YY/T 1709-2020 PDF English
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YY/T 1709-2020: Evaluation of measurement uncertainty of calibrators for in vitro diagnostic kits
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YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.100 C 44 Evaluation of measurement uncertainty of calibrators for in vitro diagnostic kits Issued on. JUNE 30, 2020 Implemented on. DECEMBER 01, 2021 Issued by. State Drug Administration
Table of Contents
Foreword... 3 1 Scope... 4 2 Normative references... 4 3 Terms and definitions... 4 4 Evaluation process... 6 5 Uncertainty of changing batch of calibrator... 20 Annex A (informative) Examples of uncertainty introduced by uniformity... 21 Annex B (informative) Examples of uncertainty introduced by stability... 23 Annex C (informative) Example of uncertainty evaluation introduced in process of valuing... 26 Bibliography... 30Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009. Attention is drawn to the possibility that some of the elements of this Standard may be the subject of patent rights. The issuing authority shall not be held responsible for identifying any or all such patent rights. This Standard was proposed by State Drug Administration. This Standard shall be under the jurisdiction of National Technical Committee on Medical Clinical Laboratory and In Vitro Diagnostic System of Standardization Administration of China (SAC/TC 136). The drafting organizations of this Standard. Beijing Institute of Medical Device Inspection, Beijing Leadman Biochemical Co., Ltd., Zhongsheng Beikong Biotechnology Co., Ltd., Beckman Coulter Trading (China) Co., Ltd., Sysmex Medical Electronics (Shanghai) Co., Ltd., Shanghai Fosun Long March Medical Science Co., Ltd., Sichuan New Health Biotech Co., Ltd. Main drafters of this Standard. Kang Juan, Liu Chunlong, Jiang Lin, Cui Jun, Su Jing, Jin Huihong, Yang Yi. Evaluation of measurement uncertainty of calibrators for in vitro diagnostic kits1 Scope
This Standard specifies evaluation methods of measurement uncertainty of calibrators for in vitro diagnostic kits. This Standard is applicable to evaluation of measurement uncertainty of product calibrators for in vitro diagnostic quantitative kits.2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 21415, In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials3 Terms and definitions
For the purposes of this document, the following terms and definitions apply. 3.1 product calibrator; calibrator The calibrator intended for the manufacturer's final product. 3.2 working calibrator; master calibrator Measurement standard used for calibration of manufacturer's permanent measurement procedures. 3.3 metrological traceability The characteristic of linking measurement results with references through a documented uninterrupted calibration chain. Every calibration introduces measurement uncertainty. 3.4 measurement uncertainty; uncertainty Non-negative parameter that characterize the dispersion given to measured value, according to the information used. [GB/T 29791.1-2013, definition A.3.35] 3.5 target uncertainty; maximum allowable measurement uncertainty The specified upper limit of the measurement uncertainty based on the intended use of the measurement result.4 Evaluation process
4.1 General 4.1.1 Basic flow According to the flow shown in Figure 1, evaluate the measurement uncertainty of in vitro diagnostic calibrator. 4.1.2 Amount of being measured and target uncertainty The manufacturer shall specify the amount of being measured, including the intended use of the amount in a specific medical decision, biological sample matrix and any type and unit of measurement related to the analyzed component, amount. 4.1.3 Sources of uncertainty See Figure 2 for evaluation of measurement uncertainty sources of calibrators for in vitro diagnostic kits. The measurement uncertainty introduced by uniformity and stability as well as the uncertainty related to the setting process together constitute the main component of the measurement uncertainty of the calibrator. 4.1.4 Uncertainty evaluation strategy The scheme proposed in this Standard is a non-restrictive scheme. Other reasonable schemes can be used to evaluate the uncertainty of the calibrator. 4.2 Measurement uncertainty introduced by uniformity, ubb 4.2.1 General The product calibrators for in vitro diagnostic kits are usually produced in batches. The measurement uncertainty ubb introduced by the uniformity between bottles within a batch, constitutes an important component of the uncertainty of the calibrator. 4.2.2 Test scheme 4.2.2.1 Test method The test method shall meet the following requirements. 4.2.2.2 Sample extraction According to random stratification method, extract the calibrator from the smallest packaging unit for uniformity inspection. Number the samples in sequence, for example, 1, 2,..., 15. 4.2.2.3 Testing Each packaging unit is respectively measured at least 3 times. Considering the fluctuation of the measurement system over time and other factors, it needs to reverse the sequence of samples between 3 measurements, for example, 1-3- 5-7-9-11-13-15-2-4-6-8-10-12-14-15-14-13-12-11-10-9-8-7-6-5-4-3-2-1-2-4-6- 8-10-12-14-1-3-5-7-9-11-13-15. 4.3 Measurement uncertainty introduced by stability, us 4.3.1 General The stability of the calibrator includes long-term stability and short-term stability. Long-term stability is the storage stability under the conditions specified by the manufacturer. Short-term stability includes transportation stability and use stability (for example, involving multiple sampling). Generally, the measurement uncertainty introduced by long-term stability, ults, constitutes an important component of the uncertainty of the calibrator. The measurement uncertainty introduced by short-term stability, usts, shall also be considered when it is not negligible. 4.6 Uncertainty reporting and evaluation When the user needs it, the manufacturer shall provide the user with the uncertainty of the calibrator assignment and be able to provide the uncertainty component results and uncertainty evaluation process.5 Uncertainty of changing batch of calibrator
Usually the calibrator needs to re-evaluate the uncertainty. If the historical batch data of uncertainty component or combined uncertainty is used, the following conditions must be met. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
