Table 2.
The subset of tests (EN 149:2001 + A1:2009) deemed essential to evaluate respiratory protective devices for COVID-19
| Performance requirement | Test method clause | Requirement |
|---|---|---|
| Visual inspection (Section 7.3 EN 149:2001 + A1:2009) | The visual inspection is carried out where appropriate by the test house prior to laboratory or practical performance tests (Clause 8.2). | |
| Packaging (7.4) | The visual inspection is carried out where appropriate by the test house prior to laboratory or practical performance tests (Clause 8.2). | Particle filtering half masks shall be offered for sale packaged in such a way that they are protected against mechanical damage and contamination before use. |
| Cleaning and disinfecting (7.6) | Testing shall be done in accordance with Clause 8.4 and Clause 8.5. With reference to 7.9.2, after cleaning and disinfecting the re-usable particle filtering half mask shall satisfy the penetration requirement of the relevant class. Testing shall be done in accordance with Clause 8.11. | After cleaning and disinfecting the re-usable particle filtering half mask shall satisfy the penetration requirement of the relevant class. |
| If the particle filtering half mask is designed to be re-usable, the materials used shall withstand the cleaning and disinfecting agents and procedures to be specified by the manufacturer. | ||
|
Practical performance (7.7) The particle filtering half mask shall undergo practical performance tests under realistic conditions. |
2 particle filtering half masks shall be tested as received in accordance with Clause 8.4. | During the tests the particle filtering half mask shall be subjectively assessed by the wearer and after the test, comments on the following shall be recorded: |
| a) head harness comfort; | ||
| These general tests serve the purpose of checking the equipment for imperfections that cannot be determined by the tests described elsewhere in this standard. | ||
| b) security of fastenings; | ||
| c) field of vision; | ||
| d) any other comments reported by the wearer on request. | ||
| Where practical performance tests show the apparatus has imperfections related to wearer’s acceptance, the test house shall provide full details of those parts of the practical performance tests which revealed these imperfections. | ||
|
Total inward leakage (7.9.1) The laboratory tests shall indicate that the particle filtering half mask can be used by the wearer to protect with high probability against the potential hazard to be expected. The total inward leakage consists of three components: face seal leakage, exhalation valve leakage (if exhalation valve fitted) and filter penetration. |
At least 5 specimens shall be tested as received in accordance with Clause 8.5. | All samples must achieve the specifics. |
| All individual exercise results tests shall be not greater than 11% (FFP2) (5% for FPP3) and, in addition, all arithmetic means for the total inward leakage shall be not greater than 8% (FFP2) (2% for FFP3). | ||
| Penetration of filter material (7.9.2) | At least 3 samples shall be tested as received for NaCl and paraffin oil (PO) for 3 min in accordance with Clause 8.11. |
The maximum penetration of test aerosol shall be: • 6% for both PO and NaCl for FFP2 • 1% for both PO and NaCl for FFP3 |
| Carbon dioxide content of the inhalation air (7.12) | At least 3 particle filtering half masks shall be tested in accordance with Clause 8.7. | The carbon dioxide content of the inhalation air (dead space) shall not exceed an average of 1.0% (by volume). |
| Head harness (7.13) | Testing shall be done in accordance with Clause 8.4 and 8.5. | The head harness shall be designed so that the particle filtering half mask can be donned and removed easily. The head harness shall be adjustable or self-adjusting and shall be sufficiently robust to hold the particle filtering half mask firmly in position and be capable of maintaining total inward leakage requirements for the device. |
| Field of vision (7.14) | Testing shall be done in accordance with Clause 8.4. | The field of vision is acceptable if determined so in practical performance tests. |
| Breathing resistance (7.16) | At least 3 samples shall be tested as received in accordance with Clause 8.9. | The maximum permitted resistances per volumetric flow rate for FFP2 are: |
| • 30 l/min – 0.7 mbar (inhale) | ||
| • 95 l/min – 2.4 mbar (inhale) | ||
| • 160 l/min – 3.0 mbar (exhale) | ||
| For FFP3 are: | ||
| • 30 l/min – 1.0 mbar (inhale) | ||
| • 95 l/min – 3.0 mbar (inhale) | ||
| • 160 l/min – 3.0 mbar (exhale) |