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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