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This specification covers the classifications, performance requirements, and test methods for the materials used in the construction of medical face masks that are used in health care services such as surgery and patient care. 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. This specification does not address all aspects of medical face mask design and performance, the effectiveness of medical face mask designs as related to the barrier and breathability properties, and respiratory protection, which may be necessary for some health care services.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 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.1.7 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.

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5.1 This test method offers a procedure for evaluating medical face mask resistance to synthetic blood penetration that is useful in establishing claims for penetration resistance performance of medical face masks and ranking their performance. However, this test method does not define acceptable levels of penetration resistance because this determination must be made by each responsible user organization based on its own specific application and conditions. Therefore, when using this test method to make claims for the performance of medical face masks, the specific conditions under which testing is conducted must be described.5.2 Medical face masks are intended to resist liquid penetration from the splatter or splashing of blood, body fluids, and other potentially infectious materials. Many factors 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 and the design of the mask itself. The surface tension range for blood and body fluids (excluding saliva) is approximately 0.042 to 0.060 N/m.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 0.042 ± 0.002 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. The synthetic blood will not always duplicate the polarity, and thus the wetting behavior and subsequent penetration, of real blood and other body fluids through protective clothing materials.5.4 During a medical procedure, a blood vessel is occasionally punctured resulting in a high velocity stream of blood impacting a protective medical face mask. The impact velocity depends on several factors, the most important being the blood pressure of the patient. Other factors include the size of the puncture and distance from the puncture. Because the pressure, and thus velocity drops quickly with large punctures, large punctures were not used to model the range of blood splatter velocities considered in this test. Furthermore, this test method is based on the assumption that the medical face mask will be in close proximity (within 300 mm or 12 in.) to the puncture area. The use of this test method is, therefore, based on selecting an appropriate blood pressure, finding the corresponding stream or impact velocity, and determining the valve time to create that stream velocity as shown in Appendix X1.5.4.1 The mean human blood pressure generally varies over a range of about 10.7 to 16.0 kPa (80 to 120 mmHg).8 In this test method, medical face masks are tested at stream velocities corresponding to 10.7 kPa, 16.0 kPa, and 21.3 kPa (80 mmHg, 120 mmHg, and 160 mmHg).5.5 This test method permits the use of other non-standard test pressures, stream velocities, fluid volumes, and specimen orientations for evaluating medical face mask penetration resistance consistent with specific applications.5.6 This test method differs from Test Method F1670/F1670M by dispensing a stream of 2 mL of synthetic blood against the target area of a complete medical mask specimen, whereas Test Method F1670/F1670M involves the continuous contact of a specimen of protective clothing with synthetic blood over the period of an hour. One minute of the exposure in Test Method F1670/F1670M is at hydrostatic pressure of 13.8 kPa [2.0 psig]. Test Method F1670/F1670M is used for preliminary evaluation of protective clothing penetration resistance to synthetic blood in conjunction with Test Method F1671/F1671M that uses a microbiological challenge. Both procedures are intended for assessment of protective clothing which has the potential to contact blood or other body fluids for extended periods of time, and under pressure.5.7 Users of this test method must realize that certain tradeoffs exist between improved resistance of medical face masks to penetration by synthetic blood and in pressure drop across mask materials as an indicator of medical face mask breathability. In general, increasing synthetic blood penetration resistance for medical face masks results in increasing pressure drop or reduced breathability for medical face masks of the same design and fit of the individual wearer.5.8 This test method evaluates medical face masks as an item of protective clothing and does not evaluate medical face masks as respirators. If respiratory protection for the wearer is needed, a NIOSH-certified respirator must be used. This test method is useful to evaluate the resistance of a respirator to penetration by synthetic blood, if warranted.5.9 This test method involves the preconditioning of specimen medical face masks in a relatively high humidity environment (85 ± 5 % relative humidity at 21 ± 5 °C [70 ± 10 °F]) to simulate the conditions of use when the wearer creates high humidity conditions by breathing through the mask. This preconditioning does not account for saturation of the interior medical face mask layer. However, additional pretreatment techniques in conjunction with this test method as described in 5.10 are permitted. Professional healthcare providers recommend that medical face masks be replaced when saturation occurs from breathing or from contact with other liquids.5.10 Testing prior to 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 clothing is occasionally compromised during use by such effects as flexing and abrasion.9 It is also possible that pre-wetting by contaminants such as alcohol and perspiration also compromises the integrity of the protective clothing. If these conditions are of concern, evaluate the performance of protective clothing for synthetic blood penetration following an appropriate pretreatment technique representative of the expected conditions of use.5.11 While this test method involves a qualitative determination of the medical face mask 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.5.12 If this procedure is used for quality control, perform proper statistical design and analysis of larger data sets when more than the required 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 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 2859-1.5.13 In the case of a dispute arising from differences in reported results when using this test method for acceptance testing of commercial shipments, conduct comparative tests between the purchaser and supplier to determine if there is a statistical bias between their laboratories. Competent statistical assistance is recommended for investigation of bias. At minimum, take a group of test specimens which are as homogeneous as possible and which are from a lot of the product of the type in question. Randomly assign test specimens in equal numbers to each laboratory for testing. Compare the average results from the two laboratories using a non-parametric test for unpaired data and an acceptable probability level chosen by the two parties before testing is begun. If a bias is found, either its cause must be found and corrected or the purchaser and the supplier must agree to interpret future test results with consideration to the known bias.1.1 This test method is used to evaluate the resistance of medical face masks to penetration by the impact of a small volume (~2 mL) of a high-velocity stream of synthetic blood. Medical face mask pass/fail determinations are based on visual detection of synthetic blood penetration.1.2 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 face exposure and assess the appropriateness of this test method for their specific application.1.3 This test method primarily addresses the performance of materials or certain material constructions used in medical face masks. This test method does not address the performance of the medical face mask’s design, construction, or interfaces or other factors with the potential to affect the overall protection offered by the medical face mask and its operation (such as filtration efficiency and pressure drop). Procedures for measuring these properties are contained in Test Method F2101 and MIL-M-36954C.1.4 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. This test method evaluates medical face masks as an item of protective clothing. This test method does not evaluate the performance of medical face masks for airborne exposure pathways or in the prevention of the penetration of aerosolized body fluids deposited on the medical face mask.1.5 The values stated in SI units or inch-pound units are to be regarded separately as standard. The pressure values stated in each system are not exact equivalents. However, as the corresponding velocities are within 1 % of each other, (see X1.4.2), reporting of the results in either units is permitted.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 and health 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.

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