First, I need to disclose my bias. I am a member of the committee that wrote 60601-1-2 2001.
Cortland is correct in bringing up the issue of essential performance. Note that in the CDV (not law yet) of 1st amendment to 60601-1-2 we have changed essential performance from a defined term to an undefined term due to the instability of IEC 60601-1 , which is still at the CDV stage. My _personal_ opinion as a representative (and only that), is that: "Thou shall not fool the customer". The 1st Amendment states quite clearly that the manufacturer will list which functions are "essential functions" in the user documentation. Note that anything I've said is ONLY MY opinion!!!!! With respect, Brent DeWitt > -----Original Message----- > From: [email protected] > [mailto:[email protected]]On Behalf Of Cortland Richmond > Sent: Thursday, April 29, 2004 8:03 PM > To: ieee pstc list > Subject: Re: Medical devices and voltage dip testing > > > > Pat Lawler posted: > >> If a product is rated for 100-240Vac operation, this means test levels > like 40Vac for 100ms (100Vac/50Hz nominal input, 60% dip for 5 > cycles). The > performance criteria makes this especially difficult - "The system shall > provide essential performance". << > > Do not forget that, in large part, the *manufacturer* must say what > "essential performance" is. > > Cortland > Disclaimer: My opinions; NOT those of my agency or where I work. > > ------------------------------------------- > This message is from the IEEE EMC Society Product Safety > Technical Committee emc-pstc discussion list. > > Visit our web site at: http://www.ieee-pses.org/ > > To cancel your subscription, send mail to: > [email protected] > with the single line: > unsubscribe emc-pstc > > For help, send mail to the list administrators: > Ron Pickard: [email protected] > Dave Heald: [email protected] > > For policy questions, send mail to: > Richard Nute: [email protected] > Jim Bacher: [email protected] > > All emc-pstc postings are archived and searchable on the web at: > http://www.ieeecommunities.org/emc-pstc This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ieee-pses.org/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
