Dear Forum,

We are developing ultrasound equipment + probes for use directly on the heart during heart surgery.

In order to use our equipment a special sterile gel must be utilized between probe and tissue. This gel is being produced by a third party.

In our IFU we need to recommend which gels that can be used with our equipment. Does anyone know after which standards such a gel will have to be tested?

temu

I can't find anything standardwise on the ISO homepage. I would, however, seem a fair guess that it should be tested for biocompatibility and be sterilized using a validated sterilization process. If I were in your shoes I would contact some of the suppliers of a gel like that and inquire what standards they follow.

:bigwave:

I agree with Gert. The ISO 10993 series on biocompatibility seems to be the one you look for. ]

There´s also another potential problem, as you´re going to use it directly on the heart i think there could be somre problems regarding leakage current (i don´t know, maybe you need to limit the amount of gel to make sure it doen´t creat an alternative path?) Anyway, this "should" be guaranteed by using the gel during the electrical safety tests. But i would keep an eye open, or even make the tests myself )i think a special test would need to be developed).

Thanks.

Our probes are all cardiac floating DF-safe. Shouldn´t that be enough?

temu

I think you meant CF?

Anyway, if you´re completely sure that your probe is CF in normal and "ALL" SFC, then you´re problably ok.

I was thinking about some corrosion problems that might arise during the product lifecycle because of the use of the gel, this isn´t usually a problem but you wuld have to take it into account. But it seems you already tested the probe regarding this kind of fault condition (and every other) so i think this might be ok.

Cheers.