Standards are published in the OJ for use with a particular directive. In this case EN 61000-3-2 and EN 61000-3-3 have been published in the OJ as standards used to conform to the EMC directive. If you choose to meet the Medical Devices Directive (Watch out that you are within it's scope!) now, then you do not have to meet these harmonic standards until they are published in the OJ under the Medical Devices Directive. Currently EN 60601-1-2 is the only EMC document listed in the OJ to date for the Medical Device Directive. It has this to say on Low Frequency emissions:
36.201.2.1 VOLTAGE FLUCTUATIONS and harmonic distortion No requirements for EQUIPMENT and/or SYSTEMS. On the other hand, you may choose to pursue your approvals under the existing national schemes until June 15 1998. In that case you would need to meet the EMC directive now and technically you would need to meet the harmonic emissions standard EN 61000-3-2. I say technically because CENELEC postponed the mandatory date for EN61000-3-2 til June 1, 1998 but Brussels refused to publish the ammendment in the OJ leaving it up to national governments to delay their enforcement of EN61000-3-2 if they so choose. See previous discussions of the harmonic standards for more background information on EN61000-3-2. Jon D. Curtis, P.E. Director of Engineering email: [email protected] Curtis-Straus LLC phone: (508) 263-1897 409 Massachusetts Avenue fax: (508) 263-4164 Acton, MA 01720 http://world.std.com/~jdc/ USA On Fri, 31 May 1996 [email protected] wrote: > Although you are correct - neither does the EMC Directive. BUT the EN for > harmonics IS in the OJ and it would seem to me to be applicable. Any one else > agree?? >
