EN 13624:2021 Quantitative suspensión test for the evaluation of fungicidal or yeasticidal activity in the medical area

Updating Chemical Disinfectants and Antiseptics Standard 

Thanks to Technical Committee CEN/TC 216 “Chemical disinfectants and antiseptics” we have the standard revised and adapted to the latest state of science, correcting errors and ambiguities, some important change to the previous version, which are the following:

De-harmonization 

The standard has been disharmonized by deleting Annex ZA and the references to MDR/MDD

Textile disinfection 

Textile disinfection has been take into account in this standard in order to test fungicidal or yeasticidal activity for further information you can see EN 16616:2015 “Chemical disinfectants and antiseptics – Chemical-thermal textile disinfection – Test method and requirements (phase 2, step 2)”.

Interfering substance 

The amounts of interfering substance used under dirty conditions are reduced in the modified method for ready-to-use products. In particular, the amounts are reduced proportionally except for the final dilution in sterile bovine albumin solution.

Neutralization Time

All products which the contact time will be 10 min or shorter the neutralización time is 10 s ± 1 s.

Chemo-thermal disinfection 

Temperature resistance of the test organisms my lead to invalid controls of experimental conditions. In such cases, Control A and water control shall be run in parallel at application temperature and at 20°C, in order to check lethal effect in the test conditions.

Strains references in national collections

CIP references were deleted and UMIP references were added.

Ask us about our schemes 2023, we advance you that the EN 13624 standard is included in our proficiency testing schedule for 2023.

We help you with the technical updates of the standards and advise you on the benefits of carrying out intercomparisons.

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