YY/T 0308-2015 (YY/T0308-2015, YYT 0308-2015, YYT0308-2015) & related versions
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YY/T 0308-2015
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S 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) -β-D-glucuronide and (1→3)-
2-acetamido-β-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 (ρ
= 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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| Standard ID | YY/T 0308-2015 (YY/T0308-2015) | | Description (Translated English) | Medical sodium hyalurouate gel | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C48 | | Classification of International Standard | 11.120.20 | | Word Count Estimation | 16,198 | | Date of Issue | 2015-03-02 | | Date of Implementation | 2016-01-01 | | Older Standard (superseded by this standard) | YY 0308-2004 | | Quoted Standard | GB/T 16886.1 | | Drafting Organization | Shanghai Qisheng Biologics Co., Ltd. | | Administrative Organization | China Food & Drug Administration Jinan Medical Devices Inspection Center | | 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 classification of medical sodium hyaluronate gel, requirements, inspection rules, signs and packaging. This Standard applies to medical sodium hyaluronate gel. Medical sodium hyaluronate gel scope includes a viscoelastic ophthalmic surgery, intra-articular injection of lubricant and surgical blocking agent. |
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