According to the conclusion reached by the Health and Youth Care Inspectorate (IGJ) after consultation with the inspectorate of Social Affairs and Employment (inspectorate SZW) and RIVM, certain standards for face masks from outside the EU (e.g. China and the US) are equivalent to the European EN-149:2001+A1:2009 and NEN-EN 14683:2019 standards for face masks. The IGJ is publishing this conclusion because it can contribute to patient safety.
The equivalent standards are as follows:
- The Chinese GB 2626-2006 standard (succeeded by the GB 2626-2019 standard) for the face masks KN95, KP95 (FFP2) and KN100, KP100 (FFP3) are equivalent to EN 149:2001+A1:2009.
- The Chinese GB 2626-2006 standard (succeeded by the GB 2626-2019 standard) for the face mask KN95 is, furthermore, equivalent to the NEN-EN 14683:2019 if the KN95 mask is marketed as a surgical mask.
- The American NIOSH 42 CFR 84 standard for the masks N95, P95, R95 (FFP2) and N100, P100, R100, P99, R99 (FFP3) is equivalent to EN 149:2001+A1:2009.
Whether a mask with equivalent standards form outside the EU are of sufficient quality, cannot be guaranteed.