Pierre,

Various engineers within a test house evaluate products differently due to
their own interpretations. The 60601 series of standards have not been
designed  to accomodate the high voltages occuring within switching power
supplies. The standards are currently being worked on to incorporate similar
requirements as for the IEC 60 950 requirements - here  working voltages are
based not on only on mains voltage but working voltages anywhere within the
equipment.

Best is to take the previously approved power supply and show it to the test
house. Tell them that you wish to have the same service.
However, I also recommend that you obtain the working papers from your local
IEC Committee for Medical Equipment and try to design the power supply to
meet the future requirements.

Regards,



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PETER S. MERGUERIAN
Technical Director
I.T.L. (Product Testing) Ltd.
26 Hacharoshet St., POB 211
Or Yehuda 60251, Israel
Tel: + 972-(0)3-5339022  Fax: + 972-(0)3-5339019
Mobile: + 972-(0)54-838175
http://www.itl.co.il
http://www.i-spec.com





-----Original Message-----
From: Pierre SELVA [mailto:[email protected]]
Sent: Monday, July 29, 2002 7:20 PM
To: Forum Safety-emc
Subject: IEC 60601-1



Hello,

As all the safety standards, IEC 60601 defines the creepage and clearance
distances regarding the working voltage of the considered insulation.
In a switching power supply, designed for medical product, one of my
customer has designed the creepage and clearance distances to be compliant
with the rated voltage, which is 230 V.
When one of the most known test house has reviewed the product, engineer
said that the creep. and clear. were not good, due to the voltage between
primary and secondary which is, at some location, about 440 V rms. This
voltage implies 16 and 9 mm distances.
These distances are very hard to obtain in the PSU (size of a PSU for
Personal computer) and mainly the optoisolators are dimensionned to comply
with it.
So, my customer had a look on other PSU certified to IEC60601 by very known
test house, and he was surprised to see that the creep. and clear. were
designed to meet 230V requirements, and not 440Vrms (the PSU had such a
voltage inside).

How can we explain this situation, and is there a solution to have a
compliant PSU with insulation designed to meet 230v distance requirements.


Thanks to all,

Pierre


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  • IEC 60601-1 Pierre SELVA
    • RE: IEC 60601-1 Peter Merguerian

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