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YY/T 1970-2025: Lipoprotein-associated phospholipase A2 testing kit (Chemiluminescent immuoassay)
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1970-2025	English	189	Add to Cart	3 days [Need to translate]	Lipoprotein-associated phospholipase A2 testing kit (Chemiluminescent immuoassay)

YY/T 1970-2025: Lipoprotein-associated phospholipase A2 testing kit (Chemiluminescent immuoassay)

---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 Lipoprotein-associated phospholipase A2 assay kit (Chemiluminescent immunoassay) Published on 2025-06-18 Implemented on July 1, 2026 National Medical Products Administration issued

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents". Drafting. Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents. This document was proposed by the National Medical Products Administration. This document is under the jurisdiction of the National Technical Committee on Standardization of Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136). This document was drafted by. Guangdong Provincial Institute of Medical Device Quality Supervision and Inspection, Beijing Institute for Medical Device Testing (Beijing Medical Biotechnology Institute). Protective Equipment Testing and Research Center), Shanghai Clinical Testing Center, Fuwai Hospital of Chinese Academy of Medical Sciences, Chongqing Medical Device Quality Inspection Center Heart, Shenzhen Pumen Technology Co., Ltd., Xiamen Wantai Kerry Biotechnology Co., Ltd. The main drafters of this document are. Pan Xiaofang, Dai Leiying, Ou Yuanzhu, Lin Yahui, Wu Jingbiao, He Lechun, Shi Dandan, and Song Liuwei. Lipoprotein-associated phospholipase A2 assay kit (Chemiluminescent immunoassay)

1 Scope

This document specifies the requirements, labeling, marking, and use of the lipoprotein-associated phospholipase A2 assay kit (chemiluminescent immunoassay). Instructions, packaging, transportation, and storage are provided, along with descriptions of the corresponding test methods. This document applies to reagents for the quantitative determination of human serum and plasma lipoprotein-associated phospholipase A2 using chemiluminescence immunoassay. Kits (hereinafter referred to as kits) include chemiluminescence analysis kits using microplates, tubes, magnetic particles, microbeads and plastic beads as carriers.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included. For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies. This document. GB/T 191 Pictorial Symbols for Packaging and Storage GB/T 21415 Metrological Traceability of Calibrators and Control Substances for the Measurement of Quantities in Biological Samples of In Vitro Diagnostic Medical Devices Source GB/T 29791.1 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 1.Terms, definitions and general terms Require GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.Professional in vitro diagnostic reagents YY/T 0466.1 Symbols for medical devices used to provide information to manufacturers - Part 1.General requirements

3 Terms and Definitions

The terms and definitions defined in GB/T 29791.1 apply to this document.

4 Requirements

4.1 Appearance The appearance should meet the following requirements. a) All components of the kit should be complete and intact, with no leakage of liquid; b) Chinese packaging labels should be clear and undamaged. 4.2 Traceability Manufacturers should provide the source, assignment process, and other details of the lipoprotein-associated phospholipase A2 calibrators in accordance with GB/T 21415 and relevant regulations. Contents such as measurement uncertainty. 4.3 Limit of Detection The detection limit should not exceed 10 ng/mL. ...