Masks & Respirators
What is Masks & Respirators testing?
Mask and respirator testing aims to determine efficiency and other structural properties such as breathability and resistance to penetration by synthetic blood. Besides determining the physical and filtration properties of masks and respirators, classification into regulatory performance levels (Level 1, 2, 3 or FFP1, FFP2, FFP3) is also a key component of the testing program.
Why Masks & Respirators testing?
Once a staple Personal Protective Equipment (PPE) in laboratories, hospitals and workplaces with high respiratory risks, face masks and other respirators have now become a crucial part of personal protection for the everyday person against airborne infections, especially in the aftermath of the Covid-19 outbreak and with other pandemic diseases predicted to occur in the future. As there is a wide variety of masks and respirators available on the global market, it is critical that these PPEs are tested and proven to provide the required level of protection for consumers and regulatory compliance with the US FDA, European CE mark, and health ministries.
How can GICG help?
GICG offers a comprehensive set of testing services for different grades of masks and respirators to ensure their continued compliance with the most current international and national standards and specifications. With specialized TSI automated filter testers, synthetic blood splash rigs, and differential pressure manometers, we provide rapid, accredited test reports accepted by healthcare procurement boards worldwide.
Accredited Standards & Laboratory Protocols
Some of the masks & respirators services provided by GICG include:
Surgical / Medical Mask Testing
ASTM F2100 (Levels 1, 2 & 3)- •Bacterial Filtration Efficiency (BFE) (≥ 95% to ≥ 98%)
- •Particulate Filtration Efficiency (PFE @ 0.1 µm latex spheres)
- •Resistance to Penetration by Synthetic Blood (80, 120, 160 mmHg)
- •Differential Pressure / Breathability (Delta P < 5.0 - 6.0 mm H2O/cm²)
- •Flammability (16 CFR Part 1610 Class 1)
European Medical Mask Standard
EN 14683:2019 (Type I, Type II, Type IIR)- •Bacterial Filtration Efficiency (BFE) (≥ 95% Type I, ≥ 98% Type II/IIR)
- •Breathability & Differential Pressure (< 40 Pa/cm² to < 60 Pa/cm²)
- •Splash Resistance Pressure (≥ 16 kPa for Type IIR)
- •Microbial Cleanliness / Bioburden (≤ 30 CFU/g per ISO 11737-1)
- •Biocompatibility (Cytotoxicity & Irritation screening)
Respirator Pre-Certification for NIOSH (N95)
NIOSH 42 CFR Part 84- •NIOSH Procedure No. TEB-APR-STP-0057 (Determination of Filter Efficiency for N95 Series)
- •NIOSH Procedure No. TEB-APR-STP-0058 (Determination of Exhalation Resistance)
- •NIOSH Procedure No. TEB-APR-STP-0059 (Determination of Inhalation Resistance)
- •NaCl Aerosol Loading Trials at 85 ± 4 L/min continuous flow
- •Total Inward Leakage (TIL) and Headband Tensile Pull Strength
Barrier Face Covering / General Face Mask
ASTM F3502- •Sub-micron Particulate Filtration Efficiency
- •Airflow Inhalation & Exhalation Resistance
- •Leakage Ratio Assessment & Sizing Evaluation
- •Laundering Life Cycle Retention (after 10, 25, or 50 wash cycles)
Specialized Test Equipment & Instrumentation
Automated Filter Tester (TSI 8130A) using Sodium Chloride and Paraffin Oil Aerosols
Synthetic Blood Splash Resistance Penetration Rig with High-Speed Pneumatic Actuator
Differential Pressure (Delta-P) Airflow Resistance Manometer System
Microbial Cleanliness Bioburden Incubators & Cleanroom Laminar Flow Workstations
Critical Quality Checkpoints & Inspection Criteria
Official Laboratory Deliverables
Frequently Asked Technical Questions
Q:What is the required sample quantity for full ASTM F2100 or EN 14683 testing?
Typically, 35 to 50 finished mask samples from the same production lot are required to complete all physical, filtration, blood splash, and microbial bioburden testing batteries.
Q:Are GICG mask test reports accepted by the US FDA for 510(k) clearances?
Yes. GICG testing laboratories are ISO/IEC 17025 accredited and test to FDA-recognized consensus standards (ASTM F2100, ASTM F1862, 42 CFR 84), making our reports directly submissible in 510(k) medical device filings.
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