1.1 本试验方法用于测定伤口敷料的微生物屏障特性。该测试旨在测量微生物在特定条件下穿透材料（伤口敷料）的能力。该定性体外试验将证明在指定的接触时间后，试验生物体在琼脂表面上的“生长”或“无生长”等结果。 1.2 试验方法包括3.0×10的初始接种物 6. ± 2.0 × 10 6. CFU/mL，接触时间为24小时至72小时 h或根据伤口敷料标签要求。为了显示屏障特性，伤口敷料不应允许受攻击的生物体渗透并到达介质表面。 1.3 以国际单位制表示的数值应视为标准。本标准不包括其他计量单位。 1.4 测试应由受过微生物技术培训的人员在适当控制的条件下进行，以确保结果的完整性和人员安全。 1.5 本标准并不旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.6 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 ====意义和用途====== 5.1 理想的伤口敷料吸收伤口渗出物，减少敷料内/敷料上的生物负载，并保护伤口免受微生物通过敷料的渗透。微生物屏障有效性测试是为了测量微生物在特定条件下穿透材料的能力。 5.2 如果制造商在其性能声明中声称具有微生物屏障特性，则该测试可用于添加或不添加抗微生物剂的固体伤口敷料。屏障可以是物理的（聚氨酯）和/或化学的（抗微生物屏障）。 5.2.1 五（5）种常用的固体伤口敷料是( 1. )水凝胶( 2. )水胶体( 3. 电影 4. )泡沫，以及( 5. )藻酸盐。液体粘合剂还可以保护伤口免受微生物感染。液体粘性敷料含有氰基丙烯酸酯或聚丙烯酸酯，它们可以快速聚合，形成固体屏障，保护伤口免受污染。 5.3 这种定性测试方法可用于确定包括液体粘合剂在内的固体伤口敷料的微生物屏障特性。 5.3.1 该测试通过使用富含营养的培养基来模拟伤口，代表了体外伤口模型，接触时间将代表在伤口上施用单一敷料的最大使用时间，培养温度为37 °C±2 °C代表人体温度。 5.4 结果记录为“增长”或“无增长” 5.4.1 敷料下面没有生长表明伤口敷料的屏障特性在防止微生物渗透穿过敷料方面是有效的。 5.4.2 敷料下方的生长表明，挑战生物体能够穿透敷料并到达介质表面，这表明微生物可以通过从外部环境穿透敷料到达伤口。

1.1 This test method is used to determine the microbial barrier properties of wound dressing. The test is designed to measure the ability of microorganisms to penetrate through a material (wound dressing) under specific conditions. This qualitative in vitro test will demonstrate results such as “Growth” or “No Growth” of the test organism on the agar surface after a specified contact time. 1.2 The test method includes an initial inoculum of 3.0 × 10 6 ± 2.0 × 10 6 CFU/mL and a contact time of 24 h to 72 h or per the wound dressing label claim. To show barrier properties, wound dressing should not allow the challenged organism to penetrate and reach the media surface. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 Testing is to be performed by individuals trained in microbiological techniques under appropriately controlled conditions to ensure the integrity of results and personnel safety. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 5.1 An ideal wound dressing absorbs wound exudates, reduces the bioburden within/on the dressing, and protects wounds from microbial penetration through the dressing. Microbial barrier effectiveness testing is performed to measure the ability of microorganisms to penetrate through a material under specific conditions. 5.2 The test may be used for solid wound dressings with or without the addition of antimicrobial agents where the manufacturer is claiming microbial barrier properties in their performance claim. Barriers can be physical (polyurethane) and/or chemical (antimicrobial barrier). 5.2.1 Five (5) commonly used solid wound dressings are ( 1 ) hydrogel, ( 2 ) hydrocolloid, ( 3 ) film, ( 4 ) foam, and ( 5 ) alginate. Liquid adhesives also protect the wound from being infected by microorganisms. Liquid adhesive dressings contain cyanoacrylate or polyacrylate, which polymerizes quickly to create a solid barrier and protect the wound from contamination. 5.3 This qualitative test method can be used to determine the microbial barrier properties of solid wound dressings including liquid adhesive. 5.3.1 The test represents an in vitro wound model by using a nutrient-rich medium to mimic the wound, the contact time will represent the maximum period of use for a single dressing application on the wound, and an incubation temperature of 37 °C ± 2 °C represents the human body temperature. 5.4 Results are documented as “Growth” or “No Growth.” 5.4.1 No growth underneath the dressing indicates the barrier properties of the wound dressing are effective at preventing microbial penetration through the dressing. 5.4.2 Growth underneath the dressing demonstrates that the challenge organism was able to penetrate the dressing and reach the media surface, indicating that microorganisms can reach the wound by penetrating through the dressing from the outside environment.