YY/T 1216-2020 English PDFUS$129.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1216-2020: (Alpha-fetoprotein determination kit) Status: Valid YY/T 1216: Historical versions
Basic dataStandard ID: YY/T 1216-2020 (YY/T1216-2020)Description (Translated English): (Alpha-fetoprotein determination kit) Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C44 Word Count Estimation: 7,736 Date of Issue: 2020-06-30 Date of Implementation: 2021-06-01 Older Standard (superseded by this standard): YY/T 1216-2013 Regulation (derived from): Announcement No. 76 (2020) of the National Medical Products Administration Issuing agency(ies): State Drug Administration YY/T 1216-2020: (Alpha-fetoprotein determination 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.(Alpha-fetoprotein determination kit) ICS 11:100 C44 People's Republic of China Pharmaceutical Industry Standard Replace YY/T 1216-2013 Alpha-fetoprotein determination kit 2020-06-30 released 2021-06-01 implementation Issued by the State Drug Administration ForewordThis standard was drafted in accordance with the rules given in GB/T 1:1-2009: This standard replaces YY/T 1216-2013 "AFP Quantitative Labeling Immunoassay Kit", compared with YY/T 1216-2013, Except for editorial changes, the main technical changes are as follows: ---Modified the standard name; ---Reagents applicable to the detection principle of "microfluidic chips, nanomaterials, etc: as carrier-coated antibodies" have been added to the scope of the regulations Box (see Chapter 1); ---The traceability standards, packaging standards, and in vitro diagnostic reagent standards for in vitro diagnostic medical device calibrators have been added to the normative references: Show label standard, delete "YY/T 0466:1" standard (see Chapter 2); ---Added traceability requirements (see 4:2); ---Modified the linear terms, requirements and corresponding detection methods (see 4:4 and 5:4); ---The accuracy requirements and corresponding testing methods have been modified (see 4:5 and 5:5); ---Modified the precision requirements, deleted the precision between analyses (see 4:6); ---Deleted specific requirements and detection methods; ---Added markings, labels, and instructions for use should comply with the requirements of GB/T 29791:2 (see Chapter 6); ---Modified the packaging should meet the requirements of GB/T 191 (see 7:1): Please note that certain contents of this document may involve patents: The issuing agency of this document 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: Drafting organizations of this standard: China Institute for Food and Drug Control, Beijing Institute of Medical Device Inspection, Beijing Huada Jibi Ai Biotechnology Co:, Ltd: Co:, Ltd:, Boao Biological Group Co:, Ltd:, Xiamen Wantaicare Biotechnology Co:, Ltd:, Guangzhou Darui Biotechnology Co:, Ltd: The main drafters of this standard: Wang Yumei, Wang Ruixia, Liu Licheng, Guo Jianfu, Sun Xudong, Wu Yingsong: Alpha-fetoprotein determination kit1 ScopeThis standard specifies the classification, requirements, inspection methods, labeling, labeling, instructions for use, and packaging of alpha-fetoprotein labeled immunoassay reagent products: Installation, transportation and storage: This standard is applicable to the detection of alpha-fetoprotein (AFP) in human blood matrix or other body fluid components based on the principle of labeled immunoassay Assay reagents, including labeling capture antibodies with enzymes, chemiluminescence, fluorescent substances, etc:, using microplates, tubes, magnetic particles, microbeads and plastic beads, and microfluidics Control chips, nanomaterials, etc: are carrier-coated antibody immunoassay kits for quantitative determination of AFP: This standard does not apply to: a) Colloidal gold labeled AFP test strip; b) Various types of radioimmunoassays labeled with radioisotopes such as 125I:2 Normative referencesThe 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 191 Packaging, Storage and Transportation Graphic Mark GB/T 21415-2008 Measurement of calibrator and control substance assignment in biological samples of in vitro diagnostic medical devices Academic traceability GB/T 29791:2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2: Professional in vitro diagnostic reagents3 categoriesAFP kits can be divided into enzyme-linked immunoassay, chemiluminescence, time-resolved immunofluorescence and other kits according to different labeling methods: According to the different solid phase carriers, it can be divided into microplates, tubes, magnetic particles, microbeads and plastic beads, microfluidic chips, nanomaterials, etc: as the carrier AFP Reagent kits: AFP kits can be divided into manual operation method and automatic instrument operation method according to the different operation process:4 requirements4:1 Appearance The kit should have complete components, the inner and outer packaging should be complete, the label should be clear, the liquid reagent should not leak, and the lyophilized component should be loose, add and remove After the resolving agent such as water, it should be completely dissolved within 20min: Note: Manufacturers can specify appropriate appearance requirements based on the packaging characteristics of their products: 4:2 Traceability The manufacturer shall provide the source of the AFP calibrator used, the traceability assignment method and the relative regulations in accordance with GB/T 21415-2008 and relevant regulations: Should be indicators and uncertainties: 4:3 Detection limit The detection limit should not be higher than 4:0IU/mL: ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1216-2020_English be delivered?Answer: Upon your order, we will start to translate YY/T 1216-2020_English as soon as possible, and keep you informed of the progress. 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Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.Question 5: Should I purchase the latest version YY/T 1216-2020?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 1216-2020 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. |
