ISO 15193:2009 Invitro診断医療機器—生物学的起源のサンプル中の量の測定—参照測定手順の内容と提示の要件 | ページ 6

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

Note 1 to entry: In 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

3.3

analytical sample

sample prepared from the laboratory sample and from which analytical portions can be taken

Note 1 to entry: The analytical sample can be subjected to various treatments before an analytical portion is taken.

3.4

analytical portion

portion of material taken from the analytical sample and on which the measurement is actually carried out, either directly or following dissolution

Note 1 to entry: The analytical portion is taken directly from the primary sample or laboratory sample if no preparation of these is required. The analytical portion is sometimes dissolved to give an analytical solution before being exposed to the measuring device.

3.5

analytical solution

solution prepared prior to measurement by dissolving an analytical portion in a liquid or solid material, with or without reaction

3.6

matrix

components of a material system, except the analyte

3.7

reference measurement procedure

measurement procedure accepted as providing measurement results fit for their use in assessing measurement trueness of measured quantity values obtained from other measurement procedures for quantities of the same kind, in calibration, or in characterizing reference materials

Note 1 to entry: Adapted from ISO/IEC Guide 99:2007, 2.7.

Note 2 to entry: The roles of reference measurement procedures are detailed in ISO 17511 and ISO 18153.

Note 3 to entry: In ISO terminology, trueness is related to bias, systematic effect and systematic error, whereas accuracy is related to both trueness (with its relations) and precision, which itself is related to standard deviation, random effect and random error.

Note 4 to entry: The term “reference measurement procedure” is intended to be understood as a measurement procedure of higher order.

3.8

analytical sensitivity

quotient of the change in an indication and the corresponding change in the value of a quantity being measured

Note 1 to entry: The term “analytical sensitivity” is not intended to be used as a synonym for “detection limit”.

Note 2 to entry: ISO/IEC Guide 99:2007 uses the term “sensitivity of a measuring system”.

3.9

analytical specificity

ability of a measurement procedure to determine solely the quantity it purports to measure

3.10

analytical interference

systematic effect on a measurement caused by an influence quantity which does not by itself produce an indication, but which causes an enhancement or depression of the indication

3.11

influence quantity

quantity that, in a direct measurement, does not affect a quantity that is actually measured, but affects the relation between the indication and the measurement result

Note 1 to entry: Adapted from ISO/IEC Guide 99:2007, 2.52.

3.12

measurand

quantity intended to be measured

Note 1 to entry: Adapted from ISO/IEC Guide 99:2007, 2.3.

Note 2 to entry: The term “analyte” is not intended to be used for measurand. Analyte is a component of a measurand.

3.13

detection limit

limit of detection

measured quantity value, obtained by a given measurement procedure, for which the probability of falsely claiming the absence of a component in a material is β, given a probability α of falsely claiming its presence

Note 1 to entry: IUPAC recommends default values for α and β equal to 0,05.

Note 2 to entry: The abbreviation LOD is sometimes used.

Note 3 to entry: The term “sensitivity” is discouraged for this concept.

Note 4 to entry: Adapted from ISO/IEC Guide 99:2007, 4.18.

3.14

calibrator

measurement standard used in calibration

Note 1 to entry: Adapted from ISO/IEC Guide 99:2007, 5.12.