ASTM E1115-11(2017) pdf free. Standard Test Method for Evaluation of Surgical Hand Scrub Formulations.
ASTM E1115 is designed to measure the reduction of microbial flora on the skin. It is intended for determining both immediate and persistent (continuing antimicrobial effect) microbial reductions, after single or repetitive treatments, or both. It may also be used to measure cumulative antimicrobial activity after repetitive treatments.
4. Suniiiiart of Test Method
4.1 ASTM E1115 is conducted on individuals selected from a group ot subjecis who have refrained from using any antimicrobials for a least one week prior to initiation of the test.
4.2 The selected subjects perform a simulated surgical scrub under the supervision of an individual competent in aseptic technique. One hand of each subject is sampled immediately after the scrub (within 1 mm), and the other hand. 6 h after scrubbing. Only one hand of a subject is sampled at a specified time. Optionally, another sampling time, 3 h for example, can be added between the immediate and 6 h sampling times. If this is desired, the panel sue must he increased by 50 % to obtain hc same number of data points at each designated sampling interval. Also, a sampling time randomization must be generated such that one-third of the hands are sampled at each sampling interval with only one hand of a subject being sampled at a sampling lime interval.
8. Subjects
8.1 Recruit a sufficient number (see Xl.l) of’ healthy subjccis who have no clinical evidence of dermaloses. open wounds. or other skin disorders. Exclude any individual receiving antibiotic Lherapy and any individual sensitive to natural rubber or latex or to a component of the formulation(s) being tested.
8.2 Instruct the subjects to avoid contact with antimicrobial products (other than the lest formulation(s) as dispensed for each scrub) for the duration of the test and for at least one week prior to the test. This restriction includes antimicrobial— containing antiperspirants. deodorants, shampoos. lotions. dishwashing liquids and soaps. and also such materials as acids, bases, and solvents. Hathing in hiocide treated pools, hot tubs, or spas should he avoided. Subjects are provided with a kit of non-antimicrobial personal care pr(xlucts for exclusive use during the test and rubber gloves to be worn when contact with antimicrobials agents cannot be avoided.