|
US$189.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1722-2020: Prealbumin testing kit (immune turbidity method)
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1722-2020 | English | 189 |
Add to Cart
|
3 days [Need to translate]
|
Prealbumin testing kit (immune turbidity method)
| Valid |
YY/T 1722-2020
|
PDF similar to YY/T 1722-2020
Standard similar to YY/T 1722-2020 YY/T 1713 YY/T 1709 YY/T 1721 YY/T 1728 Basic data | Standard ID | YY/T 1722-2020 (YY/T1722-2020) | | Description (Translated English) | Prealbumin testing kit (immune turbidity method) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 10,123 | | Date of Issue | 2020-06-30 | | Date of Implementation | 2021-12-01 | | Issuing agency(ies) | State Drug Administration | YY/T 1722-2020: Prealbumin testing kit (immune turbidity method)---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.
Prealbumin testing kit (immune turbidity method)
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Prealbumin determination kit (immunoturbidimetric method)
2020-06-30 released
2021-12-01 implementation
Issued by the State Drug Administration
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that certain contents of this document may involve patents. Publication of this document
The agency is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
Drafting organizations of this standard. Beijing Jiuqiang Biotechnology Co., Ltd., Beijing Medical Device Testing Institute, Shanghai Clinical Testing Center,
Desay Diagnostic System (Shanghai) Co., Ltd., Shenzhen Mindray Biomedical Electronics Co., Ltd., Beijing Leadman Biochemical Co., Ltd.,
Intech Innovation (Xiamen) Technology Co., Ltd.
The main drafters of this standard. Chen Yang, Li Zheng, Tang Liping, Zou Yanfang, Huang Bin, Ren Yikun, Wang Lixia.
Prealbumin determination kit (immunoturbidimetric method)
1 Scope
This standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage of the prealbumin determination kit (immunoturbidimetric method).
This standard applies to kits for quantitative detection of prealbumin in human serum or plasma by immunoturbidimetric method (hereinafter referred to as reagents).
Box), including the reagents used on manual and semi-automatic and fully automatic biochemical analyzers.
This standard does not apply to kits for the determination of prealbumin by dry chemical methods.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.Professional in vitro diagnostic reagents
3 requirements
3.1 Appearance
The appearance should meet the following requirements.
a) Each component of the kit should be complete, complete and free of leakage;
b) The label should be clear and easy to identify.
3.2 Net content
The net content of liquid reagents in the kit should not be less than the label value.
3.3 Absorbance of reagent blank
When a blank sample is added to the reagent test, the reagent blank absorbance measured at the measurement wavelength (optical path 1cm) specified in the kit instructions
The degree should not be greater than 0.3.
3.4 Analysis sensitivity
When measuring 150mg/L sample, the difference in absorbance should not be less than 0.025.
3.5 Linear
The manufacturer shall specify the linear interval of the kit, at least covering the interval of [30,550] mg/L, and meet the following requirements.
a) The linear correlation coefficient (r) should not be less than 0.990;
b) In the interval of [30,200]mg/L, the linear absolute deviation should not exceed ±20mg/L; in the interval of (200,550)mg/L, the linear
The relative deviation should not exceed ±10%.
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1722-2020_English be delivered?Answer: Upon your order, we will start to translate YY/T 1722-2020_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 1722-2020_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1722-2020_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.
|