YY/T 1477.6-2020Standard test models for primary wound dressing performance evaluation - Part 6: Animal diabetes type 2 refractory wound surface model for wound healing evaluation (English PDF)

Foreword

YY/T 1477 "Standard Test Model for Performance Evaluation of Contact Wound Dressings", including the following parts.

---Part 1. In vitro wound model for evaluating antibacterial activity;

---Part 2. Evaluation of animal scald models for promoting wound healing performance;

---Part 3. In vitro wound model for evaluating fluid control performance;

---Part 4. In vitro model to evaluate the potential adhesion of wound dressings;

---Part 5. In vitro model for evaluating hemostatic performance;

---Part 6. An animal model of difficult-to-heal wounds with type 2 diabetes to evaluate the performance of wound healing. This part is part 6 of YY/T 1477.

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.

Introduction

Animal type 2 diabetes model is an ideal animal model for evaluating the performance of contact wound dressings in promoting the healing of difficult-to-heal wounds. obtain Type 2 diabetic animals usually have two methods. One method is to use chemical drugs (such as alloxan, etc:) to destroy normal animal pancreatic B cells.

Obtain, such as induced diabetic rats. Another method is to select genetically mutated genetic diabetic animals, commonly used db/db Mice, whose Leptin receptor point mutations lead to signal pathway disorders, have typical symptoms such as obesity, hyperglycemia, poor wound healing, and metabolic disorders. Symptoms of type 2 diabetes.

Animal wound healing is different from humans. Most of the wound healing is based on contraction, while human wounds are based on crawling coverage of epidermal cells. Headquarters In the spontaneous type 2 diabetes (db/db) mouse model given by the score, the expression of myofibroblasts in the skin is reduced, and the wound is healed with fine epidermis.

Cell crawling covering is the main animal model for evaluating contact wound dressings to promote the healing of difficult-to-heal wounds.

1 Scope

This part of YY/T 1477 specifies an animal model of difficult-to-heal wounds with type 2 diabetes.

This section is applicable to the evaluation of the healing properties of hard-to-heal wound dressings.

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 document. 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 Main equipment

Small animal breathing anesthesia machine (optional), skin trephine 16mm~20mm, sterile surgical instruments, dry heat sterilizer, pathological examination equipment.

4 Experimental animals

5 Test procedure