Need help with Japanese language draft standard

Hello All: I have been given copies of two Japanese language documents that reportedly describe some proposed new telecom requirements in Japan. The first document appears to be a cover letter from the committee, while the second document appears to be the draft standard itself. I have been

RE: RTTE for Medical Devices?

Del, I'm not an RTTE expert, but from the MDD side under the 2nd edition of 60601-1-2 (2001), the function of the card and it's communications would have to be evaluated. If it falls under the ESSENTIAL FUNCTION of the medical device, it would be subject to the requirements of 60601-1-2. These