1.1本试验方法用于在连续液体接触的条件下，使用替代微生物测量防护服材料对血液传播病原体渗透的阻力。防护服材料 通过/失败 确定基于病毒渗透检测。 1.1.1本试验方法在测试具有易于吸收液体分析液的厚内衬的防护服材料时并不总是有效。 1.2本试验方法不适用于所有形式或条件下的血源性病原体暴露。试验方法的使用者应审查工人/服装暴露模式，并评估本试验方法对其特定应用的适用性。 1.3本试验方法专门用于模拟在血液和其他潜在感染性体液中传播的肝炎（B和C）和人体免疫缺陷病毒的病毒渗透。对其他病原体防护的推断必须根据具体情况进行评估。 1.4本试验方法仅针对防护服中使用的材料或某些材料结构（例如接缝）的性能，并确定其具有抗病毒能力。本试验方法不涉及服装的设计、整体结构和组件或界面，也不涉及可能影响防护服提供的整体防护的其他因素。 1.5以国际单位制或其他单位表示的数值应单独视为标准。每个系统中规定的值必须独立于其他系统使用，不得以任何方式组合值。 1.6 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全和健康实践，并确定监管限制的适用性。 ====意义和用途====== 5.1本试验方法基于试验方法 F903 用于测量化学防护服材料的耐液体渗透性。 本试验方法通常用于评估防护服单个成品的样本和防护服候选材料的单个样本。 5.1.1防护服成品包括手套、护臂、围裙、长袍、工作服、兜帽和靴子。 5.1.2短语“成品样本”包括接缝和其他不连续区域，以及防护服项目的常见连续区域。 5.2众所周知，穿过防护服材料的体液可能携带微生物污染物；然而，视觉检测方法不够灵敏，无法检测微量含液体的微生物 ( 1. , 2. , 3. ) . 8. 本试验方法使用含有Phi-X174噬菌体的培养基。本试验方法的视觉检测技术辅以能够在规定试验条件下检测病毒的生物试验。 5.3试验方法 F1670 ，可以筛选防护服材料，以抵抗将合成血液作为挑战性液体的渗透。试验方法 F1670 使用相同的渗透测试细胞和技术，但将材料样本暴露于合成血液中，并目视检测液体渗透。材料通过试验方法 F1670 然后应使用此测试方法对噬菌体渗透进行测试，以验证性能。 5.4本试验方法专门用于测量肝炎（B和C）和人类免疫缺陷病毒的替代微生物的渗透性。本试验方法中使用的替代物Phi-X174噬菌体在大小和形状上与HCV相似，但也可作为HBV和HIV的替代物。关于其他病原体防护的推断必须根据具体情况进行评估。 5.5中程序A和B中的协议部分 表1 ，将防护服材料样本暴露于Phi-X174噬菌体激发悬浮液中，涉及将渗透池加压至13.8 kPa[2 psig]。记录了该静水压力，以区分防护服材料的性能，并与通过人为因素验证获得的视觉穿透结果相关联 ( 4. ) . 然而，一些研究表明，在实际临床使用期间，机械压力可能超过345 kPa[50 psig] ( 5. , 6. ) . 因此，重要的是要了解，该试验方法并不能模拟实际使用期间可能施加在防护服材料上的所有物理应力和压力。 表1试样暴露程序 程序 压力/时间顺序和挡土墙选项 A. 0 kPa[0 psig]持续5分钟，然后13.8 kPa[2 psig]持续1分钟，然后0 kPa[0 psig]持续54分钟。 挡土墙不用于支撑试样。 B 0 kPa[0 psig]持续5分钟，然后13.8 kPa[2 psig]持续1分钟，然后0 kPa[0 psig]持续54分钟。 挡土墙用于支撑试样。必须指定类型。 5.6医用防护服材料旨在成为血液、体液和其他潜在感染性材料的屏障。许多因素可以影响体液的润湿和渗透特性，例如:表面张力；粘度流体的极性，以及材料的结构和相对亲水性或疏水性。血液和体液（不包括唾液）的表面张力范围约为0.042至0.060牛顿/米 ( 7. ) . 为了帮助模拟血液和体液的润湿特性，Phi的表面张力- 调整X174噬菌体挑战悬浮液，使其接近该表面张力范围的下限。这是通过向Phi-X174噬菌体营养肉汤中添加表面活性剂来实现的。Phi-X174噬菌体激发悬浮液的最终表面张力约为0.042±0.002 N/m。 5.7物理、化学和热应力降解前的测试可能会对保护材料的性能产生负面影响，可能会导致错误的安全感。应考虑进行其他测试，以评估储存条件和保质期对一次性产品的影响，以及清洗和灭菌对可重复使用产品的影响。 在使用过程中，保护屏障的完整性也可能因弯曲和磨损等影响而受损 ( 8. ) . 预润湿剂（如酒精）和污染剂（如汗液）也可能损害保护屏障的完整性。如果这些条件值得关注，则应在采用代表预期使用条件的适当预处理技术后，评估防护服材料的Phi-X174噬菌体渗透性能。 5.8本试验方法涉及一种敏感的测定程序，用于测定防护服材料抗替代微生物渗透的能力。 由于完成该方法所需的时间较长，它可能不适合用作材料或防护服质量控制或质量保证程序。 5.9如果本程序用于质量控制或支持有关防护服材料抗病毒特性的广泛产品声明，则应进行适当的统计设计，并分析比本试验方法中规定的数据集更大的数据集。 9 可接受的抽样计划示例见MIL-STD-105 ，ANSI/ASQC Z1.4 ，和ISO 2859-1 . 5.10本试验方法要求具备基本微生物学技术的工作知识 ( 9 ) .

1.1 This test method is used to measure the resistance of materials used in protective clothing to penetration by blood-borne pathogens using a surrogate microbe under conditions of continuous liquid contact. Protective clothing material pass/fail determinations are based on the detection of viral penetration. 1.1.1 This test method is not always effective in testing protective clothing materials having thick, inner liners which readily absorb the liquid assay fluid. 1.2 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method should review modes for worker/clothing exposure and assess the appropriateness of this test method for their specific applications. 1.3 This test method has been specifically defined for modeling the viral penetration of Hepatitis (B and C) and Human Immunodeficiency Viruses transmitted in blood and other potentially infectious body fluids. Inferences for protection from other pathogens must be assessed on a case-by-case basis. 1.4 This test method addresses only the performance of materials or certain material constructions (for example, seams) used in protective clothing and determined to be viral resistant. This test method does not address the design, overall construction and components, or interfaces of garments or other factors which may affect the overall protection offered by the protective clothing. 1.5 The values stated in SI units or in other units shall be regarded separately as standard. The values stated in each system must be used independently of the other, without combining values in any way. 1.6 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 and health practices and determine the applicability of regulatory limitations prior to use. ====== Significance And Use ====== 5.1 This test method is based on Test Method F903 for measuring resistance of chemical protective clothing materials to penetration by liquids. This test method is normally used to evaluate specimens from individual finished items of protective clothing and individual samples of materials that are candidates for items of protective clothing. 5.1.1 Finished items of protective clothing include gloves, arm shields, aprons, gowns, coveralls, hoods, and boots. 5.1.2 The phrase “specimens from finished items” encompasses seamed and other discontinuous regions, as well as the usual continuous regions of protective clothing items. 5.2 It is known that body fluids penetrating protective clothing materials are likely to carry microbiological contaminants; however, visual detection methods are not sensitive enough to detect minute amounts of liquid containing microorganisms ( 1 , 2 , 3 ) . 8 This test method uses media containing Phi-X174 Bacteriophage. The visual detection technique of this test method is supplemented with a biologically based assay capable of detecting virus under the specified test conditions. 5.3 Test Method F1670 , allows the screening of protective clothing materials for resistance to penetration with synthetic blood as a challenge liquid. Test Method F1670 uses the same penetration test cell and technique, but exposes material specimens to synthetic blood with visual detection of liquid penetration. Materials passing Test Method F1670 should then be tested against bacteriophage penetration using this test method to verify performance. 5.4 This test method has been specifically designed for measuring penetration of a surrogate microbe for Hepatitis (B and C) and the Human Immunodeficiency Viruses. The surrogate, Phi-X174 Bacteriophage, used in this test method is similar to HCV in size and shape but also serves as a surrogate for HBV and HIV. Inferences about protection from other pathogens must be assessed on a case-by-case basis. 5.5 Part of the protocol in Procedure A and B in Table 1 , for exposing the protective clothing material specimens to the Phi-X174 Bacteriophage challenge suspension, involves pressurization of the penetration cell to 13.8 kPa [2 psig]. This hydrostatic pressure has been documented to discriminate between protective clothing material performance and correlate with visual penetration results that are obtained with a human factors validation ( 4 ) . Some studies, however, suggest that mechanical pressures exceeding 345 kPa [50 psig] can occur during actual clinical use ( 5 , 6 ) . Therefore, it is important to understand that this test method does not simulate all the physical stresses and pressures that might be exerted on protective clothing materials during actual use. TABLE 1 Specimen Exposure Procedures Procedure Pressure/Time Sequence and Retaining Screen Options A 0 kPa [0 psig] for 5 min, followed by 13.8 kPa [2 psig] for 1 min, followed by 0 kPa [0 psig] for 54 min. A retaining screen is not used to support the specimen. B 0 kPa [0 psig] for 5 min, followed by 13.8 kPa [2 psig] for 1 min, followed by 0 kPa [0 psig] for 54 min. A retaining screen is used to support the specimen. The type must be specified. 5.6 Medical protective clothing materials are intended to be a barrier to blood, body fluids, and other potentially infectious materials. Many factors can effect the wetting and penetration characteristics of body fluids, such as: surface tension; viscosity; and polarity of the fluids, as well as the structure and relative hydrophilicity or hydrophobicity of the materials. The surface tension range for blood and body fluids (excluding saliva) is approximately 0.042 to 0.060 N/m ( 7 ) . To help simulate the wetting characteristics of blood and body fluids, the surface tension of the Phi-X174 Bacteriophage challenge suspension is adjusted to approximate the lower end of this surface tension range. This is accomplished by adding surfactant to the Phi-X174 Bacteriophage nutrient broth. The resulting surface tension of the Phi-X174 Bacteriophage challenge suspension is approximately 0.042 ± 0.002 N/m. 5.7 Testing prior to degradation by physical, chemical, and thermal stresses which could negatively impact the performance of the protective material, could lead to a false sense of security. Additional tests should be considered that assess the impact of storage conditions and shelf life on disposable products and the impact of laundering and sterilization on reusable products. The integrity of the protective barrier may also be compromised during use by such effects as flexing and abrasion ( 8 ) . Prewetting agents, such as alcohol, and contaminating agents, such as perspiration, may also compromise the integrity of the protective barrier. If these conditions are of concern, the performance of protective clothing materials should be evaluated for Phi-X174 Bacteriophage penetration following an appropriate preconditioning technique representative of the expected conditions of use. 5.8 This test method involves a sensitive assay procedure for determining protective clothing material resistance to penetration by a surrogate microbe. Because of the length of time required to complete this method, it may not be suitable for use as a material or protective clothing quality control or quality assurance procedure. 5.9 If this procedure is used for quality control or to support broad product claims concerning the viral resistant properties of materials used in protective clothing, proper statistical design and analysis of larger data sets than those specified in this test method should be performed. 9 Examples of acceptable sampling plans can be found in MIL-STD-105 , ANSI/ASQC Z1.4 , and ISO 2859-1 . 5.10 This test method requires a working knowledge of basic microbiological techniques ( 9 ) .