Laser Etching on Orthopedic Implants: Three Ways to Avoid Bio-Compatibility Testing

Laser marking of orthopedic instruments requires strict adherence to the requirements of biocompatibility review.The course focuses on three areas: materials selection, parameter settings, and marking regulations. It teaches attendees how to avoid problems that can lead to failed inspections, ensuring product safety and compliance, and raising production efficiency and product reliability.

Why would laser engraving trigger a mine?

The laser etching of orthopedic instruments may look simple, but if one is not careful, it can lead to problems of biological compatibility.For example, if the surface of the material is damaged or if residues are not cleaned up properly, then the examiners will "flash the red light.Today we'll discuss how to avoid these hidden pitfalls.

Minefield 1: Choosing materials by gut instinct.

Don't let "habits" trap you.

Many people think, "I used titanium alloy before and it worked fine, so it should work fine this time too." But after the engraving, they discover that the surface oxide layer has been damaged.In fact, there are often slight differences in the composition of different batches of metal, so a small test area has to be done first to confirm that the laser parameters are appropriate for the current material.

Be wary of coatings.

The most easily overlooked items are those with surface coatings (such as antimicrobial coatings).The high heat of the laser may change the chemical properties of the coating and even release harmful substances.We suggest that customers confirm with the coating supplier the maximum temperature at which the coating can be used, and adjust the engraving depth if necessary.

The second minefield: One-size-fits-all parameter settings.

More power isn't necessarily better.

If the power is too high, although the letters will be clear, it will cause the material to carbonize, leaving small particles behind.Once a manufacturer was sent back for re-examination because the power of its equipment was too high, which resulted in the formation of carbonates on its surface.

Don't be lazy about the cooling process.

When the machine is working continuously, heat accumulates, which may change the local properties of the material.We recommended that the machine be shut down for ten minutes after each batch of characters is engraved, or that a cooling device be added. That's a lot better than having to go back and do the job over again.

Landmine No. 3: No standard for content.

Too much information can be a problem.

Some manufacturers like to engrave the equipment with a lot of product information, and the result is that the letters are too close together, causing local overheating.Remember: The label only needs to meet the basic UDI requirements. Leave the detailed instructions to the outer packaging.

The size of the characters is important.

Characters smaller than 1 mm tend to become blurry after sterilization, but characters larger than 3 mm may affect the strength of the instrument.We recommend that you refer to the clinical data on similar products, and choose a font size in the 1.5-2.5 mm range.

Finally, I would like to remind everyone that every time a manufacturing process is adjusted, it is absolutely necessary to carry out a supplementary test for biocompatibility.Don't be put off by the hassle, because compared to the cost of a delay caused by a failed inspection, it's really not much.