Medical disposable surgical mask type IIR

Features of the disposable surgical mask type IIR with splash protection

  • Norm EN 14683: 2019 + AC: 2019.
  • Type IIR –> R means that the mask offers splash protection and thus you protect yourself and others.
  • The type IIR is a disposable mask with splash protection.
  • Bacterial filter performance (BFE): ≥ 98% for 3μm particles.
  • Requires a CE.
  • Masks produced outside the EU require a CE from an EC-REP (approved, certified representative in the EU of the manufacturer or an authority such as a health ministry).
  • Various manufacturers also check the masks for smaller particles, since the coronavirus is < 1μm.
    ILB had these additional tests carried out by EMPA.
  • Swissmedic is the responsible body in Switzerland for medical products.
  • In Switzerland, the Swiss National COVID-19 Science Task Force recommends “Community Masks” – BFE >70% for 1μm particles.
  • An additional Amfori BSCI certification ensures compliance with social and ecological services throughout the entire supply chain and production.
  • The masks can only be tested by accredited test centers such as SGS, TÜV, DEKRA, etc. (see EU Nando database).
  • An additional SVHC test (Substances of Very High Concern) gives end users the assurance that the tested products and materials do not contain harmful amounts of chemicals that are dangerous for human health and the environment. – ILB had this check carried out by SGS and TuV.
  • In Switzerland, 3-language packaging and operating instructions are required.

Medical face masks prevent the patient or work environment from coming into contact with large particles (e.g. saliva, mucus) ejected by the mask wearer; they also protect the wearer from blood and/or other body fluids from the patient or from the work environment, but do not offer 100% protection.

Masks of type IIREN 14683: 2019 + AC: 2019 are suitable for situations in which the medical staff is at risk of contact with the patient’s blood and/or other body fluids or from the work environment, but do not offer 100% protection.

Medical face masks are medical devices. They must be manufactured and sold in accordance with the legal requirements for medical products in the EU and according the local regulations.

In contrast to everyday masks, called community masks, special demands are made on medical products.

They must therefore comply with the European standard EN 14683:2019-10. For this, manufacturers must carry out a successful verification procedure (conformity assessment procedure according to Medical Device Directive 93/42 / EEC) to prove that their products meet all legal requirements. Only then can manufacturers apply the CE mark to the medical masks and sell them freely in Europe.

Notes for users:

The use of face masks does not replace the other protective measures such as hand hygiene or keeping your distance but complements them. The protective effect depends not only on the type of mask, but also on the correct use.

Approved bodies for testing the standard: EN 14683: 2019 + AC: 2019

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In Switzerlandthere is currently no accredited laboratory for checking the masks, that’s why ILB tests at SGS, TÜV Rheinland, TÜV Nord andDEKRA Germany.

Requirements and labelling of a Type IIR mask according to EN 14683: 2019 + AC: 2019