ISO 10993 Labs which can test Cytotoxicity, Sensitizaton and Irritation

M

moe.c.strife

#1
I am looking for an affordable lab to test a fabric based electrode for: cytotoxicity, sensitizaton and irritation as per ISO 10993 standards.

1. What are some labs you would recommend based on price and based on ease of approval from FDA? Are there any ones located in Canada, which meet both requirements? I've tried NAMSA, Pro BioLab and Contract Lab, from a google search.

2. How important is it to have it tested with GLP. I know it makes a difference of about $700 based on one of the quotes I've obtained.

Thanks,

Mohamed
 
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Adele

Involved In Discussions
#5
Hi Mohamed,

I don't know of any testing laboratories based in Canada but I haven't looked. If your prodct is Class II, I would check out the 510(k) summaries of similar products as they sometime mention the laboratory from which they have biocompatibility testing. That will give you a good idea as to labs that have had FDA approvals.

I believe GLP is very important. When we were trying to register some products in China, we had to repeat the biocompatibility testing for a few materials that were not GLP.
 
H

htquality

#6
Toxikon (Bedford MA) is the lab we use and I have been very happy with them. As far as GLP goes, I would spent the extra $$ now so that you get data that can be used in any future submission that you are planning to make...
 
Y

ymunwai

#8
Hi, I was just reading the replies and I thougth I could add another ISO10993 lab with GLP.

If you are around the Asian region, you can try TUV SUD PSB- Biocompatibility Lab with GLP. The price is negotiable. The tests that they offer include below. I can assist to provide the contact person who is in charge of the testings.
1. Cytotoxicity,
2. Intracutaneous reactivity,
3. Skin sensitization, GPMT,
4. Acute systemic toxicity,
5. (optional) In vitro haemolysis
 
P

Pascalb

#9
Hello
Is there a way to speed up the process for
ISO 10993 Labs test Cytotoxicity, Sensitizaton and Irritation
 

Ronen E

Problem Solver
Staff member
Moderator
#10
Hello
Is there a way to speed up the process for
ISO 10993 Labs test Cytotoxicity, Sensitizaton and Irritation
Hello Pascalb and welcome to the Cove :bigwave:

The answer depends on your reference point. If it's established that those tests are absolutely necessary, I think their duration can't be shortened (other than running all three in parallel). The procedures are pretty much set and have a given timeline.

There might be an alternative in trying to establish (with the aid of a qualified toxicologist / evaluator) that some or all of those tests are not necessary, based on already available information. What kind of information? Consult ISO 10993-1:2009 and that qualified evaluator.

Cheers,
Ronen.
 
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