ASTM E1173-93
(Test Method)Standard Test Method of a Evaluation of a Preoperative, Precatheterization, or Preinjection Skin Preparations
Standard Test Method of a Evaluation of a Preoperative, Precatheterization, or Preinjection Skin Preparations
SCOPE
1.1 The test method is designed to measure the reduction of the resident microbial flora of the skin.
1.2 A knowledge of microbiological techniques is required for these procedures.
1.3 In this test method, metric units are used for all applications except for linear measure, in which case inches are used, and metric units follow in parentheses.
1.4 This standard does not purport to address all of the safety problems, 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.
1.5 Performance of this procedure requires a knowledge os regulations pertaining to the protection of human subjects (1).
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Designation: E 1173 – 93
Standard Test Method for
Evaluation of a Pre-Operative Skin Preparation
This standard is issued under the fixed designation E 1173; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope containing preparations that are intended to be fast-acting and
to significantly reduce the number of organisms on intact skin.
1.1 The test method is designed to determine the ability of
4.2 Performance of this procedure requires the knowledge
a pre-operative skin preparation to reduce the resident micro-
of regulations pertaining to the protection of human subjects.
bial flora on the skin when used in a skin pre-operative
preparation procedure.
5. Apparatus
1.2 In this test method, metric units are used for all
5.1 Colony Counter—Any of several types may be used, for
applications except for distance, in which case inches are used
example, Quebec colony counter.
and metric units follow in parentheses.
5.2 Incubator—Any incubator capable of maintaining a
NOTE 1—A knowledge of microbiological techniques is required for
temperature of 30 6 2°C may be used.
these procedures.
5.3 Sterilizer—Any suitable steam sterilizer capable of
1.3 This standard does not purport to address all of the
producing the conditions of sterilization.
safety problems, if any, associated with its use. It is the
5.4 Timer (stop-clock)—One that can be read for hours and
responsibility of the user of this standard to establish appro-
minutes.
priate safety and health practices and determine the applica-
5.5 Examining Table—Any elevated surface such asa3by
bility of regulatory limitations prior to use.
6-ft table with mattress or similar padding to allow the subject
to recline.
2. Referenced Documents
6. Reagents and Materials
2.1 ASTM Standards:
E 1054 Practices for Evaluating Inactivators of Antimicro-
6.1 Bacteriological Pipette—10.0 and 2.2-mL or 1.1-mL
bial Agents Used in Disinfectant, Sanitizer, Antiseptic, or
capacity.
Preserved Products
6.2 Water Dilution Bottles—Any sterilizable glass container
having a 150 to 200-mL capacity and tight closure may be
3. Summary of Test Method 5
used.
3.1 This test method is conducted on panelists selected from
6.3 Scrubbing Cups—Sterile glass cylinders, height ap-
a group of volunteers who, after refraining from using topical
proximately 2.5 cm, inside diameter of convenient size to place
and oral antimicrobials for at least two weeks, exhibit high skin
on anatomical area to be sampled. Useful sizes range from
flora counts on the abdomen and groin.
approximately 1.5 to 4.0 cm.
3.2 Activity of the pre-operative skin preparation is mea-
6.4 Rubber Policeman—Can be fashioned in the laboratory
sured by comparing microbial counts obtained at various time
or purchased from most laboratory supply houses.
intervals after application of the pre-operative treatment to skin
6.5 Test Formulation—With directions for use.
sites located on the abdomen and in the groin to counts
6.6 Sterile Drape or Dressing —Used to cover treated skin
obtained from the same sites prior to treatment application.
sites.
6.7 Sampling Solution—Dissolve 0.4 g KH PO , 10.1 g
2 4
NOTE 2—Microbial samples are collected a minimum of three times
Na HPO and 1.0 g isocytlphenoxypolyethoxyethanol in1L
after treatment application. The first two collections are made 10 min and
2 4
30 min post treatment, and the third collection is made no less than 4 h of distilled water. Include in this formulation an inactivator
post treatment but may be made later.
specific for the antimicrobial in the test formulation. Adjust to
4. Significance and Use
See Federal Register, Vol 46, No. 17, Jan. 27, 1981.
4.1 The procedure should be used to test antimicrobial-
Presterilized/disposable bacteriological pipettes are available from most labo-
ratory supply houses.
Milk dilution bottles of 160-mL capacity having a screw-cap closure are
This test method is under the jurisdiction of ASTM Committee E-35 on
Pesticides and is the direct responsibility of Subcommittee E35.15 on Antimicrobial available from Corning Glass Co., Kimble Glass Co. or most local laboratory supply
Agents. houses.
Current edition approved Feb. 15, 1993. Published April 1993. Originally A suitable covering is TELFA Non-Adherent Dressing, No. 3279, from the
published as E 1173 – 87. Last previous edition E 1173 – 87. Kendall Co.; Hospital Products; Boston, MA 02101.
2 7
Annual Book of ASTM Standards, Vol 11.05. Triton X-100, is available from Rohm and Haas Co., Philadelphia, PA.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
E 1173
pH 7.8. Dispense in 100-mL volumes and sterilize for 20 min
at 121°C.
6.8 Dilution Fluid—Butterfield’s phosphate buffered water
adjusted to pH 7.2 and containing an antimicrobial inactivator
specific for the test formulation. (See Practices E 1054.)
6.9 Plating Medium—Soybean-casein digest agar.
7. Test and Control Skin Sites
7.1 The skin sites selected for use in evaluating the effec-
tiveness of the pre-operative skin preparation should represent
body areas that are common surgical sites and should include
both dry and moist skin area. The sites should possess bacterial
populations large enough to allow demonstrations of bacterial
reduction of up to 2.0 log cm on dry skin sites and up to 3.0
log cm on moist sites. Baseline populations of at least 4.5
2 2
log /cm on wet skin sites and of at least 3.5 log /cm on dry
10 10
FIG. 1 Illustration of Approximate Location of Test Areas
skin sites are recommended. A suitable dry skin area is the
abdomen, and a suitable moist area is the axilla or groin.
in the designated skin sites the bacterial population required to
7.2 Abdominal treatment areas are to be located within a 5
demonstrate the log reduction specified in 7.1.
by 5-in. (12.7 by 12.7-cm) site located in the vicinity below the
8.2 Instruct the volunteers to avoid contact with antimicro-
umbilicus, one either to the right or left of the median. Using
bials (other than the test formulation) for the duration of the
a 5 by 5-in. (12.7 by 12.7-cm) sterile paper template, the
test. This restriction includes antimicrobial-containing antiper-
corners of each site are marked as 1, 2, 3, and 4 directly on the
spirants, deodorants, shampoos, lotions, bathing soaps and
skin, using a sterile surgical skin marker. Numbering is to be
body powders. Volunteers also are to refrain from wearing
the same for all abdominal sites; number 1 is placed at the top
clothes that have been treated with a fabric softener. Bathing in
corner to the subject’s right, and numbers 2, 3, and 4 are
biocide treated pools, hot tubs, spas, and so forth, should be
assigned in order clockwise from 1. Each quadrant of each site
avoided.
represents a different treatment exposure of either 10 min, 30
8.2.1 Provide volunteers with a kit of non-antimicrobial
min, or $4 h. The remaining fourth quadrant is used as a
personal care products for exclusive use during the test.
baseline count site.
Volunteers are not to shower or tub bathe in the 24-h period
7.3 Similarly, usinga2by 5-in. (5.1 by 12.7-cm) sterile
prior to the application of test material or microbial sampling.
template, 2 by 5-in. (5.1 by 12.7-cm) sites are delineated on the
Sponge baths may be taken, but the skin sites to be used in the
inner aspect of both upper thighs within 2 in. and parallel to the
study are to be excluded.
leg crease below the groin. The top corners of the sites are
8.2.2 If the skin sites to be used include areas that would
numbered beginning on the subjec
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