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Table I.8.1:<br />

Basic experimental design of current methods to test the efficacy of hand <strong>hygiene</strong><br />

and surgical hand preparation formulations (Cont.)<br />

Method no. Test organism(s) Basic procedure<br />

ASTM E-2276<br />

(fingerpad<br />

method for<br />

bacteria)<br />

ASTM E-2011<br />

(whole hand<br />

method for<br />

viruses)<br />

prEN 12791<br />

(surgical hand<br />

preparation):<br />

ASTM E-1115<br />

(test method<br />

for evaluation<br />

of surgical<br />

hand scrub<br />

formulations)<br />

Escherichia coli,<br />

Serratia marcescens,<br />

Staphylococcus aureus<br />

and Staphylococcus<br />

epidermidis<br />

Rotavirus and<br />

rhinovirus<br />

Resident skin flora<br />

(no artificial<br />

contamination)<br />

Resident skin flora<br />

(no artificial<br />

contamination)<br />

Similar to ASTM E-1838.<br />

This method is designed to confirm the<br />

findings of the fingerpad method (E-1838),<br />

if necessary. Both hands are contaminated<br />

with the test virus and test formulation is<br />

used to wash or rub on them. The entire<br />

surface of both hands eluted and the eluates<br />

assayed for infectious virus.<br />

Same as for EN 1500 with the following<br />

exceptions: no artificial contamination,<br />

reference hand antisepsis 3 min rub with<br />

n-propanol 60% V/V, longest allowed treatment<br />

with product 5 min, 1 week between<br />

tests with reference and product. Test for<br />

persistence (3 h) with split hands model is<br />

optional (product shall be significantly superior<br />

to reference).<br />

The method is designed to assess immediate<br />

or persistent activity against the resident<br />

flora. Volunteers perform simulated surgical<br />

scrub and hands sampled by kneading<br />

them in loose-fitting gloves with an eluent.<br />

The eluates are assayed for viable bacteria.

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