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YY/T 1528-2017

Chinese Standard: 'YY/T 1528-2017'
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YY/T 1528-2017English150 Add to Cart 0--10 minutes. Auto immediate delivery. Myoglobin assay kit(immunoturbidimetric method) Valid YY/T 1528-2017
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BASIC DATA
Standard ID YY/T 1528-2017 (YY/T1528-2017)
Description (Translated English) Myoglobin assay kit(immunoturbidimetric method)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 8,883
Date of Issue 2017-03-28
Date of Implementation 2018-04-01
Drafting Organization Beijing Medical Device Inspection Institute, Sichuan Province into a new biotechnology limited liability company, Nanchang Baxter high-tech Co., Ltd.
Administrative Organization National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC 136)
Regulation (derived from) China Food & Drug Administration Announcement 2017 No. 38
Proposing organization China Food and Drug Administration
Issuing agency(ies) State Food and Drug Administration

YY/T 1528-2017
YY
NATIONAL PHARMACEUTICAL INDUSTRY
STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
Myoglobin Assay Kit
(Immunoturbidimetric Method)
肌红蛋白测定试剂盒(免疫比浊法)
ISSUED ON. MARCH 28, 2017
IMPLEMENTED ON. APRIL 01, 2018
Issued by. China Food and Drug Administration
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Table of Contents
Foreword ... 3
1 Scope .. 4
2 Normative References ... 4
3 Requirements ... 4
4 Test Methods .. 6
5 Label and Operating Manual .. 10
6 Package, Transportation and Storage .. 10
Myoglobin Assay Kit
(Immunoturbidimetric Method)
1 Scope
This Standard specifies the requirements, test methods, label and operating manual,
package, transportation and storage of myoglobin assay kit (immunoturbidimetric
method).
This Standard is applicable to the assay kit for the quantitative detection (hereinafter
referred to as assay kit) of myoglobin in human serum or plasma by the
immunoturbidimetric method (transmission method); it includes reagents used on the
manual, semi-automatic, fully automatic biochemical analyzers.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) are applicable to this document.
GB/T 29791.2 In Vitro Diagnostic Medical Devices - Information Supplied by the
Manufacturer (Labelling) - Part 2. In Vitro Diagnostic Reagents for Professional
Use
3 Requirements
3.1 Appearance
The appearance of assay kit shall satisfy.
a) Each component of the assay kit shall be complete, intact, without leakage of the
liquid;
b) Letter symbols on the package label shall be clear.
3.2 Content
It shall be no less than the nominal value.
shall be no greater than 10ng/mL; when sample concentration is >100ng/mL, the
relative deviation shall be no greater than 10%; 95% test sample shall meet the
above requirements.
3.8 Stability
3.8.1 General
Verify the stability of the valid period and thermal stability.
3.8.2 Stability of the valid period
The manufacturer shall specify the valid period of the product. The blank absorbance,
analysis sensitivity, linearity, repeatability, accuracy of the product test reagent within
certain time after the valid period shall meet the requirements in 3.3, 3.4, 3.5, 3.6.1,
3.7.
3.8.3 Thermal stability test
The blank absorbance, analysis sensitivity, linearity, repeatability, accuracy of the test
reagent shall meet the requirements of 3.3, 3.4, 3.5, 3.6.1, 3.7.
NOTE 1. thermal stability can’t be used to derive the product valid period, unless it is the
derivation formula based on a large amount of stability study data.
NOTE 2. generally, if the valid period is 1 year, select the product not exceeding 1 month, if the
valid period is half a year, select the product not exceeding half a month, derive similarly. If the
specified time is exceeded, the product still meets the requirements, it is also acceptable.
NOTE 3. any combination methods of 3.8.2, 3.8.3 can be selected according to the product
characteristics; however, the selected method is suitable for verifying the stability of the product;
so that ensure the product properties within the valid period shall meet the standard
requirements.
4 Test Methods
4.1 Basic requirements of instrument
For the spectrophotometer or biochemical analyzer, the wavelength range shall meet
the requirements of the reagent use; biochemical analyzer with constant temperature
device (the temperature value shall be within ±0.3°C of the specified setting value, the
fluctuation is no great than ±0.2°C); the absorbance measurement resolution shall be
0.001 above.
4.2 Appearance
reference material (CRM) or other recognized reference materials for 3 times; the test
results can be recorded as (Xi); respectively calculate the relative deviation B as per
Formula (4); if the 3 results all meet the requirements of 3.7a), then it is judged qualified.
If the results greater than or equal to 2 times are nonconforming, then it is judged
disqualified. If 1 result doesn’t meet the requirements, then re-test continuously for 20
times; respectively calculate the relative deviation as per Formula (4); if the test results
greater than or equal to 19 times meet the requirements of 3.7a), then the accuracy
shall meet the requirements of 3.7a).
Where.
Bi – relative deviation;
Xi – measurement concentration;
T – calibration concentration of reference material.
4.8.3 Enterprise reference product test
The manufacturer provides the enterprise reference product, which shall be tested as
per the routine sample; each sample shall be tested for 3 times; calculate the average
value of the test results, which shall meet the requirements of 3.7b).
4.8.4 Comparing test
Use no less than 40 human samples with different concentrations that cover the test
concentration range to perform the comparing test by the analysis system with
traceability and designed by the manufacturer. Respectively test each sample as per
the to-be-tested assay kit and selected analysis system; each sample shall be tested
once; use the li......
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