ISO 10993 (Biological Compatibility) Approved Materials

[Ronen E]

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

Hi,

FDA needs materials to be approved against ISO10993. My device needs above mentioned armbands and velcro to work with.

jess

That's understood. Well, to begin with, the FDA doesn't work with ISO 10993 per-se, but with its own matrix, which is based on ISO 10993. By the way, this matrix leaves some room for consideration regarding the tests required. Second, materials can be approved against ISO 10993 only once the type of contact and duration are determined, unless someone tests for the entire ISO 10993 battery, which I guess is not the case with the type of materials you pointed to.

I'm sorry if I'm being a pain, but regulatory affairs are typically sensitive to details.

Cheers,
Ronen.

 

[somashekar]

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

Hi,

FDA needs materials to be approved against ISO10993. My device needs above mentioned armbands and velcro to work with.

jess

Biological compatibility is for a specific type of application intended for a device, and hence as a raw material manufacturer, his claim to ISO 10993 complient material perhaps is for typical application his material would be used, based on tests that he might have got done. This can at best be an indicator for selection of such material for your device application, however it does not absolve you from the claim that your device is hence biological compatible if you use that material.
As a device manufacturer, you are required to subject your device for such tests per ISO 10993 based on the contact type which is detailed within the 10993-1.

 

[SRavi]

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

Can you suggest any manufacturer that is available in market as "off the shelf" and that complies with ISO 10993 to be used as medical device material, i.e for long term skin contact. I know Neoprene is a popular choice but unfortunately it is hard to find manufacturer who produce Neoprene with such certification (or i might not have serached that well). I have read Polyisoprene is also a good option. Please suggest me some manufacturer whose product I can use (or at least fulfills most of the standards for ISO 10993 and I might need to perform only some for my application that is long term skin contact material such as mentioned earlier)

 

[SRavi]

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

Do you know any manufacturer that I can use who produce such medical grade polymers such as neoprene. My application is use a polymer that hold a monitoring device and is in contact with skin for 18-20Hrs a day with repeating use on everyday or every other day.

I think poly-isoprene is also a good option. Please suggest me some leading manufacturer of such medical grade polymers.

 

[Ronen E]

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

Do you know any manufacturer that I can use who produce such medical grade polymers such as neoprene. My application is use a polymer that hold a monitoring device and is in contact with skin for 18-20Hrs a day with repeating use on everyday or every other day.

I think poly-isoprene is also a good option. Please suggest me some leading manufacturer of such medical grade polymers.

Are you looking for custom manufacturing or for a strap / sheet supplier (from which your component will be cut)?

Sounds like your device would have to satisfy ISO 10993 Cytotoxicity, Sensitization and Irritation test requirements, as a minimum. Please note that compliance is required in final device form and ready-to-use state.

 

[SRavi]

I can understand if I need to prove the compliance with irritation and sensitivity as this might be affected by the last design / place of contact . But if the manufacturer of such materials has already proved cytotoxicity compliance, can I use that.
Also I would appreciate it if you can also suggest some leading manufacturer of such medical grade polymer.

 

[SRavi]

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

For now I am looking for sheets of material but if prototypes succeeded to become product, I can go for customize manufacturing. How will that affect my process of complying with ISO -10993.

 

[MIREGMGR]

I'd think it'd be easiest for you to just work with a contract supplier, communicating to them the need for biocompatibility as a part of your overall specifications. Many contract suppliers will be able to provide you with specification-compliant prototypes. It rarely makes economic or technical sense to develop the capabilities to do prototyping yourself if production will be contracted out.

Of course, any such contract manufacturer will have to be convinced that your company is real and their economic prospects for eventual shared volume production and profits are good. Most contract manufacturers are wary of providing prototypes to customers who then go broke, or otherwise don't proceed, or go somewhere else for production.

 

[Ronen E]

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

If you're sourcing some elastomeric sheets that are certified against the applicable ISO 10993 parts, in their as-supplied state, and you can justify that consequent manufacturing processes (cutting, assembly, packaging, anything else...?) do not affect their chemical make-up, physical properties (except shape) and cleanliness status - you might be able to get away with it. Please pay attention to ageing effects during storage, shipping and use, that may alter the part's as-supplied (to you) properties.

However, if you are considering moulding, or any other properties-affecting manufacturing process (printing, cleaning etc.) you may be required to prove compliance in the ready-for-use state (including any in-use deterioration).

For support in Germany you may want to contact this supplier:
http :// www .medneteurope .com/Moulded-Parts-Elastom.20.0.html?&L=2 - OBSOLETE BROKEN 404 LINK(s) UNLINKED

I currently have no affiliation whatsoever with them, but have done business with them in the past. As of several years ago, this company was very serious and professional, though I wouldn't bet on low costs.

Good luck,
Ronen.

 

[SRavi]

@ 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.
I am open to the supplier from around the world (if they are more reliable, efficient, and fulfill ISO 10993 requirements) so if you happen to know other suppliers, please let me know. I would appreciate it (It might also help me get in a better position to chose the material).

I am not planning to modify already approved material as the application doesn't need it. In earlier comment, when I said customize, I only meant the shape and not changing already approved chemical properties.

I do though have one question. Does the skin irritation, sensitization test depends on the shape (or position where I use it on the skin) of the material.
for example. If a polymer is cut in size to hold a device in contact with patient skin. Does it make it necessary to again show the compliance in this form. I know you have mentioned that I might get away with it but in your experience, does people get away with it? Just making sure.

I apologize if I am being a pain but I am new to the process of ISO 10993 compliance and want to learn as much as possible from other's experience.

Kind regards,
Ravi