Microdermabrasion device - classification according to the ISO 10993-1

S

svagrovka

Registered
Hello everyone,

I'd like to consult the topic to correctly identify all endpoints according to the ISO 10993-1. I've seen some devices intended for microdermabrasion being classified as intact skin devices, nevertheless, this categorization doesn't seem to me correct since the procedure must breach the top skin. From this point of view, I'd say that these devices belong more into the category Breached or compromised surfaces. Do you have any experience?

Thanks in advance!
 
planB

planB

Super Moderator
Your device classification has to be consistent with your defined intended use. It seems you walk a fine line with these kind of devices: Googling for "microdermabrasion" returns quite lot of marketing lingo about how gentle this method is without compromising skin. On the other hand, a bunch of warnings turn up in the first search hits to not expose freshly treated skin to direct sunlight or pool water for up to a month after the treatment, the latter clearly indicating that your intact skin is actually breached/more vulnerable to some extent.

From a biological risk-management perspective: would you evaluate your device abrading enough skin material that potential leachables/extractables from your device could cause systemic effects like material-mediated pyrogenicity and acute toxicity (the two additional endpoints for limited contact duration, when you compare intact vs compromised skin exposure)?

Personally, I would be tempted to conservatively answer this question with yes, but again - this boils down to your defined intended use.

NOTE: in case you classified your device as contacting breached skin: this does not necessarily imply that you have to do more testing; in the best case you can make use of your material characterization data to address these additional endpoints comprehensively.

HTH,
 
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