IEC 60601-1 Humidity Precondition Test

[subbash]

Dear all,

We are working on diagnostic ecg device with a plastic enclosure.

The Humidity test mentioned in IEC 60601-1 , is it a Condensing humidity test or non condensing humidity test.

And I had read in previous posts that we need to take the readings once during the device is placed at ambient temperature and later after the test is completed.

Are we supposed to perform dielectric strength test and leakage current test immediately after the Humidity test is completed.....?

And can we take a waiver from performing this test, stating non hygroscopic materials....?

Thanks

 

[Pads38]

First, the test is non-condensing. That is why the device is brought up to temperature for 4 hours before being placed in the chamber.

Dielectric and leakage tests should be done as soon as possible after the treatment. Where possible, especially for dielectric, the test would be performed whilst your device is still in the humidity chamber (with the door open!).

The third paragraph of clause 5.7 (...is applied only to...parts ...influenced... by the test.) would seem to give you an 'opt out' and, until a few years ago, this is what I did. (TRF marked 'N/A No parts affected, no mineral insulation, all parts non-hygroscopic) but the body that now scrutinises our test reports no longer accepts this.

The good point is that the necessary environmental test chambers are relatively common, and those institutions that have them will normally allow use of the chamber by third parties. (For a fee!). You would still need to arrange the dielectric and leakage tests (at their premises).

 

[VinceTech]

don't forget the environment condition for transportation and storage.

 

[subbash]

First, the test is non-condensing. That is why the device is brought up to temperature for 4 hours before being placed in the chamber.

Dielectric and leakage tests should be done as soon as possible after the treatment. Where possible, especially for dielectric, the test would be performed whilst your device is still in the humidity chamber (with the door open!).

The third paragraph of clause 5.7 (...is applied only to...parts ...influenced... by the test.) would seem to give you an 'opt out' and, until a few years ago, this is what I did. (TRF marked 'N/A No parts affected, no mineral insulation, all parts non-hygroscopic) but the body that now scrutinises our test reports no longer accepts this.

The good point is that the necessary environmental test chambers are relatively common, and those institutions that have them will normally allow use of the chamber by third parties. (For a fee!). You would still need to arrange the dielectric and leakage tests (at their premises).

Dear @Pads38 ,

Thanks for the information.

 

[Kuldeep Singh]

Further More, I have a question regarding leakage current testing of ME Equipment. At present we have leakage current tester for single phase machine. Is there method to test the three phase ME Equipment with same tester.

If ans is no, Please suggest any manufacture for providing the leakage current tester for same.