|
US$559.00 ยท In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1789.1-2021: (Accurate inspection and diagnosis system performance evaluation method - Part 1: Precision)
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1789.1-2021 | English | 559 |
Add to Cart
|
5 days [Need to translate]
|
(Accurate inspection and diagnosis system performance evaluation method - Part 1: Precision)
| Valid |
YY/T 1789.1-2021
|
PDF similar to YY/T 1789.1-2021
Basic data | Standard ID | YY/T 1789.1-2021 (YY/T1789.1-2021) | | Description (Translated English) | (Accurate inspection and diagnosis system performance evaluation method - Part 1: Precision) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Word Count Estimation | 27,239 | | Issuing agency(ies) | State Drug Administration | YY/T 1789.1-2021: (Accurate inspection and diagnosis system performance evaluation method - Part 1: Precision)
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(Accurate inspection and diagnosis system performance evaluation method.Part 1.Precision)
ICS 11.100.10
C30
People's Republic of China Pharmaceutical Industry Standard
Performance evaluation method of in vitro diagnostic test system
Part 1.Precision
Part 1.Precision
Published on 2021-09-06
2023-03-01 Implementation
Released by the State Drug Administration
directory
Preface I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Symbols and Abbreviations 4
5 General 4
5.1 General Requirements 4
5.2 Precision Type 4
5.3 Sample Requirements 4
5.4 Products to be evaluated5
5.5 Evaluation Process 5
5.5.1 Flowchart 5
5.5.2 Analysis of Influencing Factors 5
5.5.3 Evaluation scheme design 6
5.5.4 Precautions for testing 6
5.5.5 Data Analysis 6
5.5.6 Results report 6
6 Evaluation of Repeatability and Intralaboratory Precision7
6.1 Test 7
6.2 Data Inspection and Analysis 7
6.2.1 Outlier test 7
6.2.2 Calculation of SS, MS 7
6.2.3 Computing s and CV 9
6.2.4 Computing confidence intervals 9
6.2.5 Example 10
7 Interlaboratory Precision Evaluation 10
7.1 Test 10
7.2 Data Inspection and Analysis 10
7.2.1 Outlier tests 10
7.2.2 Calculation of SS, DF, MS 10
7.2.3 Computing s and CV 11
7.2.4 Computing confidence intervals 12
7.2.5 Example 12
Appendix A (informative) Example of data analysis for repeatability and intra-laboratory precision evaluation (in the case of data balance) 13
Appendix B (Informative Appendix) Example of Interlaboratory Precision Evaluation Data Analysis (In the case of data balance) 16
Reference 23
foreword
YY/T 1789 "In Vitro Diagnostic Test System Performance Evaluation Method", consists of the following parts.
--- In vitro diagnostic test system performance evaluation method Part 1.Precision;
--- In vitro diagnostic test system performance evaluation method Part 2.Accuracy;
--- In vitro diagnostic test system performance evaluation method Part 3.detection limit and quantification limit;
--- In vitro diagnostic test system performance evaluation method Part 4.Linear interval and reportable interval;
--- In vitro diagnostic test system performance evaluation method Part 5.Analysis specificity;
---In vitro diagnostic test system performance evaluation method Part 6.Precision of qualitative reagents, diagnostic sensitivity and specificity, predictive
measured value.
This part is Part 1 of YY/T 1789.
This section is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents.
This part is under the jurisdiction of the National Standardization Technical Committee of Medical Clinical Laboratory and In Vitro Diagnostic System (SAC/TC136).
This section is drafted by. Beijing Medical Device Inspection Institute, Meikang Biotechnology Co., Ltd., Sysmex Medical Electronics (Shanghai)
Co., Ltd., Shenzhen Yahuilong Biotechnology Co., Ltd., Beijing Jiuqiang Biotechnology Co., Ltd., Zhongsheng Beikong Biotechnology Co., Ltd.
Co., Ltd., Beijing Leadman Biochemical Co., Ltd., Beijing Genetron Gene Technology Co., Ltd., Shandong Broke Biological Industry Co., Ltd.
Company, Shanghai Kehua Biological Engineering Co., Ltd.
The main drafters of this section. Wang Jun, Shen Min, Zhang Shuang, Huang Tao, Zhou Ming, Jiang Lin, Li Changze, Cheng Xiaolei, Xie Qinghua, Peng Bo.
Performance evaluation method of in vitro diagnostic test system
Part 1.Precision
1 Scope
This part of YY/T 1789 specifies the method for evaluating the precision performance of in vitro diagnostic testing systems.
This section applies to the manufacturer's evaluation of the precision of in vitro diagnostic test systems for quantitative testing.
This section does not apply to the performance evaluation of in vitro diagnostic test systems with results reported as nominal and ordinal scales, such as for blood cells
Cell identification, microbial typing, nucleic acid sequence identification, urine particle identification, and the results are reported as negative, positive or in vitro diagnosis of 1, 2, 3
Inspection system.
This section does not apply to medical laboratory precision performance verification, nor does it apply to product type inspection.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 4883-2008 Statistical processing and interpretation of data Judgment and processing of outliers in normal samples
GB/T 6379.2 Accuracy (correctness and precision) of measurement methods and results - Part 2.Determining repetition of standard measurement methods
Basic Methods of Reproducibility and Reproducibility
YY/T 1441 General requirements for performance evaluation of in vitro diagnostic medical devices
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
IVD medical device IVD medical device
Devices used alone or in combination, intended by the manufacturer for the in vitro testing of human specimens, solely or primarily for the purpose of providing diagnosis, monitoring
or compatibility information, devices including reagents, calibrators, control substances, sample containers, software and related instruments or devices or other
thing.
[GB/T 29791.1-2013, definition 3.27]
3.2
IVD Instrument IVDinstrument
A device or device intended by the manufacturer for use as an in vitro diagnostic medical device.
[GB/T 29791.1-2013, definition 3.26]
3.3
IVD reagent IVDreagent
A chemical, biological or immunological component, solution or preparation intended by the manufacturer for use as an in vitro diagnostic medical device.
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1789.1-2021_English be delivered?Answer: Upon your order, we will start to translate YY/T 1789.1-2021_English as soon as possible, and keep you informed of the progress. The lead time is typically 3 ~ 5 working days. The lengthier the document the longer the lead time. Question 2: Can I share the purchased PDF of YY/T 1789.1-2021_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1789.1-2021_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.
|