Biocompatibility & Chemical Characterisation acc. ISO 10993-18
Medical devices are subject to strict requirements to documentation
When medical devices are in question, the Authorities demand evidence that no biological risks are involved in the use of medical devices.
In connection with medical devices that come into direct or indirect contact with the body it is required that the manufacturers of the medical devices are familiar with the content of the chemical substances and which concentrations the users can be exposed to.
Medical Device Regulation (MDR) is valid since 26 May 2021
With the new Medical Device Regulation (MDR) have come into force on 26 May 2021, the requirements for manufacturers and distributors of medical devices have increased considerably.
Medical devices that had been approved before 26 May 2021 according to the MDD had to be recertified according to the MDR before 26 May 2024. The EU now postpones this deadline to 31 December 2017 for all high-risk products. For medium and low risk products, the deadline for re-certification has been postponed to 31 December 2028.
If you are not yet ready for the MDR, it is important to start the process now. Please send a message or give us a call - we will be happy to help you further
How can the Danish Technological Institute help you?
The laboratory at Danish Technological Institute can assist with the chemical characterization of medical devices and with analyses of extractables and leachables according to EN ISO 10993-18.
The results can be used for biological evaluation of medical devices.
If new analysis methods have to be developed, then Danish Technological Institute will enter into a close co-operation with the customer to obtain the best results.
We can carry out the following analyses:
- Studies of leachables and extractables. The studies are carried out according to ISO 10993-12:2021 and ISO 10993-18:2020
- Chemical characterization of medical devices according to ISO 10993-18:2020
- Screening analyses for unknown constituents - for organic as well as inorganic substances
- Analyses for content of residue solvents or residue monomers in medical devices
- Analyses for content of inorganic elemnets, including metals
The laboratory is accredited according to ISO/IEC 17025:2017.