On a related issue, do Conditions of Acceptability (CoA) always have to be retested for the finished product when replacing a critical part by an equivalent UL recognized part with same CoA?
We are replacing an external PSU in a medical product with an equivalent medical one with same CoA, but NRTL lab wants $3500 to retest CoA for "Minimum: Input test, temperature test, dielectric test and leakage test. More tests depend on the condition of the acceptability of the power supply".
We have isolation transformer, internal battery UPS and 5kV optos which barely require a MOOP form the PSU. Our delta risk analysis thus fails to reveal any way the replacement PSU could produce a different test result for the CoA.
Given the risk analysis mania of IEC60601-1 3rd, is there a place for a risk analysis to reduce the retesting burden?
We are replacing an external PSU in a medical product with an equivalent medical one with same CoA, but NRTL lab wants $3500 to retest CoA for "Minimum: Input test, temperature test, dielectric test and leakage test. More tests depend on the condition of the acceptability of the power supply".
We have isolation transformer, internal battery UPS and 5kV optos which barely require a MOOP form the PSU. Our delta risk analysis thus fails to reveal any way the replacement PSU could produce a different test result for the CoA.
Given the risk analysis mania of IEC60601-1 3rd, is there a place for a risk analysis to reduce the retesting burden?