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YY/T 1477.3-2016 English PDF

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YY/T 1477.3-2016: Standard test models for primary wound dressing performance evaluation--Part 3: In vitro wound model for fluid handling properties evaluation
Status: Valid

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY/T 1477.3-2016	English	259	Add to Cart	3 days [Need to translate]	Standard test models for primary wound dressing performance evaluation--Part 3: In vitro wound model for fluid handling properties evaluation	Valid	YY/T 1477.3-2016

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Basic data

Standard ID	YY/T 1477.3-2016 (YY/T1477.3-2016)
Description (Translated English)	Standard test models for primary wound dressing performance evaluation--Part 3: In vitro wound model for fluid handling properties evaluation
Sector / Industry	Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C48
Word Count Estimation	13,164
Date of Issue	2016-07-29
Date of Implementation	2017-06-01
Quoted Standard	ISO 483-2005
Regulation (derived from)	State Food and Drug Administration Notice 2016 (No.129)
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard is applicable to dressings of hyperosmotic effusion wounds, which prescribes two kinds of in vitro models of horizontal position wounds and vertical position wounds. The wound dressing is evaluated from the aspects of absorption of liquid and through water vapor. Liquid control performance of wound exudate.

YY/T 1477.3-2016: Standard test models for primary wound dressing performance evaluation--Part 3: In vitro wound model for fluid handling properties evaluation

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Standard test models for primary wound dress performance performance - Part 3. In vitro wound model for fluid handling properties 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 3. In vitro wounds for evaluating liquid control properties model Part 3. Invitrowoundmodelforfluidhandlingpropertiesevaluation 2016-07-29 released 2017-06-01 implementation State Food and Drug Administration issued

Foreword

YY/T 1477 "Standard test model for the evaluation of the performance of contact wound dressings", including the following. Part 1. In vitro wound model for evaluating antimicrobial activity; 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 3 of YY/T 1477. 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 part of the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center. This part of the drafting unit. Shandong Hengxin Detection Technology Development Center, Minnesota Mining Manufacturing Medical Equipment (Shanghai) Co., Ltd., Shandong Saikeses Pharmaceutical Technology Co., Ltd. This part of the main drafters. Xu Hui, Wang Jinhong, Han Jie, Zheng Yang, Dong Fangfang, Zhao Yan. Standard Test Model for Evaluating Performance of Contact Woven Dressings Part 3. In vitro wounds for evaluating liquid control properties model

1 Scope

This part of YY/T 1477 is suitable for dressings of hyperosmotic effusion wounds, which prescribes both the level of the wound and the vertical position of the wound in vitro Model, respectively, from the absorption of liquid and through the two aspects of water vapor to evaluate the wound dressing in the case of high bleach effusion fluid Control performance.

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. ISO 483..2005 Plastics Use of aqueous solutions to maintain constant humidity conditions for the regulation and testing of small confined spaces (Plastics-smal enclosuresforconditioningandtestingusingaqueoussolutionsmaintainthehumidityataconstantvalue

3 terms and definitions

The following terms and definitions apply to this document. 3.1 Liquid control performance fluidhandlingproperties The ability of the dressing to absorb the liquid and through the water vapor.

4 Overview

4.1 Meaning For wound dressings suitable for use in hyperosmotic effusion wounds, there is good water vapor permeability while having good liquid absorbency Very important. If the exudate absorbed by the dressing can not be exposed in time, the absorbed liquid will accumulate in the dressing for a long time, thereby damaging the wound And the integrity of the surrounding skin. This test model is based on this as the starting point, the establishment of a can assess the level of position and wound, but also the evaluation of the vertical position of the liquid In vitro model of controlled performance, from the absorption of liquid and through the two aspects of water vapor in the comprehensive evaluation of dressing in the case of high bleeding effusion Liquid control of liquid. 4.2 Test system Dressing liquid-controlled in vitro wound model test system shown in Figure 1, mainly by the ground simulation fluid to the liquid device (such as electronic pump), the wound Test equipment, electronic balance, temperature and humidity control devices and other components. The cremator simulates the liquid supply device at a rate to the continuous dressing liquid Control performance test model infusion simulation fluid. In the dressing liquid control performance test model, the dressing will absorb part of the simulated liquid side while evaporating

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