ASTM F1862/F1862M-13

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).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 by dispensing a stream of 2 mL of synthetic blood against the target area of a complete medical mask specimen whereas Test Method F1670 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 is at hydrostatic pressure of 13.8 kPa [2.0 psig]. Test Method F1670 is used for preliminary evaluation of protective clothing penetration resistance to synthetic blood in conjunction with Test Method F1671 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 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. As a 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.