EN 12353:2021 Chemical disinfectants and antiseptics

EN 12353:2021 Chemical disinfectants and antiseptics

Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity. 

This document specifies methods for keeping test organisms used and defined in European Standards for the determination of bactericidal (incl. Legionella pneumophila), mycobactericidal, sporicidal, fungicidal and virucidal (incl. bacteriophages) activity of chemical disinfectants and antiseptics drawn up by CEN/TC 216. These methods for keeping test organisms can only be carried out in connection with at least one of those standards where a reference to this document is established.


Annex A (informative) contains a non-exhaustive list of test organisms for which this document can be applied.


European Standards (EN) where this document is referenced are listed in the Bibliography.


A specific description on the preservation of bacterial spores could be added once the results of the ongoing ring trials are available.


The changes mentioned above have no impact on the test results obtained with reference to the previous version. Those results are still valid.

Important Dates 

  1. (2021-02-01) Date of ratification when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved
  2. (2021-09-01) Date of availability when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat
  3. (2021-12-32) Date of announcement latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level
  4. (2022-03-31) Date of publication latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement
  5. (2022-03-31) Date of withdrawal latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn

This document supersedes EN 12353:2013. 

The EN 12353:2021 has been revised to adapt if to the latest state of science, to correct errors and ambiguities, some important change to the previous version are the following:

  • The methods of preservation of viruses are described more detailed;
  • MEM is not the only suitable cell culture medium, therefore it was replace by the general term “cell culture medium“;
  • the used virus strains are re-drafted;
  • the description of BCYE Agar for Legionella was added;
  • the CIP numbers for fungi were deleted;

does SHAPYPRO currently have a proficiency testing program open on any of these standards?

Yes, we are open registration time in PT program according to EN 14476 Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of virucidal activity in the medical area – Test method and requirements (Phase 2/Step 1)

Not registered yet? 🤔

Registration end date: 30.07.2022

You can do it;

📧 info@shapypro.com

☎ + 34 633 596 678

thanks to illustrator @Storyset.com

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