Standards of Antimicrobial and Anti-biofilm Assay

In the academic research, different labs and groups have their protocols for evaluating antimicrobial/antibiofilm properties of modified surfaces/materials and antimicrobial agents. In the industrial R&D, adopting international standards is more reliable and trusty. Below is the summary of main standards for antimicrobial/antibiofilm assay used in medical device industry:

• Antimicrobial Effectiveness Tests in United States Pharmacopeia (USP) Chapter 51.
• Zone of Inhibition, MIC, MBC:  refer to standards from the Clinical and Laboratory Standards Institute (CLSI).
• ISO 22196, Measurement of Antibacterial Activity on Plastics and Other non-Porous Surfaces. (based on JIS Z 2801)
• ISO 20743, Determination of Antibacterial Activity of Textile Products.
• ASTM E2149, Standard Test Method for Determining the Antimicrobial Activity of Antimicrobial Agents Under Dynamic Contact Conditions.
• ASTM E2180, Standard Test Method for Determining the Activity of Incorporated Antimicrobial Agent(s) in Polymeric or Hydrophobic Materials.
• ASTM E2315, Standard Guide for Assessment of Antimicrobial Activity Using a Time-Kill Procedure.
• ASTM E1054, Standard Test Methods for Evaluation of Inactivators of Antimicrobial Agents.
• ASTM E1326 Standard Guide for Evaluating Nonconventional Microbiological Tests Used for Enumerating Bacteri.
• JIS (Japan Industrial Standard) Z 2801, Antimicrobial products–Test for Antimicrobial Activity and Efficacy.
• EN 1276, Chemical Disinfectants Bactericidal Activity Testing.
• EN 1040, Basic Bactericidal Activity of Chemical Disinfectant. 
• ASTM E2647, Standard Test Method for Quantification of Pseudomonas aeruginosa Biofilm Grown Using Drip Flow Biofilm Reactor with Low Shear and Continuous Flow.
• ASTM E2196, Standard Test Method for Quantification of Pseudomonas aeruginosa Biofilm Grown with Medium Shear and Continuous Flow Using Rotating Disk Reactor.
• ASTM E2562, Standard Test Method for Quantification of Pseudomonas aeruginosa Biofilm Grown with High Shear and Continuous Flow using CDC Biofilm Reactor.
• Guidances and SOPs by the European Committee on Antimicrobial Susceptibility Testing (EUCAST).