On Fri, 18 Jun 1999 09:25:51 -0800, Jon Griver wrote: >------------------------ > 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. My job responsibilities involve EMC, so I tend to have narrow focus. Should the original sentence should have read: A manufacturer can claim his system complies with the Medical Device Directive by testing to EN 60601-1. I think EN 60601-1 Amendment 1 includes the reference to EN 60601-1-2.
>> 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 >Date: 06/18/1999 >Time: 09:25:53 >Military & Avionics EMC Services Our Specialty >Also Environmental / Metrology / Reliability -- 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).
