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YY/T 0962-2014

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YY/T 0962-2014 英文版 1160 购买 现货,9秒内自动发货PDF,有增值税发票。 整形手术用交联透明质酸钠凝胶 有效

   
标准详细信息 YY/T 0962-2014; YY/T0962-2014; YYT 0962-2014; YYT0962-2014
中文名称: 整形手术用交联透明质酸钠凝胶
英文名称: Medical & Medicine
行业: 医药行业标准 (推荐)
中标分类: C45
国际标准分类: 11.040.40
字数估计: 20,000
发布日期: 17/6/2014
实施日期: 1/7/2015
引用标准: GB/T 16886.1; GB/T 16886.3; GB/T 16886.5; GB/T 16886.6; GB/T 16886.10; YBB 0011-2004; YY/T 0313; YY 0466; YY/T 0606.9-2007; YY/T 0640
起草单位: 中国食品药品检定研究院
归口单位: 全国外科植入物和矫形器械标准化技术委员会
标准依据: 国家食品药品监督管理总局公告2014年第30号
提出机构: 国家食品药品监督管理总局
发布机构: 国家食品药品监督管理总局
范围: 本标准规定了整形手术用交联透明质酸钠凝胶的要求、检验规则、标志、包装和由制造者提供的信息。本标准适用于整形手术用交联透明质酸钠凝胶。适用范围为面部皮肤真皮层的填充。

YY/T 0962-2014
Cross-linked sodium hyaluronate gel for plastic surgery
ICS 11.040.40
C45
中华人民共和国医药行业标准
整形手术用交联透明质酸钠凝胶
2014-06-17发布
2015-07-01实施
国家食品药品监督管理总局 发 布
目次
前言 Ⅲ
1 范围 1
2 规范性引用文件 1
3 术语和定义 1
4 材料要求 2
5 要求 2
6 检验方法 3
7 检验规则 5
8 包装 5
9 制造商提供的信息 5
附录A(规范性附录) 交联透明质酸钠粒径分布实验方法 7
附录B(规范性附录) 交联透明质酸钠凝胶针筒推挤力的测定方法 8
附录C(规范性附录) 交联透明质酸钠红外检测 9
附录D(规范性附录) 交联透明质酸钠溶胀度计算方法 10
附录E(规范性附录) 透明质酸钠含量测定 11
附录F(规范性附录) 交联剂1,4-丁二醇二缩水甘油基醚(BDDE)的残留量测定 13
附录G(规范性附录) 游离透明质酸钠含量测定 16
前言
本标准按照GB/T 1.1-2009给出的规则起草。
本文件的某些内容可能涉及专利。本文件的发布机构不承担识别这些专利的责任。
本标准由国家食品药品监督管理总局提出。
本标准由全国外科植入物和矫形器械标准化技术委员会(SAC/TC110)归口。
本标准起草单位:中国食品药品检定研究院、北京蒙博润生物科技有限公司、山东福瑞达生物医药
有限公司、杭州嘉伟生物制品有限公司。
本标准主要起草人:王召旭、付步芳、刘丽、章娜、郭学平、蒙一纯、冯晓明、王春仁。
整形手术用交联透明质酸钠凝胶
1 范围
本标准规定了整形手术用交联透明质酸钠凝胶的要求、检验方法、检验规则、标志、包装和由制造者
提供的信息。
本标准适用于整形手术用交联透明质酸钠凝胶。适用范围为面部皮肤真皮层的填充。
2 规范性引用文件
下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件,仅注日期的版本适用于本文
件。凡是不注日期的引用文件,其最新版本(包括所有的修改单)适用于本文件。
GB/T 16886.1 医疗器械生物学评价 第1部分:评价与实验
GB/T 16886.3 医疗器械生物学评价 第3部分:遗传毒性、致癌性和生殖毒性试验
GB/T 16886.5 医疗器械生物学评价 第5部分:体外细胞毒性试验
GB/T 16886.6 医疗器械生物学评价 第6部分:植入后局部反应试验
GB/T 16886.10 医疗器械生物学评价 第10部分:刺激与迟发型超敏反应试验
YBB0011-2004 预灌封注射器组合件(带注射针)(试行)
YY/T 0313 医用高分子产品包装、标识、运输和贮存
YY0466 医疗器械 用于医疗器械标志、标记和提供信息的符号
YY/T 0606.9-2007 组织工程医疗产品 第9部分:透明质酸钠
YY/T 0640 无源外科植入物 通用要求
中华人民共和国药典二部(2010年版)
3 术语和定义
下列术语和定义适用于本文件。
3.1
透明质酸 hyaluronicacid
一种由D-葡萄糖醛酸和N-乙酰基-D-葡萄糖胺通过β-(1-3)糖苷键连接而成的双糖重复结构单元
组成的线性多糖。每个双糖单元通过β-(1-4)糖苷键与另一个双糖单元连接起来。
3.2
交联剂 cross-linkingagent
用于透明质酸钠交联的化学试剂。
3.3
交联透明质酸钠凝胶 cross-linkedsodiumhyaluronategel
透明质酸钠与交联剂发生化学反应,形成的凝胶。
3.4
溶胀度 swelingdegree
交联透明质酸钠溶胀时重量变化的量度,反映该凝胶的交联程度。

YY/T 0962-2014
YY
ICS 11.040.40
C 45
Pharmaceutical Industry Standard
of the People’s Republic of China
Cross-linked sodium hyaluronate gel for plastic
surgery
整形手术用交联透明质酸钠凝胶
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).
The total amount of heavy metals shall be less than 5μg/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 2.0μg/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,
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
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.
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
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
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.
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;
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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