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Standard Test Method for Determining the Residual Kill Activity of Hand Antiseptic Formulations
Přeložit název
NORMA vydána dne 15.11.2016
Označení normy: ASTM E3058-16
Datum vydání normy: 15.11.2016
Kód zboží: NS-670703
Počet stran: 6
Přibližná hmotnost: 18 g (0.04 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM
Keywords:
alcohol-based hand rub, alcohol foam, antimicrobial, antiseptic wipe, contaminant, efficacy, hand antiseptic, hand sanitizer, healthcare personnel handrub, healthcare personnel handwash, Staphylococcus aureus, residual kill, residual activity,, ICS Number Code 11.080.20 (Disinfectants and antiseptics)
Significance and Use | ||||||||||||||
5.1 Many marketed hand antiseptics make claims of "long-lasting protection” or “extended kill” (for example 6 hours), which are typically based on results of testing as described in Test Method E1882 or Guide E2752, or both. At this time there are no standard methods for evaluating a hand antiseptic formulation for its ability to kill microorganisms on hands when a “dry” contamination event occurs at some time after product use. This test method provides a method to substantiate residual kill claims for hand antiseptics. |
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1. Scope | ||||||||||||||
1.1 This test method is designed to determine the residual killing activity of skin antiseptics against transient microbial skin flora on the hands .2 It may be used to evaluate products that are used with the aid of water and rinsed off and those that are used without the aid of water and not rinsed off. 1.2 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (see 21 CFR Parts 50 and 56). 1.3 This test method should be performed by persons with training in microbiology, in facilities designed and equipped for work with potentially infectious agents at biosafety level 2. 1.4 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. For more specific precautionary statements see 8.1. |
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2. Referenced Documents | ||||||||||||||
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