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YY/T 1160-2021 (YYT 1160-2021)

YY/T 1160-2021_English: PDF (YYT1160-2021)
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YY/T 1160-2021English159 Add to Cart 3 days Carcinoembryonic antigen testing kit YY/T 1160-2021 Valid YY/T 1160-2021

BASIC DATA
Standard ID YY/T 1160-2021 (YY/T1160-2021)
Description (Translated English) Carcinoembryonic antigen testing kit
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100.10
Word Count Estimation 8,885
Date of Issue 2021-12-06
Date of Implementation 2022-12-01
Older Standard (superseded by this standard) YY/T 1160-2009
Quoted Standard GB/T 191; GB/T 21415; GB/T 29791.2
Drafting Organization Beijing Medical Device Inspection Institute
Administrative Organization National Standardization Technical Committee of Medical Clinical Laboratory and In Vitro Diagnostic System
Regulation (derived from) Announcement No. 144 of 2021 of the State Drug Administration
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration
Summary This standard specifies the classification, requirements, test methods, labels and instructions for use, packaging, transportation and storage of carcinoembryonic antigen (CEA) assay kits. This standard applies to kits for quantitative determination of carcinoembryonic antigens based on the double antibody sandwich method, including chemiluminescence, electrochemiluminescence, fluorescence and other labeling methods for luminescence immunoassay kits and enzyme-linked immunosorbent assay kits. This standard does not apply to various types of carcinoembryonic antigen radioimmunization or immunoradiation kits labeled with radioisotopes such as 125I.

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