Jim, You are right: you can use the device, if it is certified according EN60601 ff.
Medical certification of hardware is possible and far not as expensive as one might think. The problem with certification is not hardware, it is software ! Software is part of the medical device, if the device is operated by software. You have to do full risk assessment for specific software+hardware complex for getting the certification. Experts are still discussing, what kind of software is to be considered medical (and to be certified): Software for operation of medical devices, Software for clinical data management, Software for management of patient data.....etc. Certification of Care2x -or parts of it- according to international rules would be THE MOST RELEVANT argument for clinics management in favor of Care2x. But that might still be a long way... My personal opinion is: Today hospital installation of Care2x would be considered an "individual solution" for that specific hospital. Care2x is not a closed product. As "individual solution" there is no need to get (external) certification, although careful risk assessment would be in the responsibility of clinics management staff... External certification is mainly for products, sold "as-is" for very specific use. (For example: Hardware for Multi-purpose medical bed-side information terminal) Alex ----- Original Message ----- From: "jim jones" <[EMAIL PROTECTED]> To: <[EMAIL PROTECTED]> Sent: Monday, June 28, 2004 11:45 PM Subject: Re: [Care2002-developers] A question about daily routine in hospitals > You can't use any device in the hospital next to > patient. > You gonna have problems with EMC and IEC60601. If > someone touch the device and electrocuded or if the > device fell on the patient? > Philips has some patient monitors for intensive care > which can connect to network but they aren't cheap: > http://www.medical.philips.com/main/products/patient_monitoring/ > http://www.medical.philips.com/main/products/patient_monitoring/products/intellivue_mp90/index.html > > > ____________________________________________________________ > Do You Yahoo!? > Αποκτήστε τη δωρεάν @yahoo.gr διεύθυνση σας στο http://www.otenet.gr > > > ------------------------------------------------------- > This SF.Net email sponsored by Black Hat Briefings & Training. > Attend Black Hat Briefings & Training, Las Vegas July 24-29 - > digital self defense, top technical experts, no vendor pitches, > unmatched networking opportunities. Visit www.blackhat.com > _______________________________________________ > Care2002-developers mailing list > [EMAIL PROTECTED] > https://lists.sourceforge.net/lists/listinfo/care2002-developers > ------------------------------------------------------- This SF.Net email sponsored by Black Hat Briefings & Training. Attend Black Hat Briefings & Training, Las Vegas July 24-29 - digital self defense, top technical experts, no vendor pitches, unmatched networking opportunities. Visit www.blackhat.com _______________________________________________ Care2002-developers mailing list [EMAIL PROTECTED] https://lists.sourceforge.net/lists/listinfo/care2002-developers
