JIS Z 2801: Antibacterial products – Test for antibacterial activity and efficacy (Amendment 1)

Purpose and Goals

• Evaluate and compare the antimicrobial activity of non-porous materials in laboratory-controlled testing. 

Testing

• This testing will be performed as a modification to the Japanese International Standards Association’s Test method Z 2801. 
• Sections (dimensions to be determined) of the test material will be disinfected with an ethanol solution, inoculated with a liquid bacterial suspension, and covered with a sterile film to ensure a contact area of approximately 40mm x 40mm (or equivalent). The inoculated sections will be incubated for the specified time-point in a humidified chamber. After incubation, the bacteria from each section will be recovered into a neutralizing solution and then dilution-plated on nutritive agar to provide quantifiable viable bacterial burden data for each section tested.
• Each test will include one of the microbial strains:
  • Staphylococcus aureus, a Gram-positive bacteria.
  • Escherichia coli, a Gram-negative bacteria.
  • Clostridioides difficile bacterial spores. 
• Testing will include 24 total data points per microbial strain:
  • 2 materials: 1 test materials and 1 provided/in-house negative control).
    • Note: Please provide at least 15,000 cm² of each material per time-point. 
  • 2 time-points: 0 and 24 hours.
  • 3 replicates sections of each test material at each test condition
  • 2 independent tests
• Note: Optional GLP services are available for an additional 25% fee.

Data Analysis

• In-house control results will be used to verify test validity. 
• Data will be calculated to determine the quantifiable microbial burden in colony-forming units per gram of textile material (CFU/g) remaining on each sample.
• Data will be analyzed to determine the consistency between replicate samples in each set (n=6).
• Data will be analyzed to determine the percent reductions and log reductions of microbial burdens on the/each test material compared to the negative control at each test condition. 

Typical Turn Around Time

• (per strain) 2-3 weeks following receipt of the test materials