Extractions: The How and Why
There are many mentions of extractions in medical device testing. In this episode, our hosts discuss ISO 10993-12 for sample preparations and extraction conditions. What happens to a sample when it’s received at a laboratory before they begin the testing? How do they actually get an extract out of a piece of plastic and when has the extraction gone too far? All of this and more are answered in this episode of BiocompCHATibility.
“If you are looking at the biocompatibility testing, the concept of extractions is going to come up eventually. Basically, trying to get something that we can dose into a study, whatever study that you are doing. If you are trying to simulate what the human body may pull out of a device once the body is exposed to a device. Then you are trying to assess what the hazards are from that exposure. That’s what we use extraction to do.” –Don Pohl
“Who has ever designed a medical device to be suitable for extraction in various vehicles at temperatures higher that is intended to be use? That is literally what you’re asking yourself when considering part 12. You didn’t design it to test it, you designed it to do what it’s supposed to in a clinical application. This causes some frustration.” –Don Pohl
Key Discussion Points include:
- What is the importance of working with your laboratory on selecting extraction conditions?
- Where were the extraction conditions developed?
- What is the rule of thumb to select the appropriate conditions?
- How do you consider the steps to not degrade the extracted chemicals?
Also be sure to check out our Biocompatibility Strategy Navigator.