YY/T 0471.4-2004Test methods for primary wound dressing - Part 4: Conformability (English PDF)
接触性创面敷料试验方法 第4部分:舒适性
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 23, 2004
Implementation date
January 1, 2005
Scope
YY/T 0471.4-2004 is the English-translated version of 接触性创面敷料试验方法 第4部分:舒适性.
YY/T 0471.4-2004 is the Chinese pharmaceutical industry standard, equivalent to EN 13726-4:2003, that gives the test method for the conformability of primary wound dressings - their ability to follow the shape and movement of the body.
It is Part 4 of the YY/T 0471 series, whose other parts cover absorbency, moisture vapour transmission, waterproofness, bacterial barrier properties and odour control.
It defines the primary wound dressing, conformability, extensibility and permanent set, and describes how a dressing sample is stretched to measure the force needed for a given extension and how much of that extension remains once the load is removed.
Dressing manufacturers and test laboratories use it to compare products. Issued on 23 March 2004, it has applied since 1 January 2005.
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Document preview — YY/T 0471.4-2004
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- Introduction4
- 1 Scope5
- 2 Terms and Definitions5
- 3 Test Method of Conformability5
Foreword
This Part of YY/T 0471 equivalently adopts EN 13726-4:2003 Test Methods for Primary Wound Dressing - Part 4: Conformability.
The general title for YY/T 0471 is Test Methods for Primary Wound Dressing, including the following parts:
--- Part 1: Aspects of absorbency;
--- Part 2: Moisture Vapor Transmission Rate of Permeable Film Dressings;
--- Part 3: Waterproofness;
--- Part 4: Conformability;
--- Part 5: Bacterial Barrier Properties;
--- Part 6: Odor Control.
1 Scope
This Part of YY/T 0471 describes test methods for evaluating the comfortability of primary wound dressing.
2 Terms and Definitions
For the purposes of this Part, the following terms and definitions apply.
2.1 Primary wound dressing
Material or combination of materials of any shape, state or size intended for direct contact with the wound surface.
NOTE: As the mechanical barrier of the wound, the primary wound dressing is used for the absorption or drainage of secretions to control the microbial environment of the wound, which can directly or indirectly heal the wound. Devices based on metabolic, pharmacological or immunological effects are not included.
2.2 Conformability of a wound dressing
The ability to adapt to the shape and movement of the human body.
2.3 Extensibility
The force required to stretch a wound dressing to a given stretch.
2.4 Permanent set
The increase in length after the sample is stretched and allowed to relax, expressed as a percentage of the original length.
3 Test Method of Conformability
3.1 Test conditions
The test sample shall be adjusted for at least 16 h under the conditions of (21±2) °C and relative humidity of (60±15) %; and the test shall be carried out under the same conditions. […]
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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.
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Related Standards
YY/T 0471.5-2017 — Test methods for primary wound dressings - Part 5: Bacterial barrier properties
YY/T 0471.3-2004 — Test methods for primary wound dressings - Part 3: Waterproofness
YY/T 0471.5-2004 — Test methods for primary wound dressings - Part 5: Bacterial barrier properties
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YY/T 0471.4-2004
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