Curious if ISO 10993 might apply to travel cases for portable medical equipment intended for home use.
Take hearing-aids, for example: they come with a small travel case.
Technically, the "patient" in this case is the one interacting with the case, and so there is a degree of patient contact with the case.
So, strictly by the standard, it seems that you'd need to consider biocompatibility.
However, on a practical level, it seems this is unreasonably burdensome to the manufacturer. The travel case really has nothing to do with the medical application of the device, and the nature of the way the "patient" interacts with it is really no different from any other every-day commercial case (e.g. your wallet, sun-glasses case, mobile-phone case...etc.).
What do you think?
Take hearing-aids, for example: they come with a small travel case.
Technically, the "patient" in this case is the one interacting with the case, and so there is a degree of patient contact with the case.
So, strictly by the standard, it seems that you'd need to consider biocompatibility.
However, on a practical level, it seems this is unreasonably burdensome to the manufacturer. The travel case really has nothing to do with the medical application of the device, and the nature of the way the "patient" interacts with it is really no different from any other every-day commercial case (e.g. your wallet, sun-glasses case, mobile-phone case...etc.).
What do you think?