Extractable in my DM?

Medical devices are instruments or apparatus intended for use in the medical field. It can be a stethoscope, glasses, crutches or even a dental implant, a blood bag, etc.

As you will have understood, these devices are highly likely to come into contact with the human body. It is therefore essential to check that these products present no danger to the patient, which is why it is important to ensure that the devices do not release compounds that are dangerous for the body.

MD manufacturers and distributors have already called on the Polymex team to carry out analyzes and studies of extractables according to standards 10993-7 , 12 and 18 .

What do these analyzes consist of?
The goal here is to simulate or even exaggerate the conditions under which the device would find itself once in contact with the body, in order to be able to extract as much as possible of the compounds which would be susceptible to migrating from the device to the patient. Once the extraction has been carried out, the extracts are analyzed in order to identify and quantify the extractables resulting from the conditioning.

These analyzes will make it possible to identify, for example, ultra-volatile organic compounds such as ethylene oxide , and to estimate their content in order to check that it does not exceed the acceptable threshold.

Determine whether the proportion by crosslinking in a two-component epoxy adhesive

The Polymex laboratory is able identify and quantify extractables from devices medical devices, whether of classic form (ear plugs, implants, etc.) or of complex form!
It is important that all of your needs are met, which is why the Polymex laboratory is committed to carrying out tailor-made analyzes according to your problem.

Are you a manufacturer or distributor of medical devices and wish to proceed with the analysis and study of extractables on your medical devices? Or notice a defect or failure on them and want to understand the origin? Take a look at our page dedicated to DMs or contact us!

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