ГОСТ ISO 17511-2011 Изделия медицинские для диагностики in vitro. Измерение величин в биологических пробах. Метрологическая прослеживаемость значений, приписанных калибраторам и контрольным материалам
Библиография
[1] ISO 3534-1:1993 | Statistics; vocabulary and symbols; part 1: probability and general statistical terms (Статистика. Словарь и обозначения. Часть 1. Вероятность) |
[2] ISO 15194:2002 | In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials (Изделия медицинские для диагностики in vitro. Измерение величин в пробах биологической природы. Описание стандартных образцов) |
[3] ISO 15193:2002 | In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Presentation of reference measurement procedures (Изделия медицинские для диагностики in vitro. Измерение величин в пробах биологической природы. Описание методик референтных измерений) |
[4] GUM | Guide to the expression of uncertainty in measurement, 1 |
[5] ISO 9000:2005 | Quality management systems - Fundamentals and vocabulary (Системы менеджмента качества. Основные положения и словарь) |
[6] ISO 5725-1:1994 | Accuracy (trueness and precision) of measurement methods and results. Part 1. General principles and definitions (Точность (правильность и прецизионность) методов и результатов измерений. Часть 1. Общие принципы и определения) |
[7] ISO 5725-2:1994 | 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 (Точность (правильность и прецизионность) методов и результатов измерений. Часть 2. Основной метод определения повторяемости и воспроизводимости стандартного метода измерений) |
[8] ISO 5725-3:1994 | Accuracy (trueness and precision) of measurement methods and results. Part 3. Intermediate measures of the precision of a standard measurement method (Точность (правильность и прецизионность) методов и результатов измерений. Часть 3. Промежуточные показатели прецизионности стандартного метода измерений) |
[9] ISO 5725-4:1994 | Accuracy (trueness and precision) of measurement methods and results. Part 4. Basic methods for the determination of the trueness of a standard measurement method (Точность (правильность и прецизионность) методов и результатов измерений. Часть 4. Основные методы определения правильности стандартного метода измерений) |
[10] ISO 5725-5:1998 | Accuracy (trueness and precision) of measurement methods and results. Part 5. Alternative methods for the determination of the precision of a standard measurement method (Точность (правильность и прецизионность) методов и результатов измерений. Часть 5. Альтернативные методы определения прецизионности стандартного метода измерений) |
[11] ISO 5725-6:1994 | Accuracy (trueness and precision) of measurement methods and results. Part 6. Use in practice of accuracy values (Точность (правильность и прецизионность) методов и результатов измерений. Часть 6. Использование значений точности на практике) |
[12] | WHO Guidelines for the preparation, characterization and establishment of international and other .standards and reference reagents for biological substances. Techn Rep Ser 1990; No 800 (Annex 4): 181-214 |
[13] | Kobold U, Jeppsson JO, Dulfer T, Finke A, Hoelzel W, Miedema K. Candidate reference methods for HbA1 |
[14] | Clin. Lab.Haemat. 1994; 16: 131-138 |
[15] | Report of the Expert Committee on Biological Standardization's yearly meetings, WHO Technical Report series 1989-1997, and WHO Weekly Epidem. Rec., 1997-1999 |
ISO 18153:2003 | In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials (Изделия медицинские для диагностики in vitro. Измерение величин в биологических пробах. Метрологическая прослеживаемость значений каталитической концентрации ферментов, приписанных калибраторам и контрольным материалам) |
ISO/REMCO 181:1989 | The hierarchy and traceability of certified reference materials (Иерархия и прослеживаемость аттестованных стандартных образцов) |
ISO Guide 33:1989 | Uses of certified reference materials (Использование аттестованных стандартных образцов) |
ISO Guide 30:1992 | Terms and definitions used in connection with reference materials (Термины и определения, касающиеся стандартных образцов) |
ISO Guide 32:1997 | Calibration in analytical chemistry and use of certified reference materials (Калибровка в аналитической химии и использование аттестованных стандартных образцов) |
ENV 1614:1995 | Health care informatics - Structure for nomenclature, classification, and coding of properties in clinical laboratory sciences (Информатика в медицине. Представление видов установленных свойств в лабораторной медицине) |
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, OJ, 1998, No L 331 | |
Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986; 307-10 | |
Bland JM, Altman DG. Comparing methods of measurement: why plotting difference against standard method is misleading. Lancet 1995; 1085-7 | |
Buettner J. Reference methods as a basis for accurate measuring systems. Eur J Clin Chem Clin Biochem 1991; 29: 223-35 | |
Dybkaer R. Reference materials - A main element in a coherent reference measurement system. . Eur J Clin Chem Clin Biochem 1991; 29: 241-6 | |
Eurachem, CITAC. Quantifying uncertainty in analytical measurement. 2nd edit. 2000:ii+120 pp | |
European cooperation for Accreditation of Laboratories. Traceability of measuring and test equipment to national standards. EAL-G12. 1st ed. 1995-11 | |
European Diagnostic Manufacturers Associaton. General Aspects of medical and metrological traceability in Laboratory Medicine. Position Paper. 2001-03-14, 8pp | |
Gramlich JW, Machlan LA, Britic KA, Kelly WR. Thermal ionization isotope dilution mass spectrometry as a definitive method for the determination of potassium in serum. Clin Chem 1982;28: 1309-13 | |
Hyltoft Petersen P, Stockl D, Blaabjerg O, Pedersen B, Birkemose E, Thienpont L., et al. Graphical interpretation of analytical data from comparison of a field method with a reference method by use of difference plots. Clin Chem 1997;43: 2039-46 | |
King B. Metrology in chemistry. Current activities and future requirements in Europe. Brussels: European Commission, DGXII/C/4, 1998-11: 31 pp | |
Kose V. Dissemination of units in Europe. Traceability and its assurance in a national and regional context. Metrologia 1994/95; 31: 457-66 | |
National Committee for Clinical Laboratory Standards (NCCLS).Terminology and definitions for use in NCCLS Documents, Approved Standard, NRSCL8-A, 1998-11 | |
National Institute of Standards and Technology. (Taylor BN, Kuyatt CE) Guidelines for evaluating and expressing the uncertainty of NIST measurement results. NIST Technical Note 1297. Washington: US Department of Commerce. 1994 | |
Quinn TJ. Base units of the Systeme Internationale d'Unites, their accuracy, dissemination and international traceability. Metrologia 1994/95; 31: 515-27 | |
Quinn TJ. Primary methods of measurement and primary standards. Metrologia 1997; 34: 61-5 | |
Ricos C, Juvany R, Jimenez CV, Perich C, Minchinela J, Hernandez A, et al. Procedure for studying commutability validated by biological variation. Clin Chim Acta 1997; 268: 73-83 | |
Rigg JC, Brown SS, Dybkaer R, Olesen H. Compendium of terminology and nomenclature of properties in clinical laboratory sciences (IUPAC/ IFCC Recommendations 1995). Oxford: Blackwell Science Ltd. 1995:xi+290 | |
Stockl D, Franzini C, Kratochvila J, Middle J, Ricos C, Siekmann L, Thienpont LM. Analytical specifications of reference methods. Compilation and critical discussion (From the members of the European EQA - organizers Working Group B) [Review]. Eur J Clin Chem Clin Bochem 1996; 34: 319-37 | |
Velapoldi RA, Paule RC, Schaffer R, Mandel J, Machlan LA, Gramlich JW. A reference method for the determination of potassium in serum (Special Publcation 260-60). Gaitersburg: National Bureau of Standards; 1979 |