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