators; 2. dissimilarity between candidate enzyme calibrators and the anaiyte enzymes in human
44、samples, including differences in isoforms; 3. absence of a constant inter-procedure ratio between a calibrating (reference) procedure and calibrated (routine) procedure(s), for both the enzyme calibrator and patients samples containing the anaiyte enzyme (also described as a lack of commutability).
45、 The converse of these objections constitutes a list of specifications, both for higher order enzyme reference materials and for families of measurement procedures between which calibration is proposed. The calibrator should be stable and have an anaiyte enzyme that is close in its catalytic propert
46、ies within its matrix to those of the anaiyte enzyme in the routine samples. The procedures themselves should have the same specificity for the catalytic activity of the target enzyme. Harmonization of the results of routine enzyme measurements can thus be achieved by selecting a reference measureme
47、nt procedure and identifying a family of related procedures for each clinically important enzyme. Results obtained by any procedure included within such a family will be metrologically traceable to the chosen reference measurement procedure. O IS0 2003 -All rights reserved vii Copyright Internationa
48、l Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 21:16:14 MDTNo reproduction or networking permitted without license from IHS -,-,- Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 21:16:14 MDTNo reproduction or networking permitted without license from IHS -,-,- IS0 18153:2003(E) 1 Scope This European