YY/T 1477.3-2016Standard test models for primary wound dressing performance evaluation - Part 3: In vitro wound model for fluid handling properties evaluation (English PDF)
接触性创面敷料性能评价用标准试验模型第3部分:评价液体控制性能的体外创面模型
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
July 29, 2016
Implementation date
June 1, 2017
Scope
YY/T 1477.3-2016 is the English-translated version of 接触性创面敷料性能评价用标准试验模型第3部分:评价液体控制性能的体外创面模型.
YY/T 1477.3-2016 is the Chinese pharmaceutical industry standard that describes the in vitro wound model used to evaluate the fluid handling properties of a dressing for a heavily exuding wound.
It is the third part of the YY/T 1477 series and prescribes both a horizontal and a vertical arrangement of the model, and it judges the dressing from two sides at once, the fluid it absorbs and the water vapour it lets through, under conditions of high exudate. Issued on 29 July 2016, it has applied since 1 June 2017.
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Document preview — YY/T 1477.3-2016
National Standard of the People's Republic of China
- Classification
- C 48
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative reference documents
- 3 Terms and definitions
- 4 Overview
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.
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 document. 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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
ISO 483
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Related Standards
YY/T 1477.4-2017 — Standard test models for primary wound dressing performance evaluation - Part 4: In vitro wound model for adhesion properties evaluation of dressings
YY/T 1477.2-2016 — Standard test models for primary wound dressing performance evaluation - Part 2: Animal burn model for wound healing evaluation
YY/T 1477.5-2020 — Standard test models for primary wound dressing performance evaluation - Part 5: In vitro model for hemostatic performance evaluation
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