YY/T 0471.4-2004 English PDF (YYT0471.4-2004)

This Part of YY/T 0471 describes test methods for evaluating the comfortability of primary wound dressing.

YY/T 0471.4-2004
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.120.20
C 48
Test Method for Primary Wound Dressing – Part 4:
Conformability
ISSUED ON: MARCH 23, 2004
IMPLEMENTED ON: JANUARY 01, 2005
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Terms and Definitions ... 5
3 Test Method of Conformability ... 5
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.
This Part was proposed by and under the jurisdiction of CFDA-Jinan Quality Supervision and Inspection Center for Medical Devices.
Drafting organization of this Part: Shandong Quality Inspection Center for Medical Devices. Chief drafting staffs of this Part: Zhang Qiang, Zhang Liqing, and Zhang Xiaoman. Test Method for Primary Wound Dressing – Part 4:
Conformability
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.