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YY/T 0471.5-2017: Test Methods for Primary Wound Dressings - Part 5: Bacterial Barrier Properties Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid YY/T 0471.5: Historical versions
Similar standardsYY/T 0471.5-2017: Test Methods for Primary Wound Dressings - Part 5: Bacterial Barrier Properties---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/YYT0471.5-2017YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.120.20 C 48 Replacing YY/T 0471.5-2004 Test Methods for Primary Wound Dressings - Part 5.Bacterial Barrier Properties Issued on. FEBRUARY 28, 2017 Implemented on. JANUARY 1, 2018 Issued by. China Food and Drug Administration Table of ContentsForeword... 3 1 Scope... 5 2 Terms and Definitions... 5 3 Reagents and Materials... 6 4 Challenge Microbial Preparation... 6 5 Bacterial Barrier Properties under Low-moisture Condition... 6 6 Bacterial Barrier Properties under Semi-wet Condition (Dry Outside, Wet Inside)... 9 7 Bacterial Barrier Properties under Semi-wet Condition (Wet Outside, Dry Inside)... 11 8 Bacterial Barrier Properties under Wet Condition... 13 Appendix A (informative appendix)... 15ForewordYY/T 0471 Test Methods for Primary Wound Dressings is divided into 6 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 is Part 5 of YY/T 0471. This Part is drafted in accordance with stipulations in GB/T 1.1-2009. This Part serves as a replacement of YY/T 0471.5-2004 Test Methods for Primary Wound Dressing - Part 5.Bacterial Barrier Properties. In comparison with YY/T 0471.5- 2004, there are several main technical changes as follows. ---“Dry outside, wet inside” antibacterial test method is added; ---Every test method is modified; ---Informative appendix is added; ---There are other editorial modifications. Please be noted that certain content in this Standard might involve patents. The institution that issues this Standard shall not undertake any responsibility of identifying these patents. This Part is proposed by China Food and Drug Administration. This Part is summarized by China Food and Drug Administration, Jinan Medical Devices Quality Supervision and Test Center. This Standard is drafted by. Shandong Medical Devices Quality Inspection Center, Shandong Success Pharmaceutical Technology Co., Ltd., Minnesota Medical Devices Mining and Manufacturing (Shanghai) Co., Ltd., Coloplast (China) Medical Supplies Co., Ltd. The main drafters of this Standard include. Wang Wenqing, Hao Dali, Zhengyang, Hao Jianxin, Lu Jinrong, Liyu. The issuing of the previous version of this Part of YY/T 0471 is listed as follows. YY/T 0471.5-2004, which was initially issued on March 23, 2004. Test Methods for Primary Wound Dressings - Part 5.Bacterial Barrier Properties1 ScopeThis Part of YY/T 0471 specifies test methods 1 of evaluating bacterial barrier properties of primary wound dressings that claim to have bacterial barrier properties. In this Part, test methods involve microbial detection, which shall be conducted by trained personnel in biosafety laboratories.2 Terms and DefinitionsThe following terms and definitions are applicable to this Standard. 2.1 Low-moisture Condition Under low-moisture condition, 2 sides of dressings are not wet. Under this condition, dressings shall manifest no or minimal exudate on the wound; the external surface of dressings shall be under low-moisture condition. 2.2 Semi-wet Condition Under semi-wet condition, 1 side of dressings is wet. Under this condition, there is exudate on the wound, but the external surface of dressings shall be under low- moisture condition, namely, “dry outside, wet inside”; or there is no or minimal exudate on the wound, and the external surface of dressings is expected to be under wet condition, namely, “wet outside, dry inside”. 2.3 Wet Condition Under wet condition, 2 sides of dressings are wet. Under this condition, there is exudate on the wound, and the external surface of dressings is expected to be under wet condition.3 Reagents and Materials3.1 Serratia marcescens2; 3.2 Nutrient broth medium; 3.3 Nutrient agar medium;4 Challenge Microbial Preparation4.1 Challenge Inoculum Preparation Pick Serratia Marcescens colony from the bevel of Serratia Marcescens working strain; conduct streak inoculation on the plate of nutrient agar medium. 4.2 Challenge Bacterial Solution Preparation Pick single colony of Serratia Marcescens from the plate of challenge inoculum prepared in 4.1, inoculate it in nutrient broth medium. Through overnight culture at 26 °C, obtain challenge bacterial solution (concentration. around 109 CFU/mL), which can be adopted in bacterial barrier property test under semi-wet condition (wet outside, dry inside) and wet condition. Prepared challenge bacterial solution shall preferably be used on the same day.5 Bacterial Barrier Properties under Low-moisture Condition5.1 Test Device Please see the sketch map of bacterial barrier property test device under low-moisture 2 Standard strain released by domestically and internationally acknowledged strain preservation institutions, such as ATCC 8100, CICC 10187, etc. 5.2 Test Procedure 5.2.1 Sample clamping Respectively take 3 samples, turn the internal surface of the samples towards the sampling room. Clamp the samples to the area between the challenge room and the sampling room. The mode of clamping shall be confirmed; guarantee that there is no leakage of challenge microorganism. In terms of relatively large sample, cut off the remaining part or wrap it around the test device; in terms of relatively small sample, raw materials of large samples can be adopted for testing, or an appropriate mode can be adopted to fill up the missing part for testing. 5.2.5 Challenge microbiological vitality examination After the stipulated time, operate in accordance with 5.2.4.Wipe the external surface of the samples through the mouth of the challenge room to examine challenge microbiological vitality. 5.3 Result Judgment On the plate of nutrient agar medium that is adopted for vitality examination, there shall be the growth of Serratia marcescens; otherwise, the test shall be deemed as invalid.6 Bacterial Barrier Properties under Semi-wet Condition (Dry Outside, Wet Inside)6.1 Test Device Please see the sketch map of bacterial barrier property test device under semi-wet condition (dry outside, wet inside) in Figure 2 below. 6.2 Test Method 6.2.1 Sample clamping Operate in accordance with 5.2.1. 6.2.2 Add challenge microorganism Operate in accordance with 5.2.2. 6.2.3 Add nutrient broth medium Fill up the sampling room with nutrient broth medium in the mode of sterile operation. 6.3 Result Judgment On the plate of nutrient agar medium that is adopted for vitality examination, there shall be the growth of Serratia marcescens; otherwise, the test shall be deemed as invalid.7 Bacterial Barrier Properties under Semi-wet Condition (Wet Outside, Dry Inside)7.1 Test Device Please see the sketch map of bacterial barrier property test device under semi-wet condition (wet outside, dry inside) in Figure 3 below. Challenge room shall be used to place challenge inoculum; sampling room shall be used to wipe samples. 7.2 Test Method 7.2.1 Sample clamping Operate in accordance with 5.2.1. 7.2.2 Add challenge microorganism Fill up the challenge room with challenge bacterial solution. 7.2.3 Sample challenge Operate in accordance with 5.2.3. 7.3 Result Judgment On the plate of nutrient agar medium that is adopted for vitality examination, there shall be the growth of Serratia marcescens; otherwise, the test shall be deemed as invalid. If there is no growth of microorganism on the plate of nutrient agar that is adopted for the sampling analysis of the internal surface of the sample, it shall be deemed that the sample complies with the requirement of bacterial barrier properties under semi-wet condition (wet outside, dry inside).8 Bacterial Barrier Properties under Wet Condition8.1 Test Device Please see the sketch map of bacterial barrier property test device under wet condition in Figure 4 below. Challenge room shall be used to place challenge inoculum; sampling room shall be used to place nutrient broth medium. Before test, adopt sterilization procedure that has already been confirmed to sterilize the test device for later usage. 8.2 Test Method 8.2.1 Sample clamping Operate in accordance with 5.2.1. 8.2.2 Add challenge microorganism Operate in accordance with 7.2.2. 8.2.3 Add nutrient broth medium Operate in accordance with 6.2.3. 8.3 Result Judgment On the plate of nutrient agar medium that is adopted for vitality examination, there shall be the growth of Serratia marcescens; otherwise, the test shall be deemed as invalid.Appendix A(informative appendix) Instruction for Standard Application A.1 Applicable Object Clinically speaking, infection is an important complication of wound. Primary wound dressings play a role as a mechanical barrier of wound. The bacterial barrier properties of primary wound dressings are tremendously important to the control of wound infection. However, this does not mean all the primary wound dressings are requested to manifest bacterial barrier properties. Certain types of wound with extremely low risks of infection might not need primary wound dressings with bacterial barrier properties. Furthermore, the bacterial barrier properties of some primary wound dressings that need to be matched with secondary dressings are jointly provided by the two types of dressing, and merely conducting evaluation on the bacterial barrier properties of primary wound dressings might also lead to unilateral information. The evaluation of whether a specific primary wound dressing has the bacterial barrier properties depends on intensive study of risks of infection of different types of wound. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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