ISO 10993 (Biological Compatibility) Approved Materials

Ronen E

Problem Solver
Moderator
@ Ronen,

Thank you for the suggestions.Also thank you for the supplier information. I sent them a mail regarding my query and hope to hear from them soon. <snip>

Hi Ravi,

If you can justify that changing the component's shape doesn't alter its biocompatibility status, you generally don't have to re-test or otherwise show compliance. For example, die cutting out of a supplied (already certified) sheet is likely to pass, but injection molding typically won't because the high temperatures, shear and pressure might cause significant changes.

As far as I know, position on the body doesn't affect ISO 10993 requirements, as long as we're only discussing intact skin.

The "formal" way I know for "getting away with it" is contacting one of the accredited 3rd party ISO 10993 test labs, and asking for a written opinion from their expert toxicologist. Otherwise it's just trial and error - document your justifications and see what happens when you make a regulatory submission / go through audit (not recommended but might still work).

You are very welcome to send me a private message if you're interested in further specific consultation regarding sourcing this component / material. Other than that I'll be glad to answer any general questions here.

Cheers,
Ronen.
 

robert.beck

Involved In Discussions
Re: Certification with respect to ISO 10993 (Biological Compatibility)

Did you ever find any acceptable materials? I'm wondering how to handle a situation that is very low risk, limited contact, but there is no biocompatibility information available on the material.
 

Ronen E

Problem Solver
Moderator
Re: Certification with respect to ISO 10993 (Biological Compatibility)

Did you ever find any acceptable materials? I'm wondering how to handle a situation that is very low risk, limited contact, but there is no biocompatibility information available on the material.

Hi,

In ISO 10993 terms, risk level is determined by type of contact (=contacting tissue type) and contact duration. The risk is then translated into the number and type of tests required. As far as I understand, the lowest risk (shortest duration, in tact skin) translates into the 3 basic tests. If you wish to avoid these, you could try and follow the routes I suggested in previous posts.

Cheers,
Ronen.

PS If you refer to risk in ISO 14971 (rather than ISO 10993) terms then you might be able to justify that the risk is acceptable without further testing. However, according to EN ISO 14971:2012 you must reduce all risks as much as possible to comply with the MDD's ER, hence you'll probably have to test (the 3 basic tests are not very expensive or lengthy).
 
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M

MIREGMGR

Re: Certification with respect to ISO 10993 (Biological Compatibility)

I'm wondering how to handle a situation that is very low risk, limited contact, but there is no biocompatibility information available on the material.

Test.


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