医用口罩材料检测

GB 19083-2010医用防护口罩技术要求

本标准规定了医用防护口罩的技术要求、试验方法、标志与使用说明及包装、运输和贮存。本标准适用于医疗工作环境下，过滤空气中的颗粒物，阻隔飞沫、血液、体液、分泌物等的自吸过滤式医用防护口罩。

YY 0469-2011医用外科口罩

本标准规定了医用外科口罩（以下简称口罩）的技术要求、试验方法、标志与使用说明及包装、运输和贮存。本标准适用于由临床医务人员在有创操作等过程中所佩带的一次性口罩。

YY/T 0969-2013一次性使用医用口罩

本标准规定了一次性使用医用口罩(以下简称口罩)的要求、试验方法、标志、使用说明书及包装、运输和贮存。本标准适用于覆盖使用者的口、鼻及下颌,用于普通医疗环境中佩戴、阻隔口腔和鼻腔呼出或喷出污染物的一次性使用口罩。本标准不适用于医用防护口罩,医用外科口罩。

YY/T 1497-2016医用防护口罩材料病毒过滤效率评价测试方法 Phi-X174噬菌体测试方法

本标准规定了用Phi-X174噬菌体悬浮液为替代微生物，对医用防护口罩或口罩材料进行病毒过滤效率的测试方法。本标准适用于有病毒过滤效率评价要求的医用防护口罩或口罩材料。

ASTM F2100-2019医用口罩材料性能标准规范

1.1x00a0;This specification covers testing and requirements for materials used in the construction of medical face masks that are used in providing healthcare services such as surgery and patient care. 1.2x00a0;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. 1.3x00a0;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 apply to regulated respiratory protection, which may be necessary for some healthcare services. 1.4x00a0;The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5x00a0;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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6x00a0;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.

ASTM F2100-2019e1医用口罩材料性能标准规范

1.1 This specification covers testing and requirements for materials used in the construction of medical face masks that are used in providing healthcare 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 apply to regulated respiratory protection, which may be necessary for some healthcare services. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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, 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.

ASTM F2101-2019用金黄色葡萄球菌生物气溶胶评价医用口罩材料的细菌过滤效率(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/ASQ 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 determine......

ASTM F2101-2023使用金黄色葡萄球菌生物气溶胶评估医用口罩材料细菌过滤效率（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 do 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 test method may also be used to measure the bacterial filtration efficiency (BFE) of other porous medical products such as surgical gowns, surgical drapes, and sterile barrier systems. 1.8?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