YY/T 1477.2-2016Standard test models for primary wound dressing performance evaluation - Part 2: Animal burn model for wound healing evaluation (English PDF)

Foreword

YY/T 1477 "Standard test model for the evaluation of the performance of contact wound dressings", including the following.

Part 1. Evaluation of antibacterial activity with in vitro wound model;

Part 2. Animal scald model for evaluating the healing performance of wound healing;

Part 3. In vitro wound model for evaluating liquid control performance; This part is part 2 of YY/T 1477.

This part is drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

YY/T 1477 This section specifies an overview of the animal scald model, major equipment, laboratory animals, test procedures.

This part is suitable for the evaluation of wound healing performance of scald contact wound dressing.

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 document. For undated references, the latest edition (including all modifications) applies to this document.

GB/T 16886.2 Biological evaluation of medical devices - Part 2. Animal welfare requirements (GB/T 16886.2-2011, ISO 10993-2.:2006, IDT)

3 Overview

This standard in accordance with the procedures prescribed in the back of the rat to establish a different scald degree of experimental scald animal model, in a certain period of time A number of scald animal models were used to evaluate the wound healing performance after exposure to wound wound dressings. Appendix A is given An example of an evaluation scheme for healing performance of dressings.

4 Major equipment

Scalding device, constant temperature water bath, thermometer, pathological examination equipment.

5 Experimental animals