TNI Logo The NELAC Institute

Standard Interpretation



Standard: 2016
Section: V1M5, Section 1.7.3.1 (b)


REQUEST:

V1M5: 1.7.3.1.b.i 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?

TNI FINAL RESPONSE:

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