Regulatory requirements for medical devices (including disinfectants and antiseptics) as established by the Medical Devices Directive (western market) make it imperative for all such devices to be manufactured through safe and verifiable processes that comply with health standards and environmental mandates. Unless a product follows the directive completely, it cannot be introduced into the market.
We at ImmunitasBio provide manufacturers with affordable microbiological testing towards this end. We encourage you to contact us so we can provide you with the best fit for your product claims:
VIRUCIDAL EFFICACY TEST METHODS AND SERVICES
Preliminary Testing and Guidance
- Preliminary Screening (MS2 Bacteriophage)
- Initial and Confirmatory Virucidal Effectiveness Testing for Viral Surrogates
Suspension-Based Tests
- ASTM E1052 – Standard Test Method for Efficacy of Antimicrobial Agents Against Viruses in Suspension
- EN 14476 – Chemical Disinfectants and Antiseptics – Quantitative Suspension Test for the Evaluation of Virucidal Activity in the Medical Area (Phase 2/Step 1)
Hard Surface Carrier Tests
- ASTM E1053 – Standard Test Method to Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate, Nonporous Environmental Surfaces
- AOAC Germicidal Spray Test, Modified for Viruses
- Pre-Saturated Towelettes Virucidal Effectiveness Test
Treated Surfaces and Textiles
- AATCC 100 – Assessment of Antibacterial Finishes on Textile Materials, Modified for Viruses
- ISO 21702 – Measurement of Antiviral Activity on Plastics and Other Non-porous Surfaces
- JIS Z 2801 – Measurement of Antimicrobial Activity of Plastic Surfaces
- ISO 22196 – Test for Antimicrobial Activity of Treated Surfaces
Additional Testing
- Custom Virucidal Efficacy Studies – UV/Room Device/Antimicrobial Devices
- Disinfectant Validation Studies Against Viruses
- Residual Self-Disinfection