ISO 10993 Compliance - Where to start? Class I Medical Device

J

jayquality

#1
our product (class I with measuring function) has very limited contact with skin
according to iso 10993-1 both 10993-5 and 10993-10 apply
we use basic materials such as pvc, polycarbonate (lexan sheets), anodised aluminum, sbr rubber
having a very hard time getting ANY declarations from our suppliers

- any sources for declarations of these standard materials?
- any test labs in belgium?
- any advise on next steps?
- is it enough to have sample pieces of the materials tested (our final product is very large)?
- what about flamability?
tx for any advice
 
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T

temujin

#2
Hi and welcome to the cove.

Even if you get certificates of biocompatibility from all the material vendors you probably have to test the final product as your manufacturing process might just as well introduce other substances into the product.
A certificate from the vendor should only be used as a guideline for your material selection and not for demonstrating compliance for your product.

If your product is very large, I think it is enough to submit the part with direct patient contact for testing. (for curiosity, what kind of product is it ).

Of testing labs in Belgium I have no idea, but the closest lab is not always the cheapest/ fastest. Some options include Namsa in the US and SGS which I think have a branch in Belgium.

Next steps should be to
1) decide that you really need to do some sort of 10993 tests, which you probaly already did.
2) Contact a test laboratory and ask for a quote. Based on your intended use they might help you decide which tests are necessary.
3) Start now as the testing might last for months.

A helpful guide is this (attached) from SGS.

Good Luck
 

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J

jayquality

#3
thanks for the reply
the document is very helpfull
sgs does have a branch here, i'll probably get in touch with them

our product is a flat plate where people walk or run on and we measure the pressure pattern from their feet for gait analysis
so contact time is very short, barefoot often and sometimes damaged skin (wounds on feet)

most raw material is used as-is during manufacturing, pvc is milled, aluminum is cut and drilled into
 
R

Roland Cooke

#4
I would imagine you could easily justify NOT running biocompatibility tests, if you can show that the material is industry-standard, and not overtly toxic.

You say the contact time is short, but it might make a difference if the same (foot-wound) patient is going to have repeated exposure to the surface.


However, what you really might need to do is demonstrate safe and effective cleaning methods, including recommending what cleaning agents to use. To my eye, the risk from toxic/corrosive residues from industrial cleaners is a far bigger risk than walking on a plastic mat.

(You may also need to consider if those agents might change the nature of the material over time.)


All the above might even have an impact on the design of your device - especially as any IFUs are likely to end up in the dustbin. Permanent labelling may be more appropriate.

If it turns out that you do need biocompatibility tests run, I can put you in contact with my colleagues in SGS Life Sciences, they do have a test centre in Belgium I believe.
 
J

jayquality

#5
thanks, that gives me another good angle on the situation
we do recommend cleaning with Huwa-san TR-5 (5% H2O2)
but yes, it is something to factor in

i filled in an information request on the sgs web site yesterday
 
M

micaudwell

#6
It is as well to remember that ISO 10993 does not contain any requirements to test. Its states that various characteristics should be considered and then goes on to discuss various biological evaluation tests that may be used.
It seems likely that for the application described and the materials involved a case that specific biological testing would not be necessary in this instance.
 
J

jayquality

#7
a short follow up closure on this...

i contacted a few labs but they all seem to be too busy to reply :mad:

eventually, after filling in the same contact form for 3 times, i got a call from an NB, actually someone responsible for medical devices audits and not specific for the bio testing

we had an interesting conversation, with the low risk of our product and indeed the common use of the materials, a technical file with msds's and evidence of other common products using the same materials should be enough

this guy really knew what he was talking about, a completely different story than the rep i talked to from another NB, he did not even know where i could find a test lab

we are considering changing our NB from TUV to SGS because of this
 
R

Roland Cooke

#8
I'm glad we were able to help with this.

At the end of the day, you have to justify whatever it is you end up doing.
 
G

GBurns07

#9
Hi I have looking for information regarding Biological Testing of Class 1 medical devices. The company I work for manufactures postural seats for children. Would be need to test the whole seat for Cytotoxicity, Irritation and sensitization on the whole seat or just the fabric of the cushions. The fabric is widely available. I would be grateful for some advice on this matter:cfingers::cfingers:
 
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