| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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063
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Date of Entry 12/23/2024
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FR Recognition Number
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6-504
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| Standard | |
ASTM F1862/F1862M-24
Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) |
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Scope/Abstract1.1 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 is primarily intended to address the performance of finished medical face masks. While this test method may also be used to assess performance of materials or certain material constructions used in medical face masks, it is important to note the performance of finished medical face masks may be impacted by the interaction of the materials used and how they have been assembled. Results can differ depending on testing a final finished medical face mask or materials taken from manufactured medical face masks.
1.4 This test method does not address 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).
1.5 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. |
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| Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Note: Subclause 9.2 states to test a minimum of 32 specimens (i.e. complete face masks) at the selected test pressure. If less than 32 specimens are tested, appropriate justification would be needed in the report. |
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Transition Period
| FDA recognition of ASTM F1862/F1862M-17 [Rec# 6-406] will be superseded by recognition of ASTM F1862/F1862M-24 [Rec# 6-504]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-406] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 6-406] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §878.4040 |
Mask, Surgical
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Class 2
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FXX
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| §878.4040 |
Respirator, Surgical
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Class 2
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MSH
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submissions; Guidance for Industry and FDA, issued March 2004.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contact
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| Standards Development Organization
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FDA Specialty Task Group (STG)
| General Plastic Surgery/General Hospital |
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| *These are provided as examples and others may be applicable. |
