YY/T 1549-2017 (YY/T1549-2017, YYT 1549-2017, YYT1549-2017)
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1549-2017 | English | 339 |
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Calibrator for Biochemical Analyzer
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YY/T 1549-2017
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| YY/T 1549-2024 | English | 379 |
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Calibrator for biochemical analyzer
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YY/T 1549-2024
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Newer version: YY/T 1549-2024 Standards related to: YY/T 1549-2024
| Standard ID | YY/T 1549-2017 (YY/T1549-2017) | | Description (Translated English) | Calibrator for Biochemical Analyzer | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 17,164 | | Date of Issue | 2017-05-02 | | Date of Implementation | 2018-04-01 | | Drafting Organization | Beijing Medical Device Institute, Beijing Tongren Hospital Affiliated to Capital Medical University, SisiMei Kang Biotechnology (Wuxi) Co., Ltd., Shanghai Fosun Changzheng Medical Science Co., Ltd., Changchun Dirui Medical Technology Co., Ltd., Sichuan Mike Biological Technology Co., Ltd. Ltd., Tsinghua Yangtze River Delta Research Institute in Zhejiang Province, Jiangxi Tekang Technology Co., Ltd. | | Administrative Organization | National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC 136) | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 49 | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1549-2017
Calibrator for Biochemical Analyzer
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Biochemical analyzer with calibrator
2017-05-02 released
2018-04-01 implementation
State Food and Drug Administration released
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of this document may be patentable. The release of this document
The agency does not assume responsibility for identifying these patents.
This standard proposed by the State Food and Drug Administration.
This standard by the National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC136) centralized.
This standard was drafted by Beijing Medical Device Testing Institute, Beijing Tongren Hospital affiliated to Capital Medical University, Hesseng Meikang Biotechnology
(Wuxi) Co., Ltd., Shanghai Fosun Long Zheng Medical Science Co., Ltd., Changchun Di Rui Medical Technology Co., Ltd., Sichuan Mike Ke
Co., Ltd., Tsinghua Yangtze River Delta Research Institute, Jiangxi Tekang Technology Co., Ltd.
The main drafters of this standard. Yang Zongbing, Liu Yi, Liu Xiang, Zou Ying Shu, Hu Fangyu, Wu Jie, Sun Chengyan, Sun Keqi, Hu Weijiang, Yan Yan.
Biochemical analyzer with calibrator
1 Scope
This standard specifies the terms and definitions, requirements, test methods, labeling and instructions for use, calibration, transport and
Storage and so on.
This standard applies to automatic biochemical analyzer, semi-automatic biochemical analyzer used for clinical test project analysis of the calibration material,
See Appendix A for an example of clinical test items.
This standard does not apply to biochemical analyzer electrolyte module calibrator.
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 21415-2008 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Calibration of calibrators and control substances
Learn from the source
GB/T 29791.1-2013 Information provided by manufacturers of in vitro diagnostic medical devices (LABELING) - Part 1. Terms, definitions and
common enquiries
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (LABEL) SECTION 2. PROFESSIONAL IN VITRO DIAGNOSTIC AGENTS
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Measurand is measured
The amount to be measured.
[GB/T 29791.1-2013, Definition 3.39]
3.2
Analyte analyte
Sample components with measurable properties.
[GB/T 29791.1-2013, Definition 3.3]
3.3
Calibration calibrator
Measurement standard for in vitro diagnostic instruments or system calibration.
Note. Includes commonly used terms calibrator, calibrator.
[GB/T 29791.1-2013, Definition 3.11]
3.4
Measurement standard measurementstandard
With a definite magnitude and associated measurement uncertainty, used as a reference to achieve the definition of a given quantity.
[GB/T 29791.1-2013, Definition A.3.33]
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