Face masks from China and US equivalent to European standards from freeamfva's blog

Face masks from China and US equivalent to European standards

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.To get more news about mask supplier, you can visit tnkme.com official website.

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.
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.