Enhancing the validity of virucidal activity testing of chemical disinfectants by establishing new reference substances according to EN 14476:2019

Authors

KM Roesch, C Hildebrandt, M Eggers, F Brill, M Cavalleri, J Gebel, B Hunsinger, S Loeffert, M Rausch, I Schwebke, K Steinhauer, M Exner, NT Mutters

Bibliography

Abstract

Introduction: Reference tests are crucial for ensuring the comparability and quality assurance of test results in the field of chemical disinfectant testing. For testing virucidal activity, EN 14476:2019 specifies formaldehyde as reference substance. However, due to toxicological and technical concerns, formaldehyde needs to be replaced with new and more suitable reference substances.

In order to find the replacement, in 2023-24 an international ring trial was conducted by the European Standardization Committee TC 216 WG 1 (chemical disinfectants and antiseptics, working group human medicine) with 17 participating laboratories. The goal was to evaluate the suitability of these substances for optimization of existing standards.

Materials and methods: The study assessed the stability of the test viruses used in the disinfection test – specifically, Modified vaccinia virus Ankara, Adenovirus type 5, Murine Norovirus S99, Minute Virus of Mice, Poliovirus type 1 strain LSc-2ab and Bovine Enterovirus type 1 – to two newly selected reference substances: glutaraldehyde and peracetic acid.

The study tested reproducibility and repeatability based on a predefined test protocol.

Results: The results of the two tested reference substances – glutaraldehyde and peracetic acid – provide new reference substance ranges for relevant test viruses. The findings are incorporated into the revision of the European standards, ensuring the quality assurance of efficacy testing in virucidal testing.