医用面罩材料检测

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YY/T 0691-2008传染性病原体防护装备.医用面罩抗合成血穿透性试验方法(固定体积、水平喷射)

本标准给出了检测医用面罩防合成血喷溅穿透性能的实验室试验方法。本标准主要用于评价制作医用面罩的材料或某些结构的性能。本标准不评价医用面罩的设计、结构、界面或其他能影响医用面罩总体保护能力(如过滤效率和压降)的因素。本试验不评价医用面罩的透气性或其他影响医用面罩呼吸舒适性的性能。本试验评估医用面罩的防护性能。本试验不评估医用面罩对经空气传播，或沉积在医用面罩表面体液形成气溶胶穿透传播的防护能力。

YY/T 1551.1-2017输液、输血器具用空气过滤器 第1部分:气溶胶细菌截留试验方法

YY/T 1551的本部分规定的试验方法适用于对输液、输血器具用空气过滤器成品的细菌截留能力进行评价。输液、输血器具用空气过滤膜材细菌截留能力的评价可参考本部分。本试验宜由经培训的试验人员在生物安全实验室中进行操作。

CNS 14775-2003医用面罩材料细菌过滤效率试验法─使用金黄色葡萄球菌生物气雾

本标准规定量测医用面罩材料细菌过滤效率的试验法，由过滤前之细菌量和过滤后之细菌残存量之比值评估医用面罩材料的细菌过滤效率

ASTM F2100-2001医用面罩材料的性能标准规范

1.1 This specification covers testing and requirements for materials used in the construction of medical face masks that are used in providing health care services such as surgery and patient care.1.2 This specification provides for the classification of medical face mask material performance. Medical face mask material performance is based on testing for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability.1.3 This specification does not address all aspects of medical face mask design and performance. This specification does not specifically evaluate the effectiveness of medical face mask designs as related to the barrier and breathability properties. This specification does not also apply to respiratory protection, which may be necessary for some health care services.1.4 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.1.5 The following precautionary caveat pertains only to the test methods portion, Section 9 , of this specification: 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.

ASTM F2101-2001用金黄色葡萄球菌的生物气溶胶评定医用面罩材料细菌过滤效果(BFE)的标准试验方法

1.1 This test method is used to measure the bacterial filtration efficiency (BFE) of medical face mask materials, employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials.1.2 This test method is a quantitative method that allows filtration efficiency for medical face mask materials to be determined. The maximum filtration efficiency that can be determined by this method is 99.9 %. 1.3 This test method does not apply to all forms or conditions of biological aerosol exposure. Users of the test method should review modes for worker exposure and assess the appropriateness of the method for their specific applications.1.4 This test method evaluates medical face mask materials as an item of protective clothing but does not evaluate materials for regulatory approval as respirators. If respiratory protection for the wearer is needed, a NIOSH-certified respirator should be used. Relatively high bacterial filtration efficiency measurements for a particular medical face mask material does not ensure that the wearer will be protected from biological aerosols since this test method primarily evaluates the performance of the composite materials used in the construction of the medical face mask and not its design, fit or facial sealing properties.1.5 Units--The values stated in 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 of the standard.1.6 This test method does not address breathability of the medical face mask materials or any other properties affecting the ease of breathing through the medical face mask material.1.7 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.

ASTM F2101-2007使用金黄葡萄球菌生物悬浮粒评估医用面罩材料的细菌过滤效率(BFE)用标准试验方法

1.1 This test method is used to measure the bacterial filtration efficiency (BFE) of medical face mask materials, employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials.1.2 This test method is a quantitative method that allows filtration efficiency for medical face mask materials to be determined. The maximum filtration efficiency that can be determined by this method is 99.9 %. 1.3 This test method does not apply to all forms or conditions of biological aerosol exposure. Users of the test method should review modes for worker exposure and assess the appropriateness of the method for their specific applications.1.4 This test method evaluates medical face mask materials as an item of protective clothing but does not evaluate materials for regulatory approval as respirators. If respiratory protection for the wearer is needed, a NIOSH-certified respirator should be used. Relatively high bacterial filtration efficiency measurements for a particular medical face mask material does not ensure that the wearer will be protected from biological aerosols since this test method primarily evaluates the performance of the composite materials used in the construction of the medical face mask and not its design, fit or facial sealing properties.1.5 Units The values stated in 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 of the standard.1.6 This test method does not address breathability of the medical face mask materials or any other properties affecting the ease of breathing through the medical face mask material.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.

ASTM F2101-2014用金黄色葡萄球菌的生物气溶胶评定医用面罩材料细菌过滤效果(BFE)的标准试验方法

5.1x00a0;This test method offers a procedure for evaluation of medical face mask materials for bacterial filtration efficiency. This test method does not define acceptable levels of bacterial filtration efficiency. Therefore, when using this test method it is necessary to describe the specific condition under which testing is conducted. 5.2x00a0;This test method has been specifically designed for measuring bacterial filtration efficiency of medical face masks, using Staphylococcus aureus as the challenge organism. The use of S. aureus is based on its clinical relevance as a leading cause of nosocomial infections. 5.3x00a0;This test method has been designed to introduce a bacterial aerosol challenge to the test specimens at a flow rate of 28.3 L/mm. (1 ft3/min). This flow rate is within the range of normal respiration and within the limitations of the cascade impactor. 5.4x00a0;Unless otherwise specified, the testing shall be performed with the inside of the medical face mask in contact with the bacterial challenge. Testing may be performed with the aerosol challenge directed through either the face side or liner side of the test specimen, thereby, allowing evaluation of filtration efficiencies which relate to both patient-generated aerosols and wearer-generated aerosols. 5.5x00a0;Degradation by physical, chemical, and thermal stresses could negatively impact the performance of the medical face mask material. The integrity of the material can also be compromised during use by such effects as flexing and abrasion, or by wetting with contaminants such as alcohol and perspiration. Testing without these stresses could lead to a false sense of security. If these conditions are of concern, evaluate the performance of the medical face mask material for bacterial filtration efficiency following an appropriate pretreatment technique representative of the expected conditions of use. Consider preconditioning to assess the impact of storage conditions and shelf life for disposable products, and the effects of laundering and sterilization for reusable products. 5.6x00a0;If this procedure is used for quality control, perform proper statistical design and analysis of larger data sets. This type of analysis includes, but is not limited to, the number of individual specimens tested, the average percent bacterial filtration efficiency, and standard deviation. Data reported in this way help to establish confidence limits concerning product performance. Examples of acceptable sampling plans are found in references such as ANSI/ASQC Z1.4 and ISO 2859-1. 1.1x00a0;This test method is used to measure the bacterial filtration efficiency (BFE) of medical face mask materials, employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials. 1.2x00a0;This test method is a quantitative method that allows filtration efficiency for medical face mask materials to be determined. The maximum filtration efficiency that can be determined......