GB/T 40966-2021 English PDFUS$189.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 40966-2021: Quality assessment requirements for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) antigen detection kit Status: Valid
Basic dataStandard ID: GB/T 40966-2021 (GB/T40966-2021)Description (Translated English): Quality assessment requirements for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) antigen detection kit Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: C44 Word Count Estimation: 10,198 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 40966-2021: Quality assessment requirements for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) antigen detection kit---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. Quality assessment requirements for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) antigen detection kit ICS 11.100.10 CCSC44 National Standards of People's Republic of China Novel coronavirus antigen detection kit Quality evaluation requirements Released on 2021-11-26 2022-03-01 implementation State Administration for Market Regulation Issued by the National Standardization Management Committee ForewordThis document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying patents. This document was proposed by the State Drug Administration. This document is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136). Drafting organizations of this document. China Institute for Food and Drug Control, Medical Device Technical Evaluation Center of the State Drug Administration, Beijing Medical Device Inspection Institute, Guangzhou Wanfu Biotechnology Co., Ltd., Beijing Kingwolf Bioengineering Technology Co., Ltd. The main drafters of this document. Zhou Haiwei, Liu Donglai, Ma Tingting, Xu Tingying, Xu Sihong, Yang Zhen, Xie Yi, Sun Li, Lu Xuewen, Yuan Jing. Novel coronavirus antigen detection kit Quality evaluation requirements1 ScopeThis document gives the quality evaluation requirements, test methods, labels and instructions, packaging, and transportation of the new coronavirus antigen detection kit And storage. This document is applicable to upper respiratory tract samples such as throat swabs, nasal swabs, saliva, blood samples such as serum, plasma, and whole blood, as well as sputum and respiratory tract samples. Lower respiratory tract samples such as suction tract, bronchial lavage fluid, and alveolar lavage fluid are the new coronavirus antigen detection kits for testing samples. Quality Evaluation.2 Normative referencesThe content of the following documents constitutes an indispensable clause of this document through normative references in the text. Among them, dated quotations Only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to This document. GB/T 191 Packaging, storage and transportation pictorial signs GB/T 29791.1 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 1.Terms, definitions and general Require GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.In vitro diagnostic reagents for professional use3 Terms and definitionsThe terms and definitions defined in GB/T 29791.1 apply to this document.4 Quality evaluation requirements4.1 Physical properties 4.1.1 Appearance The components of the kit should be complete and complete, and there should be no liquid leakage; the packaging label should be clear and easy to identify. 4.1.2 Film strip width The width of the film strip should not be less than 2.5mm. Note. This clause only applies to immunochromatography. 4.1.3 Liquid moving speed The liquid moving speed should not be lower than 10mm/min. Note. This clause only applies to immunochromatography. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 40966-2021_English be delivered?Answer: Upon your order, we will start to translate GB/T 40966-2021_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 GB/T 40966-2021_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 40966-2021_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 Sales@ChineseStandard.net. 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. |
