[mailto:jo...@medson.com]
Sent: Tuesday, May 22, 2001 9:06 AM
To: Dick Grobner
Cc: emc-p...@majordomo.ieee.org
Subject: RE: Production Line Test Requirements - Medical Devices
Dick,
This is the situation as I understand it. Please note that a few years ago I
did factory inspections for TUV
Ltd
-Original Message-
From: Dick Grobner [mailto:dick.grob...@medgraph.com]
Sent: Monday, May 21, 2001 18:23
To: 'Jon Griver'
Cc: IEEE EMC-PSTC E-Mail Forum (E-mail)
Subject: RE: Production Line Test Requirements - Medical Devices
Jon
Thx for the info, however, I re-checked
200105212113.oaa14...@epgc196.sdd.hp.com, Rich Nute ri...@sdd.hp.com
inimitably wrote:
Yes, for one strand. No, for five strands.
I agree with what you say. In Europe, the PEC within equipment may be
16/0.2, so the possibility of the connection being reduced to one or two
strands is, in one
Hi John:
Because continuity at low current does not ensure that the protective
circuit will carry a large fault current - it might be 'hanging on by
one strand'.
Yes, for one strand. No, for five strands.
Some years ago, I did some experiments on what
problems the 25-amp test
36BDBCA75E0FD411A80100104B93ABF202C2C079@MGCMAIL, Dick Grobner
dick.grob...@medgraph.com inimitably wrote:
Why
wouldn't a simple continuity tests as defined by UL be appropriate from
equipment coming off of the production line (assuring that the protective
earth circuit in intake)?
Because
Hi Dick,
The requirement for using 10 to 25 Amps comes from the test house. It is
their mark. If you want to use it, they can require you to do anything they
want. Is it fair, no. Does the requirement make engineering sense, no (I
believe that Rich Nute did an article on how this requirement
)?
Appreciate your feedback Jon! thanks again.
Does anyone else on this forum have any input - would appreciate it.
-Original Message-
From: Jon Griver [mailto:jo...@medson.com]
Sent: Monday, May 21, 2001 9:16 AM
To: Dick Grobner
Subject: RE: Production Line Test Requirements - Medical Devices
Dick,
To the best of my knowledge there is no EN standard or guidance on
production tests for medical equipment (There is a standard, EN 50116, for
IT equipment).
Your best bet is to discuss this with your Notified Body and to come to a
mutually acceptable set of tests.
Regards,
Jon Griver
Good Day Everyone
Question I have - Does anyone out there know if an EN standard or guidance
document exists that deals with production line test requirements of
finished medical devices.
Reading in EN60601-1 it states that the test (ground resistance, high
potential, etc.) are type test only
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