Disinfectants for Use on Hard Surfaces
DIS/TSS-1 Jan 22, 1982
EFFICACY DATA REQUIREMENTS
Disinfectants for Use on Hard Surfaces
(a) 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.
(1) 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.)
(2) 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.
(b) 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.
(l) 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.)
(2) Performance requirements. Same as in (a)(2) above.
(c) 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.
(l) 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.)
(2) Performance requirements. Same as in (A)(2) above.
(d) 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.
(1) 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.)
(2) 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.
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