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YY/T 0606.9-2007

标准搜索结果: 'YY/T 0606.9-2007'
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YY/T 0606.9-2007 英文版 970 购买 现货,9秒内自动发货PDF,有增值税发票。 组织工程医疗产品 第9部分:透明质酸钠 作废

   
标准详细信息 YY/T 0606.9-2007; YY/T0606.9-2007; YYT 0606.9-2007; YYT0606.9-2007
中文名称: 组织工程医疗产品 第9部分:透明质酸钠
英文名称: Tissue engineered medical products. Part 9: Sodium hyaluronate
行业: 医药行业标准 (推荐)
中标分类: C45
国际标准分类: 11.040.10
字数估计: 19,000
发布日期: 2007-01-31
实施日期: 2008-01-01
引用标准: GB 191-2000; GB/T 14518-1993; GB/T 16886.1-2001; GB/T 16886.3-1997; GB/T 16886.4-2003; GB/T 16886.5-2003; GB/T 16886.6-1997; GB/T 16886.10-2005; GB/T 16886.11-1997; GB/T 16886.12-2005; YY/T 0313-1998; YY 0466-2003; 中华人民共和国药典(2005年版 二部)
起草单位: 上海其胜生物材料技术研究所
归口单位: 中国药品生物制品检定所
标准依据: 中国行业标准备案公告2007年第4期(总第88期)
范围: YY/T 0606的本部分规定了用于外科植入物和组织工程医疗产品透明质酸钠的要求、试验方法、检验规则、标志、包装、运输和贮存等要求。本部分适用于透明质酸钠, 透明质酸钠可以用于制备外科植入物和组织工程医疗产品。


YY/T 0606.9-2007
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 45
Tissue engineered medical products –
Part 9. Sodium hyaluronate
组织工程医疗产品
第 9部分. 透明质酸钠
ISSUED ON. JANUARY 31, 2007
IMPLEMENTED ON. JANUARY 1, 2008
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 Classification ... 6 
5 Requirements ... 6 
6 Test methods ... 9 
7 Inspection rules ... 12 
8 Marks ... 13 
9 Packaging, transportation and storage ... 14 
Appendix A ... 15 
Appendix B ... 18 
Appendix C ... 22 
Appendix D ... 25 
References ... 28 
Foreword
YY/T 0606 Tissue engineered medical products is divided into.
— Part 1. General requirements;
— Part 2. Terminology;
— Part 3. General classification;
— Part 4. Terminology and classification of skin substitute;
— Part 5. Characterization and testing of substrates and scaffolds;
— Part 6. Type I collagen;
— Part 7. Chitosan;
— Part 8. Alginate;
— Part 9. Sodium hyaluronate;
— Part 10. In vivo assessment of implantable devices intended to repair or
regenerate articular cartilage;
— Part 12. Guide for processing cells, tissues, and organs;
— Part 13. Product conservation;
— Part 16. Guide for gel immobilization or microencapsulation of alginates
in the living cells or tissues.
This Part is the Part 9 of YY/T 0606.
The Appendixes A, B and C of this Part are normative; while the Appendix D is
informative.
This Part was proposed by China Food and Drug Administration.
This Part shall be under the jurisdiction of the National Institute for the Control
of Pharmaceutical and Biological Products.
Drafting organizations of this Part. Shanghai Qisheng Institute of Biomaterial
and Technology, and Medical Device Testing Center of the National Institute for
the Control of Pharmaceutical and Biological Products.
Main drafters of this Part. Gu Qisheng, Huang Zhiben, and Xi Tingfei.
Tissue engineered medical products –
Part 9. Sodium hyaluronate
1 Scope
This Part of YY/T 0606 specifies the requirements, test methods, testing rules,
marks, packaging, transportation and storage of the sodium hyaluronate used
in surgical implants and tissue engineered medical products.
This Part applies to the sodium hyaluronate which can be used for preparing
the surgical implants and tissue engineered medical products.
2 Normative references
The provisions in the following documents become the provisions of this Part
through reference in this Part of YY/T 0606. For dated references, the
subsequent amendments (excluding corrections) or revisions do not apply to
this Part. However, parties who reach an agreement based on this Part are
encouraged to study if the latest versions of these documents are applicable.
GB 191-2000 Packaging – Pictorial marking for handling of goods (eqv ISO
780.1997)
GB/T 14518-1993 Determination of the pH of adhesives (neq NFT 76-
103.1972)
GB/T 16886.1-2001 Biological evaluation of medical devices – Part 1.
Evaluation and testing (idt ISO 10993-1.1997)
GB/T 16886.3-1997 Biological evaluation of medical devices – Part 3. Tests
for genotoxicity, carcinogenicity and reproductive toxicity (idt ISO 10993-
3.1992)
Selection of tests for interactions with blood (ISO 10993-4.2002, IDT)
GB/T 16886.5-2003 Biological evaluation of medical devices – Part 5. Test
for in vitro cytotoxicity (ISO 10993-5.1999, IDT)
GB/T 16886.6-1997 Biological evaluation of medical devices – Part 6. Tests
for local effects after implantation (idt ISO 10993-6.1994)
GB/T 16886.10-2005 Biological evaluation of medical devices – Part 10.
Tests for irritation and delayed-type hypersensitivity (ISO 10993-10.2002,
IDT)
GB/T 16886.11-1997 Biological evaluation of medical devices – Part 11.
GB/T 16886.12-2005 Biological evaluation of medical devices – Part 12.
Sample preparation and reference materials (ISO 10993-12.2002, IDT)
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
labels, labelling and information to be supplied (ISO 15233.2000, IDT)
Pharmacopoeia of People’s Republic of China (2005 Edition, Volume 2)
3 Terms and definitions
The following terms and definitions apply to this Part of YY/T 0606.
It refers to the linear polysaccharide that is composed of disaccharide repeating
structural units generated by connecting D-glucuronic acid and N-acetyl-D-
glucosamine together via β-(1-3) glucosidic bond. Each disaccharide unit is
connected with another unit via β-(1-4) glucosidic bond.
3.2 Sodium hyaluronate
It refers to the sodium salt form of the hyaluronic acid. The molecular weight of
its structural unit is 401. The molecular structural formula is shown in the figure
below.
Note. SEE Appendix D for the additional information about the hyaluronic acid.
5.15.1 The sodium hyaluronate prepared by using the bio-fermentation
method shall be conducted with the hemolysis test for hemolytic streptococcus.
The test results shall have no hemolytic.
5.15.2 The sodium hyaluronate prepared by using the tissue extraction
method shall be conducted with relevant inspection and quarantine. The test
results shall be qualified.
5.16 Biological properties
5.16.1 General rules
The sodium hyaluronate shall be conducted with biological evaluation
any substances that have adverse effects on the human bodies.
5.16.2 Cytotoxicity test
The cytotoxic reaction shall not be greater than Level 1.
5.16.3 Intradermal reaction test
The primary irritation index (PII) shall not be greater than 0.4.
5.16.4 Acute systemic toxicity
There shall be no acute systemic toxicity.
5.16.5 Hemolysis test
There shall be no hemolytic reaction.
There shall be no skin sensitization.
5.16.7 Subcutaneous implant test
There shall be no significant differences between tissue reaction and negative
control, 14 days after implantation.
5.16.8 Genotoxicity test
There shall be no genotoxicity.
GB/T 16886.5. It shall conform to the provisions specified in the Article 5.16.2.
6.16.3 Intradermal reaction test
The determination shall be conducted according to the methods specified in the
6.13.4 Acute systemic toxicity
The determination shall be conducted according to the intraperitoneal injection
method specified in the GB/T 16886.11. It shall conform to the provisions
specified in the Article 5.16.4.
6.16.5 Hemolysis test
The determination shall be conducted according to the hemolysis test method
specified in the GB/T 16886.4. It shall conform to the provisions specified in the
Article 5.16.5.
6.16.6 Sensitization test
specified in the GB/T 16886.10. It shall conform to the provisions specified in
the Article 5.16.6.
6.16.7 Subcutaneous implant test
PREPARE the hyaluronic acid solution according to the instructions for use.
USE 3 New Zealand rabbits. Respectively SELECT 2 implant points on both
sides of the rabbit’s spine. CONDUCT the subcutaneous injection of 0.5mL of
hyaluronic acid to each point. TAKE samples for observation after 14 days.
Other test procedures shall be conducted according to the methods specified
in the GB/T 16886.6. The test procedures shall conform to the provisions
6.16.8 Genotoxicity test
The determination shall be conducted according to the methods for Ames test,
micronucleus test, and chromosome aberration test (mouse sperm test)
specified in the GB/T 16886.3. It shall conform to the provisions specified in the
Article 5.16.8.
7 Inspection rules
7.1 General rules
8.3 The storage and transportation marks shall conform to the provisions
specified in the GB/T 191.
9.1 USE appropriate packaging to ensure the safety and effectiveness of the
sodium hyaluronate products.
9.2 The packaging, transportation and storage of produ...
   
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