Coronati Consulting is able to perform test on Surgical Masks (Type I, Type II and Type IIR) according to EN 14683 and ISO 10993-1.
Some tests are performed at external qualified laboratories.
TESTS according to EN 14683:
- Bacterial filtration efficiency (BFE) according to EN 14683 Annex B paragraph 5.2.2
- Breathability according to EN 14683 Annex C paragraph 5.2.3
- Bioburden_Microbiological cleanliness EN 14683:2019 Annex D par.5.2.5 e ISO 11737-1:2018 Annex B.2
- Splash resistance mandatory for type IIR
TESTS according to ISO 10993-1:
- In Vitro Cytotoxicity (ISO 10993-5)
- Skin Irritation (ISO 10993-10)
- Skin Sensitization (ISO 10993-10)
Biocompatibility can also be assessed by performing in vitro tests whose method has been internally validated which offers reliable and faster results: this alternative approach shall be supported by a literature review.