Ron, In answer to your questions:
1) Let's assume that the component fully complies with IEC 60601-1. Unfortunately, the way tests labs will relate to this situation will depend on the lab's own internal procedures. The main concern is the level of control you have over the changes in the specification of the isolating device. Theoretically the component manufacturer could change the spec without changing the model number and without informing you. Practically, I believe that most test labs would accept this situation if there was a written commitment from the component manufacturer to inform you if there are any changes made. 2) If the isolating device is embedded in epoxy, then the test lab probably would not require the schematics of the device. If not, they would need the schematics in order to evaluate creepages and clearances. 3) Approval to another standard does not help, as the manufacturer of the component could make a change that would cause the component to no longer comply with IEC 60601-1, while still complying with its approval to the other standard. In short, you should liase with your chosen test lab on this issue. Regards, Jon Griver www.601help.com 601help - The Medical Device Developer's Guide to IEC 60601-1 On 1 May 2002 at 14:49, Ron wrote: > > > I need to use an isolating device between a sip/sop and an applied > part (BF) requiring 1500V isolation (Basic(250)). I plan on using a > digital isolator, but the component does not have IEC601 approval. > The component does have 2500V isolation and 8 mm creepage. > > Questions: > > 1) When our product is submitted for IEC601 certification, how does > the use of the non 601 approved part affect the investigation? > > 2) Does the investigator need the schematic for that component? What > if > the schematic is not available? > > 3) If the component already has other approvals (UL1950 or UL1577). > How > does this affect the approval process? > > Thanks in advance. > > [email protected] > > > ------------------------------------------- > This message is from the IEEE EMC Society Product Safety > Technical Committee emc-pstc discussion list. > > Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ > > 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://ieeepstc.mindcruiser.com/ > Click on "browse" and then "emc-pstc mailing list" > ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ 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://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list"
