Posted for Jon Griver: ------------------------ From: Jon Griver <[email protected]> Subject: Medical Device Directive, IEC 601-1-2, and IEC 1000-3-2 Date: Fri, 18 Jun 1999 14:52:16 +0300 To: [email protected]
> 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). > > > > > > > > ---------------End of Original Message----------------- -------------------------- Ed Price [email protected] Electromagnetic Compatibility Lab Cubic Defense Systems San Diego, CA. USA 619-505-2780 List-Post: [email protected] Date: 06/18/1999 Time: 09:25:53 Military & Avionics EMC Services Our Specialty Also Environmental / Metrology / Reliability -------------------------- --------- 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).
