ASTM E3383-24
(Test Method)Standard Test Method for Determining the Microbial Barrier Properties of Wound Dressing – in vitro Wound Model
Standard Test Method for Determining the Microbial Barrier Properties of Wound Dressing – in vitro Wound Model
SIGNIFICANCE AND USE
5.1 An ideal wound dressing absorbs wound exudates, reduces the bioburden within/on the dressing, and protects wounds from microbial penetration through the dressing. Microbial barrier effectiveness testing is performed to measure the ability of microorganisms to penetrate through a material under specific conditions.
5.2 The test may be used for solid wound dressings with or without the addition of antimicrobial agents where the manufacturer is claiming microbial barrier properties in their performance claim. Barriers can be physical (polyurethane) and/or chemical (antimicrobial barrier).
5.2.1 Five (5) commonly used solid wound dressings are (1) hydrogel, (2) hydrocolloid, (3) film, (4) foam, and (5) alginate. Liquid adhesives also protect the wound from being infected by microorganisms. Liquid adhesive dressings contain cyanoacrylate or polyacrylate, which polymerizes quickly to create a solid barrier and protect the wound from contamination.
5.3 This qualitative test method can be used to determine the microbial barrier properties of solid wound dressings including liquid adhesive.
5.3.1 The test represents an in vitro wound model by using a nutrient-rich medium to mimic the wound, the contact time will represent the maximum period of use for a single dressing application on the wound, and an incubation temperature of 37 °C ± 2 °C represents the human body temperature.
5.4 Results are documented as “Growth” or “No Growth.”
5.4.1 No growth underneath the dressing indicates the barrier properties of the wound dressing are effective at preventing microbial penetration through the dressing.
5.4.2 Growth underneath the dressing demonstrates that the challenge organism was able to penetrate the dressing and reach the media surface, indicating that microorganisms can reach the wound by penetrating through the dressing from the outside environment.
SCOPE
1.1 This test method is used to determine the microbial barrier properties of wound dressing. The test is designed to measure the ability of microorganisms to penetrate through a material (wound dressing) under specific conditions. This qualitative in vitro test will demonstrate results such as “Growth” or “No Growth” of the test organism on the agar surface after a specified contact time.
1.2 The test method includes an initial inoculum of 3.0 × 106 ± 2.0 × 106 CFU/mL and a contact time of 24 h to 72 h or per the wound dressing label claim. To show barrier properties, wound dressing should not allow the challenged organism to penetrate and reach the media surface.
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 Testing is to be performed by individuals trained in microbiological techniques under appropriately controlled conditions to ensure the integrity of results and personnel safety.
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
General Information
Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E3383 − 24
Standard Test Method for
Determining the Microbial Barrier Properties of Wound
1
Dressing – in vitro Wound Model
This standard is issued under the fixed designation E3383; 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 2. Referenced Documents
2
2.1 ASTM Standards:
1.1 This test method is used to determine the microbial
E2756 Terminology Relating to Antimicrobial and Antiviral
barrier properties of wound dressing. The test is designed to
Agents
measure the ability of microorganisms to penetrate through a
3
2.2 FDA Documents:
material (wound dressing) under specific conditions. This
FDA Executive Summary Classification of Wound Dressings
qualitative in vitro test will demonstrate results such as
Combined with Drugs - Prepared for the Meeting of the
“Growth” or “No Growth” of the test organism on the agar
General and Plastic Surgery Devices Advisory Panel
surface after a specified contact time.
September 20-21, 2016
1.2 The test method includes an initial inoculum of 3.0 ×
6 6
3. Terminology
10 6 2.0 × 10 CFU/mL and a contact time of 24 h to 72 h or
per the wound dressing label claim. To show barrier properties,
3.1 Definitions:
wound dressing should not allow the challenged organism to
3.1.1 For definitions of terms used in this test method, refer
penetrate and reach the media surface.
to Terminology E2756.
3.2 Definitions of Terms Specific to This Standard:
1.3 The values stated in SI units are to be regarded as
3.2.1 contact time, n—length of time, during which a wound
standard. No other units of measurement are included in this
dressing is applied to the skin in a clinical setting.
standard.
3.2.2 microbial barrier, n—a chemical or physical material
1.4 Testing is to be performed by individuals trained in
used to prevent microbes from reaching or colonizing wounds.
microbiological techniques under appropriately controlled con-
3.2.3 wound dressing, n—a sterile covering used to protect
ditions to ensure the integrity of results and personnel safety.
wounds.
1.5 This standard does not purport to address all of the
4. Summary of Test Method
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro- 4.1 The microbial barrier effectiveness procedure starts by
placing the wound dressing on the surface of an appropriate
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use. agar medium plate.
1.6 This international standard was developed in accor-
4.2 The dressing surface is then inoculated with a popula-
6 6
dance with internationally recognized principles on standard-
tion 3.0 × 10 6 2.0 × 10 CFU/mL of an appropriate challenge
ization established in the Decision on Principles for the
organism.
Development of International Standards, Guides and Recom-
4.3 Positive and negative controls are also included to
mendations issued by the World Trade Organization Technical
demonstrate the viability of the challenge organism (positive
Barriers to Trade (TBT) Committee.
control) and the aseptic processing (negative control).
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
This test method is under the jurisdiction of ASTM Committee E35 on contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct Standards volume information, refer to the standard’s Document Summary page on
responsibility of Subcommittee E35.15 on Antimicrobial Agents. the ASTM website.
3
Current edition approved April 1, 2024. Published April 2024. DOI: 10.1520/ Available from U.S. Food and Drug Administration (FDA), 10903 New
E3383-24. Hampshire Ave., Silver Spring, MD 20993, http://www.fda.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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E3383 − 24
4.4 Test and control plates are incubated upright at 37 °C 6 6.3 Cuvette, sterile, appropriate size that can fit into spec-
2 °C for 24 h to 72 h or any other time point listed on the label trophotometer cuvette chamber.
claim. After incubation, the wound dressing is carefully re-
6.4 Forceps, sterile.
moved and the agar media plate is re-incubated for 48 h or
6.5 Glass Wool.
other suitable time for the growth of the target microorganism.
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