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Standard Interpretation

SIR #: 406
Standard: 2016
Section: V1M5, Section (b)


V1M5: states, "All media shall be tested for performance (e.g., for selectivity, sensitivity, sterility, growth promotion, and growth inhibition). These tests shall be performed at a minimum with first use."

Is the intention to require that the 'minimum' testing MUST be performed during/with first use, or is 'before first use' acceptable?


Performance testing is required to be performed before the first use, or with the first use. The laboratory may determine the approach they prefer.