YY/T 1477.1-2016Standard test models for primary wound dressing performance evaluation - Part 1: In vitro wound model for antimicrobial activity evaluation (English PDF)

Foreword

This section is part 1 of the YY/T 1477 "Standard Test Model for Evaluating Performance of Contact Woven Dressings".

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

Introduction

Wounds are an ideal environment for microbial growth and reproduction, providing a growing surface for microbes and adequate nutrient supply. In clinical practice, Infection control has always been the main content of hospital infection control. The antibacterial ingredients in the antibacterial wound dressings have the effect of inhibiting the propagation of microorganisms Can reduce the chance of clinical wound infection. At present, antibacterial wound dressings have been widely used clinically, in the wound infection control System, especially in chronic wound infection control performance has also been widely recognized.

Antibacterial wound dressings in the antibacterial ingredients, such as Ag ions, its own antibacterial function has been unanimously agreed. However, with antibacterial There is no accepted evaluation method for the antibacterial activity of the ingredients. Although at home and abroad have been some antibacterial wound dressing antibacterial activity Of the relevant research reports, but these studies are basically not considered the dynamic growth of microbial organisms. This section provides an in vitro The wound model, which can continuously supply fresh nutrients to microbes, simulates the actual growth state of clinical wound microbes, The antimicrobial activity of antibacterial wound dressings was evaluated in vitro.

This part mainly describes the construction of the external wound model, and does not specify the specific evaluation method. When using this model to establish Evaluation methods, according to product characteristics and specific application of the evaluation method to confirm. This model can also be used to compare the same dressing at the same time The antibacterial activity of the point, can also be used to compare the advantages and disadvantages of different dressing antibacterial activity.

1 Scope

The in vitro wound model described in this section is used to evaluate the antimicrobial activity of contact wound dressings containing antimicrobial ingredients in vitro.

The application of this model requires the operation of microbes, which should be carried out by trained personnel in biosafety laboratories.

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.

YY 0331 Performance requirements and test methods for absorbent gauze, absorbent cotton viscose blended gauze YW0854.2 Cotton nonwovens surgical dressings - Performance requirements - Part 2. Finished dressings

3 Terms and definitions

The following terms and definitions apply to this document.

4 Overview

The test device is mainly composed of peristaltic pump and pump tube, reactor, reagent bottle and connecting pipe and so on. The schematic diagram is shown in Fig. In the peristaltic pump Use the simulated wound exudate in the reagent bottle to reach the reactor. In the reactor, the test sample or control sample and microbial action.

Subsequently, the waste from the reactor flows from the reactor into the reagent bottle for collecting the waste liquid.