Medical masks sold into the United States and Europe are commonly evaluated against different standards. For US-oriented projects, the main performance standard is ASTM F2100. For European medical masks, the primary standard is EN 14683.
The two systems test many of the same basic functions—filtration, breathability, and resistance to fluids—but they do not use the same classification system or exactly the same test requirements.
As of 2026, the current versions are ASTM F2100-26 and EN 14683:2025. ASTM F2100-26 was significantly expanded from a material-performance specification into a more complete finished-product standard covering design, labeling, user instructions, testing, and conformity assessment.
For medical mask procurement, this means an ASTM Level 2 mask should not automatically be described as the same product as an EN Type II mask simply because both require BFE ≥98%.
ASTM F2100 Uses Level 1, Level 2 and Level 3
ASTM F2100 classifies disposable medical face masks into three performance levels.
Level 1 is the lower barrier level. Level 2 provides a higher filtration and fluid-resistance specification. Level 3 provides the highest fluid-resistance level within ASTM's medical-mask classification.
The active ASTM F2100-26 standard also includes requirements covering finished-mask design, labeling, user instructions and conformity assessment.
One important point for sourcing is that ASTM Level 3 does not simply mean better bacterial filtration than Level 2. Both have a BFE requirement of at least 98%; one of the major distinctions is fluid resistance.
These performance levels remain in the current F2100-26 revision.
EN 14683 Uses Type I, Type II and Type IIR
The European system uses different terminology.
Under EN 14683:2025, medical masks are classified as:
Type I
BFE ≥95%
Type II
BFE ≥98%
Type IIR
BFE ≥98% plus splash resistance
The “R” in Type IIR is therefore important. It identifies the version with a fluid-splash resistance requirement.
The current EN 14683:2025 performance requirements include BFE, differential pressure and microbial cleanliness. Type IIR additionally requires splash resistance of at least 16.0 kPa.
EN 14683 also states that Type I masks are intended mainly for patients and other persons to reduce transmission risk and are not intended for healthcare professionals in operating rooms or comparable medical environments.
ASTM Level 2 Is Not the Same as EN Type II
This is one of the most common specification mistakes in international mask sourcing.
Both ASTM Level 2 and EN Type II require:
BFE ≥98%
But that does not make the classifications equivalent.
ASTM Level 2 includes a synthetic-blood resistance requirement at 120 mmHg, whereas EN Type II does not require splash-resistance testing. Under EN 14683, splash resistance belongs specifically to Type IIR.
Therefore, a supplier should not convert classification names simply because the BFE percentage is similar.
The actual test reports need to show which standard and test methods were applied.
ASTM Includes PFE; EN 14683 Focuses on BFE
Another important difference is particulate filtration.
Following revisions introduced before the current F2100-26 edition, the ASTM PFE requirement uses a different test approach from earlier versions, while the current Level 1 requirement is ≥80% and Levels 2 and 3 require ≥85%. The 2026 edition retained the existing performance classifications while expanding finished-product requirements.
EN 14683:2025 does not use PFE as one of the Type I, II or IIR classification criteria. Its classification is primarily built around BFE, breathability, microbial cleanliness, and—for Type IIR—splash resistance.
This is another reason ASTM and EN test reports should not be compared line by line as though they were identical systems.
Breathability Is Required Under Both Standards
Both standards recognize that a medical mask must allow adequate airflow.
Breathability is normally evaluated through differential pressure.
EN 14683:2025 specifies maximum differential pressure of:
Type I: ≤200 Pa Type II: ≤200 Pa Type IIR: ≤300 Pa
The 2025 revision also changed how differential pressure is expressed compared with previous EN editions.
ASTM F2100 also includes differential-pressure requirements, but its limits and classification structure are not identical to EN 14683.
For purchasing decisions, compare the actual differential-pressure result with the requirement of the standard being claimed rather than trying to convert an ASTM level directly into an EN type.
EN 14683 Includes Microbial Cleanliness
EN 14683 requires medical masks to meet a microbial cleanliness, or bioburden, limit.
Under EN 14683:2025, Type I, Type II and Type IIR masks have a microbial cleanliness requirement of:
≤30 CFU/g
Testing is linked to EN ISO 11737-1.
This parameter is particularly relevant for medical-mask manufacturing because it evaluates the microbial condition of the finished product before use.
ASTM F2100 approaches safety and conformity differently and should not be assumed to contain the same bioburden classification requirement.
Standards Are Not the Same as Market Authorization
A test report showing compliance with ASTM F2100 does not by itself complete all US regulatory requirements.
Likewise, an EN 14683 test report alone does not automatically mean that a medical device is fully ready for the EU market.
For EU projects, EN 14683 is used in conjunction with the applicable medical-device regulatory framework, including Regulation (EU) 2017/745 where applicable. The 2025 revision was updated with the MDR framework in mind.
Therefore, procurement teams should separate two questions:
Does the mask meet the required performance standard?
and
Does the finished product meet the regulatory requirements of the destination market?
Both need to be confirmed.
Can One Medical Mask Meet Both ASTM and EN Requirements?
Yes, a medical mask can be designed and tested to satisfy requirements under both systems.
However, the supplier should have relevant reports for each claimed standard.
For example, Rayland Medical's Type II medical mask is currently specified with BFE ≥98% and marketed against EN 14683 Type II and ASTM Level 2 requirements. Its published specification also includes breathing resistance and synthetic-blood penetration data.
For an OEM or private-label project, the safer approach is to specify both standards separately if both markets will be served.
Do not simply request:
“ASTM/EN medical mask.”
Instead, specify the required classification, such as:
ASTM F2100 Level 2
EN 14683 Type II
or, where fluid resistance is required:
ASTM F2100 Level 3
EN 14683 Type IIR
The finished product should then be tested against each required specification.
What to Check Before Ordering Medical Masks
Before approving an international medical-mask order, confirm the destination market, required ASTM level or EN type, BFE, PFE where applicable, differential pressure, fluid-resistance requirement, microbial cleanliness where applicable, test-report version, labeling, and OEM packaging.
Also check the edition number of the test report.
A report issued against ASTM F2100-19 or EN 14683:2019 should not automatically be treated as evidence of compliance with ASTM F2100-26 or EN 14683:2025 because both standards have since been revised.
Choose the Standard According to the Market
ASTM and EN standards address similar medical-mask functions, but they use different classification and testing frameworks.
For the US market, specify the appropriate ASTM F2100 level and confirm the associated regulatory requirements.
For the European market, specify EN 14683 Type I, Type II or Type IIR according to intended use, with Type IIR used when splash resistance is required.
Rayland Medical supplies Type I, Type II and Type IIR disposable medical masks and can review the required performance classification, mask construction, test documentation and packaging for different destination markets.
For international procurement, the safest approach is not to ask whether ASTM is “better” than EN. The correct standard is the one required by the destination market and clinical application—and the test documentation should match the exact mask being shipped.
