Our efficacy  is documented by third parties through the EN  17272 standard

Since October 2020, STERISAFE validates its process against the EN 17272:2020 standard (Methods of airborne room disinfection by automated process), published by the European Committee for Standardization (CEN). This standard is based on the older French national standard NF T 72-281, which prior to October 2020 was the only norm designed specifically for airborne disinfectants such as the STERISAFE PRO, and was recognized for its particularly strict fulfillment conditions.

EN 17272 defines a set of testing methods to challenge disinfectant products in real-life conditions, including a distribution test that verifies the good diffusion of a disinfectant throughout a given room. When considering any airborne disinfectant instrument, it is important to verify compliance with EN 17272.

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The biocidal efficacy requirements depend on the target organisms:

  • Bacteria: > 5-log reduction
  • Spores: > 4-log reduction in the medical area, > 3-log reduction in other areas
  • Fungi & yeasts: > 4-log reduction
  • Viruses incl. phages: > 4-log reduction
  • Mycobacteria: > 4-log reduction

STERISAFE always tests its products against recognized standards relevant to its technology, and as such can guarantee their efficacy. Considering the test conditions, the high kill-level objectives it requires, and its large target range, the EN 17272 (and previously, NF T 72-281) should be the only acceptable standard methodology for efficacy claims of airborne disinfectant products. STERISAFE has been a pioneer in using this standard in the industry of the ozone-based disinfection systems and will continue to do so.

STERISAFE PRO efficacy on bacteria, viruses, fungi and yeast

Type
(minimal log-reduction required)
Germ STERISAFE
log-reduction
% reduction
Bacteria (> 5.0) Enterococcus faecium 6.73 99.9999%
Enterococcus hirae 6.01 99.9999%
Proteus mirabilis ≥ 5.80 ≥ 99.999%
Pseudomonas aeruginosa 6.99 99.9999%
Staphylococcus aureus 6.80 99.9999%
VRE 5.51 99.999%
MRSA 4.81 99.99%
Listeria monocytogenes ≥ 7.70 ≥ 99.99999%
Escherichia coli 6.22 99.9999%
Proteus hauseri ≥ 5.18 ≥ 99.999%
Acinetobacter baumanii ≥ 5.19 ≥ 99.999%
Fungi & yeast (> 4.0) Candida albicans ≥ 5.77 ≥ 99.999%
Aspergillus brasiliensis ≥ 4.08 ≥ 99.99%
Spores (> 4.0 or > 3.0) Bacillus subtilis ≥ 3.57 ≥ 99.9%
Viruses (> 4.0) Adenovirus ≥ 4.25 ≥ 99.99%
Murine norovirus (MNV) ≥ 4.96 ≥ 99.99%
Modified Vaccinia Ankara (MVA) ≥ 4.68 ≥ 99.99%
Polyomavirus SV40 4.77 99.99%
Bovine coronavirus (BCoV) ≥ 4.75 99.99%
Mycobacteria (> 4.0) Mycobacterium terrae 4.42 99.99%
Mycobacterium avium ≥ 5.84 ≥ 99.999%

*All tests conducted according to either NF T 72-281 or EN 17272 at fully accredited laboratories. Please contact STERISAFE for more information.

“I was part of the expert meeting that was held in Geneva with other infection control specialists (…) and  in 2014 the NF T 72-281 norm was the first created to control AED (Automated Enviromental Disinfection) processes. I started working with this new technology using ozone and with the preliminary results I am satisfied and I think it is really promising!”

– Prof. Skrlin, MD & PhD clinical microbiology

The biocidal product regulation

Biocidal products aim to protect human, animals and materials against harmful organisms such as pests or bacteria, by destroying or inactivating them. Due to their mode of action, those products can be dangerous if they enter the market with insufficient or no vigorous testing. Since September 2013, the Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) acts as a legal framework with the aim to control and harmonize the rules delimiting the marketing and use of biocidal products in the European Union.

The BPR is set under the precautionary principle, and its intent is to safeguard the health of humans and the environment. All biocidal products in the EU require approval under this Regulation prior to marketing; manufacturers who overlook this requirement are operating illegally. Before acquiring any biocidal products, it is highly recommended to verify their registration under the BPR.

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STERISAFE is part of the European Ozone Trade Association (EuOTA), a group composed of manufacturers of ozone generators. The EuOTA’s aim is to consolidate ozone-based knowledge amongst companies, and duly register ozone and ozone generators under the BPR.

STERISAFE upholds its products to the highest standards and can guarantee their efficacy and safety.