YY/T 0606.8-2008Tissue engineered medical products - Part 8: Alginate (English PDF)

Foreword

YY /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 the evaluation of articular cartilage;

--- Part 12. cells, tissues, organs processing. This is Part 8 YY /0606's.

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

This part of the jurisdiction of the State Food and Drug Administration seized the Medical Device Quality Supervision and Inspection Center.

This section drafted by the State Food and Drug Administration seized the Medical Device Quality Supervision and Inspection Center.

1 Scope

YY/T 0606 This section applies to the preparation of tissue-engineered medical products and surgical implants sodium alginate.

2 Normative references

The following documents contain provisions which, through YY/T 0606 reference in this text, constitute provisions of this part. For dated reference documents Member, all subsequent amendments (not including errata content) or revisions do not apply to this section, however, according to this standard are encouraged to reach Parties to research agreement to use the latest versions of these documents. For undated references, the latest version applies to This section.

GB/T 191 Packaging - Pictorial signs

GB/T 2828.1-2003 Sampling procedures for inspection technology - Part 1. Press to accept the quality limit (AQL) retrieval batch inspection sampling plan

GB/T 16886.1-2001 Biological evaluation of medical devices - Part 1. Evaluation and testing (idt ISO 10993-1:1997)

GB/T 16886.3-1997 Biological evaluation of medical devices - Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity (Idt ISO 10993-3:1992)

GB/T 16886.4-2003 Biological evaluation of medical devices - Part 4. Selection of tests for interactions with blood (ISO 10993-4:2002, IDT)

GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity tests (ISO 10993-5:1999, IDT)

GB/T 16886.6-1997 Biological evaluation of medical devices - Part 6. Tests for local effects after implantation (idt ISO 10993-4.1994)

GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10. irritation and delayed-type hypersensitivity test (ISO 10993-10:2002, IDT)

GB/T 16886.11-1997 Biological evaluation of medical devices - Part 11. Tests for systemic toxicity (idt ISO 10993-11.1993)

GB/T 16886.12-2005 Biological evaluation of medical devices - Part 12. Sample preparation and reference materials (ISO 10993-12. 2002, IDT)

YY/T 0313-1998 Medical Polymer Co., packaging, labeling, transportation and storage People's Republic of China Pharmacopoeia (2005 edition)

USP USP26/NF21 alginate ASTMF2064-00 as alginates for biomedical and tissue engineered medical products initial material characterization and testing standard Associate Guide 1H- NMR chemical composition and sequence of ASTMF2259-03 for detecting alginate (1HNMR) standard test method

3 Terms and Definitions

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