EBME Forums Forums Maintenance Technical Assistance 62353:2008 - Medical electrical equipment.

Yeah,
I quite agree with you, most of us are more than likely using it without knowing it in effect. All I am saying is that it is just one of a range of tools that we can use, the chief one being common sense.

Hi,

Why would you want to sacrifice for a less stringent standard targetting in-service and post repair?
IEC 60601-1 has served us well all these years.

Regards

Now that IEC 601 has lost a lot of its teeth through changes, one of the biggest changes being constant references now being made to the manufacturers risk assessment.

Have any biomeds requested a copy from the manufacturer or are we now performing risk assessments on all new products brought into hospitals?

I thot risk assessment for medical equipment is quite straight forward except for equipment require site installation, site work like ceiling support structure, hacking of wall, and importantly infection control, etc.

Other than that the environment and safety part rely heavily on your ISO 14001 and OHSAS 18001.

Regards

I am still sticking to IEC 60601-1 and IEC60601-1-2.

I see, you are obviously re-manufacturing all the items you test? As IEC 60601 is a standard to bring a device to market. It is not designed for in service testing or use after repair!

In fact you are going against the MHRA document DB2006(5) which sates that an appropriate standard should be use but not IEC 60601. Since the IEC 62353 is now a British standard BS EN 62353.

What is the problem with 62353? Have you actually tried it or understood it?

One of the big points that most seem to miss or not realise the significance of is the need to compare the test results with previous results. This is not done in 60601 as all that matters is whether it passes or fails the limit values.
In 62353 you have to look at previous test values to see if there has been a significant change which would indicate a potential failure. In fact many manufactures set limits as to how much a value may change from the initial factory or acceptance test value. As an example a Siemens ultrasound unit is only allowed an increase in any leakage value of 1.5 times the initial value or 10uA whichever is the greater! This would never be picked up in an IEC 60601 test!

I understand there are those that don't like change and may see performing fewer tests (as required by 62353) as somehow unsafe but in fact if performed correctly they are in fact much safer that those of 60601 as they will pick up faults that 60601 would miss.

Open your eyes and your mind and embrace the new standard.

I particularly like the Alternative test method as, where it is suitable for use, it works really well and saves lots of time booting up and down PC based devices between tests. (That statement will open up a whole new debate!)

As I may have pointed out before, the writ of MHRA does not run to Singapore.

Maybe the MHRA have not extended their reach to Singapore yet but the I am sure IEC 62353 has?

Yes, no doubt as well as ANSI, AAMI and all the rest. Standards, like good ideas, are everywhere. You just take as many as you need!

But in the case of 62353 it is the only accepted standard for recurrent test and test after repair of medical electrical systems so saves on having to make a choice of standards.