Medical Device Emissions Limit?

Good Morning, I am in desperate need of your expert assistance. I need to define the requirements for a device that is located in a hospital operating room. Device 'X' is used during surgery and makes contact to the patient. The device will be compliant with EN 60601-1, EN 60601-1-1, EN

RE: IEC 60601-1-2 Second Edition

Ned, At a recent AAMI/FDA conference I asked Jeffery Silberberg of the FDA a similar question and his response was that the new standard would apply upon the date of recognition by the FDA. As a matter of business, I have been using the new standard (in Draft form) for the last year or two. I

RE: IEC 61000-4-3

Chris, Allow me to stir the pot a little. 1) The antenna is to be 3-meters from the calibrated field. 2) The antenna may be as long a 1-meter, front-to-back. 3) The worst performing section of the antenna is the furthest section away. If you move your antenna 1-meter closer, such that the