Paul,

Sure, sounds like good bedtime reading material (yuk yuk).
Fax:  937-435-7698

Steve U.

On Wed, 4 Aug 1999 09:25:35 +1000 Paul Klasek <[log in to unmask]>
writes:
>Concur with Steve S ;
>just may add that FDA classification is by the same coincidence class
>3 as
>well .
>
>Steve U :
>The process validations, documentations, tests and EACH component
>traceability is colossal job for those who are just entering this
>field ; it
>may strain your MRP; engineering, calibrations, R&D, and other
>departments
>to extreme .
>I remember the red tape drove me up the wall when I started to raise
>medical
>assembly after being a decade in IT .
>Whatever you do ; do not underquote = undercheck relevant
>requirements
>,records , regulatories , and legals ;
>as medical items are within FDA regulations .
>Bedtime reading recommended would be :
>FDA Subpart G : Production and Process Controls (my copy is 96)
>FDA Medical Device Design : Regulatory Requirements for Hazard
>Analysis and
>Risk Analysis
>FDA Guideline on General Principles of Process Validation
>
>and if you 'd like a copy of 98 draft of FDA GHTF Task Force Study
>Group 3:
>Process Validation Guidance ;
>Let me know the fax No, I send it over .
>
>Beats Halloween stories and MIL specs by a mile (just the cyclical
>checks on
>maintenance documentation will make you think thrice about the quote
>)
>
>As you don't assemble end item some of it may only partially or
>indirectly
>apply .
>
>See you
>
>Paul Klasek
>http://www.resmed.com
>
>-----Original Message-----
>From: Sauer, Steven T. [mailto:[log in to unmask]]
>Sent: Wednesday, 4 August 1999 0:34
>To: [log in to unmask]
>Subject: Re: [TN] class 3 medical
>
>
>Hi Steve,
>I believe according to UL, a class 3 medical device is a life support
>or
>life sustaining piece of equipment.  Two examples would be a pacemaker
>and
>an incubator.  As such the requirements of J-STD-001 or IPC-A-610
>would
>dictate class 3 requirements for the circuit card assembly and the
>substrate
>to be designed IAW class 3 requirements of 2222 and fabricated IAW
>class 3
>requirements of 6012.  Please note that it is coincidence that all
>requirements are class 3 between IPC and UL.
>
>Steve Sauer
>Manufacturing Engineer
>Xetron Corporation
>
>Reference:
>One of our Sales persons has a customer inquiring if we can build a
>"class 3 medical" type board.  Is this just a class 3 type board used
>in
>medical equipment, or is there a special category of boards out there
>classified as "medical?"
>
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