Hi, A couple of comments on the pacemaker standards.
1. Under the AMID, you must involve a Notified Body. The only reasonable route to the CE marking is Annex 2 (full QA) and submittal of the Design Dossier. 2. All accessories to a AIMD (i.e. programmers) are also under the scope of the AIMD. 3. Its been a while since I looked, but I think the correct standard is EN 45502-1. There are a number of part 2's. I am not sure if they have been released. 4. Standards are not that important. Because you have to use a NB for Annex 2 and submittal of the Design Dossier. The NB will tell you what they want to see. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail [email protected] -----Original Message----- From: [email protected] [mailto:[email protected]] Sent: Monday, March 20, 2000 12:46 PM To: EMC-PSTC Subject: Re: EN standard for pacemaker immunity As an excerise, I tried to find the directive that this standard was harmonized under. I looked on the Europa site under the EMC, Medical Device, and Active Implantable Medical Device directives to no avail. http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/re flist.html Is this standard still pending for the EU? On Thu, 16 Mar 2000 09:53:01 -0500, [email protected] wrote: >Mike, A1:1996 of EN50061:1995 has the EMC requirements for implantable >cardiac pacemakers. >It can be ordered on the web from BSI. > >Richard Woods >Sunning in Florida > > ---------- > From: Michael Taylor [SMTP:[email protected]] > Sent: Thursday, March 16, 2000 9:19 AM > To: [email protected] > Subject: EN standard for pacemaker immunity > > > Greetings all. > An issue came up that needs answers as soon as possible. Does >anyone in the > group know if there are any European standards covering pacemaker >(and > similar devices) immunity to Electric & Magnetic fields. A search >of Global > Eng. Documents product list proved fruitless. I'm sure there is >someone in > the group that has the answer. > > I will be most grateful for any answers or leads on this issue. > > Best regards. > Michael Taylor > Snowed-in, in Colorado. ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: [email protected] Michael Garretson: [email protected] For policy questions, send mail to: Richard Nute: [email protected] ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: [email protected] Michael Garretson: [email protected] For policy questions, send mail to: Richard Nute: [email protected]
