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YY/T 1435-2016: Tissue engineering medical device products--Standard guide for characterization of hydrogels
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Tissue engineering medical device products--Standard guide for characterization of hydrogels
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YY/T 1435-2016
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Basic data | Standard ID | YY/T 1435-2016 (YY/T1435-2016) | | Description (Translated English) | Tissue engineering medical device products--Standard guide for characterization of hydrogels | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C45 | | Word Count Estimation | 14,186 | | Date of Issue | 2016-07-29 | | Date of Implementation | 2017-06-01 | | Quoted Standard | GB/T 16886.1; GB/T 16886.19; YY/T 0606.5; YY/T 0606.7; YY/T 0606.8; YY/T 0606.9; YY/T 0771.1 | | Regulation (derived from) | State Food and Drug Administration Notice 2016 (No.129) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies guidelines for characterizing the biological properties of hydrogels in tissue engineering medical device products, forming kinetic, physical and chemical properties and stability, and substance transfer. | YY/T 1435-2016: Tissue engineering medical device products--Standard guide for characterization of hydrogels
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Tissue engineering medical device products - Standard guide for characterization of hydrogels
ICS 11.040.40
C45
People's Republic of China Pharmaceutical Industry Standard
Tissue engineering medical equipment products
A Guide to Hydrogel Characterization
Standardguideforcharacterization ofhydrogels
2016-07-29 released
2017-06-01 implementation
State Food and Drug Administration issued
Directory
Preface I
Introduction II
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
4 important factors for hydrogel characterization
5 Biological characteristics 3
6 Dynamics 3
7 Physical and chemical properties and stability 5
8 material transfer 6
9 evaluation test selection 7
Reference 9
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Surgical Implant and Orthopedic Equipment Standardization Technical Committee Organizational Engineering Medical Device Products Subcommittee
(SAC/TC110/SC3).
The drafting of this standard. China Food and Drug Research Institute, the joint power of Anda (Tianjin) Biotechnology Technology Co., Ltd.
The main drafters of this standard. Chen Liang, Zhu Jianmin, Fang Yu, Liu Li, Sun Xuelian, Wang Chunren.
Introduction
The hydrogel is a reticular polymer that swells in water and retains moisture in the polymer voids. Due to the existence of intermolecular crosslinking, hydration
The glue can maintain a stable structure in the solid after swelling. The hydrogel material used in tissue engineering can be derived from natural polymers (e.g., algae
Acid, chitosan and collagen), synthetic polymers [e.g., polyethylene glycol (PEG), polyvinyl alcohol (PVA)] or a mixture of both (e.g., PVA and
Chitosan or gelatin). In clinical applications, hydrogels with or without the addition of a drug and/or a biological agent may be injected or implanted in the body.
Hydrogels are used primarily in tissue engineering as transport carriers for matrix substitutes, drugs and/or preparations, and environments that make up cell culture.
In the course of the application, the effect of the hydrogel depends on its ability to allow the dissolved gas, nutrients and bioactive substances to penetrate
Ability to maintain cell growth and migration; ability to degrade; ability to release drugs and/or biological agents at a suitable rate;
Its shape ability. Therefore, it is necessary to give a suitable method for the hydrogel for tissue engineering.
Tissue engineering medical equipment products
A Guide to Hydrogel Characterization
1 Scope
This standard gives the biological properties of hydrogels used to characterize tissue engineering medical device products, forming kinetics, physical and chemical
Sexuality and stability, as well as material delivery and other characteristics of the method guide.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management
(GB/T 16886.1-2011, ISO 10993-1..2009, IDT)
GB/T 16886.19 Biological evaluation of medical devices - Part 19. Physical chemistry, morphology and surface characterization of materials
(GB/T 16886.19-2011, ISO /T S10993-19..2006, IDT)
Tissue engineering medical products - Part 5. Performance and testing of substrates and stents YY/T 0606.5
Tissue engineering medical products - Part 7. Chitosan
Tissue engineering medical products - Part 8. Sodium alginate
Tissue engineering medical products - Part 9. Sodium hyaluronate
YY/T 0771.1 Animal source medical devices - Part 1. Risk management applications (YY/T 0771.1-2009, ISO 22442-1.
2007, IDT)
Pharmacopoeia of the People's Republic of China (2010 edition)
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Hydrogel hydrogel
A gel having a three-dimensional network structure formed by a polymer chain and retaining moisture in the intermolecular voids.
3.2
Biocompatibility
The ability of a biomaterial to cause a proper response in a particular application.
[ISO /T R15499..2012, definition 3.1]
Note. In the definition of the Scientific Committee of Materials Science, "biocompatibility" is the ability of a material to interact with a host during an application.
Material material is different from other high-tech materials, the most important features. Including hemocompatibility and histocompatibility. "Biocompatible material" is physiologically
Environmental or biological, does not cause any adverse host reaction (material caused by the reaction of the body).
3.3
Exogenous factor adventitiousagents
Contaminants present in raw materials and articles used in inoculants, cell matrices and/or manufactured products, including bacteria, fungi, mycoplasma
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