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YY/T 0308-2015 English PDF (YYT0308-2015)

YY/T 0308-2015 English PDF (YYT0308-2015)

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YY/T 0308-2015: Medical sodium hyalurouate gel

This Standard specifies the classification, requirements, inspection rules, marks and packaging of medical sodium hyaluronate gel. This Standard is applicable to medical sodium hyaluronate gel. The application of medical sodium hyaluronate gel includes viscoelastic agents for eye surgery, lubricants for intra-articular injection and barriers for surgical operation.
YY/T 0308-2015
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.120.20
C 48
Replacing YY/T 0308-2004
Medical sodium hyaluronate gel
ISSUED ON. MARCH 2, 2015
IMPLEMENTED ON. JANUARY 1, 2016
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 7
2 Normative references ... 7
3 Terms and definitions ... 7
4 Classification ... 8
5 Requirements ... 8
6 Inspection rules ... 12
7 Marks ... 12
8 Packaging ... 13
Appendix A ... 14
Appendix B ... 17
Appendix C ... 19
Appendix D ... 21
References ... 23
Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009. This Standard replaces YY 0308-2004 Medical sodium hyaluronate gel.
Compared with YY 0308-2004, the main technical changes are as follows.
- Added terms, definitions and requirements for shear viscosity, elasticity, viscoelastic and weight average molecular weight (see 3.2~3.5, 5.8, 5.9, 5.10.2 of this edition);
- Deleted dynamic viscosity?€?s terms, definitions and requirements (3.2 of this edition; 5.8 of 2004 edition);
- Modified requirements for effective usage (see 5.2 of this edition; 5.2 of 2004 edition);
- Modified requirements for light transmittance (see 5.5 of this edition; 5.5 of 2004 edition);
- Modified requirements for protein content (5.11 of this edition; 5.10 of 2004 edition);
- Added requirements for refractive index (see 5.13 of this edition);
- Modified ethanol residues indicator (see 5.15 of this edition; 5.13 of 2004 edition);
- Modified bacterial endotoxin Indicator (see 5.17 of this edition; 5.15 of 2004 edition);
- Deleted description on biological test methods (5.17.2~5.17.7 of 2004 edition);
- Modified method for the determination of sodium hyaluronate (see
Appendix A of this edition; Appendix A of 2004 edition).
Please note that some of the content of this document may involve patents; the issuing agency of this document does not undertake the responsibility for the identification of these patents.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of Shandong Food and Drug Administration of China Food and Drug Administration.
Introduction
Sodium hyaluronate is a naturally occurring linear polysaccharide; it is a disaccharide structural unit composed of (1???4) -??-D-glucuronide and (1???3)- 2-acetamido-??-D-glucose. Medical sodium hyaluronate gel made after deep processing based on the characteristics of sodium hyaluronate is a non-toxic, water-soluble and biocompatible new biomaterial which shall be used for eye surgery, intra-articular lubrication, postoperative tissue adhesion after preventive surgery.
When medical sodium hyaluronate gel is used for intra-articular injection, it shall require molecular weight closer to sodium hyaluronate in normal human
synovial fluid. In eye surgery, the high shear viscosity value is especially important for surgical procedures. When it is used for postoperative tissue adhesion after preventive surgery, it mainly relies on biological barrier effect generated by high viscoelastic. Since shear viscosity values are closely related to measured temperature and shear rate, this Standard chooses shear viscosity at low shear rate (i.e. surgical instruments are operating under viscoelastic agents of anterior chamber). Meanwhile, considering ophthalmic viscoelastic and intra-articular injection products, its elasticity is also closely related to the clinical application.
Sodium hyaluronate, as an implantable biomedical materials, the content of all kinds of impurities must be strictly controlled, so as to ensure the safety and effectiveness of the use of the product. Considering that the drying and purification of sodium hyaluronate in the production process requires the use of organic solvents, but sodium hyaluronate is a difficult dry polymer material, and the organic solvent is difficult to completely evaporate; trace organic solvent in sodium hyaluronate causes the product have varying degrees of stimulation to patients during the use. Therefore, in order to minimize the adverse effect of the product on the patient, taking into account the current level of technology production, it is necessary to define a reasonable residual amount of ethanol. Considering that some manufacturers may use organic solvents besides
ethanol, it must make appropriate technical requirements and test methods. Some sodium hyaluronate is extracted from animal tissue or organ, so there may be the risk of carrying the virus and infectious agents. The manufacturer shall take effective measures to control and effectively remove or inactivate animal tissues or organs for viruses and infectious agents.
NOTE. Control measures on viruses and infectious agents in animal tissues shall refer to YY/T 0771 standards.
Some sodium hyaluronate is prepared by microbial fermentation. During the fermentation process, strain may produce metabolite by itself. The
Medical sodium hyaluronate gel
1 Scope
This Standard specifies the classification, requirements, inspection rules, marks and packaging of medical sodium hyaluronate gel.
This Standard is applicable to medical sodium hyaluronate gel. The application of medical sodium hyaluronate gel includes viscoelastic agents for eye surgery, lubricants for intra-articular injection and barriers for surgical operation. 2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing within a risk management process
Pharmacopoeia of the People's Republic of China 2010 English Edition, 2 Volumes
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 medical sodium hyaluronate gel
Gel-like solution formulated with sodium hyaluronate and for human.
3.2 shear viscosity
Ability to resist deformation rate of fluid by shear force.
NOTE 1. Quantitatively, shear viscosity is shear stress divided by shear rate under constant shear rate.
NOTE 2. Shear Viscosity is represented in Pa?€?s or usually in mPa?€?s.
NOTE 3. Shear rate refers to fluid velocity gradient, in s-1.
Try to take out the content in each single package in normal used method. After accurately weighed, it is divided by medical sodium hyaluronate gel density (?? = 1.01 g/mL), the obtained value shall not be less than 93% of the labelled amount, and the average value shall not be less than the labelled amount. 5.3 Identification
Medical sodium hyaluronate gel shall have the following reactions.
a) Product a purple red solution according to the method in Appendix A; b) Take 0.1g of medical sodium hyaluronate gel. Use distilled water for 10- fold dilution. Add 2~3 drops of cetyl pyridinium chloride (1??? 20) to
generate white flocculent precipitate;
c) Take 0.1g of medical sodium hyaluronate gel. Use distilled water for 10- fold dilution. Use platinum gold to burn, and the flame is yellow.
5.4 Content
Determine it according to the method stipulated in Appendix A and the sodium hyaluronate content should be 90.0%~120.0% of the labelled mass
concentration.
5.5 Light transmittance
Use sodium chloride solution of which the concentration is 9 g/L for 10-fold dilution of medical sodium hyaluronate gel. Take preparation solution as blank control. Determine it according to the method stipulated in Appendix IV A of Pharmacopoeia of the People's Republic of China 2010 English Edition, 2 Volumes. Record the spectral transmittance within 300 nm ~ 800 nm. Draw a line graph of light transmittance to wave length. At a wavelength within a range of 300 nm ~ 800 nm, the transmittance shall not be less than 98.0%.
5.6 pH
Use distilled water for equivalent mass ration dilution of medical sodium hyaluronate gel. Determine pH according to the method stipulated in Appendix VI H of Pharmacopoeia of the People's Republic of China 2010 English Edition, 2 Volumes, and pH shall be within 6.8~7.6.
5.7 Osmotic pressure
Make direct sampling. Determine it according to the method stipulated in Appendix IX G of Phar...

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