YY/T 1181-2021_English: PDF (YY/T1181-2021)
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YY/T 1181-2021 | English | 199 |
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(Immunochemistry kit)
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YY/T 1181-2021
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YY/T 1181-2010 | English | 359 |
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Immunohistochemistry kit
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YY/T 1181-2010
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Standard 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 | Classification of International Standard | 11.100.10 | Word Count Estimation | 9,936 | Date of Issue | 2021-09-06 | Date of Implementation | 2023-03-01 | Summary | This standard specifies the general product classification, requirements, test methods and identification, labels, instructions for use, packaging, transportation and storage of immunohistochemical kits. This standard applies to histochemical/cytochemical qualitative reagents or kits based on antigen-antibody reaction for the detection of human tissue and cell samples. | Standard ID | YY/T 1181-2010 (YY/T1181-2010) | Description (Translated English) | Immunohistochemistry kit | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | Classification of Chinese Standard | C44 | Classification of International Standard | 11.100 | Word Count Estimation | 9,966 | Date of Issue | 2010-12-27 | Date of Implementation | 2012-06-01 | Quoted Standard | GB/T 191; YY/T 0466.1-2009 | Drafting Organization | Beijing Medical Device Testing | Administrative Organization | National Standardization Technical Committee of Medical clinical testing laboratories and in vitro diagnostic systems | Regulation (derived from) | State Food and Drug Administration Notice 2010 No. 97 | Proposing organization | National laboratories and in vitro diagnostic medical systems Clinical Laboratory Standardization Technical Committee (SAC/TC 136) | Issuing agency(ies) | China Food and Drug Administration | Summary | This standard specifies the immunohistochemistry kit universal product classification, requirements, test methods and marking, labeling, instructions, packaging, transport and storage and so on. This standard applies to medical laboratories used for the antigen-antibody reaction -based detection of paraffin sections, frozen sections and smears, climbing film and other specimens of tissue/cell chemical characterization kit, the kit includes at least one resistance and color systems. |
YY/T 1181-2021
(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
foreword
This 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 Kit
1 Scope
This 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 references
The 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 use
3 Terms and Definitions
The 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.
......
YY/T 1181-2010
Immunohistochemistry kit
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Immunohistochemistry kit
Issued on. 2010-12-27
2012-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard is evaluated by immunohistochemistry kit product quality basis.
Please note that some of the content of this document may involve patents. Distribution of this document
Institutions do not assume the responsibility to identify these patents.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) proposed.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized.
This standard was drafted. Beijing Medical Device Testing, Guangzhou deep biological products Technology Co., Ltd., Fujian Mai opened new biotechnologies
Company Limited, Roche Diagnostics (Shanghai) Co., Ltd.
The main drafters of this standard. Bi Chunlei, He Mingxia, Wang Ya, Zhang, Li Yang.
Immunohistochemistry kit
1 Scope
This standard specifies the immunohistochemistry kit versatile product classifications, requirements, test methods and signs, labels, brochures, package
Loading, transport and storage and so on.
This standard applies to the use of medical laboratory based on antigen-antibody reaction for detecting paraffin sections, frozen sections and smears, climbing film
And other samples of tissue/cell chemical characterization kits, the kit comprising at least one antibody and color systems.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 191 Packaging - Pictorial signs
Symbols - Part 1 YY/T 0466.1-2009 medical equipment used with medical device labels, labeling and information. General requirements
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Immunohistochemistry immunohistochemistry, IHC
Immunocytochemistry immunocytochemistry, ICC
Using the principle of specific binding of antigen and antibody, through a chemical reaction with the markings on the antibody chromogenic material (fluorescein, an enzyme, a metal ion
Son, isotopes) color to detect tissue antigens, its positioning, qualitative and quantitative detection technology.
3.2
Antibody antibody
The immunogenic substance stimulating B- lymphocytes, and are able to bind specific immune globulin.
NOTE. immune molecules immunogenic material comprising one or more portions with a unique chemical composition that epitope.
[YY/T 0639-2008, the definition 3.9]
3.2.1
Polyclonal antibodies polyclonalantibody
It can react with the substance class of immunogenic antibodies specifically reactive mixture.
[YY/T 0639-2008, the definition 3.9.1]
3.2.2
Monoclonal antibodies monoclonalantibody
Antibodies specifically reactive with a single epitope can occur in some of the immunogenic agent.
[YY/T 0639-2008, the definition 3.9.2]
3.3
Blank blankcontrol
Immunohistochemical techniques, used to replace the first antibody-associated antibodies without substance.
NOTE. The blank may be non-immune serum or PBS and the like.
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