(a) Identification. The spore test strip consists of a carrier or strip with a known number of spores, at least 5 log10 per strip, of known resistance to a particular liquid chemical sterilant in a liquid chemical sterilant processing system. A “no growth” result from the spore test strip after the specified predetermined incubation period indicates that the liquid chemical sterilization process achieved the conditions necessary to kill the specified minimum number of viable spores on the test strip which is 5 log10 spores/strip; it does not confirm the expected full performance of the liquid chemical sterilant processing cycle because full performance is a 6 log10 spore kill in a full liquid chemical sterilization cycle.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Spore strip characterization. (i) Population of viable spores on strip shall be a minimum of 5 log10 after physical wash off of spores from the strip by exposure to liquid chemical sterilant in the liquid chemical sterilant processing system, which should be validated over the claimed shelf life.

(ii) The resistance characteristics of the viable spores on the strip should be defined and be validated over the claimed shelf life.

(iii) The spore strip description should address the carrier material, how the spores are placed on the carrier, and whether there is any feature that minimizes spore wash off. Bacteriostasis of the spore strip materials should be evaluated.

(iv) Incubation time for viable spores on the strip should be validated under the specified incubation conditions over the claimed shelf life.

(2) Simulated Use Testing. Simulated use testing should demonstrate performance of spore test strip in liquid chemical sterilant/high level disinfectant under worst case in use conditions over the claimed shelf life.

(3) Labeling. Labeling should specify appropriate instructions, warnings, cautions, limitations, and information relating to viable spore population, resistance characteristics, and interpretation of a “no growth” result.

[87 FR 8194, Feb. 14, 2022]