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Vivo Clinical Testing is proud to offer a variety of test methods to fit your efficacy evaluation needs. Vivo utilizes standard methods from organizations such as ASTM International and the European Standards (EN) Organization, which are considered suitable for testing by U.S. regulatory agencies.
ASTM sets standards for multiple industries, including that of clinical testing, providing multiple test methods for multiple product categories. For example, the ASTM E2755 Healthcare Hand Rub Method, which is designed to determine the efficacy of hand rub formulations without the use of soap or water. This differs from the ASTM E1174 Healthcare Handwash Test Method,which evaluates handwash formulations that require washing, lathering,and rinsing of the hands. These tests consist of covering the entire hands with a specific volume of bacteria and using the hand rub or hand wash formulation followed by a sampling of the hands using the glove juice method as hands are inserted into gloves with sampling solution, massaged, and sampled. ASTM E1838 Virucidal Fingerpad Test method is designed to evaluate the virus eliminating efficacy of a hand rub or hand wash on the finger pads of the hands. In addition, ASTM E2276 is designed to evaluate the bacteria eliminating efficacy of a hand rub or hand wash on the finger pads of the hands. Additionally, Vivo incorporates methods from around the world in its testing repertoire, including EN methods. The EN organization produces standards that have been approved and adopted by the European Union. Vivo Clinical Testing does provide EN1500 method testing that is designed to evaluate Chemical Disinfectant and Antiseptic- Hygenic Handrub testing, and applies to products that are intended for medical disinfection.
At Vivo Clinical Testing, we also offer preoperative, catherization, and preinjection skin preparation testing with the use of ASTM E1173 test method, which consists of testing the efficacy of these products using the natural microflora on the skin from areas such as the inguinal crease, abdomen, subclavian region, or median cubital region. The ASTM E1115 evaluates the reduction in the natural microflora on the hands using a surgical scrub treatment.