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ASTM E2149 Test Method

What’s the Purpose of the ASTM E2149 Test?

The ASTM E2149 test method evaluates the antimicrobial efficacy of materials used under dynamic contact conditions. Sometimes referred to as a “shake flask test”, It measures the antimicrobial activity of antimicrobial surfaces as they’re shaken around within a microbe-contaminated solution. Specifically designed to simulate real-world scenarios where medical devices are continuously exposed to microorganisms, this standard assesses materials’ ability to dynamically resist microbial growth.

 

How Is the ASTM E2149 Standard Used?

ASTM E2149 was designed for immobilized, non-leaching, non-water-soluble antimicrobial products or surfaces — making it particularly important in healthcare applications where contamination is a concern. Here’s a brief overview of the ASTM E2149 test method:

 

  • Test microorganisms are grown in a liquid culture before being standardized.
  • These cultures are diluted in sterile buffer solution.
  • For every product being tested, a portion of the standardized culture is put within one of three sterile containers — one that’s only bacterial suspension, one that has the microbial test substance and a last one containing an untreated control object.
  • Initial concentrations are recorded before all jars are shaken using a wrist action shaker for a predetermined amount of time.
  • Microbial concentrations in all the jars are once again counted and compared.

 

How Do You Become ASTM E2149 Compliant?

The most direct path to ensuring ASTM 32149 compliance during your device development is to partner with an experienced contract research organization. A CRO gives you access to timely testing, regulatory expertise, quality assurance and comprehensive reports.

 

NAMSA can help with all your antimicrobial testing needs — including maintaining ASTM E2149 compliance from sample preparation to process documentation. Talk to a NAMSA representative to learn more.

Test Options/Variations

MG120-000
MG120-001 Time Points