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YY/T 0606.7-2008 English PDF

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US$719.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 0606.7-2008: Tissue engineered medical products. Part 7: Chitosan
Status: Obsolete

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0606.7-2008	719	Add to Cart	3 days	Tissue engineered medical products. Part 7: Chitosan	Obsolete

Similar standards

YY/T 0640 YY/T 0663.2 YY 0948 YY/T 0606.15 YY/T 0606.14 YY/T 0606.13

Basic data

Standard ID: YY/T 0606.7-2008 (YY/T0606.7-2008)
Description (Translated English): Tissue engineered medical products. Part 7: Chitosan
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C45
Classification of International Standard: 11.040.40
Word Count Estimation: 18,193
Date of Issue: 2008-04-24
Date of Implementation: 2009-06-01
Quoted Standard: GB/T 191; GB 9969.1; GB/T 14233.2; GB/T 16886.1; GB/T 16886.3; GB/T 16886.5; GB/T 16886.6; GB/T 16886.10; GB/T 16886.11; GB/T 16886.12; YY 0466.1; YY/T 0313; YY/T 0771.1; YY/T 0771.2; YY/T 0771.3
Regulation (derived from): SFDA [2008] No. 192
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the requirements for the preparation of tissue-engineered medical products chitosan materials, test methods, inspection rules, marking, packaging, transportation and storage requirements. This standard applies to chitosan and its salts, can be used to prepare tissue engineered medical products.

YY/T 0606.7-2008: Tissue engineered medical products. Part 7: Chitosan

---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 products.Part 7. Chitosan ICS 11.040.40 C45 People's Republic of China pharmaceutical industry standards Tissue-engineered medical products - Part 7. chitosan Posted 2008-04-25 2009-06-01 implementation State Food and Drug Administration issued

Preface Ⅰ 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 Category 2 5 2 raw materials and process requirements 6 requires 2 7 Test Method 4 8 7 inspection rules 9 7 logo 10 packaging, transportation and storage 7 Appendix A (normative) Determination of Heavy Metal 8 Appendix B (normative) Determination of protein content 9 Annex C (normative) Determination of the residual amount of ethanol (GC) 11 Annex D (normative) Background 13 References 14

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. This part is proposed by the State Food and Drug Administration. This part of the jurisdiction of the Chinese Pharmaceutical and Biological Products. This section is drafted. Shanghai wins its Biologics Ltd., China Pharmaceutical and Biological Products. The main drafters of this section. Gu Qisheng, Jiang Lixia, Xi Tingfei, Feng Xiaoming, Chen Liang, Zhang Na. Tissue-engineered medical products - Part 7. chitosan

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. irritation and delayed-type hypersensitivity test 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 People's Republic of China Pharmacopoeia (2005 edition) two

3 Terms and Definitions

The following terms and definitions apply YY/T 0606 to the present section. 3.1 Chitosan chitosan From 2-acetamido-2-deoxy -D- glucopyranose (GIcNAc) and 2-amino-2-deoxy -D- glucopyranose (GlcN) by β (1 → 4) are connected in a linear polysaccharide. Chitosan is a polysaccharide chitin de-N- deacetylation generated by. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 0606.7-2008_English be delivered?

Answer: Upon your order, we will start to translate YY/T 0606.7-2008_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 0606.7-2008_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 0606.7-2008_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.