ISO 11843-5-2008 检测能力.第5部分:线性和非线性校准容器中的方法学

标准号：ISO 11843-5-2008
中文标准名称：检测能力.第5部分:线性和非线性校准容器中的方法学
英文标准名称：Capability of detection - Part 5: Methodology in the linear and non-linear calibration cases
标准类型：N04
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：N04
国际标准分类号：03.120.30;17.020
引用标准：ISO 3534-1;ISO 3534-2;ISO 3534-3;ISO 5725-1;ISO 11843-1-1997;ISO 11843-2-2000
适用范围：This part of ISO 11843 is concerned with calibration functions that are either linear or non-linear.It specifies basic methods to-- construct a precision profile for the response variable, namely a description of the standard deviation (SD) or coefficient of variation (CV) of the response variable as a function of the net state variable,-- transform this precision profile into a precision profile for the net state variable in conjunction with the calibration function, and-- use the latter precision profile to estimate the critical value and minimum detectable value of the net state variable.The methods described in this part of ISO 11843 are useful for checking the detection of a certain substanceby various types of measurement equipment to which ISO 11843-2 cannot be applied. Included are assays ofpersistent organic pollutants (POPs) in the environment, such as dioxins, pesticides and hormone-likechemicals, by competitive ELISA (enzyme-linked immunosorbent assay), and tests of bacterial endotoxinsthat induce hyperthermia in humans.The definition and applicability of the critical value and minimum detectable value of the net state variable aredescribed in ISO 11843-1 and ISO 11843-2. This part of ISO 11843 extends the concepts in ISO 11843-2 tothe cases of non-linear calibration.The critical value, Xc, and minimum detectable value, xd, are both given in the units of the net state variable. Ifxc and xd are defined based on the distribution for the response variable, the definition should include thecalibration function to transform the response variable to the net state variable. This part of ISO 11843 definesxc and xd based on the distribution for the net state variable independently of the form of the calibrationfunction. Consequently, the definition is available irrespective of the form of this function, whether it is linear ornon-linear.The calibration function should be continuous, differentiable, and monotonically increasing or decreasing.A further method is described for the cases where the SD or CV is known only in the neighbourhood of theminimum detectable value.Examples are provided.