EN ISO 17511 pdf download

EN ISO 17511 pdf download In vitro diagnostic medical devices – Measurement of quantities in biological samples – Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)
External quality assessment (survey) samples, with proven commutability, whose values have been assigned bymeans of internationally agreed reference measurement systems or internationally agreed conventional referencemeasurement systems fall within the scope of this European Standard.
This European Standard is not applicable to:
a) control materials that do not have an assigned value and are used only for assessing the precision of ameasurement procedure, either its repeatability or reproducibility (precision control materials);
b) control materials intended for intralaboratory quality control purposes and supplied with intervals of suggested
acceptable values,each interval obtained by interlaboratory consensus with respect to one specifiedmeasurement procedure,and with limiting values that are not metrologically traceable;
c) corelation between results of two measurement procedures at the same metrological level, purporting to
measure the same quantity, because such ‘horizontal correlation does not provide metrological traceability;d)
calibration derived from correlation between the results of two measurement procedures at differentmetrological levels, but with quantities having analytes of different characteristics;
e)metrological traceability of routine results to the product calibrator and their relations to any medical
discrimination limit;
f)properties involving nominal scales, i.e.where no magnitude is involved (e.g. identification of blood cells).
2 Normative references
This European Standard incorporates by dated or undated reference,provisions from other publications. Thesenormative references are cited at the appropriate places in the text, and the publications are listed hereafter.Fordated references,subsequent amendments to or revisions of any of these publications apply to this EuropeanStandard only when incorporated in it by amendment or revision.For undated references the latest edition of the
publication referred to applies (including amendments).
EN 375:2001, Information supplied by the manufacturer with in vitro diagnostic reagents for professional use.International Vocabulary of Basic and General Terms in Metrology,2nd edition, ISO,Geneva,1993.1)2)
Iso Guide 35:1989,Certification of reference materials – General and statistical principles.
3Terms and definitions
For the purposes of this European Standard, the following terms and definitions apply:
3.1
accuracy of measurement
closeness of the agreement between the result of a measurement and a true value of the measurand
[VIM:1993,3.5]
NOTE1 Accuracy of measurement is related to both trueness of measurement and precision of measurement.
NOTE2 Accuracy cannot be given a numerical value in terms of the measurand,only descriptions such as ‘sufficient or”insufficient for a stated purpose.
NOTE3 An estimator of an inverse measure of accuracy is “deviation , defined as ‘value minus a conventional true value’.NOTE 4 ISO 3534-1, instead of “a true value” in the definition above, uses the concept “the accepted reference value”, whichcan be a theoretical (true), assigned, consensus, or procedure-defined value.
NOTE5 In this standard the concept “accuracy of measurement” is related to both “rueness of measurement” (see 3.33)and “precision of measurement”*(see 3.23) whereas the Directive 98/79IEC on in vitro diagnostic medical devices uses the term’accuracy instead of “trueness”.
3.2
analyte
component represented in the name of a measurable quantity
EXAMPLE ln the type of quantity “mass of protein in 24-hour urine”. protein” is the analyte. In “amount of substance ofglucose in plasma”, “glucose” is the analyte. In both cases the long phrase represents the measurand (see 3.17).
3.3
analytical specificity
ability of a measurement procedure to measure solely the measurand
3.4
bias of measurements
difference between the expectation of the results of measurement and a true value of the measurand
NOTE An estimator is the “statistical sample bias of measurements” which is the ‘average minus its reference value’.
3.5
calibration
set of operations that establish, under specified conditions, the relationship between values of quantities indicated
by a measuring instrument or measuring system,or values represented by a material measure or a referencematerial, and the corresponding values realized by standards
[VIM:1993,6.11]
NOTE The term “standard” here refers to “measurement standard” (see 3.19), not a written standard.
3.6
calibration transfer protocoltransfer protocol
detailed description for assigning a value of a quantity to a reference material using a speclied sequence ofmeasurement procedures calibrated by higher-order reference materials for the same type of quantity
3.7
calibrator
calibration material
reference material whose value is used for the independent variable in a calibration function
3.8
certified reference materialCRM
reference material,accompanied by a certificate，one or more of whose property values are certified by aprocedure which establishes metrological traceability to an accurate realization of the unit in which the property
values are expressed, and for which each certified value is accompanied by an uncertainty at a stated level ofconfidence