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YY 0954-2015: Nonactive surgical implants - Type I collagen implants - Specific requirements
YY 0954-2015
Nonactive surgical implants - Type I collagen implants - Specific requirements
ICS 11.040.40
C45
People's Republic of China pharmaceutical industry standards
Active surgical implants Ⅰ collagen implants
Issued on. 2015-03-02
2017-01-01 implementation
China Food and Drug Administration released
Table of Contents
Introduction Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions 2
Expected performance 2 4
5 Design Properties 2
6 material 2
7 Design Evaluation 3
8 Test Method 4
Clinical evaluation 6 9
After the market surveillance 6 10
11 Manufacturing 6
12 Packaging 7
13 Information provided by the manufacturer 7
Appendix A (normative) Determination of collagen content 9
(Normative) Determination of the total hybrid protein Appendix B 11
Annex C (normative) Analysis of trace elements 13
Annex D (normative) Determination of melting point 14
Appendix E (normative) tryptophan examination 15
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Certain aspects of this standard may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the national surgical implants and orthopedic instruments Standardization Technical Committee (SAC/TC110) centralized.
This standard was drafted. Chinese Academy of Food and Drug test.
The main drafters of this standard. Kelin Nan, Fubu Fang, Wang Jian, Tang Jinglong, Chen Dandan, Feng Xiaoming, Wang Chunren.
Active surgical implants Ⅰ collagen implants
1 Scope
This standard specifies the injectable collagen implants (hereinafter referred to as implant) special requirements, it is purified (non-crosslinked)
Ⅰ collagen as a raw material preparation.
This standard specifies the implants technical requirements and test methods. Also expected product performance, design attributes, materials, design evaluation, test side
Law, clinical evaluation, post-market surveillance, manufacturing, packaging and information supplied by the manufacturer, and so do the specific instructions. Taking into account the safety of implants
Full factors.
Specified in this standard apply to the implant clinically for facial dermis and/or subcutaneous injection in order to eliminate or mitigate a variety of reasons
Cause facial wrinkles and depressions.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test
Biological evaluation of GB/T 16886.3 medical devices - Part 3. Test genotoxicity, carcinogenicity and reproductive toxicity test
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. 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
GB/T 16886.17 Biological evaluation of medical devices - Part 17. Medical Devices leachables allows the establishment of a limited amount of
GB/T 16886.18 Biological evaluation of medical devices - Part 18. Chemical characterization of materials
YY/T 0640-2008 active surgical implants General requirements
YY/T 0771.1 animal tissues and derivatives manufacture of medical devices - Part 1. Risk Analysis and Management
YY/T 0771.2 animal tissues and derivatives manufacture of medical devices - Part 2. Origin, collect and process control
YY/T 0771.3 animal tissues and derivatives used in the manufacture of medical devices - Part 3. Removal of viruses and infectious agents and
(Or) to confirm inactivated
YBB0006 prefilled syringe with borosilicate glass barrel
YBB0007 prefilled syringe with chlorobutyl rubber plunger
YBB0008 prefilled syringe with bromobutyl rubber plunger
YBB0009 pre-filled syringe with stainless steel needle
YBB0010 pre-filled syringe with a needle guard polyisoprene rubber cap
YBB0011 prefilled syringe assembly (with a needle)
People's Republic of China Pharmacopoeia (2010 edition)
ISO 14155 (all parts) Medical Device Clinical Investigation (Clinicalinvestigationofmedicaldevicesforhuman
subjects)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Ⅰ collagen typeIcolagen
By the COL1A1 and COL1A2 gene encoding α-chain gene expression, mammalian tissues the most abundant collagen, is
The fibers of collagen.
Note 1. The peptide from collagen type Ⅰ repeated Gly -XY (X bits occupy often proline, hydroxyproline occupy Y position) amino acid sequence.
Type I collagen-rich glycine (Gly), L- alanine (L-Ala), L- proline (L-Pro) and 4-hydroxyproline (4-Hypro), low sulfur content, and
Free L- tryptophan (L-Try).
Note 2. collagen triple helix structure having three α chains. Heating the case (for example, more than 60 ℃) α-chain collagen triple helix structure irreversibly
Denatured into a single strand α and β and γ certain bands (ie gelatin).
Note 3. often associated with type Ⅰ collagen and type Ⅲ collagen have Ⅴ collagen, in addition to the non-collagen proteins such as elastin and other structural molecules (amino
Polysaccharides, glycoproteins and lipoproteins complexes, etc.).
3.2
Ⅰ collagen implants typeIcolagenimplant
Under sterile conditions, the purified (non-crosslinked) Ⅰ collagen raw material is uniformly dispersed in phosphate buffer formulated with different concentrations
After the collagen suspension is filled in a pre-filled syringe made products.
3.3
Hybrid protein proteinimpurity
Collagen protein purification process residues except Ⅰ collagen outside of other proteins. Including (but not limited to). elastin,
Collagen molecule is not properly aligned, the host cell contaminants, cell culture contaminants, enzyme preparations. It may be associated with concomitant collagen type Ⅰ Ⅲ type glue
As a hybrid protein is not considered original.
3.4
Collagen degradation colagendegradation
Collagen in the role of chemical, physical and biological factors, hydrolysis and oxidation or reduction reactions, resulting in collagen chemistry
Bond breaking process.
4 expected performance
YY/T 0640-2008 Chapter 4 apply.
5 Design Properties
YY/T 0640-2008 Chapter 5 apply.
In order to achieve the desired performance requirements, design attributes to take into account effects due to material degradation caused.
6 Material
6.1 YY/T 0640-2008 Chapter 6 apply.
6.2 using collagen raw material, shall conform to the requirements of ASTMF2212-2009. Taking into account the raw materials from animal and/or human,
Would carry the risk of the virus, reference should YY/T 0771.1, YY/T 0771.2, YY/T 0771.3 management.
6.3 prefilled syringe device, should assess YBB0006, YBB0007, YBB0008, YBB0009, and YBB0010, YBB0011
Applicability of the standard, the injection device should batch test, qualified before the factory.
7 Design Evaluation
7.1 General Design Evaluation
7.1.1 YY/T 0640-2008 Chapter 7 apply.
7.1.2 in the design and manufacture of collagen implants, you should pay attention to the following issues.
a) can not endanger the health and safety of life, the clinical condition of the patient;
b) whether or collagen implants for cosmetic and/or reconstruction of tissues and organs, so that the user or patient to achieve aesthetic and psychological effects are
Taking into account the course of the impurities risks or side effects, these risks should be controlled at a minimum.
7.2 Preclinical Evaluation
7.2.1 General preclinical evaluation
Preclinical evaluation of collagen implants should be consistent with YY/T 0640-2008 requirements in 7.2.
According to the requirements of the experiment, all test samples shall be the final sterilized instrument or component.
Number of samples should be chosen to meet the requirements of this standard.
NOTE. The standard for pre-clinical evaluation, it has been validated test method reflects the current level of technological development.
7.2.2 Appearance
It should be white, milky white or slightly yellow viscous liquid, no visible foreign matter.
7.2.3 PACKING
Shall be not less than 90% of the labeled amount of loading.
7.2.4 dynamic viscosity
It should be within the indicated range.
7.3 Chemical Properties
7.3.1 Ⅰ collagen discrimination
By SDS- polyacrylamide gel electrophoresis analysis, electrophoretic bands of the sample and reference Ⅰ collagen comparing its electrophoretic
Band should be consistent.
7.3.2 collagen content
The labeled amount of 80% to 120%.
7.3.3 hybrid protein analysis
The total amount of hybrid protein implants should be below 1% of total protein.
NOTE. When any of the hybrid protein content of more than 1%, should be qualitative and quantitative analysis.
7.3.4 pH
Implants pH should be in the 6.0 to 8.0 range.
7.3.5 Residue on ignition
Residue on ignition implants should not exceed 10mg/g (mass fraction).
7.3.6 the total amount of heavy metals and trace elements
7.3.6.1 the total amount of heavy metals (Pb to Pb)
Total implant Heavy metals (Pb Pb) should be less than 10μg/g (mass fraction).
7.3.6.2 Trace Elements
Arsenic should not exceed 1μg/g (mass fraction); chromium, cadmium, copper, iron, mercury, nickel, lead, molybdenum should total no more than 50μg/g (mass fraction).
7.3.7 Melting point
Implant melting point should be within the indicated range.
7.3.8 acid hydrolyzate
Shall determine the composition of the final product (amino acid) acid hydrolysis implants.
7.3.9 tryptophan inspection
Two liquid acetic acid and sulfuric acid interface should not appear purple ring.
7.3.10 Other additives
Manufacturers should be GB/T 16886.17 requirements, and provides for the establishment of tolerances for harmful additives.
7.4 biological properties
7.4.1 Sterile
Ⅰ collagen implants should be sterile.
7.4.2 Biological Evaluation
7.4.2.1 Biological Assessment General
Shall GB/T 16886.1 requirements for biological implants were evaluated.
Toxicological evaluation should be based on scientific data, chemical characterization, toxicokinetics and toxicity related material on risk assessment. If
Necessary, should be based on detailed data and then tested and toxicological evaluation.
Including short and long term evaluation of the potential effects, including cytotoxicity, irritation, sensitization, genotoxicity, subcutaneous implantation, immunogen
Sex, systemic toxicity and carcinogenicity.
In addition to skin irritation, the manufacturer should determine and demonstrate the need for in vivo testing.
7.4.2.2 within bacterial endotoxin
Bacterial endotoxin content of the implant should be less than 0.5EU/mL.
8 test methods
8.1 Appearance
The Ⅰ collagen implants placed vertically umbrella awning lamp, illumination 1000lx, arbitrary rotation, seen from the horizontal direction, shall comply
7.2.2 provisions.
8.2 PACKING
Press the "People's Republic of China Pharmacopoeia (two)" (2010 edition) method specified in Appendix ⅩF be, shall comply with the provisions of 7.2.3.
8.3 Dynamic viscosity
Using a rotary viscometer, according to "People's Republic of China Pharmacopoeia (two)" (2010 edition) Appendix Ⅵ G second method, shearing
Rate of not less than 0.25Hz, (25 ± 0.1) ℃ under the conditions of the test results shall comply with the provisions of 7.2.4.
8.4 Ⅰ collagen discrimination
3% of acetic acid or with 0.01mol/L of hydrochloric acid diluted sample to a collagen concentration of 1mg/mL 2mg/mL solution ~.
Press the "People's Republic of China Pharmacopoeia (three)" (2010 edition) method specified in Appendix ⅣC conducted by SDS- polyacrylamide gel electrophoresis
Law, separation gel concentration of 7%, the injection volume was 20μL. Sample, Ⅰ collagen reference After analysis, the results should be consistent with 7.3.1
Provisions.
8.5 collagen content
The method according to Appendix A, the results should be consistent with the provisions of 7.3.2.
8.6 hybrid protein analysis
Accordance with the procedure in Appendix B, the results should be consistent with the provisions of 7.3.3.
8.7 pH
Press the "People's Republic of China Pharmacopoeia (two)" (2010 edition) method specified in Appendix Ⅵ H, the results should be consistent with 7.3.4
Provisions.
8.8 Residue on ignition
Press the "People's Republic of China Pharmacopoeia (two)" (2010 edition) Appendix Ⅷ N predetermined method, the results should be consistent with 7.3.5
Provisions.
The total amount of heavy metals and trace elements 8.9
8.9.1 the total amount of heavy metals (Pb to Pb)
Take Residue on ignition key under the residue left over, be Ⅷ H Method II Press the "People's Republic of China Pharmacopoeia (two)" (2010 edition) Appendix
The results should be consistent with the provisions of 7.3.6.1.
8.9.2 Trace Elements
According to the method prescribed in Appendix C, the results shall comply with the provisions of 7.3.6.2.
8.10 Melting point
According to the method prescribed in Appendix D, the results should be consistent with the provisions of 7.3.7.
8.11 acid hydrolyzate
A.1 according to the method prescribed, the test samples were prepared by acid hydrolysis solution by amino acid analyzer to determine the acid hydrolysis of the implant in the final product
Amino acid composition, the results should meet the requirements of 7.3.8.
8.12 Tryptophan inspection
According to the method specified in Appendix E, the results shall comply with the provisions of 7.3.9.
8.13 Additive
Dependin...