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YY 0954-2015 English PDF (YY0954-2015)

YY 0954-2015 English PDF (YY0954-2015)

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YY 0954-2015: Nonactive surgical implants - Type I collagen implants - Specific requirements

This standard specifies the specific requirements for injectable collagen implants (abbreviated as implants) which are prepared from purified (noncross-linked) type I collagen as a starting material.
YY 0954-2015
YY
MEDICAL INDUSTRY STANDARD
OF THE PEOPLE 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 ??L. 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...

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