1.1 本试验方法用于评估防护服中使用的材料在连续液体接触条件下对合成血液渗透的抵抗力。防护服合格/不合格判定基于对合成血液渗透的视觉检测。 1.1.1 这种测试方法在测试具有厚内衬的防护服材料时并不总是有效的，这些内衬容易吸收合成血液。 1.2 本试验方法是一种选择防护服材料的方法，用于后续进行更复杂的屏障试验，如试验方法所述 1671英尺/1671米 . 1.3 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。 测试方法的使用者必须审查工作/服装暴露的模式，并评估该测试方法对其特定应用的适用性。 1.4 本试验方法仅涉及防护服中使用的材料或某些材料结构（例如接缝）的性能。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保护的其他因素。 1.5 以国际单位制或英寸-磅单位表示的值应单独视为标准值。每个系统中所述的值可能不是完全等效的；因此，每个系统都应独立使用。 将两个系统的值结合起来可能会导致不符合标准。 1.6 本标准并不旨在解决与其使用相关的所有安全问题（如果有的话）。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，并确定监管限制的适用性。 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阻力。本试验方法通常用于评估防护服单个成品的试样和防护服候选材料的单个样品。 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 “成品样本”一词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 医用防护服材料旨在成为血液、体液和其他潜在传染性物质的屏障。 许多因素会影响体液的润湿和渗透特性，如液体的表面张力、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42至60 dyn/cm（0.042至0.060 N/m） ( 1. ) . 7. 为了帮助模拟血液和体液的润湿特性，将合成血液的表面张力调整为接近该表面张力范围的下限。合成血液的表面张力约为40±5 dyn/cm（0.040±0.005 N/m）。 5.3 合成血液混合物是用红色染料和增稠剂制备的，红色染料有助于视觉检测，增稠剂模拟血液的流动特性。 5.4 程序A和B中的协议部分 表1 为了用合成血液暴露防护服材料样本，需要将测试单元加压至13.8kPa[2.0psig]。该静水压力已被记录在案，用于区分防护服材料的性能，并与人为因素验证获得的视觉穿透结果相关联 ( 2. ) 然而，一些研究表明，在临床使用过程中可能会出现超过345 kPa[50 psig]的机械压力 ( 3. , 4. ) 因此，重要的是要理解，这种测试方法并不能模拟实际使用过程中施加在防护服上的所有物理应力和压力。 该测试方法用于识别那些需要进一步评估微生物挑战的防护服材料。 5.5 由于该测试方法使用视觉观察而不是分析测量来确定渗透性，因此将该测试方法用作血液和其他体液可能渗透的初步评估。使用测试方法，通过微生物挑战和分析技术进行后续测试 1671英尺/1671米 . 注1: 由于材料可能通过测试方法而未通过测试方法，因此无法根据该测试方法提出病毒抗性声明 1671英尺/1671米 . 5.6 测试时不考虑物理、化学和热应力的退化，这可能会对防护屏障的性能产生负面影响，从而导致错误的安全感。 考虑评估一次性产品的储存条件和保质期的影响，以及可重复使用产品的洗涤和消毒效果的测试。在使用过程中，由于弯曲和磨损等影响，保护屏障的完整性也可能受到损害 ( 5. ) 也有可能，酒精和汗液等污染物质的预润湿也会损害保护屏障的完整性。如果这些条件令人担忧，请在采用代表预期使用条件的适当预处理技术后，评估合成血液渗透防护服材料的性能。 5.7 虽然该测试方法涉及在特定测试条件下定性确定防护服材料对合成血液渗透的抵抗力，但可以将该测试方法用作材料质量控制或保证程序。 5.7.1 如果此程序用于质量控制，当测试三个以上的试样时，应对数据进行适当的统计设计和分析。这种分析包括但不限于测试的单个样本的数量、通过或失败的平均百分比，或两者兼而有之，并有标准偏差。以这种方式报告的数据有助于建立有关产品性能的置信区间。可接受的抽样计划示例见MIL-STD-105E、ANSI/ASQC Z1.4和ISO 2859-1等参考文献 .

1.1 This test method is used to evaluate the resistance of materials used in protective clothing to penetration by synthetic blood under conditions of continuous liquid contact. Protective clothing pass/fail determinations are based on visual detection of synthetic blood penetration. 1.1.1 This test method is not always effective in testing protective clothing materials having thick inner liners which readily absorb the synthetic blood. 1.2 This test method is a means for selecting protective clothing materials for subsequent testing with a more sophisticated barrier test as described in Test Method F1671/F1671M . 1.3 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method must review modes for work/clothing exposure and assess the appropriateness of this test method for their specific application. 1.4 This test method addresses only the performance of materials or certain material constructions (for example, seams) used in protective clothing. 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 either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard. 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 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 fluid, 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 42 to 60 dyn/cm (0.042 to 0.060 N/m) ( 1 ) . 7 To help simulate the wetting characteristics of blood and body fluids, the surface tension of the synthetic blood is adjusted to approximate the lower end of this surface tension range. The resulting surface tension of the synthetic blood is approximately 40 ± 5 dyn/cm (0.040 ± 0.005 N/m). 5.3 The synthetic blood mixture is prepared with a red dye to aid in visual detection and a thickening agent to simulate the flow characteristics of blood. 5.4 Part of the protocol in Procedures A and B in Table 1 for exposing the protective clothing material specimens with synthetic blood involves pressurizing the test cell to 13.8 kPa [2.0 psig]. This hydrostatic pressure has been documented to discriminate between protective clothing material performance and to correlate with visual penetration results that are obtained with a human factors validation ( 2 ) . Some studies, however, suggest that mechanical pressures exceeding 345 kPa [50 psig] can occur during clinical use ( 3 , 4 ) . Therefore, it is important to understand that this test method does not simulate all the physical stresses and pressures that are exerted on protective clothing garments during actual use. This test method is offered to identify those protective clothing materials that warrant further evaluation with a microbiological challenge. 5.5 Since this test method uses visual observation rather than analytical measurements to determine penetration, use this test method as a preliminary evaluation for possible penetration of blood and other body fluids. Perform subsequent testing with a microbiological challenge and analytical technique using Test Method F1671/F1671M . Note 1: No viral resistance claims can be made based on this test method, as materials can pass the test method and fail Test Method F1671/F1671M . 5.6 Testing without considering degradation by physical, chemical, and thermal stresses which could negatively impact the performance of the protective barrier could lead to a false sense of security. Consider tests which assess the impact of storage conditions and shelf life for disposable products, and the effects of laundering and sterilization for reusable products. The integrity of the protective barrier can also be compromised during use by such effects as flexing and abrasion ( 5 ) . It is also possible that prewetting by contaminating materials such as alcohol and perspiration can also compromise the integrity of the protective barrier. If these conditions are of concern, evaluate the performance of protective clothing materials for synthetic blood penetration following an appropriate preconditioning technique representative of the expected conditions of use. 5.7 While this test method involves a qualitative determination of the protective clothing material resistance to penetration by synthetic blood under specific test conditions, it is possible to use this test method as a material quality control or assurance procedure. 5.7.1 If this procedure is used for quality control, perform proper statistical design and analysis of the data when more than three specimens are tested. This type of analysis includes, but is not limited to, the number of individual specimens tested, the average percent passing or failing, or both, with a standard deviation. Data reported in this way helps to establish confidence limits concerning product performance. Examples of acceptable sampling plans are found in references such as MIL-STD-105E, ANSI/ASQC Z1.4, and ISO 2859-1 .