Access to a particular Medical Device Electronic Communication Test Port

previously i was told that in order to avoid testing on a particular port that we need to require a tool to access it (not normal use).

another person then says as long as we state in the manual that we don't need to go secure it (tool to access).

does anyone happen to know where in the standards it says?

hi. im new. and i work in medical (yeah...)

Re: Access to a particular Electronic Communication Test Port

As long as the voltages are <60Vdc / 42Vp(for ac), then then it is OK. Technically, the risk of the user touching the port and the patient should be assessed, and the instruction manual should state for the user not to touch the port and the patient at the same time.

But the upshot is that it is very common to have accessible signal ports in normal use.

Re: Access to a particular Electronic Communication Test Port

hi peter (and co)

i was able to find the info i needed.

iec 60601 3rd ed

5.9.2 accessible parts
5.9.2.1 test finger
...
"even after opening the acess covers and removal of parts, including lamps, fuses, fuseholders, without the use of a tool or according to the instruction for use."

thanks!