|
US$159.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1917-2023: Anti-Xa testing kit(chromogenic assay)
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1917-2023 | English | 159 |
Add to Cart
|
3 days [Need to translate]
|
Anti-Xa testing kit(chromogenic assay)
| Valid |
YY/T 1917-2023
|
PDF similar to YY/T 1917-2023
Basic data | Standard ID | YY/T 1917-2023 (YY/T1917-2023) | | Description (Translated English) | Anti-Xa testing kit(chromogenic assay) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100.10 | | Word Count Estimation | 8,840 | | Date of Issue | 2023-09-05 | | Date of Implementation | 2024-09-15 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements, markings, labels and instructions for use, packaging, transportation and storage of anti-Xa determination kits (chromogenic substrate method), and describes the corresponding test methods. This standard is applicable to the anti-Xa assay kit using the chromogenic substrate method for quantitative detection of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) in human plasma samples. | YY/T 1917-2023: Anti-Xa testing kit(chromogenic assay)---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.
ICS 11.100.10
CCSC44
Pharmaceutical Industry Standards of the People's Republic of China
Anti-Xa assay kit (chromogenic substrate method)
Published on 2023-09-05
Implemented on 2024-09-15
Released by the State Drug Administration
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents"
Drafting.
Please note that some content in this document may be subject to patents. Release of this document
The Agency assumes no responsibility for identifying patents.
This document is proposed by the National Medical Products Administration.
This document is under the jurisdiction of the National Standardization Technical Committee for Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136).
This document was drafted by. Beijing Jishuitan Hospital, Shanghai Zhenyuan Diagnostic Supplies Technology Co., Ltd., Beijing Institute of Medical Device Inspection
(Beijing Medical Biological Protective Equipment Inspection and Research Center), Beijing Stagau Diagnostic Products Trading Co., Ltd., Roche Diagnostic Products
(Shanghai) Co., Ltd., Beijing Jiuqiang Biotechnology Co., Ltd., Sysmex Medical Electronics (Shanghai) Co., Ltd., Beijing Secoxide
Technology Co., Ltd., Shanghai Sun Biotechnology Co., Ltd.
The main drafters of this document. Wu Jun, Wang Ping, Song Wei, Guo Xin, Yao Xuehua, He Lina, Su Jing, Ding Chonghui, Zhang Wenjie, and Xie Yonghua.
Anti-Xa assay kit (chromogenic substrate method)
1 Scope
This document specifies the requirements, marking, labeling and instructions for use, packaging, transportation and storage of anti-Xa assay kits (chromogenic substrate method),
Corresponding test methods are described.
This document is applicable to the chromogenic substrate method anti-Xa assay kit (hereinafter referred to as the "kit"), which is used to perform common assays in human plasma samples.
Quantitative detection of heparin (UFH) and low molecular weight heparin (LMWH).
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, 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 Terms and definitions
There are no terms or definitions to be defined in this document.
4 requirements
4.1 Appearance
The appearance should meet the following requirements.
a) All components of the kit should be complete and without leakage, and the labels should be clear and easy to identify;
b) Liquid reagents should be clear and transparent;
c) The freeze-dried product should be clear and transparent after reconstitution.
4.2 Blank limit
Should not be higher than 0.08IU/mL.
4.3 Detection limit
Should not be higher than 0.1IU/mL.
4.4 Linear
4.4.1 Unfractionated heparin (UFH) linearity
The linearity of the kit for unfractionated heparin (UFH) covers at least [0.1, 1.2]IU/mL. Within the linear interval, the slope of the linear regression equation is
Within the range of 1±0.05, the correlation coefficient r≥0.980.
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1917-2023_English be delivered?Answer: Upon your order, we will start to translate YY/T 1917-2023_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 1917-2023_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1917-2023_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.
|