YY/T 1181-2021 English PDFUS$199.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1181-2021: (Immunochemistry kit) Status: Valid YY/T 1181: Historical versions
Basic dataStandard ID: YY/T 1181-2021 (YY/T1181-2021)Description (Translated English): (Immunochemistry kit) Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C44 Word Count Estimation: 9,915 Issuing agency(ies): State Drug Administration YY/T 1181-2021: (Immunochemistry kit)---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.(Immunochemistry kit) ICS 11.100.10 C44 People's Republic of China Pharmaceutical Industry Standard Replace YY/T 1181-2010 Immunohistochemistry Kit Published on 2021-09-06 2023-03-01 Implementation Released by the State Drug Administration forewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY/T 1181-2010 "Immunohistochemistry Kits", compared with YY/T 1181-2010, except for editorial changes The main technical changes are as follows. ---In the scope, the original "this standard applies to the detection of paraffin sections, ice and Tissue/cytochemical qualitative kits for frozen sections, smears, smears and other specimens” was revised to “This standard applies to antigen-antibody-based Reaction, histochemical/cytochemical qualitative reagents or kits for the detection of human tissue and cell samples, etc." (see Chapter 1, Chapter 1 of the.2010 edition); --- Deleted "The kit includes at least primary antibody and color development system" from the scope (see Chapter 1 of the.2010 edition); ---In the normative reference document "YY/T 0466.1-2009 Medical Devices for Medical Device Labeling, Marking and Providing Information The symbol of Part 1.General requirements" is revised to "GB/T 29791.2 Letters provided by manufacturers of in vitro diagnostic medical devices Information (Marking) Part 2.In Vitro Diagnostic Reagents for Professional Use" (see Chapter 2, Chapter 2 of the.2010 edition); ---Definition "Using the principle of specific binding of antigens and antibodies, the chromogenic substances (fluorescein, fluorescein, Enzymes, metal ions, isotopes) color development to detect tissue cell antigens, localization, qualitative and quantitative detection technology" Changed to "Using the principle of specific binding of antigen and antibody, through chemical reaction, the chromogenic substance (fluorescein, fluorescein, Enzymes, metal ions, isotopes, chromogens) color development to detect tissue cell antigens, localization, qualitative and semi-quantitative detection technology” (see 3.1, 3.1 of the.2010 edition); ---Definition "antibody mixture that can react specifically with a certain type of immunogenic substance" is revised to "can recognize different antigenic Clustered Immunoglobulin Molecular Mixtures" (see 3.2.1, 3.2.1 of the.2010 edition); ---In the definition note, "blank control can be non-immune serum or PBS, etc." is revised to "blank control can be non-immune serum, PBS, etc." or non-specific negative control reagents, etc." (see 3.3, 3.3 of the.2010 edition); --- In the definition, "tissue or cell slice" is changed to "tissue or cell slice" (see 3.4, 3.5, 3.4, 3.5 of the.2010 edition); ---Definition "There are multiple samples with different antigen contents in one slice at the same time, including strong positive tissue control with antigen, weak antigen Positive tissue control and antigen-negative tissue control" was revised to "Multiple tissues or different antigen contents exist simultaneously in one section. samples, including antigen strong positive tissue control, antigen weak positive tissue control and antigen negative tissue control or different expression process degree of tissue control” (see 3.6, 3.6 of the.2010 edition); ---Terms and Definitions "Background under the microscope, is expected to appear outside a specific location of a cell (other cells or intercellular substance)" "Non-specific staining" was changed to "non-specific staining during non-specific staining immunostaining, any non-specific staining Staining resulting from a heteroantigen-antibody reaction is often referred to as "nonspecific staining" (see 3.7, 3.7 of the.2010 edition); ---Definition "Under the microscope, there is obvious color development in the specific position of the expected cells in the positive tissue slice, and no background appears" modification It is defined as "under the microscope, there is significant color development in the specific location of the expected cells in the positive slide, and there is no background staining or non-specificity. Dyeing appears" (see 3.8, 3.8 of the.2010 edition); ---In the classification, "corresponding methods can be divided into immunofluorescence method, radioimmunoassay, immunoenzymatic method and immunogold-silver method, etc." is revised to "corresponding method" Methods can be divided into immunofluorescence, autoradiography, immunoenzymatic, immunoferritin and immunogold and silver” (see 4.2, 4.2 of the.2010 edition); --- "complete packaging, no damage" is revised to "complete packaging, no damage, no leakage of liquid" [see 5.1b), 5.1b) of the.2010 edition]; --- "Positive control staining result is positive, the location of positive staining should be accurate, no background staining" is modified to "Positive control staining result positive, the location of the positive staining should be accurate, without background staining or non-specific staining” [see 5.2a),.2010 edition of 5.2a)]; --- Logos, labels and instructions for use are changed to "shall comply with the relevant provisions of GB/T 29791.2" (see Chapter 7,.2010 edition of Chapter 7). Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents. This standard is proposed by the State Drug Administration. This standard is under the jurisdiction of the National Standardization Technical Committee of Medical Clinical Laboratory and In Vitro Diagnostic System (SAC/TC136). This standard was drafted by. Beijing Medical Device Inspection Institute, Fuzhou Maixin Biotechnology Development Co., Ltd., Agilent Technologies (China) Co., Ltd. Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd., Xiamen Tongling Biomedical Technology Co., Ltd., Gene (Technology) Shanghai Co., Ltd. Division, China National Institute for Food and Drug Control. The main drafters of this standard. Bi Chunlei, Yang Qinghai, Liu Jia, Yuan Jun, Guo Jincan, Wang Dong, Sun Nan. The previous editions of the standard replaced by this standard are as follows. ---YY/T 1181-2010. Immunohistochemistry Kit1 ScopeThis standard specifies the general product classification, requirements, test methods and identification, labels, instructions for use, and packaging of immunohistochemical kits. packaging, transportation and storage. This standard applies to histochemical/cytochemical qualitative reagents based on antigen-antibody reaction for the detection of human tissue and cell samples, etc. or kit.2 Normative referencesThe following documents are essential for the application of this document. For dated references, only the dated version applies to this article pieces. 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 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) - Part 2.In vitro diagnostic reagents for professional use3 Terms and DefinitionsThe following terms and definitions apply to this document. 3.1 Immunocytochemistry immunocytochemistry; ICC Using the principle of specific binding between antigens and antibodies, the chromogenic substances (fluorescein, enzymes, metals, etc.) labeled on the antibody are made through chemical reaction. It is a technique for detecting tissue cell antigens, and for localization, qualitative and semi-quantitative detection. 3.2 Antibody A specific immunoglobulin that is produced by stimulating B-lymphocytes by immunogenic substances and can bind to immunogenic substances. NOTE. Molecules of immunogenic substances contain one or more moieties with unique chemical constituents, i.e. epitopes. [YY/T 0639-2019, Definition 3.1] 3.2.1 polyclonal antibody polyclonalantibody A mixture of immunoglobulin molecules capable of recognizing different antigenic determinants. [YY/T 0639-2019, Definition 3.11] 3.2.2 Monoclonal antibody monoclonalantibody An antibody that reacts specifically with a single epitope of an immunogenic substance. [YY/T 0639-2019, Definition 3.10] 3.3 blank control In immunohistochemistry, a substance that does not contain related antibodies used to replace the primary antibody. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1181-2021_English be delivered?Answer: Upon your order, we will start to translate YY/T 1181-2021_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 1181-2021_English with my colleagues?Answer: Yes. 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