Patrick, David I do not believe that David's answer is correct. Harmonised standards are harmonised within the framework of a specific Directive. As far as I know EN 60601-1-2 is the only EMC standard harmonised within the framework of the Medical Devices Directive. The EMC Directive does not apply the medical devices, so EN 61000-3-2 does not apply.
Jon Griver ITL (Product Testing) Ltd. http://www.itl.co.il At 14:25 18/06/99 -0400, you wrote: > >Pat: >61000-3-2 is a horizontal standard and it applies to all products unless >specifically excluded by 61000-3-2. The criteria is defined by CENELEC and >it is not necessarily specified by the individual product standards. This >is why it is so important to watch basic and horizontal standards even >though they may not called out in the product standards. These >cross-the-board standards are sleepers and can effect manufacturer's through >the back door. > >Industry has decided to fight 61000-3-2 in the IEC and try to achieve >realistic requirements. The US national committee has just released a >position paper on harmonics requirements. If anyone needs a copy I can post >it on this net. >Dave George >Unisys > >-----Original Message----- >From: [email protected] [mailto:[email protected]] >Sent: Thursday, June 17, 1999 7:55 PM >To: [email protected] >Subject: Medical Device Directive, IEC 601-1-2, and IEC 1000-3-2 > > > >I was asked the following question, and wasn't sure about the answer: > >1) A manufacturer can claim his system complies with the Medical Device >Directive by testing to EN 60601-1-2:1993. > >2) EN 60601-1-2:1993 does not have any requirements to test to IEC 1000-3-2. > >3) Does that mean that the harmonic standard does not apply to this system >when >it becomes mandatory in 2001? > > >I realize the Second Edition of IEC60601-1-2 is just around the corner, and >that edition _does_ call out the harmonic test. However, I've been told >that >it may not take effect until 2003. >-- >Patrick Lawler >[email protected] > >--------- >This message is coming from the emc-pstc discussion list. >To cancel your subscription, send mail to [email protected] >with the single line: "unsubscribe emc-pstc" (without the >quotes). For help, send mail to [email protected], >[email protected], [email protected], or >[email protected] (the list administrators). > > >--------- >This message is coming from the emc-pstc discussion list. >To cancel your subscription, send mail to [email protected] >with the single line: "unsubscribe emc-pstc" (without the >quotes). For help, send mail to [email protected], >[email protected], [email protected], or >[email protected] (the list administrators). > > > --------- This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to [email protected] with the single line: "unsubscribe emc-pstc" (without the quotes). For help, send mail to [email protected], [email protected], [email protected], or [email protected] (the list administrators).
