YY/T 1709-2020 PDF English
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 1709-2020 | English | 325 |
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Evaluation of measurement uncertainty of calibrators for in vitro diagnostic kits
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YY/T 1709-2020: Evaluation of measurement uncertainty of calibrators for in vitro diagnostic kits
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1709-2020
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... 30
Foreword
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 kits
1 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 materials
3 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.
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