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YY/T 1529-2024: ELISA analytical instruments
Status: Valid YY/T 1529: Evolution and historical versions
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ELISA analytical instruments
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Basic data | Standard ID | YY/T 1529-2024 (YY/T1529-2024) | | Description (Translated English) | ELISA analytical instruments | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100.10 | | Word Count Estimation | 18,174 | | Date of Issue | 2024-09-29 | | Date of Implementation | 2025-10-15 | | Older Standard (superseded by this standard) | YY/T 1529-2017 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements, identification, labeling and instructions for use, packaging, storage and transportation of enzyme-linked immunosorbent assays, and specifies the corresponding test methods. This standard applies to enzyme-linked immunosorbent assays that use the enzyme-linked immunosorbent assay (ELISA) method and the Lambert-Beer law as the measurement principle to perform quantitative or qualitative analysis of the substance to be tested, generally including detection modules, filling modules, incubation modules, cleaning modules, etc. | YY/T 1529-2024: ELISA analytical instruments---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 1529-2017
ELISA
Released on 2024-09-29
Implementation on October 15, 2025
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 1529-2017 "Enzyme-linked Immunoassay Analyzer". Compared with YY/T 1529-2017, except for structural adjustments and editing
In addition to the changes in performance, the main technical changes are as follows.
--- Changed the scope (see Chapter 1, Chapter 1 of the.2017 edition);
--- Deleted the classification (see Chapter 4 of the.2017 edition);
--- Added half-peak width requirements (see 4.2.1);
--- Changed the sensitivity index (see 4.2.6, 5.2.6 of the.2017 edition);
--- Added the average residual liquid requirement for the cleaning module (see 4.2.8);
--- Increased accuracy and precision requirements for filling modules (see 4.2.9);
--- Added the requirements for temperature accuracy and fluctuation of the incubation module (see 4.2.10);
--- Added repeatability requirements for clinical projects (see 4.2.11);
--- Added sample carryover contamination requirements (see 4.2.12);
--- Added electrical safety related standard requirements (see 4.3, 5.3 of the.2017 edition);
--- Added the half-peak width test method (see 5.3, 6.3 of the.2017 edition);
--- Added the test method for the average residual liquid volume of the cleaning module (see 5.10);
--- Added the accuracy and precision test method of the filling module (see 5.11);
--- Added the test method for temperature accuracy and fluctuation of the incubation module (see 5.12);
--- Added repeatability test methods for clinical projects (see 5.13);
--- Added sample carryover contamination test method (see 5.14).
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), China Customs
Science and Technology Research Center, Beijing Shuimujiheng Biotechnology Co., Ltd., Shenzhen Yahuilong Biotechnology Co., Ltd., Shandong Boco
Bio-Industry Co., Ltd. and Shenzhen Aikon Biotechnology Co., Ltd.
The main drafters of this document are. Zhao Bingfeng, Wang Yikai, Yang Zongbing, Huang Tao, Xie Qinghua, Li Yunqi and Li Zheng.
The previous versions of this document and the documents it replaces are as follows.
---First published in.2017 as YY/T 1529-2017, this is the first revision.
ELISA
1 Scope
This document specifies the requirements, identification, labeling and instructions for use, packaging, storage and transportation of enzyme-linked immunosorbent analyzers (hereinafter referred to as analyzers).
The corresponding test methods are described.
This document applies to the enzyme-linked immunosorbent assay (ELISA) method and the Lambert-Beer law as the measurement principle.
An enzyme-linked immunosorbent analyzer for quantitative or qualitative analysis of a substance generally includes a detection module, a filling module, an incubation module, a cleaning module, etc.
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 191 Pictorial markings for packaging, storage and transportation
GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use Part 1.General requirements
GB 4793.6 Safety requirements for electrical equipment for measurement, control and laboratory use Part 6.Characteristics of laboratory material heating equipment
Special requirements
GB/T 14710 Environmental requirements and test methods for medical electrical appliances
GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use Part 1.General requirements
GB/T 18268.26 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use Part 26.Special requirements
In vitro diagnostic (IVD) medical devices
GB/T 29791.3 Information provided by the manufacturer of in vitro diagnostic medical devices (labeling) Part 3.Professional in vitro diagnostic instruments
YY 0648 Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-101.In vitro diagnostic (IVD) medical equipment
Special requirements for
JJG861 ELISA Analyzer Verification Procedure
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
The process includes the adsorption of antigen or antibody on a solid phase carrier (called coating), the test sample (containing the antibody or antigen to be tested) and the enzyme-labeled antibody or antibody.
The antigen or antibody bound to the solid phase carrier reacts with the antigen or antibody bound to the solid phase carrier according to a certain procedure to form an antigen-antibody complex.
The amount of the combined enzyme marker is in a certain ratio to the amount of the analyte in the sample. After the enzyme reaction substrate is added, the substrate is catalyzed by the enzyme to generate a colored product.
The color reaction of the substrate is used to determine whether there is a corresponding immune reaction. The depth of the color reaction is related to the amount of the corresponding antibody or antigen in the specimen.
In proportional relationship.
3.2
Enzyme-linked immunosorbent assay (ELISA) and Lambert-Beer law are used to quantitatively or qualitatively analyze the substances to be tested.
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