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YY/T 1192-2011 (YY/T1192-2011)

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YY/T 1192-2011English145 Add to Cart 0--3 minutes. Auto-delivery. Human chorionic gonadotropin (HCG) quantitative detection reagent (kit) (Chemiluminescent immunoassay) Valid


YY/T 1192-2011: PDF in English (YYT 1192-2011)
YY/T 1192-2011 
YY
ICS 11.100
C 44
INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Human chorionic gonadotropin (HCG) quantitative
detection reagent (kit) (chemiluminescent immunoassay)
ISSUED ON. DECEMBER 31, 2011
IMPLEMENTED ON. JUNE 1, 2013
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3 
1  Scope ... 4 
2  Normative references ... 4 
3  Classification ... 4 
4  Technical requirements ... 5 
5  Test methods ... 6 
6  Marks, labels and instructions ... 9 
7  Packaging, transportation and storage ... 11 
Bibliography ... 12 
Foreword 
This standard was drafted in accordance with the rules specified in GB/T 1.1-2009.
Please note that some contents in this document may involve patents. The issuing
organization of this document does not bear the responsibility to identify these patents.
This standard was proposed by the China Food and Drug Administration.
This standard shall be centralized by the China Clinical Laboratory Testing and In Vitro
Diagnostic Test System of Standardization Administration of China (SAC/TC 136).
Drafting organization of this standard. Beijing Institute of Medical Device Testing, Beijing
Yuande Medical Engineering Co., Ltd., Beijing Chemclin Biotech Co., Ltd., Roche
Diagnostic Products (Shanghai) Co., Ltd., and Zhengzhou Autobio Lv Ke Bioengineering
Co., Ltd.
The main drafters of this standard. Wang Ruixia, Tang Lei, Cheng Yinghao, Cai Xiaorong,
and Li Xiaoxia.
Human chorionic gonadotropin (HCG) quantitative
detection reagent (kit) (chemiluminescent
immunoassay)
1  Scope 
This standard specifies the classification, requirements, test method, marks, labels,
instructions, packaging, transportation and storage etc. of the human chorionic
gonadotropin quantitative detection reagent (kit) (chemiluminescent immunoassay).
This standard is applicable to the quantitative detection of human chorionic gonadotropin
(HCG) reagent (kit) [hereinafter referred as “HCG reagent (kit)”] of the human blood matrix
or other body fluid components, based on the principle of chemiluminescent immunoassay.
It includes the enzymatic and non-enzymatic chemiluminescent immunoassay detection
reagent (kit) in the carrier of microplates, pipes, magnetic particles, microbeads and
plastic beads.
This standard does not apply to.
a) The calibrators and quality-control materials of human chorionic gonadotropin that
are intended for separate sale;
b) The biochip that uses chemiluminescent immunoassayas the principle.
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.
GB/T 21415-2008 In vitro diagnostic medical devices - Measurement of quantities in
biological samples - Metrological traceability of values assigned to calibrators and
control materials
3  Classification 
HCG reagent (kit) can be divided into enzymatic and non-enzymatic chemiluminescent
immunoassay reagents (kits) according to different principle of chemiluminescence.
According to different solid-phase carriers, it can be divided into the chemiluminescent
a) Product names and packaging specifications;
b) Name, address, contact information of manufacturers or after-sales service
organization;
c) Medical device registration certificate number;
d) Product standard number;
e) Product batch number;
f) Expiration date;
g) Storage conditions.
6.2 Marks and labels of each component package of reagent (kit)
It shall contain at least the following contents.
a) Product name and packaging specifications;
b) Name or trademarks of the manufacturers;
c) Product batch number;
d) Expiration date;
e) Storage conditions.
6.3 Instructions of reagent (kit)
It shall contain at least the following contents.
a) Product name;
b) Packaging specifications;
c) Intended use;
d) Detection principle;
e) Main compositions;
f) Storage conditions and expiration date;
g) Applicable instrument;
h) Sample requirement;
i) Detection method;
j) Reference value (Reference range);
k) Explanation of the detection result;
l) The limitations of detection methods;
m) Product performance index.
n) Instructions for analytical interference (hemolysis, lipemia, jaundice, etc.);
o) Instructions for specificity analysis (cross-reactants);
p) Precautions;
q) References;
r) Name, address, contact information of manufacturers or after-sales service
organization;
s) License number of medical device manufacturing enterprise (limited to domestic
enterprises);
t) Medical device registration certificate number;
u) Product standard number;
v) Approval and modified date of instructions.
7  Packaging, transportation and storage 
7.1 Package
Reagent (kit) shall be packaged according to the requirements of the manufacturing
enterprise.
7.2 Transportation
Reagent (kit) shall be transported according to the requirements of the manufacturing
enterprise.
7.3 Storage
Reagent (kit) shall be stored under the conditions specified by the manufacturing
enterprise.
Bibliography 
1. YY/T 0316-2008 Medical devices — Application of risk management to medical
devices (ISO 14971. 2007, IDT)
2. YY/T 0466.1-2009 Devices — Symbols to be used with medical device labels,
labelling and information to be supplied — Part 1.General requirements (ISO
15223.1-2009, IDT)
3. GB/T 191-2008 Packaging - Pictorial marking for handling of goods
4. GB/T 9969-2008 General principles for preparation of instructions for use of
industrial products
......
 
(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/YYT1192-2011