Black Laser Marking | Ideal for Medical Products
Permanent, Corrosion-Resistant Black Laser Marking Ideal for Medical Technology
Achieve high-contrast, FDA-compliant UDI codes on medical devices and other components using ultrashort pulse lasers – without compromising material integrity or using harsh chemicals.
Meet the Requirements of the Medical Field
Many industries need reliable and efficient processes that deliver high-quality results, but perhaps none more so than the medical equipment field. Between handling compliance needs, maintaining patient safety, and avoiding faulty parts and marks, medical device production facilities have a lot to juggle, and black laser marking is the ideal solution for these concerns.
The Challenges of Sterilization and UDI Compliance
Because of their use in patient care, medical devices need to undergo aggressive cleaning cycles to ensure sterilization. These cleaning cycles often feature high temperatures, harsh chemicals, and ultrasonic baths which, over time, can significantly wear down inkjet markings and traditional thermal laser markings created via annealing. This is because oxides are created that can eventually fade during repeated autoclaving and passivation.
| Marking Method | How It Holds Up to Sterilization |
|---|---|
| Inkjet marking | Worn down over time by high temperatures, harsh chemicals, and ultrasonic baths. |
| Thermal laser marking (annealing) | Creates oxides that can fade during repeated autoclaving and passivation. |
| Black laser marking (USPL) | Intrinsically corrosion-resistant surface structure that remains legible after numerous cleaning and passivation cycles. |
Meanwhile, the FDA’s regulations and the EU’s medical device regulations (MDR) stipulate that permanently legible labels with unique device identification (UDI) codes must accompany certain medical items for the product’s entire lifecycle.
So medical device companies and medical facilities that want to maintain compliance need an effective solution that will endure cleaning cycles and maintain full legibility – enter black laser marking.
Cold Black Marking with Ultrashort Pulse Lasers
Black laser marking uses ultrashort pulse lasers, or USPL, operating in the range of picoseconds (one trillionth of a second) to femtoseconds (one quadrillionth of a second).
How It Works
| 1 | These short pulses don’t simply burn a surface – they restructure it. |
| 2 | Since the pulses are so short, the process is virtually “cold”. |
| 3 | The lasers create periodic nanostructures on a material’s surface, trapping and absorbing light so that marks of a deep, matte black color are produced. |
Why It Helps
- No thermal stress cracks. Due to the process’s cold markings, stress cracks do not form on essential medical components and other parts.
- Corrosion resistance stays intact. With black laser marking’s negligible heat-affected zones, chrome and steel on metal components remain in place, forming a self-healing oxide film that’s extremely corrosion-resistant.
- High chemical integrity. The process withstands passivation without fading, so cleaning cycles can be carried out without damage.
- Permanent, UDI-compliant marks. The dark marks the process creates meet the UDI requirements imposed by the FDA and MDR.
- Value beyond medical. These same attributes benefit any industry — permanent, repeatable, and legible marks aid in general traceability, asset tracking, anti-counterfeit measures, product branding, and much more.
Why ACSYS Is Your Source for Black Laser Marking Systems
ACSYS is an experienced partner of medical device manufacturing companies, providing diverse systems that can facilitate black laser marking through the use of ultrashort pulse lasers. Our laser systems:
- Ensure maximum precision and sterility, even for the smallest components
- Can handle complex 3D geometries, maintaining uniform markings
- Are versatile, user-friendly, and highly automated
- Easily produce UDI-compliant markings, barcodes, serial numbers, logos, and much more
- Feature processing options for marking, engraving, cutting, structuring, and welding in select units
Our team has been providing customers with application consultations, process development, and customized hardware and software integrations for over twenty years. From process development through training and support, we do it all, providing you with turnkey solutions you can count on.
FAQs on Black Marking
Can black marking be applied to very small or delicate medical parts?
Yes. The ultrashort pulse lasers used in the black marking process can apply markings at very small spot sizes, making them ideal for applications like creating filigree markings and data matrix codes on small surface areas.
Do black markings fade if instruments are passivated?
No. Unlike traditional annealing, black marking creates a surface structure that’s intrinsically corrosion-resistant, producing marks that remain legible even after numerous cleaning and passivation cycles.
Is the black color created by applying a chemical or additive to the metal?
No. The deep black color is created entirely by the laser modifying the surface nanostructure to trap light, known as light scattering. No material ablation. No chemical additives.
Meet Essential UDI Compliance with Black Laser Marking
Don’t let yourself fall victim to fines and penalties due to illegible and fading markings. Invest in a high-quality laser system from ACSYS to create permanent black laser marks. Contact our team to discuss equipment options.