Disinfectants for Use on Hard Surfaces

Limited efficacy claims. The label of a disinfectant which is effective against a specific major group of microorganisms only (e.g., Grampositive or Gram-negative) must specify the major group against which it is effective.

Test requirements. The AOAC Use-Dilution Method (for water soluble powders and liquid products) or the AOAC Germicidal Spray Products Test (for spray products) is required. Sixty carriers must be tested with each of 3 samples, representing 3 different batches, one of which is at least 60 days old, against Salmonella choleraesuis ATCC 10708 (for effectiveness against Gram-negative bacteria) or Staphylococcus aureus ATCC 6538 (for effectiveness against Gram-positive bacteria). (Sixty carriers per sample; a total of 180 carriers.)
Performance requirements. To support products represented in labeling as "disinfectants", killing on 59 out of each set of 60 carriers is required to provide effectiveness at the 95% confidence level.

General or broad-spectrum efficacy claims. Label claims of effectiveness as a "general disinfectant" or representations that the product is effective against a broad spectrum of microorganisms are acceptable if the product is effective against both Gram-positive and Gram-negative bacteria.

Test requirements. Use the AOAC Use-Dilution Method or the AOAC Germicidal Spray Product Test as in (a)(l). Sixty carriers must be tested against each of both S. choleraesuis and S. aureus with each of 3 samples, representing 3 different batches, one of which is at least 60 days old. (120 carriers per sample; a total of 360 carriers.)
Performance requirements. Same as in (a)(2) above.

Hospital or medical environment efficacy claims. Label claims for use of disinfectants in Hospital or medical environments are acceptable only for those products that are effective for general or broad-spectrum disinfection and additionally against the nosocomial bacterial pathogen Pseudomonas aeruginosa.

Test requirements. Employ the AOAC Use-Dilution Method or the AOAC Germicidal Spray Products Test as in (a)(l). Sixty carriers must be tested against each of S. choleraesuis, S. aureus, and Pseudomonas aeruginosa ATCC 15442 with each of 3 samples, representing, one of which is at least 60 days old. (180 carriers per sample; a total of 540 carriers.)
Performance requirements. Same as in (A)(2) above.

Other microorganisms. Substantiated label claims of effectiveness of a disinfectant against specific microorganisms other than the designated test microorganism(s) are permitted, but not required, provided that the target pest is likely to be present in or on the recommended use areas and surfaces and thus may present a potential problem.

Test requirements. Effectiveness of disinfectants against specific microorganisms other than those named in the AOAC Use Dilution Method, AOAC Germicidal Spray Products Test, AOAC Fungicidal Test, and AOAC Tuberculocidal Activity Method (II. Confirmative In-Vitro Test), but not including viruses, must be determined by either the AOAC Use-Dilution Method or the AOAC Germicidal Spray Products Test as in (a)(l). Ten carriers must be tested against each specific microorganism with each of 2 samples, representing 2 different batches. (10 carriers per sample, a total of 20 carriers.)
Performance requirements. Killing of the test microorganism on all carriers is required. Plate count data, on appropriate culture media, must be submitted on each test microorganism to disclose that a concentration of at least 104 microorganisms survive the carrier-drying step in order to provide meaningful results.