ASTM E2361-13(R2021) pdf free download

ASTM E2361-13(R2021) pdf free download.Standard Guide for Testing Leave-On Products Using In-Situ Methods
1. Scope
1.1 This guide covers test methods and sampling procedure options for leave-on products for consumer and hospital personnel. Leave-on products, such as alcohol hand rubs and lotions containing antimicrobial ingredients, are increasingly marketed and used by consumers and health care personnel. These products are distinguished from conventional washing and scrubbing preparations in that they do not rely on the rinsing, physical removal, and antimicrobial action in deter- mining their effectiveness. Although agitation and friction may serve to release organisms from the skin and folds and crevices, organisms are then killed in situ and are not rinsed from the skin surface before sampling. Appropriate test methods for the hands have been published, while other sampling methods will be needed for testing body areas other than the hands. 1.1.1 Researchers have described techniques to identify the expanded flora we now know can be present on the skin. It is impractical, ifnot prohibitive to attempt to recover and identify these varieties oforganisms with each test. At some point in the design of a test, a decision is necessary for defining the target organisms. Should the sampling be designed to recover as much of the microflora as possible or a particular portion of it? Consideration oftransient and resident, superficial and deep, or aerobic and anaerobic flora must be included in defining the objective in testing products. The recovery methods selected for any testing must be based on the projected use of the product type being tested. 1.2 Methods of recovery after application of the contami- nating organisms to a part of the body other than by the agitation/rubbing of the hands against a glass petri plate also need examination. Consideration should be given to contact plating, controlled swabbing with a template, and cup scrub- bing (detergent/agitation used) since the target organisms for recovery are likely to be on the superficial layers of skin. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 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 appro- priate safety, health, and environmental practices and deter- mine the applicability ofregulatory limitations prior to use. 1.5 This international standard was developed in accor- dance with internationally recognized principles on standard- ization established in the Decision on Principles for the Development of International Standards, Guides and Recom- mendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
3. Summary of Guide
3.1 In this guide, choices of recovery techniques after the use of antimicrobial products will be considered. By the nature of the distribution of the skin flora, these sampling techniques estimate the flora remaining after antimicrobial use; some of it is superficial and some hidden. An appropriate sampling method can be selected depending on product use and the importance of superficial (transient) and hidden or deep (mostly resident) flora. Recent publications have revealed a greater variety of organisms that populate the skin and com- prise the skin microbiome (1, 2). 4 This information requires a larger selection of recovery media. For certain applications, such as acne studies or when recovery of the greatest diversity of organisms is desired, specific anaerobic/microaerophilic media should be used. 3.2 This guide was originally written because ASTM Sub- committee E35.15 worked on its own test method for leave-on products used without water, but found that the EN1500 protocol encompassed the test method that had been devel- oped. In 2010, a new standard test method specifically de- signed to evaluate the efficacy of leave-on product was approved under the designation Test Method E2755. This guide has now been updated to cover Test Method E2755. 3.3 ASTM has Test Method E1174 to test water-aided handwash products for health-care personnel. This test method includes both wash-off and leave-on products. It has been revised (E1174–13) to include special instructions for leave-on products to use another Test Method E2755(–11) that has been published for testing leave-on hand treatment products. 3.4 This CEN type of test methodology is widely used in European and Scandinavian countries but has not been widely used in the United States, although the use of alcohol/alcohol gel hand rubs has expanded greatly here in the last few years. The underlying question is whether a test method designed for a leave-on product like alcohol or the conventional hand washing followed by sampling in a glove or plastic bag is more appropriate.