Overview

Spore production has resulted in the following problems in the past: The chemical susceptibility of B. cereus and B. subtilis spore suspensions prepared in accordance with EN 13704 and EN 17126 did not meet the specified requirements/log reductions due to the lack of buffering of the glutardialdehyde. The updated version of EN 13704 lacks verification of chemical susceptibility for C. sporogenes using reference substances. Data for glutardialdehyde (GA) and peracetic acid (PAA) shall be collected and incorporated into a revised EN 13704. These issues can be avoided if the notes and information contained in the document are followed. The chemical susceptibility test for C. difficile spore suspensions according to EN 17126 remains unchanged and has been included in this Technical Report for the sake of completeness. In addition, EN 13704 and EN 17126 lack a test method for distinguishing between the sporicidal and sporistatical activity of a product, which is included in EN 14347. Thus an additional test is provided in order to determine or rule out sporistatical activity. This information will be taken into consideration during the revision of EN 17126 and EN 13704, or incorporated during the revision of EN 12353, and then referenced in the two aforementioned standards. This document provides further information and recommendations on the preparation of spores, as well as a test method for determining or ruling out sporistatic activity. Committee NA 176-03-06 AA "Chemische Desinfektionsmittel und Antiseptika in der Humanmedizin" ("Chemical disinfectants and antiseptics in human medicine") at DIN is responsible for this standard.

Responsible national committee

NA 176-03-06 AA - Chemical disinfectants and antiseptics in human medicine  

Responsible european committee

CEN/TC 216/WG 5 - Strategy Group