YY/T 0471.4-2004 PDF EnglishUS$175.00 · In stock · Download in 9 seconds
YY/T 0471.4-2004: Test methods for primary wound dressing. Part 4: Conformability Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
Similar standardsYY/T 0471.4-2004: Test methods for primary wound dressing. Part 4: Conformability---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0471.4-2004PHARMACEUTICAL 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 ContentsForeword ... 3 Introduction ... 4 1 Scope ... 5 2 Terms and Definitions ... 5 3 Test Method of Conformability ... 5ForewordThis 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: Conformability1 ScopeThis Part of YY/T 0471 describes test methods for evaluating the comfortability of primary wound dressing.2 Terms and DefinitionsFor 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 Conformability3.1 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. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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