YY/T 1679-2021 English PDFUS$469.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1679-2021: Tissue engineering medical device products - Bone - Standard guide for pre-clinical in vivo evaluation in critical size segmental bone defects Status: Valid
Basic dataStandard ID: YY/T 1679-2021 (YY/T1679-2021)Description (Translated English): Tissue engineering medical device products - Bone - Standard guide for pre-clinical in vivo evaluation in critical size segmental bone defects Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C45 Word Count Estimation: 25,295 Issuing agency(ies): State Drug Administration YY/T 1679-2021: Tissue engineering medical device products - Bone - Standard guide for pre-clinical in vivo evaluation in critical size segmental bone defects---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. Tissue engineering medical device products - Bone - Standard guide for pre-clinical in vivo evaluation in critical size segmental bone defects ICS 11.040.40 C45 People's Republic of China Pharmaceutical Industry Standards Tissue engineering medical device product bone Guidelines for preclinical evaluation of critical size bone defects in vivo Released on 2021-03-09 2022-04-01 implementation Issued by the National Medical Products Administration Table of contentsForeword Ⅲ Introduction Ⅳ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Animal model 3 5 Defect site 5 6 Joint load and braking 5 7 Experimental Step 5 8 Evaluation and results 6 9 Analysis 7 Appendix A (informative appendix) Common animal model parameters for critical size defect assessment of bone repair 8 Appendix B (informative appendix) CSD model example 10 Reference 18ForewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the 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 organized by the National Technical Committee for Standardization of Surgical Implants and Orthopaedic Devices, and the Sub-Technical Committee of the Organizational Engineering Medical Device Products (SAC/TC110/SC3) Centralized. This standard was drafted. Southern Medical University, China Food and Drug Control Institute, Chinese People's Liberation Army General Hospital. The main drafters of this standard. Ouyang Jun, Dai Jingxing, Yang Yuchao, Xu Liming, Guo Quanyi, Shao Anliang.IntroductionThis standard is a general guideline for evaluating bone tissue engineering medical products (TEMPs) Pieces. The drafting of this standard refers to ASTMF2721-09(14) (Standardguideforpre-clinicalinvivoevaluationin criticalsizesegmentalbonedefects). Bone tissue engineering medical products refer to the ability to repair bone defects or rebuild bone tissue in the body The products, including natural biological materials, synthetic biological materials (biocompatible and biodegradable) or composite materials, may contain fine Cells or biologically active substances (such as growth factors, synthetic polypeptides, plasmids or cDNA, etc.). Part of the critical size bone defect described in this standard Damage model refers to the smallest bone defect in the body that cannot be repaired by itself during the life of the animal without treatment. Therefore, this model is Test and evaluate the ability of bone tissue engineering medical products to induce or promote bone growth. The purpose of this standard is to provide a series of in vivo animal models for clinical repair or regeneration of bone tissue engineering medical products (TEMPs) preclinical research. Before using the in vivo model evaluation described in this standard, appropriate national standards or industry standards should be used Evaluation of cytotoxicity and biocompatibility of materials or (and) TEMPs. This standard includes descriptions of animal models, surgical observations, tissue processing, and qualitative and quantitative analysis of tissue specimens. The standard contains descriptions and principles of various animal models, including rats, rabbits, dogs, goats, and sheep. Based on imaging, organization The results obtained from the analysis of science and mechanics are briefly described, which is of reference value. Users need to consider more when designing specific test methods. Many factors. This standard does not include testing of raw materials, preparation of biological materials, sterilization, and packaging of final products. Any method in this standard may produce results that are inconsistent with actual clinical manifestations in specific applications. Therefore, it is not ruled out. His available testing methods are used for preclinical evaluation. The material needs to be suitable for its intended purpose. Of course, according to the characteristics of the material, additional production Physical testing and evaluation are also necessary. The values mentioned in this standard are all international standard units, and other measurement units are not included in this document. This standard is not intended to solve all safety issues, but also related to its use. The user of the standard is responsible for ensuring the safety and determination of the experiment The applicability of the rules. The results of animal models may not necessarily predict the results of humans, so the potential application conditions of humans need to be interpreted carefully. Tissue engineering medical device product bone Guidelines for preclinical evaluation of critical size bone defects in vivo1 ScopeThis standard specifies the general rules for the evaluation of the critical size bone defect in vivo for the expected repair or regeneration of bone tissue implant bone formation activity; for bone defects The preparation of animal models of injury, the location and scope of bone defect, the type of defect, the preparation and evaluation of implants provide relevant parameters. This standard applies to the preparation of partial critical size bone defect models, and the rational use of critical size bone defect models to induce or Testing and evaluation of bone tissue engineering medical products that promote bone growth.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 reference documents, the latest version (including all amendments) is applicable to this document. GB 14925 Laboratory Animal Environment and Facilities GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Process of Risk Management The Pharmacopoeia of the People's Republic of China (2015 Edition) Four3 Terms and definitionsThe following terms and definitions apply to this document. 3.1 Bone regeneration The resulting bone formation process is similar to natural bone tissue in histological, biochemical and mechanical properties. 3.2 Bonerepair The process of healing wounded bone tissue through cell proliferation and synthesis of new extracellular matrix. 3.3 Compactbone It is an ossified connective tissue characterized by lamellar bone with bone units. Lamellar bones consist of highly regular concentric thin plate-like structures composition. 3.4 Corticalbone One of the two main types of bone tissue. Cortical bone is dense, forming the surface of the bone. 3.5 Critical size defect criticalsizedefect; CSD A bone defect that occurs naturally or artificially does not heal without external intervention. Clinically, the word It is suitable for the non-healing condition of healthy adults who have been observed for 6 consecutive months after the defect appears. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1679-2021_English be delivered?Answer: Upon your order, we will start to translate YY/T 1679-2021_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 1679-2021_English with my colleagues?Answer: Yes. 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