Cl 5.7 Humidity preconditioning required for all Medical Electrical Equipment?

michael Cejnar

Involved In Discussions
#1
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?
 
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Peter Selvey

Staff member
Super Moderator
#2
I worked for 3 different agencies and frequently used the rationale to skip the hygroscopic test, and there was never any internal problems with reviewer and certification bodies, including in the CB scheme.

But it is an individual judgement call based on experience. I came across certain cases where it the humidity test was important, for example, checking the seal in powder insulated heaters, quality of impregnated paper based insulation used in some older or larger types of transformer, and insulation unknown materials. Having that experience makes it clear that in other cases it's not really important, noting that most modern insulating materials have very low water absorption rates.

If the insulation system is made up of approved (recognized) components like like optocouplers, capacitors, PVC wiring, connectors, then it's also clear the humidity test can be skipped. Most NRTLs allow manufacturers to list "any" or "various" as long as the part is approved and fits the listed specifications. If the humidity test was really important, this practice could not be allowed.
 
N

NickM

#3
Also, check your particular standards. Some particulars for large fixed medical equipment like MR (-2-33), waive humidity preconditioning. There are a few reasons for this.

1) It is very impractical to try to find a humidity chamber for large ME equipment like an MR system

2) The equipment has tight environmental operating specifications

3) The equipment installation takes days-weeks which would evaporate any potential condensation build up due to transport/storage.

If there is nothing in your particular standards, you need to focus on the statement in -1, which states "This treatment is applied only to those ME EQUIPMENT parts which are influenced by the climatic conditions that are simulated by the test." Couple points regarding this statement:

a) You would need to provide sufficient objective evidence that your equipment is not influenced by test. The hydroscopic argument is valid but is challenging to prove out. You would basically need to list out the raw material of all the insulation in the product and then find water absorption specs on those materials.

b) You don't necessarily need to do conditioning on the entire device, only the "parts which are influenced". Isolation devices would be a good example that need to be considered. If the isolation is provided in a component (i.e., power supply) that has already been certified to 60601 or 60950, there is a possibility that the conditioning was already performed at that component level and you can just show that data.
 
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