IEC 60601-1 Humidity Precondition Test

subbash

Involved In Discussions
#1
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
 
Elsmar Forum Sponsor
#2
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).
 

subbash

Involved In Discussions
#4
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

Involved In Discussions
#5
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.
 
Thread starter Similar threads Forum Replies Date
E Humidity Pre-Conditioning IEC 60601-1 (2005) IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
JoCam IEC 60601-1 and 60601-1-2 retest after PCBA change IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
K IEC 60601-1:2005/AMD2:2020, Why this standard version is 3.0? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C IEC 60601 - 8.8.3 Dielectric Strength test. 4kv being applied to the ground conductor?! IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R IEC 60601-1 Clause 15.3.2, Push test IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
A Defining a lower ESD test level in IEC 60601 safety test IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
J IEC 60601-1-11 Home Class II With Ballasts IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Coverage and differences: EN 60601-1:2006+A12:2014 Vs AAMI/IEC 60601-1:2005+AMD1:2012 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T IEC 60601-1-8:2020 Is it necessary to change the alarm melody? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Is it normal / sufficient to have only the IEC 60601-1-2 test report without indicating IEC 60601-1? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S IEC 60601-2-30 - Is it mandatory to claim alarms? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Y Auditory alarm standard IEC 60601-1-8 Reliability Analysis - Predictions, Testing and Standards 0
R IEC 60601-1 - Power Supply Cords (Section 8.11.3.1) IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Outsourcing IEC 60601-1 Ed 3.2 Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
R Complex IEC 60601-1 gap assessment IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D SINGLE FAULT CONDITION, short circuit and open circuit of any component (IEC 60601-1 3.1) IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
H IEC 60601-1 ME equipment or ME system IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R IEC 60601-1 - 11.1.3 e) Test criteria - Temperature Measurements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R IEC 60601-1 - Magnesium oxide used for the electrical insulation of heating elements IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Z IEC 60601-2-25; Frequency response test Medical Device and FDA Regulations and Standards News 1
N IEC 60601-1-1 - Stress test, reference voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
B IEC 60601 - Creepage Distance - Relay that acts as a means of physical mechanical protection Process Maps, Process Mapping and Turtle Diagrams 0
T Single Fault Condition IEC 60601 Clause 8.7.1 shorting Cr/Cl in Patient Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
M What to Expect from Next IEC 60601-1 and IEC 60601-1-2 Amendments? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
D IEC 60601-1 - Service life testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
R Hand transmitted vibration 9.6.3 of IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
A IEC 60601 11.2.2.1 Risk of Fire in an Oxygen Rich Environment, Source of Ignition IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
E PEMS Hazards - IEC 60601 Clause 14.6 - Internal data use - Pressure sensor IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
W IEC 60601 - Essential performance c.2.34 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B IEC 60601-2-43 - Clause 203.6.103 - Physical button? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M IEC 60601-1 1988 - Device developed in 2012 with standard of 1988 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A IEC 60601-1 Dielectric Strength test for battery operated devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E IEC 60601-1 - Unearthed Medical Device Metal Parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
JoCam Failure to test Class I medical device to IEC 60601-1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R IEC 60601-1 - Different methods of achievement of the isolation IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K What is mean by Oxygen Rich Environment as per the IEC 60601-1 clause no 11.2.2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
K Dielectric strength test as per IEC 60601-1 -Infant incubator IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Unused SIP/SOPs - IEC 60601-1 and IEC 60601-1-2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K Proper document of SMPS used in infant warmer for IEC 60601-1 testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K Sequence of testing in IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B IEC 60601-2-10 - Accuracy of Pulse Parameters - Required Measurement Uncertainty IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B Has anyone done an IEC 60601-1 gap analysis to IEC 60335? Medical Device and FDA Regulations and Standards News 4
K Question on whether IEC 60601-2-62 standard is applied IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
DitchDigger IEC 60601-1 subclause 5.1 - Adequate evaluation in lieu of testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B IEC 60601 Cl. 8.4.3 - ME EQUIPMENT intended to be connected to a power source by a plug / Plug discharge IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B Transformer Requirements - IEC 60601-1 vs. IEC 61558-2-15 IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
T Clearance and Creepage according to Subclause 8.9.1 for MOPP IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4

Similar threads

Top Bottom