ASTM E2361-13

Standard Guide for Testing Leave-On Products Using In-Situ Methods

SIGNIFICANCE AND USE
4.1 The United States has concentrated attention and testing efforts on surgical scrubbing far more than on hand care in patient-to-patient routines. Great Britain, the originators of infection control nursing, have always had their focus on infection transmission. In the United States, published articles have documented the short exposure time for health care personnel who do wash their hands between patients. The average is less than 10 s. The ideal product for the reduction of transient flora is one that rapidly kills or removes or both the microbial load acquired during health care activities. The emphasis on rapidity is essential simply because health care personnel will not take the necessary time when using conventional hand-washing products. The use of products not intended for use with water has increased dramatically and their use is common in European countries largely because of convenience and effectiveness. A second characteristic is the level of antimicrobial action. The use of a rapid and potent active product to reduce work-acquired microbial flora is ideal.  
4.2 Since the change from strictly in-vitro testing of topical antimicrobials for use on skin to simulated use testing in hand washing, prepping, site access testing, and sampling, emphasis has always been on washing hands, agitating, rubbing, and brushing with liquid on the skin site to estimate bacteria removed after testing.  
4.3 The use of hard agitation has diminished with surgical scrubs without brushes or with only mild agitation and friction.  
4.4 There is a history of microbial dispersal (9) and increase in surface bacteria from deeper layers resulting from showering (10-12), washing, scrubbing, and agitation. In the normal situation on the skin, there is a superficial, surface flora and a deeper or hidden flora  (5). The proportion of one to the other has been addressed by Selwyn (4) and his judgment is that from 20 to 50 % of the flora is “deep.” The intent in skin sampling has...
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 determining 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, if not prohibitive to attempt to recover and identify these varieties of organisms 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 of transient 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 contaminating 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 scrubbing (detergent/agitation used) since the target organisms for recovery are likely to be on th...

General Information

• Status: Historical
• Publication Date: 31-Mar-2013
• ICS: 11.140 - Hospital equipment
• Technical Committee: E35 - Pesticides, Antimicrobials, and Alternative Control Agents
• Drafting Committee: E35.15 - Antimicrobial Agents

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E2361 − 13
Standard Guide for
1
Testing Leave-On Products Using In-Situ Methods
This standard is issued under the fixed designation E2361; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.4 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.1 This guide covers test methods and sampling procedure
responsibility of the user of this standard to establish appro-
options for leave-on products for consumer and hospital
priate safety and health practices and determine the applica-
personnel. Leave-on products, such as alcohol hand rubs and
bility of regulatory requirements prior to use.
lotions containing antimicrobial ingredients, are increasingly
marketed and used by consumers and health care personnel.
2. Referenced Documents
These products are distinguished from conventional washing
2
and scrubbing preparations in that they do not rely on the 2.1 ASTM Standards:
E1174 Test Method for Evaluation of the Effectiveness of
rinsing, physical removal, and antimicrobial action in deter-
Health Care Personnel Handwash Formulations
mining their effectiveness.Although agitation and friction may
E1327 Test Method for Evaluation of Antimicrobial Hand-
servetoreleaseorganismsfromtheskinandfoldsandcrevices,
wash Formulations by Utilizing Fingernail Regions
organisms are then killed in situ and are not rinsed from the
E2755 Test Method for Determining the Bacteria-
skin surface before sampling.Appropriate test methods for the
Eliminating Effectiveness of Hand Sanitizer Formulations
hands have been published, while other sampling methods will
Using Hands of Adults
be needed for testing body areas other than the hands.
3
1.1.1 Researchers have described techniques to identify the
2.2 European Standard:
expanded flora we now know can be present on the skin. It is
EN1500 Chemical Disinfectants and Antiseptics-Hygienic
impractical,ifnotprohibitivetoattempttorecoverandidentify
Handrub-Test Method Requirements (phase 2/step 2)
thesevarietiesoforganismswitheachtest.Atsomepointinthe
approved by CEN (Comité Européen de Normalisation)
design of a test, a decision is necessary for defining the target
organisms. Should the sampling be designed to recover as
3. Summary of Guide
much of the microflora as possible or a particular portion of it?
3.1 In this guide, choices of recovery techniques after the
Considerationoftransientandresident,superficialanddeep,or
use of antimicrobial products will be considered. By the nature
aerobic and anaerobic flora must be included in defining the
of the distribution of the skin flora, these sampling techniques
objective in testing products. The recovery methods selected
estimate the flora remaining after antimicrobial use; some of it
for any testing must be based on the projected use of the
is superficial and some hidden. An appropriate sampling
product type being tested.
method can be selected depending on product use and the
1.2 Methods of recovery after application of the contami-
importance of superficial (transient) and hidden or deep
nating organisms to a part of the body other than by the
(mostly resident) flora. Recent publications have revealed a
agitation/rubbing of the hands against a glass petri plate also
greater variety of organisms that populate the skin and com-
4
need examination. Consideration should be given to contact
prise the skin microbiome (1, 2). This information requires a
plating, controlled swabbing with a template, and cup scrub-
larger selection of recovery media. For certain applications,
bing (detergent/agitation used) since the target organisms for
such as acne studies or when recovery of the greatest diversity
recovery are likely to be on the superficial layers of skin.
of organisms is desired, specific anaerobic/microaerophilic
media should be used.
1.3 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
standard.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
1
This guide is under the jurisdiction of ASTM Committee E35 on Pesticides, Standards volume information, refer to the standard’s Document Summary page on
Antimicrobials, and Alternative Control Agents and is the direct responsibility of the ASTM website.
3
Subcommittee E35.15 on Antimicrobial Agents. Available from British Standards Institute (BSI), 389 Chiswick High Rd.,
Current edition approved April 1, 2013. Published June 2013. Originally London W4 4AL, U.K.
4
approved
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: E2361 − 04 (Reapproved 2007) E2361 − 13
Standard Guide for
1
Testing Leave-On Products Using In-Situ Methods
This standard is issued under the fixed designation E2361; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
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 determining 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, if not prohibitive to attempt to recover and identify these varieties of organisms 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 of transient 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 contaminating 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 scrubbing (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 the 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 appropriate safety and health practices and determine the applicability of regulatory
requirements prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
E1174 Test Method for Evaluation of the Effectiveness of Health Care Personnel Handwash Formulations
E1327 Test Method for Evaluation of Antimicrobial Handwash Formulations by Utilizing Fingernail Regions
E2755 Test Method for Determining the Bacteria-Eliminating Effectiveness of Hand Sanitizer Formulations Using Hands of
Adults
3
2.2 European Standard:
EN1500 Chemical Disinfectants and Antiseptics-Hygienic Handrub-Test Method Requirements (phase 2/step 2) approved by
CEN (Comité Européen de Normalisation)
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
1
This guide is under the jurisdiction of ASTM Committee E35 on Pesticides, Antimicrobials, and Alternative Control Agents and is the direct responsibility of
Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved Nov. 1, 2007April 1, 2013. Published November 2007June 2013. Originally approved in 2004. Last previous edition approved in 20042007 as
E2361 – 04.E2361 – 04 (2007). DOI: 10.1520/E2361-04R07.10.1520/E2361-13.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from British Standards Institute (BSI), 389 Chiswick High Rd., London W4 4AL, U.K.
Copyright © ASTM International, 100 Barr Harbor Drive,
...