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.