YY/T 0606.10-2008Tissue engineered medical products - Part 10: Guide for in vivo assessment of implants for repair or regeneration of articular cartilage (English PDF)
组织工程医疗产品 第10部分：修复或再生关节软骨的植入物体内评价指南
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
April 25, 2008
Implementation date
June 1, 2009
Scope
YY/T 0606.10-2008 is the English-translated version of 组织工程医疗产品 第10部分：修复或再生关节软骨的植入物体内评价指南.
YY/T 0606.10-2008 is the Chinese standard "Tissue engineered medical products - Part 10: Guide for in vivo assessment of implants for repair or regeneration of articular cartilage".
Its scope clause reads: YY/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. Its clauses include terms and definitions.
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Document preview — YY/T 0606.10-2008
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C45
Issued by: National Medical Products Administration
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
1 Scope
YY/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 references
The 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 Definitions
The 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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.
Referenced standards
Normative references
YY/T 0606 · ISO 10993
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YY/T 0606.12-2007 — Tissue engineered medical products - Part 12: Guide for processing cells, tissues and organs
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