YY/T 1164-2021 English PDFUS$199.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1164-2021: Human chorionic gonadotropin (HCG) detection kit (colloidal gold immunochromatographic assay) Status: Valid YY/T 1164: Historical versions
Basic dataStandard ID: YY/T 1164-2021 (YY/T1164-2021)Description (Translated English): Human chorionic gonadotropin (HCG) detection kit (colloidal gold immunochromatographic assay) Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C44 Word Count Estimation: 10,119 Issuing agency(ies): State Drug Administration YY/T 1164-2021: Human chorionic gonadotropin (HCG) detection kit (colloidal gold immunochromatographic 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. Human chorionic gonadotropin (HCG) detection kit (colloidal gold immunochromatographic assay) ICS 11:100:10 CCSC44 People's Republic of China Pharmaceutical Industry Standard Replacing YY/T 1164-2009 Human chorionic gonadotropin (HCG) detection kit (Colloidal Gold Immunochromatography) Published on 2021-12-06 2022-12-01 Implementation Released by the State Drug Administration forewordThis document is in accordance with the provisions of GB/T 1:1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Principles of Standardization Documents" drafted: This document replaces YY/T 1164-2009 "Human Chorionic Gonadotropin (HCG) Test Strip (Colloidal Gold Immunochromatography)", and Compared with YY/T 1164-2009, in addition to editorial changes, the main technical changes are as follows: --- Added normative references GB/T 29791:1-2013, GB/T 29791:2; deleted the diagnosis of human chorionic gonadotropin Procedures for the manufacture and inspection of reagents (colloidal gold method) (2000) (see Chapter 2, Chapter 2 of the:2009 edition); ---Added qualitative detection, semi-quantitative detection, detection limit, C5~C95 interval in terms and definitions; deleted human chorionic gonadotropin Terms and definitions of test strips (see Chapter 3, Chapter 3 of the:2009 edition); --- Modified the width requirements and corresponding detection methods (see 4:1:2 and 5:2:2, 4:1:2 and 5:3:2 of the:2009 edition); --- Modified the requirements for the speed of movement and the corresponding detection methods (see 4:1:3 and 5:2:3, 4:1:3 and 5:3:3 of the:2009 edition); --- Modified the detection limit requirements and corresponding detection methods (see 4:1:4 and 5:2:4, 4:2 and 5:4 of the:2009 edition); --- Modified negative specificity and positive specificity, unified as specificity (see 4:1:5, 4:3 of the:2009 edition); --- Added semi-quantitative requirements and corresponding detection methods (see 4:2 and 5:3); --- Modified the provisions of labels and instructions for use (see Chapter 7 of the:2009 edition); --- Increased packaging should comply with the provisions of GB/T 191 (see 7:1): Please note that some content of this document may be patented: The issuing agency of this document assumes no responsibility for identifying patents: This document is proposed by the State Drug 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 is drafted by: Beijing Medical Device Inspection Institute, China National Institute for Food and Drug Control, Chongqing Medical Device Quality Inspection Center: The main drafters of this document: Sun Li, Zhu Jinsheng, Yu Ting, He Lechun: The previous versions of this document and its superseded documents are as follows: ---First published in:2009 as YY/T 1164-2009; ---This is the first revision: Human chorionic gonadotropin (HCG) detection kit (Colloidal Gold Immunochromatography)1 ScopeThis document specifies the human chorionic gonadotropin (HCG) detection kit (colloidal gold immunoassay) Immunochromatography) (hereinafter referred to as HCG test strip) terms and definitions, technical requirements, test methods, labels and instructions for use, packaging, transportation, storage: This document is applicable to the qualitative and semi-quantitative detection of HCG content in human urine samples based on the principle of colloidal gold immunochromatography: Reagent test kit:2 Normative referencesThe contents of the following documents constitute essential provisions of this document through normative references in the text: Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document: GB/T 191 Graphical signs of packaging, storage and transportation GB/T 29791:1-2013 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 1: Terms, definitions and common enquiries 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 29791:1-2013 and the following apply to this document: 3:1 Qualitative examination qualitativeexamination A set of operations to identify or classify substances based on their chemical or physical properties: Note 1: Generally only two types of test results (positive/negative, yes/no, yes/no, etc:) are reported: Note 2 to entry: It is distinguished by the fact that there is only one possible medical decision point at the critical value: [Source: GB/T 29791:1-2013, A:3:43, with modifications] 3:2 semiquantitativeexamination Essentially a qualitative test with added response level options (positive level, dilution to get a positive result, or comparison to a color chart): The response results can be presented using an ordinal scale, etc: Example: Test results can be reported as "-" "±" " "" " ": [Source: EP19(2nded), 1:4:2] 3:3 detection limit limitofdetection The measured value obtained by a given measurement procedure, for which, given the probability of misjudgment of the presence of a component in the claimed substance, α, the sound is The misjudgment probability of the absence of this component is called β: ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1164-2021_English be delivered?Answer: Upon your order, we will start to translate YY/T 1164-2021_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 YY/T 1164-2021_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1164-2021_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.Question 5: Should I purchase the latest version YY/T 1164-2021?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 1164-2021 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically. |
