EN 14683 sets the requirements for medical face masks. There is one distinction that is confused more often than any other: a medical mask and an FFP respirator work in opposite directions.
Medical mask versus respirator
| Medical mask (EN 14683) | Respirator (EN 149) | |
|---|---|---|
| Who it protects | The environment and the patient from the wearer | The wearer from the environment |
| Face seal | Not required | Mandatory and tested |
| Regulation | Medical device (MDR) | PPE (2016/425) |
Types
| Type | Bacterial filtration efficiency | Splash resistance |
|---|---|---|
| Type I | ≥ 95% | No |
| Type II | ≥ 98% | No |
| Type IIR | ≥ 98% | Yes (16 kPa) |
Type I is chiefly for patients and visitors; Type II for clinical staff; Type IIR for procedures where there is a risk of blood or body fluid splash.
The standard also sets a breathing resistance limit and a microbial cleanliness requirement. A mask must be changed as soon as it becomes damp — a wet mask loses its barrier and becomes a growth medium in its own right.