EN 16777

Chemical disinfectants and antiseptics – Quantitative non-porous surface test without mechanical action for the evaluation of virucidal activity of chemical disinfectants used in the medical area. Test method and requirements (phase 2/step 2)

Summary

EN16777 is a hard surface-based test method for evaluating the efficacy of chemical disinfectants used in the medical area against viral contaminants on surface.  The required viruses vary depending on the type of efficacy claims for the test product (general virucidal activity, limited spectrum virucidal activity, or virucidal activity against enveloped viruses). This method uses stainless steel discs as “carriers”; therefore, it is different from a suspension test. 

Typical Test Substances

• Surface disinfectants
• Instrument disinfectants
• Sanitizers 

Outline of Test Procedure

• Clean, sterile stainless steel disc
• Add virus and allow it to dry
• Add test substance (liquid) via direct pipetting
• Hold for contact time (not longer than 5 minutes or 60 minutes)
• Add neutralizer and vortex to recover virus
• Assay for Infectious Virus (quantitative assay)

Regulatory Agencies / Purpose

• European Agencies
• Other international agencies 
• R&D and Marketing

Similar Methods

• ASTM E1053 
• ASTM E2197