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YY 0954-2015 English PDF

YY 0954-2015_English: PDF (YY0954-2015)
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YY 0954-2015English140 Add to Cart 0--9 seconds. Auto-delivery Nonactive surgical implants - Type I collagen implants - Specific requirements Obsolete YY 0954-2015
YY/T 0954-2015English399 Add to Cart 4 days [Need to translate] Nonactive surgical implants--Type Ⅰ collagen implants--Specific requirements Valid YY/T 0954-2015
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BASIC DATA
Standard ID YY 0954-2015 (YY0954-2015)
Description (Translated English) Nonactive surgical implants. Type I collagen implants. Specific requirements
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C45
Classification of International Standard 11.040.40
Word Count Estimation 19,198
Date of Issue 2015-03-02
Date of Implementation 2017-01-01
Quoted Standard GB/T 16886.1; GB/T 16886.3; GB/T 16886.4; GB/T 16886.5; GB/T 16886.6; GB/T 16886.10; GB/T 16886.11; GB/T 16886.12; GB/T 16886.17; GB/T 16886.18; YY/T 0640-2008; YY/T 0771.1; YY/T 0771.2; YY/T 0771.3; YBB 0006; YBB 0007; YBB 0008; YBB 0009; YBB 0010; YBB 0011; ISO 14155-2011
Drafting Organization Chinese Institute of Food and Drug test
Administrative Organization National Surgical implants and orthopedic devices Standardization Technical Committee
Regulation (derived from) The State Food and Drug Administration Announcement 2015 No. 8
Proposing organization China Food and Drug Administration
Issuing agency(ies) China Food and Drug Administration
Summary This Standard specifies the requirements for injectable collagen implant agent, it is purified (non-crosslinked) I collagen as a raw material preparation. This Standard specifies the implant agent requirements and test methods. Also expected product performance, design attributes, materials, design evaluation, testing methods, clinical evaluation, any post-market monitoring, manufacturing, packaging and information supplied by the manufacturer, and so do the specific instructions. Taking into account the safety of implanted Jing factor. This Standards required by applicable implant agent used clinically in the face of the dermis and/or subcutaneous injection, in order to eliminate or mitigate a variety of causes facial wrinkles and depressions.


YY 0954-2015 YY MEDICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.40 C 45 Nonactive surgical implants - Type I collagen implants - Specific requirements ISSUED ON. MARCH 02, 2015 IMPLEMENTED ON. JANUARY 01, 2017 Issued by. China Food and Drug Administration of China Table of contents Foreword ... 3  1 Scope ... 4  2 Normative references ... 4  3 Terms and definitions ... 5  4 Expected performance ... 7  5 Design properties ... 7  6 Material ... 7  APPENDIX A (Normative) Determination of collagen content ... 17  APPENDIX B (Normative) Determination of total protein impurity content ... 20  Appendix C (Normative) Trace element analysis ... 24  Appendix D (Normative) Determination of melting point ... 26  Appendix E (Normative) Tryptophan examination ... 27  Foreword This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Some of the contents of this standard may be related to patents. The issuer of this document is not responsible for identifying such patents. This standard was proposed by China Food and Drug Administration of China. This standard shall be under the jurisdiction of the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices (SAC/TC 110). The drafting organizations of this standard. China Food and Drug Research Institute. The main drafters of this standard. Ke Linnan, Fu Bufang, Wang Jian, Tang Jinglong, Chen Dandan, Feng Xiaoming, Wang Chunren. Nonactive surgical implants - Type I collagen implants - Specific requirements 1 Scope This standard specifies the specific requirements for injectable collagen implants (abbreviated as implants) which are prepared from purified (non- cross-linked) type I collagen as a starting material. This standard specifies the implant technical requirements and testing methods. It also specifies the expected performance, design properties, materials, design evaluation, test methods, clinical evaluation, post-marketing surveillance, manufacturing, packaging, and information provided by the manufacturer, taking into account the safety factors of implant. The implants as specified in this standard are suitable for use in dermal layers and/or subcutaneous injections for clinical use, in order to eliminate or reduce facial wrinkles and depressions caused by various reasons. 2 Normative references The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this Standard. GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing within a risk management process GB/T 16886.3 Biological evaluation of medical devices Part 3. Test for genotoxicity carcinogenicity and reproductive toxicity GB/T 16886.4 Biological evaluation of medical devices - Part 4. Selection of tests for interactions with blood GB/T 16886.5 Biological evaluation of medical devices - Part 5. Test for vitro cytotoxicity GB/T 16886.6 Biological evaluation of medical devices - Part 6. Tests for local effects after implantation GB/T 16886.10 Biological evaluation of medical devices - Part 10. Tests for irritation and delayed-type hypersensitivity 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 GB/T 16886.17 Biological evaluation of medical devices - Part 17. Establishment of allowable limits for leachable substances GB/T 16886.18 Biological evaluation of medical devices - Part 18. Chemical characterization of materials YY/T 0640-2008 Non-active surgical implants - General requirements YY/T 0771.1 Medical devices utilizing animal tissue and their derivatives - Part 1. Application of risk management YY/T 0771.2 Medical devices utilizing animal tissue and their derivatives - Part 2. Controls on sourcing, collection and handling YY/T 0771.3 Medical devices utilizing animal tissue and their derivatives - Part 3. Application of risk management YBB 0006 Borosilicate glass syringes for prefilled syringes YBB 0007 Chlorinated butyl rubber piston for prefilled syringes YBB 0008 Bromobutyl rubber piston for prefilled syringes YBB 0009 Stainless steel injection needle for prefilled syringes YBB 0010 Polyisoprene rubber needle guard for prefilled syringes YBB 0011 Prefilled syringe assembly (with injection needle) Pharmacopoeia of the People's Republic of China (2010 version) ISO 14155 (All Parts) Clinical investigation of medical devices for human subjects 3 Terms and definitions The following terms and definitions apply to this document. b) Regardless of the use of collagen implants for cosmetic and/or tissue and organ reconstruction in order to make the users satisfy with the aesthetic or psychological effects, it shall consider the risks or side effects of the impurities in the process of use; AND it shall minimize such risks. 7.2 Preclinical evaluation 7.2.1 General preclinical for preclinical evaluation The preclinical evaluation of collagen implants shall comply with the requirements in 7.2 of YY/T 0640-2008. In accordance with the requirements of the experiment, all test samples shall be the finally sterilized equipment or components. The number of samples shall be chosen in accordance with the requirements of this standard. Note. The preclinical evaluation and the proven test methods in this standard reflect the current level of technological development. 7.2.2 Appearance It shall be white, milky white or yellowish viscous liquid, without visible foreign matter. 7.2.3 Loading capacity It shall not be less than 90% of the indicated capacity. 7.2.4 Dynamic viscosity It shall be within the indicated range. 7.3 Chemical characteristics 7.3.1 Type I collagen identification After the SDS-polyacrylamide gel electrophoresis analysis, COMPARE the electrophoretic bands of the samples and the type I collagen reference product, AND the electrophoretic bands shall be consistent. 7.3.2 Collagen content It shall be 80% ~ 120% of the indicated amount. 7.3.3 Protein impurity analysis the test results shall comply with the provisions of 7.2.4. 8.4 Identification of type I collagen USE the 3% acetic acid or 0.01 mol/L hydrochloric acid to dilute the sample into a solution with a collagen concentration of 1 mg/mL ~ 2 mg/mL. FOLLOW the methods as specified in Appendix IV C of the Pharmacopoeia of the People's Republic of China (volume III) (2010 version); USE the SDS-polyacrylamide gel electrophoresis, with the separation gel concentration in 7% AND the sample amount of 20 µL. Through analyzing the sample and type I collagen reference substance, the results shall comply with the provisions of 7.3.1. 8.5 Collagen content FOLLOW the method of Appendix A, AND the results shall comply with the provisions of 7.3.2. 8.6 Protein impurity analysis FOLLOW the method of Appendix B, AND the results shall comply with the provisions of 7.3.3. 8.7 pH FOLLOW the methods as specified in Appendix VI H of Pharmacopoeia of the People's Republic of China (volume II) (2010 version), AND the results shall comply with the provisions of 7.3.4. 8.8 Residues on ignition FOLLOW the methods as specified in Appendix VI N of the Pharmacopoeia of the People's Republic of China (volume II) (2010 version), AND the results shall comply with the provisions of 7.3.5. 8.9 Total heavy metals and trace elements 8.9.1 Total amount of heavy metals (calculated as Pb) The residues left under the residues on ignition shall follow the 2nd method of Appendix VIII H of the Pharmacopoeia of the People's Republic of China (volume II) (2010 version), AND the results shall comply with the provisions of 7.3.6.1. 8.9.2 Trace elements FOLLOW the methods as specified in Appendix C; AND the results shall comply with the provisions of 7.3.6.2. The requirements of Chapter 8 in YY/T 0640-2008 apply. 12 Packaging The requirements in Chapter 10 of YY/T 0640-2008 apply. 13 Information provided by the manufacturer 13.1 General principles The requirements in Chapter 11 of YY/T 0640-2008 AND the following requirements apply. 13.2 Implants materials The manufacturer shall provide a description of the implant material. 13.3 Nominal capacity It shall indicate the nominal capacity of the implants. 13.4 Information on life expectancy The manufacturer shall provide information relevant to the intended sustained performance of the device in accordance with the design. Such information includes indications that are important factors influencing the actual life of the implant. Note. In practice, it is not possible to accurately predict the actual life of the implant. This prediction is only a design requirement. 13.5 Operating instructions If applic... ......