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YY/T 1870-2023: (General requirements for liquid chromatography-mass spectrometry kits)
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1870-2023 | English | 169 |
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(General requirements for liquid chromatography-mass spectrometry kits)
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YY/T 1870-2023
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Basic data | Standard ID | YY/T 1870-2023 (YY/T1870-2023) | | Description (Translated English) | (General requirements for liquid chromatography-mass spectrometry kits) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of International Standard | 11.100.10 | | Word Count Estimation | 8,842 | | Date of Issue | 2023-01-13 | | Date of Implementation | 2024-01-15 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage of liquid chromatography-mass spectrometry detection kits. This standard applies to kits for quantitative detection of human samples (whole blood, serum, plasma, urine, etc.) by liquid chromatography-mass spectrometry. | YY/T 1870-2023: (General requirements for liquid chromatography-mass spectrometry kits)---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 Standard of the People's Republic of China
General requirements for liquid chromatography-mass spectrometry kits
Released on 2023-01-13
2024-01-15 Implementation
Released by the State Drug Administration
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"
to be drafted.
Please note that some contents of this document may refer to patents. Publishing of this document
The Agency assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
This document was drafted by. Beijing Institute of Medical Device Testing, Shanghai Xuhui District Central Hospital, Food and Drug Evaluation and Inspection of Shandong Province
Center, Shanghai Clinical Laboratory Center, Meikang Biotechnology Co., Ltd., Shenzhen Huada Gene Co., Ltd.
The main drafters of this document. Sun Xueqing, Li Shuijun, Guo Jinshuang, Ju Yi, Shen Min, Zhang Shenyan.
General requirements for liquid chromatography-mass spectrometry kits
1 Scope
This document specifies the requirements, test methods, labels and instructions for use of liquid chromatography-mass spectrometry detection kits, packaging, transportation and
storage.
This document is applicable to kits for quantitative detection of human samples (whole blood, serum, plasma, urine, etc.) by liquid chromatography-mass spectrometry
(hereinafter referred to as the kit).
Note. The kit generally includes pretreatment solution, internal standard solution, calibrator, quality control product and other related components.
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
this document.
GB/T 21415 Metrology traceability of measuring calibrators and control substances in biological samples of in vitro diagnostic medical devices
origin
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labelling) Part 2.In vitro diagnostic reagents for professional use
YY/T 1789.5 In vitro diagnostic test system performance evaluation method - Part 5.Analytical specificity
3 Terms and Definitions
This document does not have terms and definitions that need to be defined.
4 requirements
4.1 Appearance
Manufacturers should specify appropriate appearance requirements according to the packaging characteristics of their own products. Generally, there should be the composition and properties of each component of the kit;
Requirements for packaging, clear labels, etc.
4.2 Net content
The net content should not be less than the marked value.
4.3 Traceability
The manufacturer shall provide the source, assignment process and measurement uncertainty of the calibration products used in accordance with GB/T 21415 and relevant regulations
content.
4.4 Linearity
The following requirements shall be met within the linear interval given by the manufacturer.
a) The correlation coefficient (r) should not be less than 0.9900;
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