Medical devices

The term medical device is used to name any instrument, device, equipment, material or product intended to be used for medical purposes.

A medical device can be in external contact with the patient or it can be partially or totally implanted.
This is why there are different classes of medical devices depending on the risk they present to the health of the patient:
1) Low risk: glasses, crutches, ...
2) Moderate / measured risk: contact lenses, ultrasound devices, dental crowns, etc.
3) High / significant risk: lens disinfection products, condoms, etc.
4) Highest risk: implants, prostheses, ...
Classification des dispositifs médicaux

You meet needs:

You are a producer of cleaning products, detergents or other products that may contain surfactants and you need a competent and responsive laboratory for analytical service.

Do not hesitate to tell us about your needs and your problem, we will find a solution adapted to your request.


Polymex supports you:

Polymex supports you:

Given their contact or their presence inside the patient's body, it is important to ensure that the MD does not present any danger to its user, which is why MDs are subject to many standards throughout their life. manufacturing process.
Our laboratory is particularly interested in standard 10 993 entitled " Biological evaluation of MDs ".
This standard requires verification that the devices do not release compounds dangerous to the body such as ethylene oxide or ethylene hydrochloride.
These medical devices are therefore subjected to a large number of procedures to ensure patient safety, including cleaning to standards in order to ensure safe marketing.
Polymex is also able to verify proper cleaning by analyzing Total Organic Hydrocarbons (HCT) and Total Organic Carbon (TOC) according to NFENISO 9377-2 and NFENISO 1484 standards.
As you will have understood, the Polymex laboratory is able to analyze your medical devices, whether it is to assess their cleanliness or to test the level of leachable material according to the 10993 standard.
Determination of residual HCT/TOC in medical devices

Determination of residual HCT/TOC in medical devices

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Task analyzes on orthopedic prostheses

Task analyzes on orthopedic prostheses

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Biological evaluation of medical devices - Standard 10993-7

Biological evaluation of medical devices - Standard 10993-7

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