Biocompatibility classification for Lancet

K

Krishna Priya T

Starting to get Involved
#1
#1
Hi,

lancet is neither skin contact nor contact with blood path. can you please tell me the classification in which it will fall as per ISO 10993-1?
 
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planB

planB

Super Moderator
#2
#2
Krishna,

what is the nature and duration of body contact your lancet has? What is the intended use of your device?
 
chris1price

chris1price

Trusted Information Resource
#3
#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.
 
planB

planB

Super Moderator
#4
#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.
Click to expand...
HTH,

Gerhard
 
chris1price

chris1price

Trusted Information Resource
#5
#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.
 
K

Krishna Priya T

Starting to get Involved
#6
#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?
 
planB

planB

Super Moderator
#7
#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
 
J

Jnks_Meddev

#8
#8
Hi Everyone,

I am doing the gap analysis on our product to see if there is any change with the updated ISO 10993:2018. Can someone please let me know how do I go about this? Is there a checklist or something that I can refer to ensure any updates required for our product?
I need to make sure that the testing documents has no effect as well as conformance to ER with the updated revision.
 
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