YY/T 0308-2015Medical sodium hyaluronate gel (English PDF)
医用透明质酸钠凝胶
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 2, 2015
Implementation date
January 1, 2016
Scope
YY/T 0308-2015 is the English-translated version of 医用透明质酸钠凝胶.
YY/T 0308-2015 is the Chinese pharmaceutical industry standard for medical sodium hyaluronate gel, the viscoelastic gel used in ophthalmic surgery and in other procedures.
It specifies the classification, the requirements, the inspection rules, the marks and the packaging, covering the sodium hyaluronate content and the molecular weight, the dynamic viscosity and the pH, the osmolality and the clarity, the protein and the heavy metal limits, the bacterial endotoxins and sterility, and the biological evaluation of the material. Issued on 2 March 2015, it has applied since 1 January 2016.
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Document preview — YY/T 0308-2015
National Standard of the People's Republic of China
- Replacing
- YY 0308-2004
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- Introduction5
- 1 Scope7
- 2 Normative references7
- 3 Terms and definitions7
- 4 Classification8
- 5 Requirements8
- 6 Inspection rules12
- 7 Marks12
- 8 Packaging13
- Appendix A14
- Appendix B17
- Appendix C19
- Appendix D21
- References23
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).
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.
3.3 Elasticity
After the material is deformed by an external force, the external force is removed to restore nature to its original shape.
4 Classification
4.1 Medical sodium hyaluronate gel is divided by clinical applicability into. for ophthalmic use, for surgical use and for intra-articular injection use.
4.2 Medical sodium hyaluronate gel is generally divided according to product packaging specifications into.
5 Requirements
5.1 Appearance
According to Appendix IX H of Pharmacopoeia of the People's Republic of China 2010 English Edition, 2 Volumes,
5.2 Effective usage
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 (rho = 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.
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.
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.
5.9 Elasticity
For sodium hyaluronate used for ophthalmology and intra-articular, it shall use rheometer to conduct frequency scan at shear rate of 0.01 Hz ~ 100 Hz at (25±0.2)°C. Draw logarithmic line graphs of viscous modulus G" and elastic modulus G' and logarithmic line graph of frequency. The shear frequency corresponding to G" = G' shall be less than the labelled value.
5.10 The average molecular weight
5.10.2 Weight average
molecular weight and molecular distribution factor
5.11 Protein content
Determine in the method stipulated in Appendix C. The protein content in sodium hyaluronate shall not be greater than 0.1% (mass fraction).
5.15 The residual amount of ethanol
Determine in the method stipulated in Appendix D. The residual amount of ethanol in medical sodium hyaluronate gel shall not be greater than 200 µg/g.
5.16 Sterility
Inspect in the method stipulated in Appendix XI H of the People's Republic of China 2010 English Edition, 2 Volumes. Medical sodium hyaluronate gel should be sterile.
5.17 Bacterial endotoxin
Use bacterial endotoxin test water to dilute the medical sodium hyaluronate gel.
Inspect by the method stipulated in Appendix XI E of the People's Republic of China 2010 English Edition, 2 Volumes. Bacterial endotoxin per milliliter of medical sodium hyaluronate gel shall be less than 0.5 EU.
6 Inspection rules
6.2 Type inspection
6.1 Group-batch
Medical sodium hyaluronate gel feed of same batch shall be produced in same feeling and same technology.
7 Marks
7.1 The following marks shall be on the bulk packaging.
7.2 The following marks shall be on the small packaging or accompanying documentation.
8 Packaging
It shall use a dose packaging for the small packaging of medical sodium hyaluronate gel shall use. Packaging design of convenient use is preferred. […]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.
Referenced standards
Similar standards
Editions of YY/T 0308
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 0308-2015 | Medical sodium hyaluronate gel | current edition | Current |
| YY 0308-2004 | Medical sodium hyaluronate gel | previous edition | Superseded |
This page sells the current edition, YY/T 0308-2015. Earlier editions are listed for reference only.
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Related Standards
GB/T 16886.1-1997 — Biological evaluation of medical devices--Part 1: Guidance on selection of tests
GB/T 16886.1-2001 — Biological evaluation of medical devices - Part 1: Evaluation and testing
GB/T 16886.1-2011 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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