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YY/T 1817-2022: Thyroglobulin testing kit (chemiluminescent immunoassay)
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1817-2022 | English | 159 |
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Thyroglobulin testing kit (chemiluminescent immunoassay)
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YY/T 1817-2022
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Basic data | Standard ID | YY/T 1817-2022 (YY/T1817-2022) | | Description (Translated English) | Thyroglobulin testing kit (chemiluminescent immunoassay) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 7,782 | | Issuing agency(ies) | State Drug Administration | YY/T 1817-2022: Thyroglobulin testing kit (chemiluminescent immunoassay)---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.
Thyroglobulin testing kit (chemiluminescent immunoassay)
ICS 11.100.10
CCSC44
People's Republic of China Pharmaceutical Industry Standard
Thyroglobulin Assay Kit
(chemiluminescence immunoassay)
Published on 2022-05-18
2023-12-01 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 of Standardization Documents"
drafted.
Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is under the jurisdiction of the National Standardization Technical Committee for Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136).
This document is drafted by. Beijing Medical Device Inspection Institute, Beijing Tongren Hospital Affiliated to Capital Medical University, Shenzhen New Industry Biomedical
Science Engineering Co., Ltd., Abbott Trading (Shanghai) Co., Ltd.
The main drafters of this document. Liu Yanchun, Sun Xueqing, Liu Xiangyi, Yuan Jinyun, Wu Xiaojun.
Thyroglobulin Assay Kit
(chemiluminescence immunoassay)
1 Scope
This document specifies the requirements, test methods, labeling, labeling, instructions for use, packaging, transportation and
storage.
This document applies to the assay kit for the quantitative detection of thyroglobulin in human blood based on the principle of chemiluminescence immunoassay, including
Including enzymatic and non-enzymatic chemiluminescence immunoassay assay kits using microplates, tubes, magnetic particles, microbeads and plastic beads as carriers, including manual
Manual operation method and automatic operation method of instruments.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document.
GB/T 191 Graphical signs of packaging, storage and transportation
GB/T 21415 Metrological traceability of measurement calibrators and control substance assignments in biological samples of in vitro diagnostic medical devices
origin
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.In vitro diagnostic reagents for professional use
3 Terms and Definitions
There are no terms and definitions that need to be defined in this document.
4 Requirements
4.1 Appearance
Manufacturers should specify appropriate appearance requirements according to the packaging characteristics of the product. Generally, the components and properties of the kit should be included; internal and external packaging, labeling
Clearly signed and other requirements.
4.2 Traceability
The manufacturer shall provide the source, assignment process and measurement uncertainty of the calibrators used in accordance with GB/T 21415 and related regulations
content.
4.3 Linear
Within the linear interval given by the manufacturer (the lower limit is not higher than 2ng/mL, and the upper limit is not lower than.200ng/mL), the correlation coefficient (r) should not be small
at 0.9900.
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