|
US$159.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1444-2016: Total protein test reagent
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1444-2016 | English | 159 |
Add to Cart
|
3 days [Need to translate]
|
Total protein test reagent
| Valid |
YY/T 1444-2016
|
PDF similar to YY/T 1444-2016
Basic data | Standard ID | YY/T 1444-2016 (YY/T1444-2016) | | Description (Translated English) | Total protein test reagent | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 8,890 | | 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, labels, instructions for use, packaging, transport and storage of the total protein assay kit (biuret method). This standard applies to the use of biuret method for human serum (plasma) in the quantitative detection of the total protein kit, based on the principle of spectrophotometry, including manual reagents and semi-automatic, automatic biochemical analyzer used in the reagent. This standard does not apply to the total protein assay kit for dry chemical methods. | YY/T 1444-2016: Total protein 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.
Total protein test reagent
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Total Protein 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, the Health and North Biological Technology Co., Ltd., Xisen US Kang biotechnology (no
Tin) Co., Ltd., Hitachi High-tech (Shanghai) International Trade Co., Ltd. Beijing Branch, Shanghai Kehua Biological Engineering Co., Ltd.
The main drafters of this standard. Yang Zongbing, Jiang Lin, Hu Fangyu, Cheng Qing, Xiao Lu Sheng.
Total Protein Assay Kit
1 Scope
This standard specifies the requirements, test methods, labels, instructions, packaging, shipping and storage of the total protein assay kit (biuret method)
And so on.
This standard is applicable to the use of biuret method for human serum (plasma) in the total protein quantitative detection kit, based on spectrophotometry
Including hand reagents and reagents used in semi-automatic, fully automated biochemical analyzers.
This standard does not apply to the total protein assay kit for dry chemical methods.
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
The net content of the liquid reagent shall be not less than the indicated value.
3.3 Reagent Blank Absorbance
Reagent blank absorbance should not be greater than 0.200.
3.4 Analysis of sensitivity
70g/L sample absorbance difference (ΔA) should be not less than 0.150.
3.5 Linearity
The linear range of the kit should cover [30.0,100.0] g/L.
a) the linear correlation coefficient r should be not less than 0.995;
b) The linear deviation should not exceed ± 6.0%.
3.6 precision
3.6.1 Repeatability
Repeat the test (70.0 ± 10.0) g/L of the sample, the results of the coefficient of variation (CV) should not be greater than 2%.
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1444-2016_English be delivered?Answer: Upon your order, we will start to translate YY/T 1444-2016_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 1444-2016_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1444-2016_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.
|