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YY 0308-2004 English PDF (YY0308-2004)

YY 0308-2004 English PDF (YY0308-2004)

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YY 0308-2004: Medical sodium hyaluronate gel

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 surgery.
YY 0308-2004
ICS 11.120.20
Classification. C 48
Medicine Industry Standard
of the PEOPLE 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)-??-D-glucuronic acid and (1???3)-2-acetaminophen-??-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 ??C. 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 ??C.
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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