EBME Forums Forums Maintenance Test Equipment IEC 62353

I get the impression that many who are performing medical electrical safety tests like to speed a long time doing these tests! If you use typical 60601 tests on a PC based ultrasound with ECG and say 5 probes with a typical boot up/down of 10 to 15 mins then you could easily spend a few hours performing the tests.

Using 62353 Alternative methods, assuming you had ensured the power switch is in the on position, it would take about 5 mins to do the tests and then just the time it takes to boot up and perform a function test (as required by 62353) and your done.

Many manufactures are now updating their service material to 62353 and often choose the Alternative method for speed and safety. I know Siemens have recently updated their Ultrasound product electrical safety service instructions to 62353 and have adopted the Alternative method.

My own suspicions are that the folk we have been hearing from don't get around to carrying out EST on ultrasound systems very often!

As an aside, I wonder why 62353 explictly includes the requirement that a functional test be carried out? Myself, I have always considered EST to be part of PM (and not the other way around).

An electrical safety test with no electricity involved what a perfect way to make sure everything passes and is "safe".

As to the matter of time....a good ES tester should be able to power the device on, then when it has booted you then start the tests in normal polarity. you then power it down, reverse polarity, boot the device and do the tests again. I was using a tester that did this well over 10years ago..... and what device takes 10minutes to boot? No modern stuff surely.
But yes there is plenty of old stuff around still.
But surely EST is about making sure the device is safe rather than cutting corners to tick the "I have done it" box in as short a time as possible.
Robert

Can we take it that you're not a great fan of 62353 then, Robert?

Well, if you read IEC 62353 you would know the Alternative method tests apply an AC voltage equal to the mains voltage to perform the test. So we do indeed have electricity involved!

Think of it as a souped up insulation test, except you never get the same reading (infinity) with the DUT either plugged into the test meter or not! You get a accurate representation of the true device leakage, which is directly related to the 60601-1 open neutral value.

Also not many test meters I know can switch from performing equipment leakage tests to applied parts leakage tests without interrupting the mains supply to the EUT.

Three years on ... does anyone have an up to date list of which testers are now available to carry out tests to 62353?

I'm thinking of portable types able to follow the Alternative Method.

Are any completely battery powered?

Wouldn't a Rigel/Seaward 288 do the job Geoff?

Indeed it would (does) ... but what about the others?

I think Fluke manufacture a few various devices Geoff, but it does state ' Tests Parts of IEC 62353 & 60601 '. We only use 288's though so I can't really comment on these

As far as I can see these are the currently available units:

Rigel (Seaward) 288+ (IEC 60601 & IEC 62353 Including Applied Parts)
Rigel (Seaward) 62353+ (IEC 60601 & IEC 62353 Including Applied Parts)
Rigel (Seaward) SafeTest 60 (IEC 60601 & IEC 62353)

Fluke ESA 609 (IEC 60601 & IEC 62353 but no Alternative method)
Fluke ESA 612 (IEC 60601 & IEC 62353 Including Applied Parts)
Fluke ESA 615 (IEC 60601 & IEC 62353 Including Applied Parts)
Fluke ESA 620 (IEC 60601 & IEC 62353 Including Applied Parts)

GOSSEN METRAWATT SECULIFE SR ( IEC 62353)
GOSSEN METRAWATT SECULIFE SB (IEC 60601 & IEC 62353 Including Applied Parts)
GOSSEN METRAWATT SECULIFE ST (IEC 60601 & IEC 62353 Including Applied Parts)

Bender UNIMET 300ST (IEC 62353)
Bender UNIMET 400ST (IEC 62353 Including Applied Parts)
Bender UNIMET 810ST (IEC 60601 & IEC 62353 Including Applied Parts)

BENNING ST 750 A (IEC 62353 Including Applied Parts - EU Plug only)

DATATREND Systems Inc vPad-Mini (IEC 60601 & IEC 62353 Including Applied Parts)
DATATREND Systems Inc vPad-Rugged 2 (IEC 60601 & IEC 62353 Including Applied Parts)
DATATREND Systems Inc vPad-ES 2 (IEC 60601 & IEC 62353 Including Applied Parts)

Clearly the Rigel (Seaward) and Fluke units are the most popular units.

I would never recommend purchasing any unit that could not perform the IEC 62353 Alternative Method, since this not only saves a lot of time but many manufactures now show this as the only method to use in their service documentation.

Anyone who is sceptical the Alternative test is not as safe or effective as the Direct or Differential methods should conduct a few tests of their own and compare values. In all cases you will see the Alternative will be about double the Direct or Differential method proving it is effective. Clearly at the end of all testing a functional test is required by IEC 62353 but this is always when the unit is not going to have any further tests or work performed on the device. I.e. confirming it is ready for return to the user.