Does Cl 5.7 Humidity preconditioning have to be performed on all MEE?
Our CB Certified Ed2 Test Report called Cl. 5.7 as N/A, stating: ?Humidity conditioning was not required under Cl 4.10 of IEC60601-1, as no hydroscopic material was used which would cause a safety hazard.?. Several prior test said the same thing.
A recent external Test Lab review of our internal IEC60601-1 Ed3 delta Test Report disagreed:
"Seldom is it possible to eliminate humidity conditioning prior to leakage current and dielectric testing."
The relevant Ed3 Cl5.7 states:
"Prior to the tests of 8.7.4 and 8.8.3, all ME EQUIPMENT or its parts shall be subjected to a humidity preconditioning treatment."...but then gives an out clause: "This treatment is applied only to those ME EQUIPMENT parts which are influenced by the climatic conditions that are simulated by the test."
So can humidity testing in Cl 5.7 be omitted if there are no parts likely to be affected, as per the Clause and our CB Certificate?
Or has our CB certificate been in error for the past 12 years?
Our CB Certified Ed2 Test Report called Cl. 5.7 as N/A, stating: ?Humidity conditioning was not required under Cl 4.10 of IEC60601-1, as no hydroscopic material was used which would cause a safety hazard.?. Several prior test said the same thing.
A recent external Test Lab review of our internal IEC60601-1 Ed3 delta Test Report disagreed:
"Seldom is it possible to eliminate humidity conditioning prior to leakage current and dielectric testing."
The relevant Ed3 Cl5.7 states:
"Prior to the tests of 8.7.4 and 8.8.3, all ME EQUIPMENT or its parts shall be subjected to a humidity preconditioning treatment."...but then gives an out clause: "This treatment is applied only to those ME EQUIPMENT parts which are influenced by the climatic conditions that are simulated by the test."
So can humidity testing in Cl 5.7 be omitted if there are no parts likely to be affected, as per the Clause and our CB Certificate?
Or has our CB certificate been in error for the past 12 years?