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Hi Geoff, Thanks for the information. I keep forgetting about the 'self-certification' for Class 1 devices. I'm really following up a question from a lady who spent several months in an ICU with no AAC available. Her hospital didn't appear to have any idea of what could be done to assist her and I made the assumption that the EMC problem might have been a deciding factor. Are there any guidelines out there for AAC users in ICU? I haven't got a particular device in mind. Thanks again, Aidan. ----- Original Message ----- From: Harbach Geoff To: [log in to unmask] Sent: Tuesday, February 01, 2005 2:18 PM Subject: Re: Communication Aids in Intensive Care Hi Aidan. I would guess that most ITU's are full of electronic equipment that should have increased immunity to electrical noise due to the close proximity to other equipment with which they must work. It is not necessarily certain that all AT equipment comes under the MDD, it depends on whether the manufacturers declare it so. I wonder if all AT manufacturers have made an EMC declaration according to the latest version of 60601-1-2. http://www.bsiamericas.com/MedicalDevices/Updates/052704.xalter This would then give you some idea of the emissions characteristics of the device in question. You could then make a judgement as to the likely occurrence of interference. Do you have a particular device in mind? Geoff.