Disposable Medical Mask Testing Equipment and Standards
Medical textiles or protective clothing testing instruments are used to make the disposable medical masks or protective clothing safe and efficient to wear. As we are facing the COVID-19 pandemic in 2020, each and every medical equipment should be tested according to protective clothing standards to protect ourselves from the coronavirus disease. All the disposable medical mask testing equipment, protective clothing test list, and medical mask testing standards are presented in this article.
Knowing the list of Disposable Medical Mask Testing Equipment and their Standards is important. Because the face mask is related to health, keep our breathing safe in a toxic environment. It filters all the toxic things that come inside our nose and mouth.
Disposable Medical Mask Test List:
Medical mask or protective clothing test includes the following:
- Breathing resistance test,
- Synthetic blood penetration resistance test,
- Material tension test, and
- Flammability test.
Disposable Medical Mask Testing Standards:
Medical textiles or protective clothing testing equipment does comply with medical masks and protective clothing testing standards which are listed in the below:
- EN14683,
- EN149,
- ASTM F2100,
- GB19083,
- GB2626,
- ISO 22609,
- ASTM F1862, etc.
1. ASTM F2100 – Standard Specification for Performance of Materials Used in Medical Face Masks
This is a widely recognized U.S. standard. It classifies masks into three levels based on performance.
| Test Criteria | Level 1 (Low Barrier) | Level 2 (Moderate Barrier) | Level 3 (High Barrier) |
|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥ 95% | ≥ 98% | ≥ 98% |
| Particulate Filtration Efficiency (PFE) @ 0.1 micron | ≥ 95% | ≥ 98% | ≥ 98% |
| Breathability (Delta P) *@ 8 L/min* | < 5.0 mm H₂O/cm² | < 6.0 mm H₂O/cm² | < 6.0 mm H₂O/cm² |
| Synthetic Blood Penetration (mmHg) | 80 | 120 | 160 |
| Flammability | Class 1 | Class 1 | Class 1 |
*Level 1 is for general use, Level 2 for low-to-moderate fluid exposure, and Level 3 for high-risk surgical procedures.*
2. EN 14683:2019 – Medical Face Masks – Requirements and Test Methods
This is the primary European standard. It classifies masks as Type I, Type II, and Type IIR.
| Test Criteria | Type I | Type II | Type IIR |
|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥ 95% | ≥ 98% | ≥ 98% |
| Breathability (Delta P) *@ 8 L/min* | < 40 Pa/cm² (< 4.1 mm H₂O/cm²) | < 40 Pa/cm² (< 4.1 mm H₂O/cm²) | < 60 Pa/cm² (< 6.1 mm H₂O/cm²) |
| Synthetic Blood Penetration (kPa) | Not Required | Not Required | ≥ 16.0 kPa ( ~120 mmHg) |
| Microbial Cleanliness (CFU/g) | ≤ 30 | ≤ 30 | ≤ 30 |
- Type I: Not intended for surgical use, for patients and others to reduce spread of infections.
- Type II: For general use in healthcare settings (non-surgical).
- Type IIR: “R” for Splash Resistance. For use in surgical procedures where there is a risk of fluid exposure.
3. YY 0469-2011 – Surgical Masks (Chinese Standard)
This is the Chinese standard for surgical masks and is very similar in structure to the ASTM and EN standards.
| Test Criteria | Requirement |
|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥ 95% |
| Particulate Filtration Efficiency (PFE) @ 0.1 micron | ≥ 30% |
| Synthetic Blood Penetration | ≥ 120 mmHg (16 kPa) |
| Breathability (Delta P) | ≤ 49 Pa/cm² |
| Microbial Cleanliness | ≤ 20 CFU/g |
| Skin Irritation | Non-irritating |
Medical Mask Testing Equipment/ Machine List:
All the medical textiles or protective clothing testing machine names have presented in the following:
1. Face Masks Synthetic Blood Penetration:
It is used to test the splash resistance of face masks, by generating a tiny flow of synthetic blood and splash it on the center of the masks.
2. Impact Penetration Tester:
It is used to determine the resistance of fabric to the penetration of water by impact, and thus can be used to predict the probable resistance of fabrics to rain penetration.
3. Mask Particle Filtration Efficiency (PFE):
This type of tester is used to test the particle filtration efficiency of surgical face masks, mask raw fabric results in percentage level, and such N95 means 95% filtration level.
4. Masks Bacterial Filtration Efficiency:
It is used to determine the bacterial filtration efficiency (BFE) of surgical face masks, medical face masks, to identify the protective clothing performance from being exposed to bacterial airborne environments.
5. Medical Mask Differential Pressure:
It is a lab testing instrument which is used to determine breath ability of medical face masks or surgical face masks.
6. Medical Textiles Tensile Testing Machine:
It is used to determine compression rate, elongation, bending, tearing, peeling shear force, adhesive force, finished or semi-finished products (such as medical masks), ear hangers for medical masks, medical protective clothing, surgery elongation of clothing, curtains, etc.
7. Martindale Abrasion & Pilling Tester:
It is used to determine the abrasion and pilling resistance of all kinds of textile structures.
8. Auto Water Vapor Permeability Tester:
It is used to determine the water vapor permeability of different textile and clothing fabrics including composite fabrics, coating fabrics, sportswear fabrics and industrial fabrics.
9. 45 Degree Flammability Tester:
It is used to determine the fabric flammability or fabric burning test.
10. Hydrostatic Head Tester:
It is used to determine the resistance of fabrics and films to water penetration under pressure while firmly clamped in the test rig of standard area.
11. Sweating Guarded Hotplate:
It is used to determine the thermal resistance characteristics of textiles for clothing to check the ability to protect from heat.
12. Medical Masks Flammability Tester:
It is used to test the flammability of medical masks, to ensure the safety of masks to wear in.
13. Schildknecht Flexing Tester:
It is used to determine the resistance of coated fabrics to damage by flexing due to oscillation at 500 times per minute.
14. Temperature Humidity Chamber:
This type of test is applied for water vapor permeability testing when equipped with related kits.
Conclusion
The dependability of disposable medical face masks is not determined by luck but by systematic and strict tests. The highly advanced gadgets that are used for determining the amount of air that can pass through the mask (filtration), how easily the mask can be breathed through (breathability).
And how much fluid the Disposable Medical Mask can resist (fluid resistance) gives the numerical data that is essential for verifying that these protective devices that are so necessary actually work, this way both healthcare staff and patients are protected. Getting to know these standards and the instruments supporting them is very important for bringing about quality and compliance in the medical device sector.
