Face masks from China and US equivalent to European standards
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.
National coordination of scarce protective equipment
A great deal of personal protective equipment is needed to keep healthcare professionals safe while caring for corona patients. The Ministry of Health, Welfare and Sport (VWS) has set up the National Consortium for Medical Devices (LCH) in order to centralise the procurement and distribution of this scarce equipment to ensure availability. The LCH procures personal protective equipment and medical devices that are in danger of running out.
Prior to distribution via the LCH, RIVM carries out random quality tests to demonstrate whether the masks that do not carry the CE mark provide the correct protection. The most important aspect is to determine whether the mask in question is effective enough at preventing the entry of particles. An assessment is, moreover, made of whether products are well packaged, are sound, that the marks are correct and that the expiry date has not been exceeded.
The following sentence is no longer applicable. As of 1 September 2020, the LCH only purchases products with a CE marking.
Providers, suppliers and manufacturers can approach the LCH with their offers via email@example.com.
A manufacturer can determine the intended use of a product and can market face masks as personal protective equipment and/or as medical devices. The IGJ supervises medical devices in accordance with Directive 93/42/EEC. The SZW Inspectorate is the market regulator for personal protective equipment (Regulation (EU) 2016/425).
The IGJ is allowing manufacturers to deliver medical devices, such as surgical face masks, without a CE mark at the explicit request of care providers if there are insurmountable shortages due to the coronavirus. Besides, the IGJ allows the LCH to supply surgical face masks not complying with the relevant regulation.
The inspectorate SZW is temporarily allowing the marketing of personal protective equipment, such as FFP1, FFP2 and FFP3 face masks, that are not CE marked but that demonstrably meet the safety and health requirements of Regulation (EU) 2016/425 solely for the use of healthcare professionals. Information on this is given on the page on product safety and certification.
This news release was updated on 15 May 2020.