Re: Serial Number Format - Medical Devices

At 06:55 +0100 26/6/2001, John Woodgate wrote: 36BDBCA75E0FD411A80100104B93ABF202C2C24B@mgcmail, Dick Grobner dick.grob...@medgraph.com inimitably wrote: Referencing the Medical Device Directive, Annex I, paragraph 13.3 The label must bear the following particulars: (l), year of manufacture

RE: Products Electrical Ratings De-rated for Eurpoean Branch Circuits

The tardiness of this reply is due to my employer's insistence upon performance of tasks of their choosing to accommodate remuneration in the locally common monetary exchange units. Jim Eichner pointed out a fallacy in my below statement and I must acquiesce. By operating from memory (but I

RE: In-line Fuses

Brian, Try to convince your safety test house that this component is in the secondary and no need for approvals and proper ratings. I believe all that is necessary is to see that it meets the requirements in the end-product standard - temperatures under normal and abnormal conditions and a ball

Re: Serial Number Format - Medical Devices

I'd say both are probably right. I've never done medical. But, I have run into this type of thing when I was doing ISO-9001 as a lead auditor. Critical words for interpretation are This indication may be included ... It specifically says *may* which means either *you can* or *you don't

RE: EN 55011 Fundamental ISM frequencies

Doug, Doug asked: Do the unrestricted limits for the ISM frequencies really apply to both radiated and conducted or to only radiated emissions? I think yes and here is why. The 2nd ED of 60601-1-2 required testing to 61000-4-6 at a level of 10V at the ISM frequencies below 80 MHz and 3V

In-line Fuses

We have an application where an In-Line Fuse would be an easy fit to a problem. The fuse and holder would be added to an existing internal cable harness in a piece of Lab Equipment (EN61010-1 for safety). The wire that needs the fuse has 120 Volts ACrms and we need to limit the current to 5

Re: Serial Number Format - Medical Devices

36BDBCA75E0FD411A80100104B93ABF202C2C24B@mgcmail, Dick Grobner dick.grob...@medgraph.com inimitably wrote: Referencing the Medical Device Directive, Annex I, paragraph 13.3 The label must bear the following particulars: (l), year of manufacture for active devices other than those covered by (e).

Re: IP xx

John, Please dont shoot me, I am only a piano player ... ;-) FYI: Recognized labs have guided us to the 950, but during this IEEE Society Product Safety discussion we have realized that that might have made the wrong choice. We will take contact with them. All the best from Oslo Amund