1.1 该试验方法用于测量防护服中使用的材料在连续液体接触条件下使用替代微生物对血源性病原体渗透的抵抗力。防护服材料通过/失败的确定基于病毒渗透的检测。 1.1.1 该测试方法在测试具有容易吸收液体测定流体的厚内衬的防护服材料时并不总是有效的。 1.2 本试验方法不适用于所有形式或条件的血源性病原体暴露。测试方法的使用者应审查工人/服装暴露模式，并评估该测试方法对其特定应用的适用性。 1.3 该测试方法专门用于模拟在血液和其他潜在传染性体液中传播的肝炎（乙型和丙型）和人类免疫缺陷病毒的病毒渗透。必须根据具体情况评估针对其他病原体的保护推断。 1.4 该测试方法仅涉及防护服中使用并确定为抗病毒的材料或某些材料结构（例如接缝）的性能。该测试方法不涉及服装的设计、整体结构和部件、或界面或可能影响防护服提供的整体保护的其他因素。 1.5 以SI单位或其他单位表示的值应单独视为标准值。每个系统中陈述的值必须独立于另一个系统使用，不能以任何方式组合值。 1.6 本标准并不旨在解决与其使用相关的所有安全性问题（如果有）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践并确定法规限制的适用性。1.7 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）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 本试验方法基于试验方法 F903 用于测量化学防护服材料对液体渗透的抵抗力。该测试方法通常用于评估防护服单个成品的样品和防护服候选材料的单个样品。 5.1.1 防护服的成品包括手套、护臂、围裙、长袍、工作服、头罩和靴子。5.1.2 短语“来自成品的样品”包括接缝和其他不连续区域，以及防护服物品的通常连续区域。 5.2 众所周知，渗透防护服材料的体液很可能携带微生物污染物；然而，视觉检测方法不够灵敏，不足以检测微量的含有微生物的液体 ( 1- 3 ) . 该测试方法使用含有Phi-X174噬菌体的培养基。该测试方法的目视检测技术由能够在规定的测试条件下检测病毒的基于生物学的测定补充。 5.3 试验方法 F1670/F1670M 允许筛选防护服材料对合成血作为挑战液体的渗透抵抗力。试验方法 F1670/F1670M 使用相同的渗透测试单元和技术，但将材料样本暴露于合成血液中，并目视检测液体渗透。试验方法不合格的材料 F1670/F1670M 也可能失败 F1671/F1671M 材料通过试验方法 F1670/F1670M 然后应使用该测试方法进行噬菌体渗透测试，以验证性能。 5.3.1 用于测试方法之外的额外筛选能力 F1670/F1670M 、试验方法 F903 包括可选的技术，例如使用替代的激发流体、改进的静水压力和激发时间序列，以及添加荧光染料，其可以增强视觉检测并增加可观察到的穿透事件的可能性。这些技术可用于筛选、产品开发或故障分析。而测试方法 F1670/F1670M 和 F903 可以用作可选的筛选工具，它们不能取代执行 F1671/F1671M 以证明对血源性病原体渗透的抵抗力。 5.4 该测试方法专门设计用于测量肝炎（乙型和丙型）和人类免疫缺陷病毒的替代微生物的渗透。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。关于预防其他病原体的推断必须根据具体情况进行评估。 5.5 中程序A和B中的方案部分 表1 为了使防护服材料样品暴露于Phi-X174噬菌体攻击悬浮液，涉及将穿透单元加压至13。8千帕[2磅/平方英寸]。该静水压力已被记录以区分防护服材料性能，并与通过人为因素验证获得的目视穿透结果相关联 ( 4 ) 然而，一些研究表明，在实际临床使用期间可能出现超过345 kPa[50 psig]的机械压力 ( 5 , 6 ) 因此，重要的是要理解这种测试方法并不能模拟在实际使用过程中可能施加在防护服材料上的所有物理应力和压力。 5.6 医用防护服材料旨在成为血液、体液和其他潜在传染性材料的屏障。许多因素可以影响体液的润湿和渗透特性，例如流体的表面张力、粘度和极性，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 N/m ( 7 ) 为了帮助模拟血液和体液的润湿特性，将Phi-X174噬菌体攻击悬浮液的表面张力调节至近似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噬菌体攻击悬浮液的所得表面张力约为0.042±0.002 N/m。 5.7 在物理、化学和热应力降解之前进行测试可能会对保护材料的性能产生负面影响，这可能会导致错误的安全感。应考虑进行额外的试验，以评估储存条件和保质期对一次性产品的影响，以及洗涤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效应而受到损害 ( 8 ) 预润湿剂(例如酒精)和污染剂(例如汗液)也可能损害保护屏障的完整性。如果这些条件是值得关注的，应在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 该测试方法包括用于确定防护服材料对替代微生物渗透的抵抗力的灵敏测定程序。由于完成该方法所需的时间长度，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 如果本方法用于质量控制或支持有关防护服中所用材料的抗病毒特性的广泛产品声明，则应对比本试验方法规定的数据集更大的数据集进行适当的统计设计和分析。 可接受的采样计划的示例可以在MIL-STD-105E、ANSI/ASQ Z1.4和ISO 2859-1中找到。 5.10 该测试方法需要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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 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 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- 3 ) . 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/F1670M allows the screening of protective clothing materials for resistance to penetration with synthetic blood as a challenge liquid. Test Method F1670/F1670M uses the same penetration test cell and technique, but exposes material specimens to synthetic blood with visual detection of liquid penetration. Materials that fail Test Method F1670/F1670M may also fail F1671/F1671M . Materials passing Test Method F1670/F1670M should then be tested against bacteriophage penetration using this test method to verify performance. 5.3.1 For additional screening capability beyond Test Method F1670/F1670M , Test Method F903 includes optional techniques such as the use of alternative challenge fluids, modified hydrostatic pressure and challenge time sequences, and the addition of fluorescent dye that may enhance visual detection and increase the likelihood of observable penetration events. These techniques may be useful for screening, product development, or failure analysis. While Test Methods F1670/F1670M and F903 can be used as optional screening tools, they do not replace the need to perform F1671/F1671M to demonstrate resistance to blood-borne pathogen penetration. 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 Procedures 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. 5.6 Medical protective clothing materials are intended to be a barrier to blood, body fluids, and other potentially infectious materials. Many factors can affect 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. Examples of acceptable sampling plans can be found in MIL-STD-105E, ANSI/ASQ Z1.4, and ISO 2859-1. 5.10 This test method requires a working knowledge of basic microbiological techniques ( 9 ) .