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YY/T 1213-2013 English PDF (YYT1213-2013)

YY/T 1213-2013 English PDF (YYT1213-2013)

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YY/T 1213-2013: Follicle stimulating hormone quantitative labelling immunoassay kit
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 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.
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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