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YY/T 1477.1-2016: Standard test models for primary wound dressing performance evaluation--Part 1: In vitro wound model for antimicrobial activity evaluation
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Standard test models for primary wound dressing performance evaluation--Part 1: In vitro wound model for antimicrobial activity evaluation
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YY/T 1477.1-2016
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Basic data | Standard ID | YY/T 1477.1-2016 (YY/T1477.1-2016) | | Description (Translated English) | Standard test models for primary wound dressing performance evaluation--Part 1: In vitro wound model for antimicrobial activity evaluation | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C48 | | Classification of International Standard | 11.120.20 | | Word Count Estimation | 13,127 | | Date of Issue | 2016-01-26 | | Date of Implementation | 2017-01-01 | | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1477.1-2016: Standard test models for primary wound dressing performance evaluation--Part 1: In vitro wound model for antimicrobial activity evaluation
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Standard test models for primary wound dress performance performance - Part 1. In vitro wound model for antimicrobial activity evaluation
ICS 11.120.20
C48
People's Republic of China Pharmaceutical Industry Standard
Standard Test Model for Evaluating Performance of Contact Woven Dressings
Part 1. In vitro wound model for evaluating antimicrobial activity
Part 1. Invitrowoundmodelforantimicrobialactivityevaluation
2016-01-26 release
2017-01-01 Implementation
State Food and Drug Administration issued
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.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This section is proposed by the State Food and Drug Administration.
This part of the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center.
This part of the drafting unit. Shandong Province, medical equipment product quality inspection center, Shandong Hengxin detection technology development center.
This part of the drafters. Wang Wenqing, Guoxian Hu, Wu Shifu, Yu Zhaqin, Hao Shubin.
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.
Standard Test Model for Evaluating Performance of Contact Woven Dressings
Part 1. In vitro wound model for evaluating antimicrobial 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 article
Pieces. 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.
3.1
Antimicrobial activity
Inhibitory or killing ability of contact dressings containing antimicrobial ingredients against microorganisms.
3.2
In vitro wound model invitrowoundmodel
A test device capable of continuously supplying fresh nutrients to the microorganism to simulate the actual growth state of the wound microbes,
Antimicrobial activity of antimicrobial dressings provides a test platform.
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.
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