Patrick, In my previous answer, please ignore item 2. I misread IEC 1000-3-2 for IEC 1000-4-2.
Jon >Patrick, > >1) EN 60601-1-2 just covers EMC, while the scope the Medical Devices Directive >includes safety, risk analysis, medical efficacy, biocompatibily, software >validation, etc. > >Medical products are classified into Classes, 1, 11a, 11b and 111. Self >declaration can be used for most, but not all, Class 1 products (the least >critical). Even this this case, self declaration is based on a technical file >that includes much more than EN 60601-1-2. > >In all other cases, approval is via a Notified Body under the Medical Devices >Directive. Approval covers the manufacturer as well as the product, as some >level of ISO 9000 approval is required. The ISO 9000 audit is carried out by >the Notified Body itself. There is a complex relationship between the Class of >product and the level of ISO 9000 approval required. > >2) EN 60601-1-2 does have ESD requirements, but to IEC 801-2, which is older >than IEC 1000-3-2. > >3) EMC requirements for medical equipment are covered by the Medical Devices >Directive, not the EMC Directive. So if harmonics are not mentioned in EN >60601-1-2, then it is not required. > > >Jon Griver >ITL (Product Testing) Ltd. >http://www.itl.co.il > > > >> >> >>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).
