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:

Are you a manufacturer of medical devices and want to check the conformity of your products, assess their cleanliness, check their harmlessness according to the NF EN ISO 10993 standard, or even notice the appearance of a defect and you want to understand its origin?
Contact us!
With a complete analytical park and a competent team, the laboratory is able to meet your needs while meeting the requirements imposed by the various standards to which these devices are subject.

Polymex accompanies you:

Given their contact , or even their presence inside the patient's body, it is important to ensure that the MD presents no danger to its user, which is why MDs are subject to numerous standards throughout their life. their manufacturing process.
Our laboratory offers analyzes relating to the NF EN ISO 10993 standard entitled " Biological evaluation of Medical Devices ", and is particularly interested in the aspects relating to sample preparation ( NF EN ISO 10993-12 ) and chemical characterization. ( NF EN ISO 10993-18 ).
This standard requires verification that the devices do not release compounds that are dangerous to the body (study by screening), or that there are no residues from the manufacturing process, for example sterilization residues of the oxide type. ethylene or ethylene hydrochloride (NF EN ISO 10993-7).
These medical devices are therefore subject to a large number of procedures to ensure patient safety, including cleaning to standards in order to ensure risk-free marketing.
Polymex is also able to verify proper cleaning by analyzing total organic hydrocarbons ( HCT ) and total organic carbon ( TOC ) according to NF EN ISO 9377-2 and NF EN ISO 1484 standards.

You will find more information in the brochure! Click here !

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.

Other examples of benefits for medical devices:

Determination of residual HCT / TOC in medical devices (Based on standards NF EN ISO 9377-2 and 1484)
Determination of residual HCT/TOC in medical devices

Determination of residual HCT/TOC in medical devices

MDs must meet strict standards because they are implanted inside the body. The presence of stains, inclusion or any other defect renders..
Task analyzes on orthopedic prostheses

Task analyzes on orthopedic prostheses

Medical devices are subject to standard 10993-7 which specifies the permissible limits of residues of ethylene oxide and ethylene..
Biological evaluation of medical devices - Standard 10993-7

Biological evaluation of medical devices - Standard 10993-7

Standards 10993-12 and 18 deal with the extraction of materials and analysis techniques allowing us to identify and quantify the elements..
10993 -12 & 18

10993 -12 & 18