HOME   Cart(1)   Quotation   About-Us Tax PDFs Standard-List
Powered by Google-Search & Google-Books www.ChineseStandard.net Database: 189760 (2 Jul 2022)

YY/T 1213-2013 (YY/T1213-2013)

Standard IDContents [version]USDSTEP2[PDF] delivered inName of Chinese StandardStatus
YY/T 1213-2013English155 Add to Cart 0--3 minutes. Auto-delivery. Follicle stimulating hormone quantitative labelling immunoassay kit Obsolete


YY/T 1213-2013: PDF in English (YYT 1213-2013)
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
......
 
(Above excerpt was released on 2014-12-08, modified on 2021-06-07, translated/reviewed by: Wayne Zheng et al.)
Source: https://www.chinesestandard.net/PDF.aspx/YYT1213-2013