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YY/T 0962-2014 English PDF (YYT0962-2014)

YY/T 0962-2014 English PDF (YYT0962-2014)

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YY/T 0962-2014: Cross-linked sodium hyaluronate gel for plastic surgery

This Standard specifies the requirements, test methods, inspection rules, marks, packaging and information provided by manufacturers of cross-linked sodium hyaluronate gel for plastic surgery.
YY/T 0962-2014
YY
ICS 11.040.40
C 45
Pharmaceutical Industry Standard
of the PEOPLE Republic of China
Cross-linked sodium hyaluronate gel for plastic
surgery
ISSUED ON. JUNE 17, 2014
IMPLEMENTED ON. JULY 1, 2015
Issued by. China Food and Drug Administration
Table of Contents
Foreword??...??3
1 Scope??...??4
2 Normative references??...??4
3 Terms and definitions??...??5
4 Material requirements??...??5
5 Requirements??...??6
6 Inspection methods??...??7
7 Inspection rules??...??10
8 Packaging??...??10
9 Information provided by manufacturers??...??11
Annex A??...??14
Annex B??...??15
Annex C??...??16
Annex D??...??17
Annex E...??19
Annex F??...??22
Annex G??...??27
Foreword
This Standard was drafted in accordance with rules given in GB/T 1.1-2009. Some of the content of this document may involve patents. The issuing organization of this document does not undertake the responsibility of identifying these patents. This Standard was proposed by the China Food and Drug Administration.
This Standard shall be under the jurisdiction of the National Standardization Technical Committee of Surgical Implants and Orthopedic Devices (SAC/TC 110).
Drafting organizations of this Standard. National Institutes for Food and Drug Control, Beijing Mengborun Biotechnology Co., Ltd., Shandong Freda Biopharm Co., Ltd., Hangzhou Jiawei Biological Product Co., Ltd.
Main drafters of this Standard. Wang Zhaoxu, Fu Bufang, Liu Li, Zhang Na, Guo Xueping, Meng Yichun, Feng Xiaoming, Wang Chunren.
Cross-linked sodium hyaluronate gel for plastic surgery
1 Scope
This Standard specifies the requirements, test methods, inspection rules, marks, packaging and information provided by manufacturers of cross-linked sodium hyaluronate gel for plastic surgery.
This Standard applies to cross-linked sodium hyaluronate gel for plastic surgery. The application scope is the filling of facial skin dermis.
2 Normative references
The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this standard.
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing
GB/T 16886.3 Biological evaluation of medical devices - Part 3. Tests for genotoxicity carcinogenicity and reproductive toxicity
GB/T 16886.5 Biological evaluation of medical devices - Part 5. Test for in vitro cytotoxicity
GB/T 16886.6 Biological evaluation of medical devices - Part 6. Tests for local effects after implantation
GB/T 16886.10 Biological evaluation of medical devices - Part 10. Tests for irritation and delayed-type hypersensitivity
YBB 0011-2004 Assemblages for prefilled syringes (with stainless steel needles) (Trial)
YY/T 0313 Package, label, transport and storage for medical polymer products YY 0466 Medical devices - Symbols to be used with medical device labels labeling and information to be supplied
biological fermentation method shall not be more than 0.1% (mass fraction). 5.11 Total amount of heavy metals
The total amount of heavy metals shall be less than 5??g/g.
5.12 Residual amount of cross-linking agents
The residual amount of cross-linking agents shall include residual amount of cross- linking agent in sodium hyaluronate particles. 1,4-Butanediol diglycidyl ether (abbreviated as BDDE) cross-linking agent shall be less than 2.0??g/g. If other cross- linking agents are used, it shall provide quality control indicators and test methods. 5.13 Additives, lubricants
If the lubricant is free sodium hyaluronate, it shall be within the indicated range. If auxiliaries, such as additives and lubricants, are added during the production process, it shall provide their limit requirements and test methods.
5.14 Sterility
Cross-linked sodium hyaluronate gel shall be sterile.
5.15 Bacterial endotoxin
Bacterial endotoxin of cross-linked sodium hyaluronate gel shall be less than 0.5EU/mL.
5.16 Hemolytic streptococcus hemolysin
There shall be no hemolytic zone.
5.17 Biological evaluation
Cross-linked sodium hyaluronate gel shall be conducted with biological evaluation according to the requirements of GB/T 16886.
5.18 Degradation test
Degradation of cross-linked sodium hyaluronate for plastic surgery refers to the reaction of its degradation and absorption until the material disappears under local microscopic without local inflammation, excluding the further metabolic processes of material outside the implanting locals. If the degradation time of products is too long, it can choose other suitable methods to conduct degradation test.
6 Inspection methods
DETERMINE according to the method of Annex E; REMOVE free sodium hyaluronate (if contains), which shall comply with the requirements of 5.9.
6.10 Protein
DETERMINE the protein content of sodium hyaluronate?€? raw materials according to the method specified in Annex B of YY/T 0606.9-2007, which shall comply with the specifications of 5.10.
6.11 Total amount of heavy metals
DETERMINE the total amount of heavy metals [in lead (Pb)] according to the third method in Annex VIII H of Pharmacopoeia of the People's Republic of China (2nd part), which shall comply with the specifications of 5.11.
6.12 Residual amount of cross-linking agents
TEST according to the method specified in Annex F, which shall comply with the requirements of 5.12.
If other cross-linking agents are used, it shall provide the quality control indicators. All test methods of residual amount of cross-linking agents shall be able to detect residual amount of cross-linking agents in cross-linked sodium hyaluronate particles. 6.13 Additives, lubricants
The determination of free sodium hyaluronate content is shown in Annex G. If auxiliaries, such as additives and lubricants, are added during the production process, it shall provide their limit requirements and test methods.
6.14 Sterility
TEST according to the method specified in the annex of Pharmacopoeia of the People's Republic of China (2nd part), which shall comply with the requirements of 5.14. 6.15 Bacterial endotoxin
EXTRCT cross-linked sodium hyaluronate gel with the water used for bacterial endotoxin detection; TEST according to the method specified in the annex of Pharmacopoeia of the People's Republic of China (2nd part), which shall comply with the requirements of 5.15.
6.16 Hemolytic streptococcus hemolysin
TAKE 1mL of cross-linked sodium hyaluronate gel; INOCULATE directly on a blood agar plate medium; CALTIVATE in a (37??1)??C incubator for 24h. The result shall meet e) Patient's name and contact information.
9.2.4 Information told to patients
A statement that doctors are required to ensure to provide the information to patients; the following information shall be told to patients by doctors before surgery; some relevant informed content shall also be provided in an appropriate manner after surgery (for example, filling in the patient card).
a) Product?€?s name or trade name; manufacturer?€?s address;
b) Description of implants, including type and main chemical composition; c) Manufacturer identification card, etc. for trace (for example. serial number and batch number);
d) Actual injection volume;
e) Life expectancy;
f) The following warning. inform patients that the injection of implants is an irreversible process; once injected, these implants can not be taken out by any method;
g) Expected results;
h) Expected risks. information includes all potential local complications, such as. allergic reactions, inflammation, liquidity or displacement to unintended sites; it shall also explain oth...

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