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YY/T 1549-2024: Calibrator for biochemical analyzer
Status: Valid YY/T 1549: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| 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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| 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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Basic data | Standard ID | YY/T 1549-2024 (YY/T1549-2024) | | Description (Translated English) | Calibrator for biochemical analyzer | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100.10 | | Word Count Estimation | 18,166 | | Date of Issue | 2024-02-07 | | Date of Implementation | 2025-03-01 | | Older Standard (superseded by this standard) | YY/T 1549-2017 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements, labels, instructions for use, packaging, transportation and storage of calibrators for biochemical analyzers, and describes the corresponding test methods. This document is applicable to calibrators used on fully automatic biochemical analyzers and semi-automatic biochemical analyzers for analysis of clinical testing items. This document does not apply to calibrators for electrolyte modules of biochemical analyzers. | YY/T 1549-2024: Calibrator for biochemical analyzer---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.
ICS 11.100.10
CCSC44
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY/T 1549-2017
Calibrators for biochemical analyzers
Released on 2024-02-07
2025-03-01 Implementation
The State Drug Administration issued
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document replaces YY/T 1549-2017 “Calibrators for Biochemical Analysis”. Compared with YY/T 1549-2017, except for the structural adjustment and editing
In addition to the logical modifications, the main technical changes are as follows.
--- Added the definition of "total allowable error" (see 3.6);
--- Changed the uniformity requirements (see 4.7, 4.7 of the.2017 edition);
--- Changed the stability requirements (see 4.8, 4.8 of the.2017 edition);
--- The uniformity test method has been changed (see 5.8, 5.8 of the.2017 edition);
--- Changed the stability test method (see 5.9, 5.9 of the.2017 edition);
--- Changed the labeling and instructions for use requirements (see Chapter 6, Chapter 6 of the.2017 edition).
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Clinical Testing Laboratories and In Vitro Diagnostic Systems (SAC/TC136).
This document was drafted by. Beijing Medical Device Inspection Institute (Beijing Medical Biological Protection Equipment Inspection and Research Center), Beijing Shuimu
Jiheng Biotechnology Co., Ltd., Beijing Jinyuan Medical Testing Laboratory Co., Ltd., the First Medical Center of the General Hospital of the Chinese People's Liberation Army, Beijing
Jingantu Bioengineering Co., Ltd., Beijing Jiuqiang Biotechnology Co., Ltd., Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Di
Rui Medical Technology Co., Ltd., MyBiotech Co., Ltd., Sysmex Biotech (Wuxi) Co., Ltd., Sinopharm Biopharmaceuticals
Technology Co., Ltd.
The main drafters of this document are. Song Wei, Yang Zongbing, Chen Baorong, Yang Qiuliang, Liu Chunlong, Wang Xiaojian, Wan Xianzi, Chang Shuqin, Long Tengxiang, Hu Fangyu,
Jin Ling.
The previous versions of this document and the documents it replaces are as follows.
---First published in.2017 as YY/T 1549-2017;
---This is the first revision.
Calibrators for biochemical analyzers
1 Scope
This document specifies the requirements, labeling and instructions for use, packaging, transportation and storage of calibrants for biochemical analyzers and describes the corresponding
Test method.
This document is applicable to calibrants used in fully automatic biochemical analyzers and semi-automatic biochemical analyzers for analysis of clinical test items.
Note. See Appendix A for examples of clinical test items.
This document does not apply to calibrants for electrolyte modules of biochemical analyzers.
2 Normative references
The contents of the following documents constitute the essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 21415 Metrological traceability of values assigned to calibrators and control materials for the measurement of quantities in biological samples of in vitro diagnostic medical devices
Origin
GB/T 29791.2 Information provided by the manufacturer of in vitro diagnostic medical devices (labeling) Part 2.Professional in vitro diagnostic reagents
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
The measured
The quantity to be measured.
[Source. GB/T 29791.1-2013, 3.39]
3.2
Analyte
A component of a sample that has a measurable property.
[Source. GB/T 29791.1-2013, 3.3]
3.3
Calibrator
Measurement standards used for calibration of in vitro diagnostic instruments or systems.
Note. This includes the commonly used terms calibration fluid and calibrant.
[Source. GB/T 29791.1-2013, 3.11]
3.4
measurement standard measurement standard
A defined realization of a given quantity with a definite value and associated measurement uncertainty, used as a reference.
[Source. GB/T 29791.1-2013, A.3.33]
3.5
A non-negative parameter that characterizes the dispersion of the values of the quantity being measured, based on the information used.
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