#2
Krishna,

what is the nature and duration of body contact your lancet has? What is the intended use of your device?
 
#3
From my understanding, a lancet is usually a spike or needle used to puncture the skin in order to provide a blood sample. They certainly "contact intact skin" and also "Breached or compromised surfaces"; and would be of limited duration.
 
#4
In case the nature of body contact is really the one that Chris suspects, the category according to ISO 10993-1:2018 is either "Limited contact to breached or compromised surface", or "Limited tissue contact", both with the following endpoints according to Table A.1:
  • Physical and/or chemical information
  • Cytotoxicity
  • Sensitization /Irritation or intracutaneousreactivity
  • Material mediated pyrogenicity
  • Acute systemic toxicity
ISO 10993-1:2018, section 5.3.2 might also be useful in case the contact duration is very short:

Some medical devices with limited exposure (A) have very brief/transitory contact with the body (e.g. lancets, hypodermic needles, capillary tubes that are used for less than one minute). These generally would not require testing to address biocompatibility.
HTH,

Gerhard
 
#5
Hi Gerhard

Thanks for the update about 10993-1:2018; that's good information that I had not seen.

I just spent 10 minutes wondering why I did not know about the 10993-1:2018 version. It is currently only an ISO standard and has not yet been published as EN ISO10993-1 or BS EN ISO....... The 2009 is still the harmonized version.
 
#6
Thanks Gerhard and Chris for the update.

I am not understanding contact to breached or compromised surface wrt Lancet. can you please brief on this.

Whether blood sample will be collected from breached or compromised surface?
 
#7
Krishna,

breached or compromised skin: opposite of intact or undamaged skin.

In case you do not get in contact with circulating blood, collecting blood samples does not introduce additional biological hazards to the list above.

@Chris: Depending on your notified body, their stance on "state of the art" may over-rule the concept of harmonized standards, since the harmonization process for medical devices essentially came to a stand-still in the past years.

HTH,

Gerhard
 

Top Bottom