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YY/T 1240-2014 (YY/T1240-2014)

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YY/T 1240-2014: PDF in English (YYT 1240-2014)

YY/T  1240‐2014 
ICS 11.100
C 44
D-Dimer reagent (kit)
ISSUED ON. JUNE 17, 2014
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3 
1  Scope ... 4 
2  Normative references ... 4 
3  Terms and definitions ... 4 
4  Requirements ... 5 
5  Test methods ... 6 
6  Marks, labels and instructions ... 8 
7  Packaging, transportation and storage ... 10 
Annex A (Informative) The application of patient assessment and pre-test
probability ... 12 
Annex B (Informative) Applicable instructions about D-Dimer ... 13 
Bibliography ... 15 
This Standard is drafted according to the rules specified in GB/T 1.1-2009.
Please note that some contents of this Document may involve patents. The issuing
authority of this Document does not undertake the responsibility of identifying these
The Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of National Technical Committee (SAC/TC
136) on System of Medical Clinical Test Lab and in Vitro Diagnostic System of
Standardization Administration of China.
Drafting organizations of this Standard. People’s Liberation Army General Hospital, Beijing
Institute of Medical Device Testing, Beijing Success Technology Development Co., Ltd,
and Werfen Medical Device International Trading (Shanghai) Co., Ltd.
The main drafters of this Standard. Li Jian, Bi Chunlei, Ding Chonghui, and Yu Hui.
D-Dimer reagent (kit)
1  Scope 
This Standard specifies the term and definition, requirements, test methods, symbols,
labels and instructions, packing, transportation, and storage of D-Dimer quantitative
detection reagent (kit).
This Standard applies to immunoturbidimetric D-Dimer reagent (kit) (hereinafter referred
to as D-D reagent) used in laboratory.
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
GB/T 191 Packaging - Pictorial marking for handling of goods
GB 3100 The international system of units and its application
GB 3101 General principles concerning quantities, units and symbols
GB 3102 (All parts) Quantities and Units
YY/T 0466.1-2009 Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1. General requirements
3  Terms and definitions 
For the purpose of this Document, the following terms and definitions apply.
immunoturbidimetric D-dimer assay
The homogeneous latex particles, coated by monoclonal antibody, COMBINE with the
degradation product’s specificity of the soluble fibrin of D-D antigen determinants in
plasma. So that it makes the latex particles to coagulate each other. The coagulation
degree is proportional to the concentration of D-Dimer in the specimen. At certain
5.7 Report pattern
VERIFY the reporting template. It shall meet the requirements specified in 4.6.
6  Marks, labels and instructions 
6.1 General requirements
The general requirements of symbols, labels and instructions are as follows.
a) The form and content of the labels and instructions shall adapt to the expected uses
of the reagent (kit);
b) Use the symbols specified in YY/T 0466.1. If there is no relevant standard or users
fail to understand the symbols used, those symbols and colors shall be explained in
the instructions;
c) The numerical unit provided shall be understood by users. Use the symbols
specified in GB3100-3102;
d) The microbiological status of the product shall be explained when using the product;
e) Unless it is easy to know how to use the reagent (kit), there shall have instructions.
— There shall have relevant instructions or symbols to prompt users to carefully
read the instructions before using the reagent (kit);
— The language used in the instructions shall be understood by the expected
f) Emphasize and prompt users the important changes of the reagent (kit) and the
position of the relevant information;
g) Warn users the possible risks and dangers by words or symbols;
h) The name, letter, number, symbol, color and graph of each component of the
reagent (kit) shall be marked in the same way;
i) The reagent instructions can be put in the packing as separated pages, which can
be on the external surface of the container, in the manual, in the operation manual,
or integrated with the instructions of the instruments or analyzing system.
j) The reagent instructions can be in electronic version.
k) Some of the instructions can be provided in a coded form, and be explained in the
system operation manual;
l) If there is no detailed instructions attached to the reagent (kit), the manufacturing
enterprise shall make sure that users can get a correct version of the reagent (kit)
m) The labels of the exterior packing and initial packing shall include the required
information, which shall be described by intelligible words or symbols;
Examples. The quality, font and font size of the printing;
n) The labels and instructions provided with the reagent (kit) shall include how to
handle and store the reagent before using.
6.2 Labels for outer packing
The label in the exterior packing shall provide the following information.
a) Reagent name;
b) Packaging specifications;
c) IVD reagents;
d) Storage conditions;
e) Batch number;
f) Valid period;
g) Registration certificate number;
h) Product standard number;
i) Name and address of manufacturing enterprise.
6.3 Labels for inner packing
The label in the interior packing shall provide the following information.
a) Reagent name;
b) Packaging specifications;
c) Storage conditions;
d) Batch number;
e) Valid period;
f) Name of the manufacturing enterprise.
6.4 Operating instructions
B.2.3.3 When performing clinical assessment, the tested reagent shall be compared with
another D-dimer reagent system that has been confirmed by authentic institution and
possesses the VTE diagnosing function.
B.2.3.4 Negative predictive value (NPV) is 97% and above (lower limit of 95%
confidence interval is not lower than 95%). The auxiliary diagnosis has no specific
requirement to sensitivity.
B.2.4 Used for the exclusion diagnosis of VTE
B.2.4.1 Characteristics. The clinical doctor excludes the VTE through D-dimer
experiment, combining PTP.
B.2.4.2 The VTE-suspected patients are continuously selected in clinical research. It
shall be performed at 3 centers at least. The 3 centers use the same PTP principle. The
sample size possesses the statistical significance (Both incidences of DVT and
PE >10%).
B.2.4.3 The clinical assessment takes the imaging diagnosis result (clinical fact) as the
criterion. If the imaging diagnosis does not confirm VTE, then the patient will be traced for
3 months to confirm the negative result.
B.2.4.4 Negative predictive value (NPV) is 97% and above (lower limit of 95%
confidence interval is not lower than 95%). The sensibility is not lower than 95% (the lower
level of 95% confidence interval is not lower than 90%).
1) Huang Yueqin. Clinical Epidemiology. Beijing. People's Medical Publishing House,
2) Jack Hirsh, Agnes Y. Y. Lee. How we diagnose and treat deep vein thrombosis. Blood,
2002. 99. 3102-3110
3) Wells, P.s.., D.R. Anderson, et al. Evaluation of D-dimer in the diagnosis of suspected
deep-vein thrombosis. N Engl J Med. 2003; 349 (13). 1227-1235.
4) Clinical and Laboratory Standards Institute. Quantitative D-dimer for the Exclusion of
Venous Thromboembolic Disease; Approved Guideline. CLSI document H59-A(ISBN
(Above excerpt was released on 2015-02-05, modified on 2021-06-07, translated/reviewed by: Wayne Zheng et al.)
Source: https://www.chinesestandard.net/PDF.aspx/YYT1240-2014