医用口罩用材料性能的标准规范检测
ASTM F2100-2003医用口罩用材料性能的标准规范
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 F2100-2003a医用口罩用材料性能的标准规范
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 F2100-2020医用口罩用材料性能的标准规范
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. 1.1.1?This specification addresses medical masks with ties (surgical masks) and ear loops (procedure masks or isolation masks). 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 their overall barrier and breathability properties. 1.3.1?This specification does not include any specific design criteria for medical face masks; however, surgical masks are differentiated by having ties to allow adjustment of the medical face mask fit in comparison to procedure or isolation masks, which use ear loops to affix the mask to the wearer’s face. 1.4?This specification does not address requirements for regulated respiratory protection devices such as respirators, which may be necessary for some healthcare services and exposure to inhalation hazards. Note 1:?Performance requirements for NIOSH-approved N95 respirators are described in 42 CFR Part 84. Additional requirements for NIOSH-approved N95 respirators intended for use in healthcare settings are described in the Memorandum of Understanding between FDA and NIOSH. FDA/NIOSH MOU 225-18-006, November 2017 and the NIOSH Conformity Assessment Letter to Manufacturers, NIOSH CA 2018-1010, November 2018. 1.5?The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6?The following precautionar
ASTM F2100-2021医用口罩用材料性能的标准规范
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. 1.1.1?This specification addresses medical masks with ties (surgical masks) and ear loops (procedure masks or isolation masks). 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 their overall barrier and breathability properties. 1.3.1?This specification does not include any specific design criteria for medical face masks; however, surgical masks are differentiated by having ties to allow adjustment of the medical face mask fit in comparison to procedure or isolation masks, which use ear loops to affix the mask to the wearer’s face. 1.4?This specification does not address requirements for regulated respiratory protection devices such as respirators, which may be necessary for some healthcare services and exposure to inhalation hazards. Note 1:?Performance requirements for NIOSH-approved N95 respirators are described in 42 CFR Part 84. Additional requirements for NIOSH-approved N95 respirators intended for use in healthcare settings are described in the Memorandum of Understanding between FDA and NIOSH. FDA/NIOSH MOU 225-18-006, November 2017 and the NIOSH Conformity Assessment Letter to Manufacturers, NIOSH CA 2018-1010, November 2018. 1.5?The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6?The following precautionar
