Hi Robert. You asked: <Need to find the compliance requirements for medical therapy equipment that uses high power X-Rays to destroy tumours. Both for US market and the European market.>
Essentially, this equipment is covered by the EC Medical Devices Directive in Europe, and as such must comply with the relevant standard, EN 60601. This standard covers all aspects of medical equipment safety, electrical, mechanical, etc. so life is relatively easy in that particular respect. The standard needs working through though, lots of parts covering lots of subjects. You will be looking at the parts covering linear accelerators and simulators, all is there! Good luck. Chris Duprés Surrey, UK. --------- This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to [email protected] with the single line: "unsubscribe emc-pstc" (without the quotes). For help, send mail to [email protected], [email protected], or [email protected] (the list administrators).
