YY/T 0606.7-2008Tissue engineered medical products - Part 7: Chitosan (English PDF)

Foreword

YY/T 0606 "tissue-engineered medical products" is divided into. Tissue-engineered medical products - Part 1. General requirements; Tissue-engineered medical products - Part 2. Terminology; Tissue-engineered medical products - Part 3. General classification;

Tissue Engineered Medical Products Part 4. skin substitute (object) of the terminology and classification;

Tissue-engineered medical products - Part 5. Matrix and stent performance and testing; Tissue engineered medical products - Part 6. I collagen; Tissue-engineered medical products - Part 7. chitosan; Tissue-engineered medical products - Part 8. sodium alginate; Tissue Engineered Medical Products Part 9. sodium hyaluronate;

Tissue-engineered medical products - Part 10. repair or regeneration in vivo evaluation of articular cartilage implants;

Tissue-engineered medical products - Part 11. decalcified bone ectopic bone induced histological evaluation guidelines;

Tissue-engineered medical products - Part 12. cells, tissues, organs processing guide; Tissue-engineered medical products - Part 13. Automatic cell count;

Tissue-engineered medical products - Part 14. Test methods and evaluation matrix scaffold immune response. ELISA method;

Tissue engineered medical products - Part 15. Test method for evaluating the immune response matrix and bracket. lymphocyte proliferation test; Tissue-engineered medical products - Part 16. Saving Guide; Tissue-engineered medical products - Part 17. exogenous factor evaluation guidelines;

Tissue-engineered medical products - Part 18. alginate gel or microencapsulated fixed guide;

Tissue-engineered medical products - Part 19. Repair and replacement of bone tissue implant bone formation activity in vivo evaluation guidelines;

Tissue-engineered medical products - Part 20. Test method for evaluating the immune response and stent matrix. cell migration test. This is Part 7 YY /0606's.

This section of the Appendix A, Appendix B, Appendix C is a normative appendix, Appendix D is informative appendix.

1 Scope

YY/T 0606 This section specifies the requirements for the preparation of tissue-engineered medical products chitosan materials, test methods, inspection regulations Then, signs, packaging, transportation and storage requirements.

This section applies to chitosan and its salts, can be used in the preparation of tissue-engineered medical products.

2 Normative references

The following documents contain provisions which, through YY/T 0606 this part of the terms of reference in 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 Research on whether parties can try the latest version of these documents. For undated reference documents, the latest versions apply to this section.

GB/T 191 Packaging - Pictorial signs

GB 9969.1 Instructions General Industrial Products

GB/T 14233.2 Infusion, transfusion, injection equipment test methods - Part 2. Biological test methods

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing

GB/T 16886.3 Biological evaluation of medical devices - Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity

GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity tests Tests for local effects after implantation. GB/T 16886.6 Biological evaluation of medical devices - Part 6

GB/T 16886.10 Biological evaluation of medical devices - Part 10.

GB/T 16886.11 Biological evaluation of medical devices - Part 11. Tests for systemic toxicity

GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference materials Symbols - Part 1 YY 0466.1 medical equipment used with medical device labels, labeling and information. General requirements

YY/T 0313 Medical Polymer Co., packaging, labeling, transportation and storage

YY/T 0771.1 animal source of medical equipment - Part 1. Application of risk management

YY T 0771.2 animal source of medical devices - Part 2 /. source control, collection and disposal

YY/T 0771.3 animal origin medical devices - Part 3. viruses and transmissible spongiform encephalopathy (TSE) removed and inactivated factor confirm

3 Terms and Definitions

The following terms and definitions apply YY/T 0606 to the present section.