Laser Marking of Implantable Medical Devices

When laser marking medical implants, one must pay close attention to material compatibility, parameter refinement and regulatory compliance.By matching the material characteristics with the laser type, and using a combination of medium-low power with high frequency and short pulses, it is possible to ensure a clear marking without damaging the instrument structure.In daily operation, the equipment must be regularly calibrated and the cooling conditions monitored, and the UDI coding standard must be strictly followed to ensure the effectiveness of the medical traceability system.Rational use of laser marking technology can both increase the permanence of markings and meet the strict requirements for quality control.

Why must laser be used to mark implants?

For implantable medical devices, such as bone screws and artificial joints, the permanence and accuracy of the identification directly affect patient safety.Traditional ink printing is easily worn off, while laser etching can produce a clear code less than 0.1 mm deep on the surface of titanium, stainless steel, and other materials. The code will not blur even after high-temperature sterilization or long-term immersion in bodily fluids.

Three important steps to take before laser marking.

Don't be lazy about testing for material compatibility.

Different materials react differently to different wavelengths of laser light.For example, the cobalt-chromium alloy requires adjustment to a 1064-nanometer fiber laser, while the PEEK polymer is more suitable for ultraviolet lasers.By testing out the process on scraps of material beforehand, it is possible to avoid burning the material too deeply or leaving the marks indistinct.

The parameters are set "accurate, steady, and fine.

Setting the power to 50-70 %, the speed to 800-1200 mm / s, and the frequency to 20-50 kHz can meet the marking needs of most orthopedic equipment.The most important thing is that the mark not be deeper than 10 % of the material's thickness, otherwise it could affect the strength of the tool.

Don't forget to check the regulations.

Both the FDA and ISO 13485 clearly require that the labels on implants include a UDI code, a batch number, and manufacturer information.Before printing, you must be sure that the content and layout are in compliance with the law. In particular, the QR code must be the right size and contrast so that it can be read by a scanner.

A guide to avoiding pitfalls.

If the label turns yellow or carbonizes, it's probably because the power is too high or the focal point is off.If not, reduce the power by 10 % and try again, while also checking to see if the lens is clean.If the edge of a mark appears jagged, try increasing the fill density or adjusting the beam overlap rate.

By calibrating the optical path once a month, you can reduce 70 % of the problems with marking deviation.Remember to replace the filter in the cooling system, and if the water temperature exceeds 25 ℃, immediately check the system. If the machine cannot dissipate heat properly, it will shorten the laser's life.