Docket Management
Docket: 01N-0275 - Electronic Products; Performance Standard-Diagnostic X-Ray Systems
Comment Number: EC -3

Accepted - Volume 1

Comment Record
Commentor Mr. joseph Arnaudo Date/Time 2003-04-07 19:58:37
Organization Philips Medical Systems SSR NA
Category Company

Comments for FDA General
Questions
1. General Comments Their is a contradiction between the IEC 60601-2-7 and the proposed 21CFR1020.32. The proposed amendments to 21CFR1020.32 requires a fixed 5 minutes interval for each warning which will continue to sound for a least 1 second (ref:1020.32H2ii). Assuming an active sound time of 10 seconds to be ending automatically, this means that in case the sound stops, the sound will reappear in 4 minutes and 50 seconds. The IEC 60601-2-7 standard (clause 29.1.104B) requires that it shall be possible to reset the timing device at any time, io order to stop the warning. The working reset implies a manual reset, and not an automatic one. So, in case the operator stops the sound in 10 seconds, the sound will reappear in 5 minutes (in case he has set the timing device to 5 minutes), and not in 4 minutes and 50 seconds. This is based upon the fact that clause 29.1.104.b.2(IEC 60601-2-7) states to permit further periods of LOADING, each not exceeding five minutes, to be accumulated, during which no warning is given. I interpret during which no warning is given to mean as long as the warning sounds, the count off (till 5 minutes) is not activated. This diffeence between the FDA and IEC could impose a practical problem for manufacturers on how should they install the X-ray sytems in US(FDA) vs Europe(IEC)? Also please note that the FDA proposed 21CFR1020.32 for each active X-ray tube an audible signal shall sound at each fixed interval of 5 minutes (which implies the elimination of the flexibility of preseting the signal up to a maximum time of 5 minutes)and the audible signal shall sound for at least 1 second (which implies that it is no longer required to reset the audible signal).




EC -3