Path:
Home >
MISC >
Page348 > WS/T 490-2016
| Std ID | Version | USD | Buy | Deliver [PDF] in | Title (Description) |
| WS/T 490-2016 | English | 399 |
Add to Cart
|
3 days [Need to translate]
|
Guideline to calibration of clinical chemistry measurement system
|
Click to Preview a similar PDF
Basic data
| Standard ID | WS/T 490-2016 (WS/T490-2016) |
| Description (Translated English) | Guideline to calibration of clinical chemistry measurement system |
| Sector / Industry | Health Industry Standard (Recommended) |
| Classification of Chinese Standard | C50 |
| Classification of International Standard | 11.020 |
| Word Count Estimation | 10,165 |
| Date of Issue | 2016-07-07 |
| Date of Implementation | 2016-12-15 |
| Quoted Standard | GB/T 6682; JJF 1001; WS/T 403; YY/T 0654; JCGM 200 |
| Regulation (derived from) | State-Health-Announcement (2016)9 |
| Issuing agency(ies) | National Health and Family Planning Commission of the People's Republic of China |
| Summary | This standard specifies a general calibration method for clinical chemistry (clinical biochemistry) measurement systems. This standard is applicable to the routine calibration of the clinical chemistry measurement system of the medical institution, and the manufacturer of the IVD can also refer to it. |
WS/T 490-2016: Guideline to calibration of clinical chemistry measurement system
---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.
Guideline to calibration of clinical chemistry measurement system
ICS 11.020
C50
People's Republic of China health industry standards
Clinical chemistry measurement system calibration guide
2016-07-07 released
2016-12-15 Implementation
People's Republic of China National Health and Family Planning Commission released
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard was drafted. Nantong University Hospital, Beijing Aerospace General Hospital, National Health and Family Planning Commission Clinical Laboratory, Yancheng first
People's Hospital, Shanghai Clinical Laboratory, Yancheng Dongtai People's Hospital, First Affiliated Hospital of China Medical University, Affiliated Kunming Medical College
A hospital, Zhejiang Institute of Yangtze River Delta Research Institute.
The main drafters of this standard. Wang Huimin, Chen Baorong, Yang Zhenhua, Zhang Chuanbao, left Yuanyuan, Wang Yanqiu, Juyi, Zhou Yugui, Kang Hui, Duan Yong,
Hu Wei Jiang.
Clinical chemistry measurement system calibration guide
1 Scope
This standard specifies the clinical chemistry (clinical biochemistry) measurement system universal calibration method.
This standard applies to medical institutions routine laboratory clinical chemistry measurement system calibration of the measurement items, the relevant in vitro diagnostic manufacturers
Can refer to use.
2 Normative references
The following documents for the application of this document is essential. 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 6682 analytical laboratory water specifications and test methods
JJF1001 common measurement terms and definitions
WS/T 403 clinical biochemical tests routine project analysis of quality indicators
YY/T 0654 automatic biochemical analyzer
JCGM200 International Metrology vocabulary basic and common concepts and related terminology (VIM) [InternationalVocabularyof
Metrology-Basic and General Concepts and Associated Terms (VIM)]
3 Terms and abbreviations
3.1 Terms and definitions
The following terms and definitions apply to this document.
3.1.1
Indication indication
The value given by the measuring instrument or measuring system.
Note 1. Indication can be visual or audible, but also transmitted to other devices. Indication is usually indicated by the position and number indicated on the analog output display
Output The number displayed or printed, the code output code, the assignment of the physical measurement is given.
Note 2. Indication and the corresponding measured value does not have to be the same amount of value.
【VIM20124.1】
3.1.2
Measuring instruments measuringinstrument
Equipment used alone or in combination with one or more auxiliary equipment for making measurements.
Note 1. A single measuring instrument is a measuring system.
Note 2. The measuring instrument can be an indicator measuring instrument, it can be a physical measuring tool.
【VIM20123.1】
3.1.3
Measuring system measuringsystem
A set of one or more sets of measurements suitable for the information required to obtain a measured quantity within a specified interval for a particular type of measurement
...