北检（北京）检测技术研究院

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 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 and health practices and determine the applicability of regulatory limitations prior to use.

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.

This test method measures the initial filtration efficiency of materials used in medical face masks by sampling representative volumes of the upstream and downstream latex aerosol concentrations in a controlled airflow chamber.

This test method provides specific test techniques for both manufacturers and users to evaluate materials when exposed to aerosol particle sizes between 0.1 and 5.0 x03BC;m.

This test method establishes a basis of efficiency comparison between medical face mask materials.

This test method does not establish a comprehensive characterization of the medical face mask material for a specific protective application.

This test method does not assess the overall effectiveness of medical face masks in preventing the inward leakage of harmful particles.

The design of the medical face mask and the integrity of the seal of the medical face mask to the wearer''s face are not evaluated in this test.

This test method is not suitable for evaluating materials used in protective clothing for determining their effectiveness against particulate hazards.

In general clothing design is a significant factor which must be considered in addition to the penetration of penetration of particulates.

1.1 This test method establishes procedures for measuring the initial particle filtration efficiency of materials used in medical facemasks using monodispersed aerosols.

1.1.1 This test method utilizes light scattering particle counting in the size range of 0.1 to 5.0 x03BC;m and airflow test velocities of 0.5 to 25 cm/s.

1.2 The test procedure measures filtration efficiency by comparing the particle count in the feed stream (upstream) to that in the filtrate (downstream).

1.3 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.

1.4 The following precautionary caveat pertains only to the test methods portion Section 10 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.