EN 16615

Chemical disinfectants and antiseptics – Quantitative test method for the evaluation of bactericidal and yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area (4- field test) – Test method and requirements (phase 2, step 2)

Summary

EN16615 is a standard test method for quantitatively evaluating the microbial elimination (inactivation and removal) efficacy by liquid disinfectants or pre-impregnated disinfectant wipes on non-porous surfaces.  This method uses a plastic (PVC with PUR surface coating) as a “carrier”; and the test substance (standard wipe soaked with the test solution or pre-moistened ready-to-use test wipe) is used to treat the contaminated surface using a mechanical action.  Thus, the test evaluates the total elimination efficacy (inactivation and removal) by the test product.  The method may also be adapted to evaluate viral elimination capability.

Typical Test Substances

• Liquid disinfectants
• Pre-impregnated (pre-moistened) disinfectant wipes

Outline of Test Procedure

• PVC carrier
• Add micro-organism and allow to dry
• Treat carrier with the test substance (standard wipe soaked with test solution or pre-impregnated wipe) using a unitary weight involving a back-and-forth mechanical action
• Hold for contact time (usually seconds to minutes)
• Swab with neutralizer to elute off surviving micro-organism
• Plating and counting (quantitative assay)

Regulatory Agencies / Purpose

• European Agencies
• Other international agencies 

Similar Methods

• EPA Residual Efficacy Test Methods