YY/T 1754.2-2020 English PDF (YYT1754.2-2020)

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YY/T 1754.2-2020: Preclinical animal study of medical devices - Part 2: Model of skin defect in induced diabetic rats
YY/T 1754:2-2020
(Preclinical Animal Research of Medical Devices Part 2: Induced Diabetic Rat Skin Defect Model)
ICS 11:100:20
C30
People's Republic of China Pharmaceutical Industry Standard
Preclinical Animal Research of Medical Devices
Part 2: Induced diabetic rat skin defect model
2020-09-27 release
2021-09-01 implementation
Issued by the State Drug Administration
Preface
YY/T 1754 "Preclinical Animal Research of Medical Devices" includes the following two parts:
---Part 1: General requirements;
---Part 2: Induced diabetic rat skin defect model:
This part is Part 2 of YY/T 1754:
This section was drafted in accordance with the rules given in GB/T 1:1-2009:
Please note that certain contents of this document may involve patents: The issuing agency of this document is not responsible for identifying these patents:
This part was proposed by the State Drug Administration:
This part is under the jurisdiction of the National Standardization Technical Committee for Biological Evaluation of Medical Devices (SAC/TC248):
Drafting organizations of this section: China Institute for Food and Drug Control, Shandong Medical Device Product Quality Inspection Center, Jinan Pansheng Biotechnology
Technology Co:, Ltd:
The main drafters of this section: Han Qianqian, Zhang Ping, Wang Luanluan, Liu Zengxiang, Wang Chunren, Xing Zhiqing, Li Wenting:
introduction
Diabetes is an endocrine and metabolic disease characterized by high glucose caused by insufficient insulin in the body: Diabetic patients due to
Microvascular and peripheral neuropathy, leading to skin dystrophy, easy to be damaged, prone to secondary infection, and poor repair ability, leading to ulcers, gangrene and
Skin defect: At present, various skin wound repair materials and medical device products have been widely used in clinical practice, and some products are used in diabetic patients:
The skin repair also showed a certain effect:
This part aims to establish an economical and effective preclinical animal model, which is expected to be used for the skin wounds of patients with skin damage caused by diabetes:
Provide reference for the evaluation of preclinical effectiveness of surface repair materials and products:
This part mainly describes the method of constructing the model of skin defect in induced diabetic rats, and does not specify a specific evaluation method:
When using this model to establish an evaluation method, the method needs to be confirmed based on product characteristics and specific applications: This part should not be used as an evaluation method:
The only basis for the effectiveness of materials or devices:
Preclinical Animal Research of Medical Devices
Part 2: Induced diabetic rat skin defect model
1 Scope
This part of YY/T 1754 specifies the method for constructing a model of skin defect in induced diabetic rats:
This section applies to the evaluation of the preclinical effectiveness of medical device products that treat skin ulcers and damage caused by diabetes:
2 Normative references
The following documents are indispensable for the application of this document: For dated reference documents, only the dated version applies to this article
Pieces: For undated references, the latest version (including all amendments) applies to this document:
GB/T 16886:2 Biological Evaluation of Medical Devices Part 2: Animal Welfare Requirements
3 Experimental principle
Injecting streptozotocin (STZ) to induce diabetes in rats, excise the back skin of diabetic rats to construct skin defects in diabetic rats
model:
4 Instruments and reagents
4:1 Main instruments
4:1:1 Electronic weight scale:
4:1:2 Camera:
4:1:3 Microscope:
4:1:4 Blood glucose meter:
4:2 Reagents
4:2:1 Streptozotocin (STZ):
4:2:2 Sodium citrate (analytical purity):
4:2:3 Citric acid (analytical purity):
5 Experimental animals
5:1 General
Animal testing should be carried out in a laboratory approved by the national accreditation body and in compliance with the welfare of experimental animals, and should comply with GB/T 16886:2
Requirements:
5:2 Species and requirements of animals
Commonly used experimental animals are rats, SPF grade, 5-6 weeks old: The animal weight difference should not exceed ±20% of the average: Choice sensitive