Technical Information

How ASTM sets the standard

ASTM defines more than 12,500 international standards for safety and quality cross a wide variety of industries and services. Healthcare organizations globally adopt ASTM recommendations to implement best practices.

For masks, ASTM sets three levels of barrier protection:


Level 1: Low barrier protection

Generally used for short procedures and exams that don’t involve aerosols, spray or fluids.

Level 2: Moderate barrier protection:

For low to moderate levels of aerosols, spray and/or fluids.

Level 3: Maximum barrier protection

For heavy levels of aerosols, spray and/or fluids.



To determine if a mask is Level 1, 2 or 3, ASTM evaluates several characteristics, including bacterial filtration efficiency, sub-micron particulate filtration, differential pressure and flame spread. The greatest difference between the three levels is in the mask’s resistance to penetration by synthetic blood.

How are masks typically selected today?

According to a recent survey conducted among hundreds of OR nurses, non-OR nurses, infection control practitioners and other clinicians, the most influential factor when selecting a mask is simply what’s available at the facility. Following that are training, comfort and habit. Only 44 percent of survey respondents ranked ASTM standards as an influencer—and that leads to a significant safety issue.

According to the same study, 75 percent of participants use the incorrect PPE for the procedure or setting.That may lead not only to staff and patient health risks, but also regulatory citations and fines. Following ASTM standards would help solve the problem, but awareness of them is low:

• 48 percent of OR staff are unaware of ASTM standards and the different levels of protection.

• 57 percent of face mask units sold in 2016 did not have or claim an ASTM rating.

While 84 percent of facilities surveyed have a mask selection protocol, more than half of clinicians said they use their medical judgment when selecting a mask—even if that falls outside the protocol. The encouraging news is that 95 percent of those surveyed said they would change their selection if they had higher awareness of ASTM standards.

Choosing the right mask

A guide to ASTM barrier protection standards

 Surgical masks

Primarily used by OR staff.Intended for a high risk of fluid exposure.

Surgical N95 Fold Style

Protection against residual surgical smoke or on patients with known or suspected aerosol transmittable diseases Used for situations where interacting with patients that may have airborne infectious disease

Surgical N95 Cup Style

Protection against residual surgical smoke or on patients with known or suspected aerosol transmittable diseases Used for situations where interacting with patients that may have airborne infectious disease

 




Understanding ASTM levels of protection is Key



Characteristics DT-MSK-001 DT-MSK-002 DT-MSK-003
Resistance to penetration by synthetic blood, minimum pressure in mm Hg for pass result 80 mm Hg 120 mm Hg 160 mm Hg
Differential pressure, mm H20/cm2 (Breathability) < 4.0 < 5.0 < 5.0
Bacterial filtration efficiency ≥ 95% ≥ 98% ≥ 98%
Sub-micron particulates filtration efficient at 0.1 micron ≥ 95% ≥ 95% ≥ 95%
Flame spread Class 1 Class 1 Class 1

Codes ASTM F2100-11 Levels
DT-MSK-001 Level 1: Low barrier protection General use for short procedures and exams that don’t involve aerosols, spray or fluids
DT-MSK-002 Level 2: Moderate barrier protection For low to moderate levels of aerosols, spray and/or fluids
DT-MSK-003 Level 3: Maximum barrier protection For heavy levels of aerosols, spray and/ or fluids

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