|
US$159.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1421-2016: Apolipoprotein B test reagent
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1421-2016 | English | 159 |
Add to Cart
|
3 days [Need to translate]
|
Apolipoprotein B test reagent
| Valid |
YY/T 1421-2016
|
PDF similar to YY/T 1421-2016
Basic data | Standard ID | YY/T 1421-2016 (YY/T1421-2016) | | Description (Translated English) | Apolipoprotein B test reagent | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 8,834 | | Date of Issue | 2016-01-26 | | Date of Implementation | 2017-01-01 | | Quoted Standard | YY/T 0466.1 | | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the requirements, test methods, labeling, labeling and instructions for use of the apolipoprotein B assay kit, packaging, transport and storage requirements. This standard applies to the immunoturbidimetric method (transmission method) on human serum or plasma apolipoprotein B quantitative detection of the kit, including manual and semi-automatic, automatic biochemical analyzer on the use of reagents. | YY/T 1421-2016: Apolipoprotein B test reagent---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Apolipoprotein B test reagent
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Apolipoprotein B assay kit
2016-01-26 release
2017-01-01 Implementation
State Food and Drug Administration issued
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The release of this document
The Agency does not assume responsibility for identifying these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Medical Laboratory Laboratory and in vitro diagnostic system Standardization Technical Committee (SAC/TC136) centralized.
The drafting of this standard. Beijing Medical Device Testing Institute, Shanghai Rongsheng Biological Pharmaceutical Co., Ltd., Shenzhen Mindray Biomedical Electronics
Co., Ltd., Jiangxi Tekang Technology Co., Ltd., the British Branch of the new (Xiamen) Technology Co.,
The main drafters of this standard. Bi Chunlei, Zhang Zhengqiang, Du Haiou, Tang Wei, Yan Xiao, Du Jiao.
Apolipoprotein B assay kit
1 Scope
This standard specifies the requirements for apolipoprotein B assay kits, test methods, labeling, labeling and instructions, packaging, shipping and storage.
And other requirements.
This standard applies to immunoturbidimetry (transmission method) for human serum or plasma apolipoprotein B quantitative detection of the kit, including
Manual and semi-automatic, automatic biochemical analyzer used on the reagent.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements
3 request
3.1 appearance
Should specify the normal appearance requirements.
3.2 Capacity
Should not be less than the marked value.
3.3 Reagent Blank Absorbance
Should specify the reagent blank absorbance requirements.
3.4 Analysis of sensitivity
Test the concentration of 1.00g/L of the sample, absorbance difference (ΔA) should be less than 0.15.
Note. The test wavelength is 340nm, other test wavelengths or through the sample pre-dilution test can be adjusted accordingly.
3.5 Linearity
The linear range of the kit should cover [0.40,2.00] g/L.
a) The linear correlation coefficient (r) should be not less than 0.990;
b) [0.40,2.00] g/L interval, the linear deviation should not exceed ± 10%.
3.6 precision
3.6.1 Repeatability
Repeated test (1.00 ± 0.50) g/L of human serum or control substance, the results of the coefficient of variation (CV) should not be greater than 3%.
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1421-2016_English be delivered?Answer: Upon your order, we will start to translate YY/T 1421-2016_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time. Question 2: Can I share the purchased PDF of YY/T 1421-2016_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1421-2016_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.
|