YY/T 1160-2021 (YYT1160-2021)

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Related Standard	Status	PDF
YY/T 1160-2021	English	159	Add to Cart	3 days [Need to translate]	Carcinoembryonic antigen testing kit	YY/T 1160-2021	Valid	YY/T 1160-2021

YY/T 1160-2021
Carcinoembryonic antigen testing kit
ICS 11:100:10
CCSC44
People's Republic of China Pharmaceutical Industry Standard
Replace YY/T 1160-2009
Carcinoembryonic Antigen (CEA) Assay Kit
Published on 2021-12-06
2022-12-01 Implementation
Released by the State Drug Administration
foreword
This document is in accordance with the provisions of GB/T 1:1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Principles of Standardization Documents"
drafted:
This document replaces YY/T 1160-2009 "Carcinoembryonic Antigen (CEA) Quantitative Determination Reagent (Kit) (Chemiluminescence Immunoassay)", and
Compared with YY/T 1160-2009, in addition to editorial changes, the main technical changes are as follows:
--- Changed the standard scope (see Chapter 1, Chapter 1 of the:2009 edition);
--- Added normative references GB/T 191, GB/T 29791:2 (see Chapter 2);
---Increase the detection limit, linearity of the measurement system in terms and definitions, delete the minimum detection limit, analysis specificity (see Chapter 3,
Chapter 3 of the:2009 edition);
--- Changed the requirements for accuracy and the corresponding detection methods (see 5:3 and 6:3, 5:3 and 6:3 of the:2009 edition);
--- Changed the detection limit requirements and corresponding detection methods (see 5:4 and 6:4, 5:4 and 6:4 of the:2009 edition);
--- Changed the linearity requirements and the corresponding detection methods (see 5:5 and 6:5, 5:5 and 6:5 of the:2009 edition);
--- Deleted the product inspection rules (see Chapter 7 of the:2009 edition);
--- Changed the provisions of labels and instructions for use (see Chapter 7, Chapter 8 of the:2009 edition);
--- Increased packaging should comply with the provisions of GB/T 191 (see 8:1):
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, Kemei Diagnostic Technology Co:, Ltd:, Beijing Huaketai Biotechnology Co:, Ltd:
Co:, Ltd:, Roche Diagnostics (Shanghai) Co:, Ltd:
The main drafters of this document: Sun Li, Zhu Jinsheng, Wang Jianmei, Xiao Yi, Cai Xiaorong:
The previous versions of this document and its superseded documents are as follows:
---First published in:2009 as YY/T 1160-2009;
---This is the first revision:
Carcinoembryonic Antigen (CEA) Assay Kit
1 Scope
This document specifies the classification, requirements, test methods, labels and instructions for use, packaging, transportation of carcinoembryonic antigen (CEA) assay kits
and storage, etc:
This document is applicable to kits for quantitative determination of carcinoembryonic antigens based on the double-antibody sandwich method, including chemiluminescence, electrochemiluminescence, fluorescence
Luminescence immunoassay kits and enzyme-linked immunosorbent assay kits for light and other labeling methods:
This document does not apply to various carcinoembryonic antigen radioimmunization or immunoradiation kits labeled with radioisotopes such as 125I:
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
The following terms and definitions apply to this document:
3:1