Biocompatibility Testing for Implantable Medical Devices according to ISO 10993

[Tiffany]

Hi all,

I have queries on the type of biocompatibility testing according to ISO 10993 series should be carried out for implantable medical devices.(implant > 30 days)

This queries generated where I have different type of biocompatibility testings which recommended by two different testing lab.

Could any experts here to help me up for this queries??

Thanks.

BRegards,
Tiff

[Marcelo Antunes]

If there´s differences between testing labs, how about you contact your notified body (or equivalent)?

[Roland Cooke]

IIRC it also makes a difference where in the body the device will be implanted.

[EColby]

I am unable to submit a link in this response (apparently because I am new to posting). So I suggest going to the FDA website and looking up "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices" G95-1. Be sure to click on the links for Table 1 and 2. I found those tables helpful.

[Ajit Basrur]

In Reply to Parent Post by EColby

I am unable to submit a link in this response (apparently because I am new to posting). So I suggest going to the FDA website and looking up "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices" G95-1. Be sure to click on the links for Table 1 and 2. I found those tables helpful.

Welcome to the Cove and thanks for providing valuable link

This is the link that Ecolby referred - Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices May 1, 1995 (G95-1)