REGULATORY PART (CERTIFICATES & COMPLIANCE)
▶ Certified Medical Device in Class I according to 2017/745 MDR.
▶ ISO 9001:2015 & ISO 13485:2016 – Ensures high-quality manufacturing.
▶ ASTM F838-05 Validated – Certified bacterial retention against Legionella, Pseudomonas, and Brevundimonas Diminuta.
▶ Specific validations for the prevention of retrograde contamination:
• Test according to ISO 22196;
• Test under conditions.
▶ Biocompatibility & Safety – Compliant with FDA, EPA, and European Biocidal Product Regulations (BPR).
▶ Nuova S.B. System Patent – Our filters are paten- ted, tested, and validated for virus retention, offering enhanced protection against Adenovirus, Poliovirus, and Norovirus.













