ASTM E1174–13. Standard Test Method for Evaluation of the Effectiveness of Health Care Personnel Handwash Formulations.
Test accredited by ENAC (National Accreditation Entity)
This test uses contamination of the hands of fifteen adult subjects, for each combination of test substance to be analyzed. These subjects will refrain from using any product that contains antimicrobial agents for at least one week before the test. To do this, they will be provided with a personal grooming kit, without antimicrobial products, for exclusive use during the test. This standard provides the option of using some of the following test organisms: Escherichia coli or Serratia marcescens. In IVAMI, Escherichia coli will be used, unless the use of Serratia marcescens is specifically indicated.
The test product is evaluated after a single application and after up to eleven contaminations/consecutive applications in a single day, previously performing a hand wash to remove grease and dirtiness and familiarize the subjects with the technique of hand washing. Contamination with the test organism is done by placing an aliquot of the suspension on the entire surface of the hand and rubbing for 20 ± 5 seconds. This process is repeated three times to minimize the loss of the test organism during propagation. After the three contaminations followed with the organism, a basal recovery is carried out, that is, a reference sample is taken after the contamination process to determine the number of marker organisms that survive in the hands. The hands of the subjects are contaminated before taking the reference bacterial sample and before each wash with the test material. The washing process with the test product will be followed according to the manufacturer's instructions.
The effectiveness of the test material is measured by comparing the amount of bacteria recovered in contaminated hands exposed to the test product with respect to the number recovered from the contaminated hands exposed to the reference material, such significant reduction is evaluated with the Wilcoxon statistical method.
The customer must choose a contact time, a test concentration or manufacturer's instructions on how to add the product and the number of applications of the test substance that is to be incorporated in the test. The applicant for the test must record these requirements on the test form.