Could XRF help medtech companies identify hazardous substances?
X-ray fluorescence (XRF) is a non-destructive process commonly used to determine the elemental configuration of materials. It can be used to identify hazardous substances used in medical device manufacturing, helping companies comply with evolving regulations such as Restriction of Hazardous Substances (RoHS) regulations.
How Does X-Ray Fluorescence Work?
When X-rays are irradiated, they impact the inner-shell electrons of the constituent atoms and move them in the direction of an outer shell. The outer shell electrons then rush toward the inner shells to take the place of the gaps.
X-ray fluorescence technology encompasses the release of these distinctive secondary X-rays. The secondary X-rays can be found in a substance that has been stimulated by high-energy X-rays (or gamma rays).
One of the main benefits of the XRF is that it is a non-destructive testing process. Analysts can evade damage to the assets they examine; therefore, they are able to find more defects. In addition, the non-destructive method is usually less expensive. Other processes can be costly because the product is wasted in the testing stages.
How Is XRF Technology Compliant with Medical Device Manufacturing Criteria?
Medical manufacturers strive to build the safest products. They conduct the most-reliable methods for screening, testing, and verifying in order to be compliant with RoHS regulations. These regulations are constantly changing as new information is revealed about hazards.
The RoHS Directive identifies substances that are restricted, including:
- Bis (2-ethylhexyl) phthalate (DEHP)
- Butyl benzyl phthalate (BBP)
- Dibutyl phthalate (DBP)
- Diisobutyl phthalate (DIBP)
- Hexavalent chromium
- Polybrominated biphenyls (PBB)
- Polybrominated diphenyl ethers (PBDE)
California also has restrictions and requirements similar to the RoHS. They state that all electronic products sold in California must meet the same criteria as those sold in the European Union.