Non Corrode Black Marking for Medical Devices
Black marking using lasers covers a multitude of applications from packaging to medical devices and everything in between. Lasers are capable of creating identification marks on numerous materials including plastics and stainless steel.
The requirement for Unique Device Identification (UDI) by the EU’s Medical Device Directive and USA’s FDA regulations on medical devices creates some distinctive and quite challenging issues for manufacturers of medical devices. In an industry where traceability of devices is paramount and ensuring that devices are equally safe to use, it falls on the device manufacturers to come up with the solutions. Advances in medical device UDI marking have increased confidence in device manufacturer’s to deliver parts that fulfil the high standards required to ensure identification marks and codes are suitable.
Key requirements for suitable UDI include:
- Traceability ensured from the device manufacturer for the whole life of the product
- Non-corroding markings that do impair device functionality. Do not degrade in situ within the body or cause contamination whilst being utilized
- High contrast markings permanently legible at all angles
- Able to withstand multiple rigorous autoclave cleaning processes to high temperatures and high humidity
- Compatibility with a range of different medical devices and grades of materials
- Legislative requirements on traceability cover a wide spectrum of medical devices in diverse applications from pacemakers, implants, replacement knees & hips, dental implants & dental tools, surgical instruments/tools, electronic/laboratory equipment & tools, to name a few.
Using the OpTek process, codes and marks remain permanent and are more suitable due to their corrosion resistance, viewing angle consistency and deep-black colouring, something not available with standard laser marking processes.
In addition to the appropriate laser process, OpTek are uniquely positioned to provide automated component handling and positioning ready for laser marking. This ensures accurate location of the mark, increases throughput and minimizes the need for user handling. This can be in the form of subcontract manufacturing services at one of OpTeks global locations or through OpTek providing fully integrated (deliverable) laser marking workstations.
Need our help? Fill out our form to ask our OpTek experts.