NMR device classification

We have some trouble about the classification according to CISPR 11 of a diagnostic NMR device. In my opinion the radio frequency energy is NOT genereted for treatment of material (human body). This condition applies only to therapy equipment that produce some change in the body. For that

transportation environmental condition

Hello all! Does anybody know the foreseeable environmental condition (temperature, humidity, pressure) you have during transportation of a device on a plane? Of course they depend on flight heigth, but is it possible to get rough, common-sense data for the design of packaging? Many thanks

FDA classification for electrocardiographs

We have submitted a 510(k) file for one of our ECG devices. The indication for use is to be used by a physician to analyze cardiac performance and in the description we say: can be equipped with a resting interpretation program offered to the physician on advisory basis only. We classified it

VDE 0565

Hello! Within the technical data of a power line choke I read: compliance with VDE 0565. I guess it's a large German standard about safety (?) and performances (?) of passive components used in power line filters. Does anybody know the corresponding IEC or CENELEC standards (if any)? The

IEC 601-1 Amdts

Hello! IEC 601-1 has two important amendments (A1: 1993; A2: 1995) that have significantly changed many clauses. Does anybody know if a version is available with the new text repalcing the old one? (A fine cut-and-paste work!) Thanks M.P. ---