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

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

This Part of YY/T 1754 specifies the method for constructing a model of skin defect in induced diabetic rats. This Part applies to the evaluation of the preclinical effectiveness of medical device products for the treatment of skin ulcers and damage caused by diabetes.
YY/T 1754.2-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.100.20
C 30
Preclinical animal study of medical devices - Part 2:
Model of skin defect in induced diabetic rats
ISSUED ON: SEPTEMBER 27, 2020
IMPLEMENTED ON: SEPTEMBER 01, 2021
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative references ... 5
3 Experimental principle ... 5
4 Apparatus and reagents ... 5
5 Test animal ... 6
6 Test process ... 6
7 Test report ... 8
Appendix A (Informative) Examples of histological semi-quantitative analysis methods of model of skin defect in induced diabetic rats ... 9
Preclinical animal study of medical devices - Part 2:
Model of skin defect in induced diabetic rats
1 Scope
This Part of YY/T 1754 specifies the method for constructing a model of skin defect in induced diabetic rats.
This Part applies to the evaluation of the preclinical effectiveness of medical device products for the treatment of skin ulcers and damage caused by diabetes. 2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 16886.2, Biological evaluation of medical devices - Part 2: Animal welfare requirements
3 Experimental principle
Induce rat diabetes by injection of streptozotocin (STZ); excise the back skin of diabetic rats to construct a skin defect model of diabetic rats.
4 Apparatus and reagents
4.1 Main apparatuses
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 reagent).
One day after the successful establishment of the diabetic rat model, begin to establish the skin injury model. After anesthesia, place the rat on the operating table, with the back facing up; remove the back hair, to fully expose the back skin. After routine surgical disinfection, remove the 2 cm ?? 2 cm full-thickness skin from the back of the rat (other verified wounds are also available). 6.1.4 Test product sampling
The test rats should be randomly divided into a blank control group, a test product group, and/or a control product group (such as a commercially available product); the number of each group shall meet the requirements of statistical analysis. For the blank control group, only use sterile gauze/applicator to cover the skin wound on the back of the rat and fix, without other treatment; for the test product group and/or control group, use the relevant test product and/or control substance to cover the skin would on the back of the rat, and use sterile gauze/applicator to cover and fix. All animals are raised in single cages. Observe the activities and diet of the animals every day, and replace the litter in time.
6.2 Test result and evaluation
6.2.1 General
The recommended observation period is at least 21 days. Select a reasonable observation time point according to the product characteristics. At least include the observation indicators of 6.2.2 ~ 6.2.4.
6.2.2 General wound recovery
It is advisable to roughly judge the recovery of the wound through the exudation, adhesion and wound retraction of the rat's wound.
6.2.3 Wound healing rate
The time point should be observed after the operation; take pictures of the wound; use image processing software or other verified software to measure the wound area. Wound healing rate is the ratio of the difference between the original wound area and the unhealed area of the wound to the original wound area. See Formula (1) for the calculation of wound healing rate:
Where:
R -- Wound healing rate;
A0 -- Original area of the wound, in square centimeters (mm2);

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