YY/T 1213-2019_English: PDF (YY/T1213-2019)
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Follicle stimulating hormone testing kit
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YY/T 1213-2019
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YY/T 1213-2013 | English | 170 |
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Follicle stimulating hormone quantitative labelling immunoassay kit
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Standard ID | YY/T 1213-2019 (YY/T1213-2019) | Description (Translated English) | Follicle stimulating hormone testing kit | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | Classification of Chinese Standard | C44 | Classification of International Standard | 11.100 | Word Count Estimation | 10,172 | Date of Issue | 2019 | Date of Implementation | 2020-06-01 | Summary | This standard specifies the classification, requirements, test methods, labels and instructions for use, packaging, transportation and storage of follicle stimulating hormone assay kits. This standard applies to kits for quantitative determination of follicle-stimulating hormone based on the principle of double-antibody sandwich method, including immunoassay kits using enzyme labeling, (electro)chemiluminescence labeling, (time-resolved) fluorescent labeling and other labeling methods. This standard does not apply to: reagents for semi-quantitative determination of follicle-stimulating hormone (such as test strips, etc.) labeled with colloidal gold or other methods; Reagent test kit. | Standard ID | YY/T 1213-2013 (YY/T1213-2013) | Description (Translated English) | Follicle stimulating hormone quantitative labelling immunoassay kit | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | Classification of Chinese Standard | C44 | Classification of International Standard | 11.100 | Word Count Estimation | 9,988 | Quoted Standard | YY/T 0466.1 | Drafting Organization | Chinese Academy of Food and Drug Testing | Administrative Organization | National Medical clinical testing laboratories and in vitro diagnostic systems for Standardization Technical Committee | Regulation (derived from) | State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall) | Proposing organization | State Food and Drug Administration | Issuing agency(ies) | State Food and Drug Administration | Summary | This standard specifies: FSH quantitative labeled immunoassay kit classification, requirements, test methods, marking, labeling, instructions, packaging, transportation and storage. This standard applies to: Principle quantitative determination of follicl |
YY/T 1213-2019
Follicle stimulating hormone testing kit
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 1213-2013
Follicle stimulating hormone assay kit
Foliclestimulatinghormonetestingkit
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Content
Foreword III
1 range 1
2 Normative references 1
3 Category 1
4 Requirements 1
5 Test method 2
6 Labels and instruction manual 4
7 Packaging, transportation, storage 4
Reference 5
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 1213-2013. In addition to editorial changes, major technical changes compared to YY/T 1213-2013
as follows.
--- Modified the standard name;
--- Added information on the GB/T 29791.2 in vitro diagnostic medical device manufacturer (marked) in the normative reference document
Part 2. Professional in vitro diagnostic reagents, delete GB 9969-1998, YY 0466-2003 and GB/T 21415-
2008/ISO 17511.2003 (see 2);
--- Revised the requirements for detection limits and the corresponding detection methods (see 4.2 and 5.2);
---Modified linear requirements and corresponding detection methods (see 4.3 and 5.3);
--- Revised the accuracy requirements and corresponding detection methods (see 4.4 and 5.4);
--- Removed the precision within the analysis and the precision between the analysis, combined into the intra-assay precision (see 4.5.1);
--- Revised the requirements for specificity (see 4.6);
--- Deleted the measurement value item of the quality control item;
---Modified the label and the instructions for use (see Chapter 6).
--- Increased packaging should comply with the provisions of GB/T 191 (see 7.1).
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
This standard was drafted. China Food and Drug Control Research Institute, Beijing Medical Device Inspection Institute, Roche Diagnostics Products (Shanghai) Co., Ltd.
Division, Siemens Medical Diagnostics Products (Shanghai) Co., Ltd., Abbott Trade (Shanghai) Co., Ltd., Orson Multi Devices Trading (China) Co., Ltd.
Boao Bio Group Co., Ltd.
The main drafters of this standard. Huang Ying, Yu Ting, Qu Shoufang, Sun Nan, Huang Jie, Wang Ruixia, Cai Xiaorong, Ge Yawen, Wang Shaoying, Xiao Wei, Wang Xuefeng,
Wu Xiaojun, Shi Weihong, Guo Jianfu.
This standard replaces YY/T 1213-2013.
Follicle stimulating hormone assay kit
1 Scope
This standard specifies the classification, requirements, test methods, labels and instructions for use of the follicle stimulating hormone assay kit, packaging, transportation,
Storage.
This standard applies to the kit for quantitative determination of follicle stimulating hormone by the double antibody sandwich method, including enzyme labeling, (electro) chemical
An immunoassay kit for labeling methods such as photo-marking, (time-resolved) fluorescent labeling.
This standard does not apply to semi-quantitative determination of follicle stimulating hormone reagents (eg, test strips, etc.) by colloidal gold or other methods;
A variety of follicle stimulating hormone radioimmunoassay or immunoradiometric kits labeled with a radioisotope such as 125I.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation icon
GB/T 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents
3 classification
According to different labeling methods, it can be divided into enzyme label, (electro) chemiluminescent label, (time-resolved) fluorescent label, etc.
The same can be divided into microplate type, tube type, magnetic particles, microspheres and plastic beads; can be divided into manual operation methods and instruments according to different operating procedures
Automatic operation method.
4 requirements
4.1 Appearance
Manufacturers should specify appropriate appearance requirements based on the packaging characteristics of their products. Generally, there should be components and traits of each component of the kit; internal and external
Requirements for packaging, labeling, etc.
4.2 Detection limit
Should not be higher than 2.0 IU/L.
4.3 Linear
Within the linear range given by the manufacturer (the lower limit should not be higher than 2.0 IU/L, the upper limit should be no less than 100 IU/L), and the correlation coefficient (r) should not
Below 0.9900.
4.4 Accuracy
Accuracy should meet one of the following requirements.
a) In the linear range specified by the kit, the follicle stimulating hormone national (or international) standard is tested, and the relative deviation of the determination results should be
YY/T 1213-2019
Follicle stimulating hormone testing kit
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 1213-2013
Follicle stimulating hormone assay kit
Foliclestimulatinghormonetestingkit
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Content
Foreword III
1 range 1
2 Normative references 1
3 Category 1
4 Requirements 1
5 Test method 2
6 Labels and instruction manual 4
7 Packaging, transportation, storage 4
Reference 5
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 1213-2013. In addition to editorial changes, major technical changes compared to YY/T 1213-2013
as follows.
--- Modified the standard name;
--- Added information on the GB/T 29791.2 in vitro diagnostic medical device manufacturer (marked) in the normative reference document
Part 2. Professional in vitro diagnostic reagents, delete GB 9969-1998, YY 0466-2003 and GB/T 21415-
2008/ISO 17511.2003 (see 2);
--- Revised the requirements for detection limits and the corresponding detection methods (see 4.2 and 5.2);
---Modified linear requirements and corresponding detection methods (see 4.3 and 5.3);
--- Revised the accuracy requirements and corresponding detection methods (see 4.4 and 5.4);
--- Removed the precision within the analysis and the precision between the analysis, combined into the intra-assay precision (see 4.5.1);
--- Revised the requirements for specificity (see 4.6);
--- Deleted the measurement value item of the quality control item;
---Modified the label and the instructions for use (see Chapter 6).
--- Increased packaging should comply with the provisions of GB/T 191 (see 7.1).
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
This standard was drafted. China Food and Drug Control Research Institute, Beijing Medical Device Inspection Institute, Roche Diagnostics Products (Shanghai) Co., Ltd.
Division, Siemens Medical Diagnostics Products (Shanghai) Co., Ltd., Abbott Trade (Shanghai) Co., Ltd., Orson Multi Devices Trading (China) Co., Ltd.
Boao Bio Group Co., Ltd.
The main drafters of this standard. Huang Ying, Yu Ting, Qu Shoufang, Sun Nan, Huang Jie, Wang Ruixia, Cai Xiaorong, Ge Yawen, Wang Shaoying, Xiao Wei, Wang Xuefeng,
Wu Xiaojun, Shi Weihong, Guo Jianfu.
This standard replaces YY/T 1213-2013.
Follicle stimulating hormone assay kit
1 Scope
This standard specifies the classification, requirements, test methods, labels and instructions for use of the follicle stimulating hormone assay kit, packaging, transportation,
Storage.
This standard applies to the kit for quantitative determination of follicle stimulating hormone by the double antibody sandwich method, including enzyme labeling, (electro) chemical
An immunoassay kit for labeling methods such as photo-marking, (time-resolved) fluorescent labeling.
This standard does not apply to semi-quantitative determination of follicle stimulating hormone reagents (eg, test strips, etc.) by colloidal gold or other methods;
A variety of follicle stimulating hormone radioimmunoassay or immunoradiometric kits labeled with a radioisotope such as 125I.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation icon
GB/T 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents
3 classification
According to different labeling methods, it can be divided into enzyme label, (electro) chemiluminescent label, (time-resolved) fluorescent label, etc.
The same can be divided into microplate type, tube type, magnetic particles, microspheres and plastic beads; can be divided into manual operation methods and instruments according to different operating procedures
Automatic operation method.
4 requirements
4.1 Appearance
Manufacturers should specify appropriate appearance requirements based on the packaging characteristics of their products. Generally, there should be components and traits of each component of the kit; internal and external
Requirements for packaging, labeling, etc.
4.2 Detection limit
Should not be higher than 2.0 IU/L.
4.3 Linear
Within the linear range given by the manufacturer (the lower limit should not be higher than 2.0 IU/L, the upper limit should be no less than 100 IU/L), and the correlation coefficient (r) should not
Below 0.9900.
4.4 Accuracy
Accuracy should meet one of the following requirements.
a) In the linear range specified by the kit, the follicle stimulating hormone national (or international) standard is tested, and the relative deviation of the determination results should be
......
YY/T 1213-2013
YY
ICS 11.100
C 44
INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Follicle stimulating hormone quantitative
labelling immunoassay kit
ISSUED ON. DECEMBER 21, 2013
IMPLEMENTED ON. OCTOBER 1, 2014
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Classification ... 4
4 Requirements ... 5
5 Test methods ... 6
6 Marks, labels and instructions ... 8
7 Packaging, transportation and storage ... 10
Bibliography ... 11
Foreword
This standard was drafted in accordance with the rules specified in GB/T 1.1-2009.
Please note that some contents in this file may involve patents. The issuing organization
of this file does not bear the responsibility to identify these patents.
This standard was proposed by the China Food and Drug Administration.
This standard shall be under the jurisdiction of China Clinical Laboratory Testing and In
vitro Diagnostic Test System of Standardization Administration of China (SAC/TC 136).
Drafting organization of this standard. National Institutes for Food and Drug Control.
The main drafters of this standard. Huang Ying, Shen Shu, Yu Ting, Zhang Chuntao, and
Gao Shangxian.
Follicle stimulating hormone quantitative labelling
immunoassay kit
1 Scope
This standard specifies the classification, requirements, test method, marks, labels,
instructions, packaging, transportation and storage etc. of the follicle stimulating hormone
quantitative labelling immunoassay kit.
This standard is applicable to follicle stimulating hormone (FSH) kit [herein after referred
to as “FSH kit”] that is quantitatively determined and based on the principle of double
antibody sandwich method. It includes the FSH immunoassay kit of quantitative
determination by using enzyme labelling, (electrical) chemiluminescent labelling, (time
resolution) fluorescence labelling and other labelling methods as the capture antibodies;
and taking micro-plates, tubes, magnetic particles, micro-beads and plastic beads and
others as the carrier coated antibodies.
This standard does not apply to.
a) Colloidal gold labeled FSH test strip;
b) Various types of FSH radio-immunity or IRMA kit labeled with 125I and other
radioactive isotopes.
2 Normative references
The articles contained in the following documents have become part of this document
when they are quoted herein. For the dated documents so quoted, all the modifications
(Including all corrections) or revisions made thereafter shall be applicable to this
document.
YY/T 0466.1 Devices — Symbols to be used with medical device labels, labelling
and information to be supplied — Part 1. General requirements
3 Classification
The FSH kits can be classified into enzyme labelling FSH kit, (electrical)
chemiluminescent labelling FSH kit, (time resolution) fluorescence labelling FSH kit etc.,
according to the various labelling methods. It can also be divided into different kinds of
FSH kits taking micro-plates, pipes, magnetic particles, micro-beads and plastic beads as
carrier, according to the various solid phase carriers. It can be divided into manual
CV — Coefficient of variation.
5.5.2 Analytical within-precision
Two or three quality control products are set up in different areas of dose-response curves.
The coefficient of variation (CV) of measured value of quality control products shall be in
accordance with the provisions of 4.5.2 among independent analysis with no less than 3
times. The calculation method is same as 5.5.1.
Note. Independent analyses includes. Among different independent experiments, among different
time periods within the period of validity of the kit, among different laboratories with the same
kit and among different operators, etc.
5.5.3 Within-batch precision
Two or three quality control products are set up in different areas of dose-response curves.
The coefficient of variation (CV) of measured value of quality control products shall be in
accordance with the provisions of Clause 4.5.2 among at least 3 batches of products. The
calculation method is same as 5.5.1.
5.6 The measured value of quality control products
Two or three quality control products are set up in different areas of dose-response curves.
The measured results of the kit shall be in accordance with the provisions of Clause 4.6.
5.7 Specificity
The sample with specificity shall be prepared to a prescribed concentration by using the
kit buffer system. The measured results of the kit shall be in accordance with the
provisions of 4.7.1, 4.7.2 and 4.7.3.
5.8 Stability
After the kit is preserved according to the provisions of Clause 4.8.1 or 4.8.2, the
measured results shall be in accordance with related provisions of Clause 4.1, 4.2, 4.3,
4.4, 4.5.1, 4.5.2 and 4.6.
6 Marks, labels and instructions
6.1 Outer package of kit
It shall be in compliance with the requirements of YY/T0466.1, and at least contains the
following content.
a) Product name, specification;
b) Name, address and contact information of manufacturers;
m) Product performance index;
n) Precautions;
o) References;
p) Manufacturing enterprise;
q) License number of medical device manufacturers (limited to domestic enterprises);
r) Medical Device Registration Certificate Number;
s) Product standard number;
t) Approval and modified date of instructions.
7 Packaging, transportation and storage
7.1 Package
Intact, free of leakage and damage.
7.2 Transportation
The transportation of the kit shall be in compliance with the requirement of the
manufacturer.
7.3 Storage
The kit shall be kept under the conditions specified by the manufacturer.
Bibliography
1. GB/T 3358.1 Statistics — Vocabulary and symbols — Part 1.General statistical terms
and terms used in probability
2. JJF 1001-2011 General Terms in Metrology and Their Definitions
3. Ye Yingwu. National clinical laboratory operation specification. Edition 3. Nanjing.
Southeast Press, 2006
4. YY/T 0316-2008 Medical devices — Application of risk management to medical
devices (ISO 14971. 2007, IDT)
5. Chinese Pharmacopoeia Commission. General principles of Radioimmunoassay Kit.
6. Chinese Pharmacopoeia Commission. Chinese Requirements for Biological Products
(2000)
7. Guo Zuchao. Statistical Methods for Medical Use, Edition 3. Beijing. People Health
Press, 1988
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