YY/T 1465.2-2016 PDF EnglishUS$120.00 · In stock · Download in 9 seconds
YY/T 1465.2-2016: Immunogenic Evaluation Method of Medical Devices - Part 2: Serum Immunoglobulin and Complement Component Detection (Enzyme-Linked Immunosorbent Assay) Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
Similar standardsYY/T 1465.2-2016: Immunogenic Evaluation Method of Medical Devices - Part 2: Serum Immunoglobulin and Complement Component Detection (Enzyme-Linked Immunosorbent Assay)---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1465.2-2016 YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.01 C 30 Immunogenic Evaluation Method of Medical Devices - Part 2.Serum Immunoglobulin and Complement Component Detection (Enzyme-Linked Immunosorbent Assay) Issued on. JANUARY 26, 2016 Implemented on. JANUARY 01, 2017 Issued by. China Food and Drug Administration Table of ContentsForeword... 3 Introduction... 4 1 Scope... 5 2 Normative References... 5 3 Terms and Definitions... 5 4 Abbreviation... 6 5 Test Animal... 6 6 Test Principle... 6 7 Test Procedures... 7 8 Test Report... 9 Bibliography... 10ForewordYY/T 1465 Immunogenic Evaluation Method of Medical Devices consists of the following parts. --- Part 1.T Lymphocyte Transformation Test In Vitro; --- Part 2.Serum Immunoglobulin and Complement Component Detection (ELISA Method). This Part belongs to Part 2 of YY/T 1465. This Part was drafted as per the rules specified in GB/T 1.1-2009. Please note that some contents of this document may involve patents. The issuing organization of this document shall not assume the responsibility for identifying these patents. This Part was proposed by China Food and Drug Administration. This Part shall be under the jurisdiction of National Technical Committee for Standardization of Biological Evaluation on Medical Devices (SAC/TC 248). Drafting organizations of this Part. Jinan Quality Supervision and Inspection Center for Medical Devices of China Food and Drug Administration; Institute for Medical Devices Control of National Institutes for Food and Drug Control; and Sichuan Testing Center for Biomaterials and Medical Devices. Chief drafting staffs of this Part. Gai Xiaoxiao, Yin Yuxia, Wang Xin, Chen Liang, Xu Jianxia, Yuan Tun, and Liang Jie.1 ScopeThis Part gives the method using the enzyme-linked immunosorbent assay to determine the levels of serum immunoglobulin and complement component; it is suitable for the evaluation of immune response products induced by medical devices/materials.2 Normative ReferencesThe following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this document. GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1.Evaluation and Testing GB/T 16886.2 Biological Evaluation of Medical Devices - Part 2.Animal Welfare Requirements GB/T 16886.12 Biological Evaluation of Medical Devices - Part 12.Sample Preparation and Reference Materials3 Terms and DefinitionsFor the purposes of this document, the terms and definitions given in GB/T 16886.1 and GB/T 16886.20 apply.4 AbbreviationThe following abbreviations are applicable to this document.5 Test Animal5.1 General All animal tests shall be carried out in the laboratories approved by the national accreditation agency and in compliance with all applicable regulations for laboratory animal welfare; and shall also comply with the requirements of GB/T 16886.2. 5.2 Animal species and requirements The commonly used experimental animal is a mouse. This Part recommended to use the healthy Grade-SPF, 6-8 weeks of age, half male and half female, BALB/c mice, which have not been tested.6 Test PrincipleJointly incubate the serum and antibody (primary antibody) coated in a microplate to form an antigen-antibody complex.7 Test Procedures7.1 Sample preparation Prepare the sample according to the principle of GB/T 16886.12.Whenever possible, the medical devices shall be tested in a “standby” state. 7.2 Selection of dose level 7.2.1 Select the dose range referring to the existing immunological research data and information on the toxicokinetic aspects of the test substance and related substance so as to avoid the excessive toxicity. Such information can also help to determine the frequency of dose administration. 7.3 Animal treatment The in-situ contact method shall be used according to the characteristics of the device and the intended clinical use site. For the devices that are difficult to simulate clinical use and contact, it is advisable to demonstrate the selected contact mode. If using the sample extract to test, it shall establish corresponding extraction medium to treat the control group. 7.4 Test grouping 7.5 Test cycle It is advisable to determine the observation cycle of the test sample according to the results of preliminary test. The test mode of the preliminary test is the same as the major test; generally, take 3 test animals to carry out the preliminary test. 7.6 Preparation of serum 7.7 Detection of serum immunoglobulin 7.7.1 Test method It is recommended to use the commercially available ELISA kit; detect according to the kit instructions. 7.8 Detection of serum complement component 7.8.1 Test method It is recommended to use the commercially available ELISA kit; perform the complement component test as per the kit instructions. Other validated test methods can also be used.8 Test ReportThe test report shall contain the following information. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of English version of YY/T 1465.2-2016 be delivered?Answer: The full copy PDF of English version of YY/T 1465.2-2016 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.Question 2: Can I share the purchased PDF of YY/T 1465.2-2016_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1465.2-2016_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. 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