REGULATORY PART (CERTIFICATES & COMPLIANCE)
▶ ISO 9001:2015 & ISO 13485:2016 Certified – 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.
▶ Specific validation regarding the sterilization of the devices and Evaluation of the Bioburden according to the standard
• ISO 1137-2:2015;
• ISO 11737-1:2006/AC:2009;
• ISO 11737-2:2019.
▶ PED Directive 2014/68/EC Compliance – Meets European pressure equipment safety regulations.
▶ 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.













