Certifications & clinical evidence
Certifications and clinical evidence
Regulatory approvals, quality certifications and published evidence for the technologies we supply. We list only information we have verified from the manufacturer or the issuing authority. Documents are available on request.
Regulatory approvals and certifications
Verified approvals
| Zener (UVX) | FDA 510(k) clearance K252128; model ZEN-001-B1; Class II; product code FRA; 21 CFR 880.6500 medical ultraviolet air purifierU.S. FDA, 510(k) K252128 (PDF) |
|---|---|
| HYPERION (Finsen Tech) | Class IIa CE medical device; approved by the British Standards Institution (BSI), as stated by the manufacturerFinsen Tech |
| THOR UVC (Finsen Tech) | Manufacturer states performance exceeds BSi 8628Finsen Tech |
| PLASMAIR Guardian (airinspace) | CE marking under the Low Voltage (2014/35/EU) and EMC (2014/30/EU) directives, per the user manualairinspace user manual |
| airinspace (company) | ISO 9001 quality management certificationairinspace |
| Local registration | Registration with national health authorities is confirmed per product and per country for each projectCapnova |
Clinical and technical evidence
Published and manufacturer evidence
Published studies are listed with their design so you can judge them. Manufacturer-reported data are labelled as such.
The Plasmair decontamination system is protective against invasive aspergillosis in neutropenic patients
Fernandez-Gerlinger MP, et al. Infection Control & Hospital Epidemiology. 2016;37(7):845–851. Retrospective cohort, 156 patients, haematology ICU.
Open source →Far-UVCAntimicrobial activity of filtered far-UVC light (222 nm) against different pathogens
Laboratory study using a UVX far-UVC fixture with a built-in filter removing wavelengths above 235 nm.
Open source →Far-UVCAntiviral effect of 222 nm far-UVC light against human coronavirus, rhinovirus and murine norovirus
Laboratory study on dried inocula using a UVX far-UVC fixture.
Open source →UVC room disinfectionManufacturer-reported clinical data for THOR UVC
Finsen Tech reports a 37% reduction in acquisition of healthcare-associated infections with daily use. Study details available from the manufacturer on request.
Open source →Equipment decontaminationThird-party efficacy testing for ZEUS
Finsen Tech reports a log 9 reduction in a 30-second cycle in third-party testing. Test reports on request.
Open source →Far-UVCThird-party testing for Zener
UVX cites testing to ANSI/AHAM AC-5, ASHRAE 241 and FDA GLP. Reports on request.
Open source →Technical and validation documentation
- Product datasheets and installation requirements
- Manufacturer test reports and certificates
- Declarations of conformity where applicable
- Commissioning and validation records for installed projects
- Operator manuals and training records
Ask our team for the documents you need for tenders, committees or accreditation.
Need documents for a tender or committee?
Tell us which products and which documents you need.