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?" > >############################################################## >TechNet Mail List provided as a free service by IPC using LISTSERV >1.8c >############################################################## >To subscribe/unsubscribe, send a message to [log in to unmask] with >following >text in >the body: >To subscribe: SUBSCRIBE TECHNET <your full name> >To unsubscribe: SIGNOFF TECHNET >############################################################## >Please visit IPC web site (http://www.ipc.org/html/forum.htm) for >additional >information. >If you need assistance - contact Gayatri Sardeshpande at >[log in to unmask] or >847-509-9700 ext.5365 >############################################################## > >############################################################## >TechNet Mail List provided as a free service by IPC using LISTSERV >1.8c >############################################################## >To subscribe/unsubscribe, send a message to [log in to unmask] with >following text in >the body: >To subscribe: SUBSCRIBE TECHNET <your full name> >To unsubscribe: SIGNOFF TECHNET >############################################################## >Please visit IPC web site (http://www.ipc.org/html/forum.htm) for >additional >information. >If you need assistance - contact Gayatri Sardeshpande at >[log in to unmask] or >847-509-9700 ext.5365 >############################################################## ############################################################## TechNet Mail List provided as a free service by IPC using LISTSERV 1.8c ############################################################## To subscribe/unsubscribe, send a message to [log in to unmask] with following text in the body: To subscribe: SUBSCRIBE TECHNET <your full name> To unsubscribe: SIGNOFF TECHNET ############################################################## Please visit IPC web site (http://www.ipc.org/html/forum.htm) for additional information. If you need assistance - contact Gayatri Sardeshpande at [log in to unmask] or 847-509-9700 ext.5365 ##############################################################