YY/T 0308-2015_English: PDF (YY/T0308-2015)
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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Count Estimation | 16,198 | | Date of Issue | 2015-03-02 | | Date of Implementation | 2016-01-01 | | Older Standard (superseded by this standard) | YY 0308-2004 | | Quoted Standard | GB/T 16886.1 | | Drafting Organization | Shanghai Qisheng Biologics Co., Ltd.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. | | Standard ID | YY 0308-2004 (YY0308-2004) | | Description (Translated English) | Medical sodium hyaluronate gel | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C48 | | Classification of International Standard | 11.120.20 | | Word Count Estimation | 14,130 | | Date of Issue | 2004-11-08 | | Date of Implementation | 2005-11-01 | | Older Standard (superseded by this standard) | YY 0308-1998 | | Drafting Organization | Shanghai Qisheng Institute of Biomaterials Technology | | Administrative Organization | Jinan, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center | | Regulation (derived from) | 2005 Bulletin No. 2 industry standard | | Proposing organization | State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the classification of medical sodium hyaluronate gel, requirements, inspection rules, marking and packaging. This standard applies to medical sodium hyaluronate gel. Medical sodium hyaluronate gel for ophthalmic surgery include fillers, lubricants and intraarticular surgery blocking agent. | | Standard ID | YY 0308-1998 (YY0308-1998) | | Description (Translated English) | Medical hyaluronan gel | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C48 | | Word Count Estimation | 10,156 | | Date of Issue | 1998/4/8 | | Date of Implementation | 1998/10/1 | | Regulation (derived from) | 2005 No. 2 Industry-Standard Circular |
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...
......
YY 0308-2004
ICS 11.120.20
Classification. C 48
Medicine Industry Standard
of the People’s Republic of China
Replacing YY 0308-1998
Medical sodium hyaluronate gel
Issued on November 8, 2004 Implemented on November 1, 2005
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 6
2 Normative references ... 6
3 Terms and Definitions... 7
4 Classification... 7
5 Requirements ... 7
6 Rules for inspection ... 12
7 Symbols... 12
8 Packing ... 13
Appendix A ... 14
Appendix B ... 17
Appendix C ... 18
References and Original Chinese Documents ... 22
Foreword
This Standard replaces YY 0308-1998 Medical Sodium Hyaluronate Gel. This
revision mainly revises and supplements the contents of the fifth chapter. The
clause number and contents of other chapters remain the same or have a little
changes.
This Standard and YY 0308-1998 have following main differences.
— ADD effective usage, content, osmolality, dynamic viscosity and the
requirements of the residues of ethanol;
— REVISE transmittance, pH value, protein content and the index of
bacterial endotoxin content;
— REVISE the test method of biology, ADOPT the test method of standard
GB/T 16886.
The Appendix A, Appendix B and Appendix C of this Standard are all
normative.
This Standard is proposed and under the jurisdiction of Ji’nan Medical
Equipment Quality Supervision and Inspection Center of State Food and Drug
Administration.
This Standard is drafted by organizations. Shanghai Qisheng Institute of
Biomaterials Technology, Shandong Medical Equipment Quality Supervision
and Inspection Center.
This Standard is mainly drafted by. Gu Qisheng, Wang Wenbin, Luo Hongyu,
Yan Kai, and You Shaohua.
This Standard was first published in October 1998.
Introduction
Sodium hyaluronate is a kind of natural linear polysaccharide, which is made
up by disaccharide structural unit combined with (1→4)-β-D-glucuronic acid
and (1→3)-2-acetaminophen-β-D-glucose. According to the characteristics of
sodium hyaluronate’s structural unit, the medical sodium hyaluronate gel, after
deep processing, is a kind of new biomaterial which is species-less specificity,
non-toxic, well-solubility and well-biocompatibility. It is widely used in various
eye surgeries; in prevention and cure of post-traumatic arthritis or
degenerative arthritis; in prevention of postoperative intestinal and pelvic
adhesion in abdominal and pelvic surgeries of normal surgeries and obstetrics;
and in prevention of organic adhesion in tendon, joint and nerve surgeries.
Medical sodium hyaluronate gel as adjuvant of surgeries, shall have
molecular weight that is very similar to the sodium hyaluronate in human
body’s normal synovial fluid when used in intra-articular injection; in eye
surgeries, high dynamic viscosity value is important to operation; when used to
prevent postoperative tissue from adhesion, it mainly depends on biological
barrier effect produced by high viscoelasticity. For dynamic viscosity value, it is
closely related to determined temperature and shear rate. This Standard
choose dynamic viscosity value under low shear rate (i.e. under the state of
surgical devices operated in anterior chamber’s viscoelasticity).
Sodium hyaluronate as a kind of body-implanted medical biological material,
the contents of various impurities must be strictly controlled, to ensure the
security and effectiveness of the product. Given that during the purification and
evaporation of sodium hyaluronate which needs to use ethanol; the sodium
hyaluronate is a kind of hard-drying polymer materials; and the ethanol is hard
to volatilize completely, the residual amount of ethanol in sodium hyaluronate
will have different levels of stimulation actions to patients when used. So, in
order to reduce the adverse effects on patients whenever possible, and
considering the present production technology level, it is essential to have
Medical sodium hyaluronate gel
1 Scope
This Standard specifies classification, requirements, rules for inspection,
packing and marking of medical sodium hyaluronate gel.
This Standard applies to medical sodium hyaluronate gel. The applicable
scope of medical sodium hyaluronate gel includes the fillers of eye-surgeries,
lubricants of intra-articular injections and blockers of surgeries.
2 Normative references
The clauses in following documents become the clauses of this Standard by
the reference of this Standard. For dated reference, all subsequent
amendments (not including corrective contents) or editions are not applicable
to this Standard. However, parties who enter into agreement, based on this
Standard, are encouraged to study if the latest edition of those documents can
be used. For undated references, the latest edition applies.
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and
testing (idt ISO 10993-1. 1997)
GB/T 16886.3 Biological evaluation of medical devices - Part 3. Tests for
genotoxicity, carcinogenicity and reproductive toxicity (idt ISO 10993-3.1992)
GB/T 16886.5 Biological evaluation of medical devices - Part 5. Tests for
cytotoxicity. in vitro methods (GB/T 16996.5-2003, ISO 10993-5.1999, IDT)
GB/T 16886.6 Biological evaluation of medical devices - Part 6. Tests for local
effects after implantation (idt ISO 10993-6. 1994)
GB/T 16886.10 Biological evaluation of medical devices - Part 10. Tests for
irritation and skin sensitization (idt ISO 10993-10. 1995)
YY/T 0313-1998 Package, label, transport and storage for medical polymer
products
YY 0466-2003 Medical devices - Symbols to be used with medical device
5.17.6 Subcutaneous implant
Test according to the method provided by GB/T 16886.6. INJECT 0.5mL
medical sodium hyaluronate gel at each implantation point. SAMPLE it after
14d and OBSERVE it under microscope. The compatibility of sample’s
surrounding tissue shall be good. The slight inflammatory reaction mainly
consisted of neutrophilic infiltrate is visible.
5.17.7 Genotoxicity
DILUTE medical sodium hyaluronate gel with sterile sodium chloride solution
of which mass concentration is 9 g/L till 1 mg/mL. Tested according to the
method provided by GB/T 16886.3, the result shall be negative.
6 Rules for inspection
6.1 Batches
The medical sodium hyaluronate gel produced on the same day and produced
by the same process shall be the same lot number.
6.2 Type test
6.2.1 Type test is universal test, in which the biological property test shall be
conducted according to the requirements of GB/T 16886.1.
6.2.2 For type test, randomly SAMPLE 5 pieces each for 5.1~5.2; other
performance tests shall accord to the requirements of the Standard. If all test
items are qualified, the judgment of type test is qualified, otherwise the
judgment of type test is unqualified.
7 Symbols
7.1 The outer packing shall have following symbols at least.
a) Product name;
b) Manufacturer's name and address;
c) Classification, specifications;
d) Lot number or date of production;
e) Expiration date;
Appendix A
(Normative appendix)
Test of the content of sodium hyaluronate
A.1 Principle
Glucuronic acid reacts with carbazole reagent and generates reddish-purple
color after the hydrolysis of the sodium hyaluronate. The shade of the color is
proportional to the content of glucuronic acid.
A.2 Equipment
Analytical balance, ultraviolet spectrophotometer or equal equipment, swirl
mixer or equivalent equipment.
A.3 Solution preparation
A.3.1 Caracole ethanol solution of which volume fraction is 0.1%
WEIGH out 0.1 g carbazole. ADD 100 mL dehydrated alcohol to dissolve it.
PUT the solution into a dark brown bottle. STORE it under 4 ºC. The solution is
valid for 12 months.
A.3.2 Glucuronic acid (GA) standard solution
WEIGH out 10 mg glucuronic acid precisely. PUT it in a 100 mL measuring
flask. DILUTE GA to the graduation. SHAKE it well. STORE the solution under
4 ºC.
A.3.3 0.025 moI/L tetraborate sodium sulfate solution
WEIGHT out 9.54 g of sodium tetraborate (Na2B4O7.10H2O). ADD 1 L of
concentrated sulfuric acid. COVER it. SHAKE it at irregular time until the
sodium tetraborate is completely dissolved. STORE the solution at room
temperature. It is valid for 12 months.
Note. all the reagents used in the experiment are analyt...
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