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YY/T 1754 Preclinical animal study of medical devices includes the following two parts:
——Part 1: General considerations;
——Part 2: Model of skin defect in induced diabetic rats.
This is Part 2 of YY/T 1754.
This part is developed in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this standard shall not be held responsible for identifying any or all such patent rights.
This part was proposed by the National Medical Products Administration of People’s Republic of China.
This part is under the jurisdiction of the National Technical Committee on Biological Evaluation on Medical Device of Standardization Administration of China (SAC/TC 248).
Drafting organizations of this part: National Institutes for Food and Drug Control, Shandong Quality Inspection Center for Medical Devices, Ji’nan Pan Sheng Biological Technology Limited Company
Chief drafters of this part: Han Qianqian, Zhang Ping, Wang Luanluan, Liu Zengxiang, Wang Chunren, Xing Zhiqing and Li Wenting.
Introduction
Diabetes is an endocrine and metabolic disease characterized by high glucose due to insufficient insulin in the body. Because of pathological changes of micro vessels and peripheral nerves, diabetic patients’ skin suffers from dystrophy, damage, secondary infection and poor repair ability, which leads to ulcer, gangrene and skin defect. At present, various skin wound repair materials and medical devices have been widely applied to clinic, and some products have also shown certain effects in skin repair of diabetic patients.
The purpose of this part is to establish an economical and effective preclinical animal model, and to provide reference for the preclinical effectiveness evaluation of skin wound repair materials and products expected to be used for patients with skin wound caused by diabetes.
This part mainly describes the construction method of model of skin defect in induced diabetic rats, but does not specify the specific evaluation method. When this model is used to establish an evaluation method, the method shall be confirmed according to product characteristics and specific application, and this part should not be used as the only basis for evaluating whether a material or device is effective.
Preclinical animal study of medical devices—
Part 2: Model of skin defect in induced diabetic rats
1 Scope
This part of YY/T 1754 provides a method for constructing the skin defect model of diabetic rats.
This part is applicable to the preclinical effectiveness evaluation of medical devices and products for treating skin ulcers and lesions caused by diabetes.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies.
GB/T 16886.2 Biological evaluation of medical devices—Part 2: Animal welfare requirements
3 Test principle
Model of skin defect in diabetic rats is established by injecting streptozocin (STZ) to induce diabetes of rats, and then excising the back skin of diabetic rats.
4 Instruments and reagents
4.1 Main Instruments
4.1.1 Electronic scale.
4.1.2 Camera.
4.1.3 Microscope.
4.1.4 Blood glucose meter.
4.2 Reagents
4.2.1 Streptozocin (STZ).
4.2.2 Sodium citrate (analytically pure).
4.2.3 Citric acid (analytically pure).
5 Test animals
5.1 General
Animal tests shall be conducted in laboratories approved by national accreditation bodies and in accordance with the welfare of test animals, and shall meet the requirements of GB/T 16886.2.
5.2 Species and requirements of animals
The commonly used test animals are rats, SPF grade, aged 5 to 6 weeks. The difference of animal weight shall not exceed ±20% of the average value. Select sensitive and stable strains (SD male rats are recommended). If rats of other strains are selected, their suitability shall be explained.
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Test principle
4 Instruments and reagents
5 Test animals
6 Test process
7 Test report
Annex A (Informative) Examples of histological semi-quantitative analysis methods for model of skin defect in induced diabetic rats
