Biocompatibility - ISO 10993 and SVHC Requirements

R

Riskophil

#1
#1
Hi everyone,

I have a question regarding the biocomp Evaluation of a medical device.

What we usually do is evaluating the device according to ISO 10993 (cytotox, sensitization, Irritation...).

We are also stating that our Primary packaging materials (eye drops) are free of phtalates and BPA in this context.
Here we are further referring to a document that states numerous "Free of..." parts. We are also adressing SVHC, GMO, BSE/TSE, Heavy Metals and a lot more.

I was wondering of what would be really mandatory and what not since the ISO 10993 never requested one of those Topics (to my knowledge) explicitly. So how can you show safety without exaggerating everything.

Is it even possible to leave out some of the components that are not in contact with either the product or the Patient.

Thank you and Kind regards,

Phil
 
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Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#2
#2
Hi Phil,

Risk management is the way to go.

You have to distinguish between regulatory requirements and market (client) requirements.

As far as I know, ISO 10993 doesn't deal directly with any of the specifics you mentioned.

Some regulations relate to phthalates, BSE/TSE and heavy metals, but applicability depends on the geographical regulatory domain (EU, USA etc.) and the specifics of your devices.

I suggest you put it all in a Risk Management framework (ISO 14971 or similar), identify the concerns and the applicable regulations and address them as necessary through one or more of: standard compliance, other testing, supply chain evidence or your own declarations / justifications. That would be an acceptable way of demonstrating safety.

Whatever is not required for mitigating a risk or addressing a regulatory requirement can be dropped, provided that it's not explicitly required by a client. Keep in mind though that your marketing guys might argue that some of those "free of..." statements have general positive market appeal and should therefore stay even though no explicit requirement exists...

I hope that the above is not completely useless to you...:)

Cheers,
Ronen.
 
Last edited:
J

Julie O

#3
#3
I know of no reason to evaluate a component for biocompatibility if it is not in contact with the product or the USERS. Users can include patients, physicians, and other personnel. Let your intended use be your guide.

I second Ronen's comment about marketing. I would get their input before dropping any claims, even ones that don't seem technically relevant to you.
 
A

Ashwin N

#4
#4
My Medical Device complies only with ISO 10993-1:2009 regulations. What should be the steps taken to upgrade to ISO 10993-1:2018 regulations? Also, what is the last date for doing this upgrade?
 
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