YY/T 0606.10-2008 English PDFUS$259.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0606.10-2008: Tissue engineered medical product. Part 10: In vivo assessment of implantable devices intended to repair or regenerate articular cartilage Status: Valid
Basic dataStandard ID: YY/T 0606.10-2008 (YY/T0606.10-2008)Description (Translated English): Tissue engineered medical product. Part 10: In vivo assessment of implantable devices intended to repair or regenerate articular cartilage Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C45 Classification of International Standard: 11.040.40 Word Count Estimation: 11,114 Date of Issue: 2008-04-25 Date of Implementation: 2009-06-01 Quoted Standard: GB/T 16886.1-2001 Regulation (derived from): SFDA [2008] No. 192 Issuing agency(ies): State Food and Drug Administration Summary: This standard specifies the repair or regeneration of articular cartilage implanted inside the object evaluation General. The implant in this section may be of natural or synthetic biological material (biocompatible and biodegradable), or a composite material constituted may contain cells, drugs, or growth factors, synthetic peptides, and other bioactive or cDNA plasmids factor. This standard specifies the rabbits, dogs, pigs, goats, sheep and other different species of animal models and corresponding test procedures, as well as morphological, biochemical and biomechanical tissue analysis results of measurement and evaluation methods. YY/T 0606.10-2008: Tissue engineered medical product. Part 10: In vivo assessment of implantable devices intended to repair or regenerate articular cartilage---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 engineered medical product.Part 10. In vivo assessment of implantable devices intended to repair or regenerate articular cartilage ICS 11.040.40 C45 People's Republic of China pharmaceutical industry standards Tissue-engineered medical products - Part 10. Repair or Regeneration of articular cartilage implanted into the body evaluation guidelines Posted 2008-04-25 2009-06-01 implementation State Food and Drug Administration issued ForewordYY/T 0606 "tissue-engineered medical products" is divided into. --- Part 1. General requirements; --- Part 3. General classification; --- Part 4. skin product classification; --- Part 5. Matrix and stent performance and testing; --- Part 6. Ⅰ collagen; --- Part 7. chitosan; --- Part 8. sodium alginate; --- Part 9. hyaluronic acid; --- Part 10. implanted in the body to repair or regenerate cartilage evaluation guidelines; --- Part 12. cell, tissue, organ processing; --- Part 13. automatic cell counting method. This section YY/T Part of 100,606. This part is proposed by the State Food and Drug Administration. This part of the jurisdiction of the State Food and Drug Administration seized the Medical Device Quality Supervision and Inspection Center. This in part by the Chinese Pharmaceutical and Biological Products, Zhejiang University drafted. The main drafters of this section. Chen Liang, Ouyang magnificent, Xi Tingfei, Wang Chunren. Tissue-engineered medical products - Part 10. Repair or Regeneration of articular cartilage implanted into the body evaluation guidelines1 ScopeYY/T 0606 provisions of this part of the repair or regeneration of articular cartilage implanted in the body of General Evaluation. This section of the implant Biological material may be natural or synthetic (biocompatible and biodegradable), or a composite structure, can comprise cells, drugs, or growth Factor, synthetic polypeptides, cDNA plasmid or other bioactive factors. This section describes the rabbits, dogs, pigs, goats, sheep and other animal models of different species of the genus and the corresponding test procedures, as well as morphology, tissue-ingrowth The results of measurement and evaluation methods were chemical and biomechanical analysis.2 Normative referencesThe following documents contain provisions which, through reference YY/T 0606 and become part of the provisions of this section. For dated references, All subsequent amendments (not including errata content) or revisions do not apply to this section, however, encourage the agreement on this section Whether the parties can study the latest versions of these documents. For undated reference documents, the latest versions apply to this section. GB/T 16886.1-2001 Biological evaluation of medical devices - Part 1. Evaluation and testing (idt ISO 10993-1.1997)3 Terms and DefinitionsThe following terms and definitions apply YY/T 0606 to the present section. 3.1 Natural cartilage has a similar morphology, biochemistry and tissue formation biomechanical properties of articular cartilage samples. 3.2 Damaged cartilage or a substitute by cell proliferation and extracellular matrix synthesis of new healing process. 3.3 Cartilage matrix contains a large number of parallel or interwoven arrangement of collagen fibers, the chemical composition of cartilage collagen type Ⅰ, no fixed Few shaped matrix, chondrocytes often distributed in rows between the fiber bundle. 3.4 Located on the surface of the articular cartilage, the main component of cartilage matrix proteoglycans and water, the fibers are made of plastic consisting of collagen type Ⅱ Protofibrils, cartilage chondrocytes located lacuna. 4. Significance and Use Objective 4.1 section is to provide a variety of animal models for clinical repair or regeneration of articular cartilage tissue engineered medical products Before evaluation. 4.2 part comprises animal model introduction, operation points, as well as organizations dealing with qualitative and quantitative analysis of tissue samples and the like. Users should be in accordance with section 4.3 GB/T 16886.1 Biological Evaluation of Medical Devices standards, making this part of the body Before evaluation, material and cytotoxicity and biocompatibility tests/or instruments. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0606.10-2008_English be delivered?Answer: Upon your order, we will start to translate YY/T 0606.10-2008_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. 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