Bob, No, you haven't overlooked anything. The standard allows either level "based on their intended use" (clause 36.201.1). Annex CCC gives some guidelines, but basically Class A is generally acceptable for hospitals and Class B for medical devices for home use.
As a comment on the approach to EMC for medical devices, I would say the standards seem to say "do the best you can, but don't let EMC considerations prevent effective medical treatment if compliance is impossible". I give as an example the particular standard for lithotripters, IEC 60601-2-36. Lithotripters are used to break up kidney stones, and work on the basis of mechanical shocks produced by a spark plug fired under water. As you could guess, such a device has little chance of complying with emissions requirements. Clause 36 of IEC 60601-2-36 states "Compliance with IEC 60601-1-2 will be maintained, except during the triggering and generation cycle of the pressure pulse release." - basically the device has to comply, except when it's actually in use!!. Regards, Jon Griver http://www.601help.com The Medical Device Developer's Guide to IEC 60601-1 From: <[email protected]> To: <[email protected]> Sent: Wednesday, October 27, 2004 4:01 PM Subject: EN 60601-1-2 > In the 2002 version of EN 60601-1-2, I cannot find specific emission level > requirements for equipment that is sold for use in a hospital. It seems > common sense to me that you would want your equipment to conform to Class B > especially if you are using it in an operating room or an intensive care > unit but I cannot find this in the standard. It seems to imply that > equipment can be either Class A or Class B especially in hospitals that are > on their own power system. Have I overlooked something? > > Bob Heller > 3M EMC Laboratory, 76-1-01 > St. Paul, MN 55107-1208 > Tel: 651- 778-6336 > Fax: 651-778-6252 > ======================================================= > > ---------------------------------------------------------------- > This message is from the IEEE Product Safety Engineering Society > emc-pstc discussion list. Website: http://www.ieee-pses.org/ > > To post a message to the list, send your e-mail to [email protected] > > Instructions: http://listserv.ieee.org/listserv/request/user-guide.html > > List rules: http://www.ieee-pses.org/listrules.html > > For help, send mail to the list administrators: > > Ron Pickard: [email protected] > Scott Douglas [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 Product Safety Engineering Society emc-pstc discussion list. Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to [email protected] Instructions: http://listserv.ieee.org/listserv/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Ron Pickard: [email protected] Scott Douglas [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
