Biocompatibility Testing for Implantable Medical Devices according to ISO 10993

T

Tiffany

#1
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. :argue:

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

Thanks.

BRegards,
Tiff
 
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Marcelo

Inactive Registered Visitor
#2
Re: Biocompatibility Testing

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

Roland Cooke

#3
Re: Biocompatibility Testing

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

EColby

#4
Re: Biocompatibility Testing

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.
 
#5
Re: Biocompatibility Testing

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 :bigwave:

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