Research for infection protection

The new standard for sporicidal testing of disinfectants in the field of human medicine according to EN 17126

Background

The efficacy of chemical disinfectants must be tested using standardised test methods in order to be able to classify a product as effective for the intended use according to its claim. In contrast to the claims "bactericidal", "mycobactericidal", "virucidal" and "fungicidal", until recently there was no test standard for disinfectants declared as "sporicidal" for the human medical sector in European standardisation. The claim of sporicidal efficacy of disinfectants was therefore based on EN 13704, which is intended for testing chemical disinfectants for food, industry, household and public facilities - a common procedure. However, since the test conditions of EN 13704 are not adapted to the field of human medicine, this gap was closed with the adoption of EN 17126.

 

What is changing with the new EN 17126?

With the publication of DIN EN 17126 in February 2019, a European standard is available for the first time that defines the requirements for testing the sporicidal efficacy of chemical disinfectants in the field of human medicine. The test method described therein takes into account the application conditions that have an influence on the effect in practice (e.g. exposure time, temperature, test organisms and exposure substance). The most important changes compared to EN 13704 are:

  • This is the first time that sporicidal activity against Clostridioides (C.) difficile, the most significant spore former in the health sector, has been included as independent spectrum efficacy.
  • In addition, the sporicidal efficacy against Bacillus (B.) subtilis and B. cereus can be investigated, thereby covering both anaerobic and aerobic spore patterns.
  • The spore production procedure was amended to include a reference substance. The acceptance criteria were increased from 3 to 4 log10 levels (see table below).
MethodStage/DomainSporeLog10-
reduction
Classification
EN 13704:2018P2,S1 (PT4)B. subtilis3sporicidal
EN 17126:2018P2,S1 (PT2)C. difficile
B. subtilis & B. cereus
4sporicidal against C. difficile
sporicidal

Table 1: Comparison of EN 13704 and EN 17126 regarding test methods for sporicides. EN=European Standard; P2=Phase 2; S1=Stage 1

Compared to EN 13704, the new EN 17126 results in more stringent requirements regarding the sporicidal efficacy of products.

What does this mean in practice?

Disinfectants that were tested and advertised on the basis of the EN 13704 standard, which was still valid at the time, can be used until the expiry date. These products have not lost their effectiveness, but merely do not or not yet fulfil the new, higher requirements of EN 17126. EN 13704 remains valid in the area of food, industry, household and public facilities.

The decision whether to continue using a sporicidal product labelled according to EN 13704 must therefore be made by the health facility itself on the basis of its risk management. The remaining efficacies of a disinfectant remain unaffected by the change, as the assessment of efficacies against them is not affected. Should the healthcare facility exclude the use of the EN 13704 labeled product for itself, the disinfectant can still be used there in areas that do not require sporicidal efficacy. Do you still have questions about the claimed sporicidal efficacy of certain products? Please contact your sales contact or contact person to find out which products in the HARTMANN portfolio meet the new standard.