Pre-injection swab test

Method for Evaluation of Preinjection Skin Preparations


Regulatory reference: According to ASTM ASTM E1173 – 15.
Claim: Effectiveness of alcohol swabs
Application field: Finished products.
Description of the test: The test method is designed to measure the reduction of the microflora of the skin for Preinjection Skin Preparations. This test method is conducted on human subjects selected randomly from a group of subjects who, after refraining voluntarily from using topical and oral antimicrobials for at least two weeks (14 days), exhibit acceptably high normal flora counts on the skin sites to be used in testing.
Posted in Effectiveness of alcohol swabs, Claim for OTC, Claim for medical devices