 | SilverStream’s Anti-Biofilm Effectiveness Evaluation of an Ionic Silver Solution against Dual Species In-Vitro Wound Biofilms Center for Biofilm Engineering, Montana CBE – USA |
SilverStream® Solution and SilverStream® Gel Safety
Summary of Biocompatibility Testing Conducted on SilverStream® Solution & SilverStream Gel®
| Biological Effect | Results |
|---|---|
| Irritation | Non-Irritant |
| Acute Systemic Toxicity | Non-Toxic |
| Sensitization | Non-Sensitizing |
| Cytotoxicity Study ISO Direct Contact Method | Non-Cytotoxic |
| Repeated Subcutaneous Toxicity (rats) | Non-Toxic (Gel only) |
| Material-mediated Pyrogenicity (rabbits) | Non-Pyrogenic (Gel only) |
| Assessment of Potential Wound Healing (swine) | Passed (Gel only) |
SilverStream® Solution
 | USP 51 Antimicrobial Preservative Effectiveness Test Nelson Laboratories |
| USP 61 Microbial Limits Nelson Laboratories |
| USP 81 Antimicrobial Susceptibility Test Nelson Laboratories |
| Minimum Inhibitory Concentration (MIC) / Minumum Bactericidal Concentration (MBC) Nelson Laboratories |
 | ISO 10993:5 : Tests for in vitro cytotoxicity Namsa Laboratories |
| ISO 10993:10 : Tests for irritation and skin sensitization Namsa Laboratories |
| ISO 10993-11:2017: Tests for systemic toxicity Namsa Laboratories |
SilverStream® Gel
| USP 51 Antimicrobial Preservative Effectiveness Test Nelson Laboratories |
| USP 61-62 Microbial Limits Nelson Laboratories |
| USP 81 Antimicrobial Susceptibility Test Nelson Laboratories |
| ISO 10993:5 : Tests for in vitro cytotoxicity Namsa Laboratories |
| ISO 10993:10 : Tests for irritation and skin sensitization Namsa Laboratories |
| ISO 10993-11:2017: Tests for systemic toxicity Namsa Laboratories |
