Laser marking on medical devices

Medical devices and components

Laser marking on medical devices and components is necessary to ensure product quality, prevent counterfeiting and increase patient safety.

A UDI code is mandatory for manufacturers in almost all countries worldwide. For this reason, Laser marking has taken on a key role in the process of manufacturing medical devices and components of all safety classes.
As a marking process between laser engraving and marking the former certainly prevails as it does not affect the material unlike engraving.

Advantages of laser marking on stainless steel, titanium, and plastic

Safer than any other technology

LASIT collaborates with the ELEN group, specialized in supplying the medical sector across all levels. LASIT conducts research and testing projects with ELEN. This leads to the implementation of new technologies to support this sector.

Biologically compatible

Laser marking does not compromise component hygiene and codes withstand cleaning with alkaline substances and sterilization at high temperatures.

Resists corrosion

LASIT offers 100-hour component salt spray testing, with a citric and nitric passivation cycle post-marking.

Discover the precision that makes the difference

Download the brochure to explore our industrial laser technology solutions in detail.

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Discover why our clients choosed us

"We’ve chosen LASIT a few years ago and we are so happy with the laser marking machines->home we use. Their customer services is always available. The high quality of their components makes this supplier a great partner for our company."
Mirko CalviProduction Specialist
BREMBO

"I came across LASIT about 9 years ago and since then I have kept collaborating with them to develop new machines to add to our production processes. We still collaborate with LASIT because of the quality, reliability, and automations of their products. Behind a product there is a successful company where people are eager to take on new challenges."
Andrea de Danieli Engineering Manager
MANFROTTO

"I can only speak wonders about them. I had a problem with a laser installed on the equipment, which we solved brilliantly, thanks to their indications. Despite the fact that I didn’t monitor this system personally, their indications were so clear that it all went pretty smoothly."
Franco ToffoloProduct Manager
ELECTROLUX

"The technical system of Lasit machines is perfect for use on Automotive components. Support of our qualified Lasit team comes with each specific machine"
Ricardo Benjamin MartinezMechanical Engineer
AMERICAN AXLE & MANUFACTURING

"We met LASIT when he was still little more than a small craftsman; we have lived with LASIT its path of exponential growth in a few years and appreciated the great capacity for transformation, innovation and proposal of "ad hoc" solutions for the customer."
Gabriele RavelliSenior Purchasing Manager
BERETTA

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UDI code laser marking

The UDI (Unique Alphanumeric Identification) code is applied to medical devices to ensure product Traceability, benefiting both manufacturers and the patients themselves. The code is mandatory and serves to guarantee:

Compliance with quality standards

Optimization of replacement times

Increased efficiency and standardization of instrumentation sets

Analysis in case of loss or theft thanks to localization

Laser marking on medical devices and components

Laser marking is the most widely used technology in medical industries, as it ensures the highest standards of safety and durability.

Direct marking in the medical industry follows a precise code system – GS1-128 and GS1 Datamatrix – containing mandatory information for traceability purposes.

Our laser marker uses the following processes to apply these codes:

Cold marking: the oxide film remains intact, while the surface darkens

Laser engraving: removes surface material from the component

Black laser marking: surface heating

GS1-128 LINEAR BARCODE (commonly used for UDI data capture)

DI (Device Identifier)

Mandatory, it is the fixed part of the UDI code that identifies the product and the specific version or model

PI (Production Identifier)

Conditional, is the variable part of the UDI encoding that can include one or more of the following information:

Production batch number (10), -> serial number (17)

expiry date (15), -> production date (12)

distinct identification code for cell, tissue or tissue-based product

The UDI code must be visible to the human eye and applied to all devices, which can be divided into the following categories:

Class I devices (low risk)

Class II devices (moderate risk), such as pumps and syringes

Class III devices (high risk), such as heart valves, implants, and pacemakers

Laser marking resists corrosion and chemical agents. The result is permanently visible and does not fade. Laser marking is the most reliable tool for operating room devices, as the size numbers (on scalpels for example) are useful to surgeons during operations. Laser marking thus plays a fundamental role.

Laser marking process: Annealing

Annealing is the most common laser marker process used on medical devices and components. Annealing gives an impalpable surface laser marking. The surface is completely smooth to the touch. Unlike other marking and engraving processes, no material is removed. The surface is therefore unaltered and the marking defined.

Marking on stainless steel

Detergents, disinfectants, sterilization and passivation processes can corrode the UDI codes on stainless steel medical devices and components. A preventive study of these factors can avoid this situation, as can setting ideal marking parameters to ensure long-lasting results and unchanged contrast.

Marking on plastic and UV laser

For plastics, usually test-tubes or very thin tubes, LASIT has replaced the UV technology with laser technology that marks all medical devices and components while maintaining high-quality standards.

Fly UV

Fly UV colors the surface of the product with a photochemical process and the heat produced by the marking is so limited that it does not damage the medical device or component.
With a typical pulse duration of 20 ns and a beam diameter of 10 µm, the FlyUV processes surfaces without damaging them, unlike normal infrared marking on plastics. This laser is ideal for the medical sector (catheters and insulin pumps can be given a durable marking, resistant to sterilization), and for glass components which can be watermarked.

Laser marking: resistance to the passivation process

In the LASIT Laser Test laboratory, we carry out resistance tests of the laser marking to citric passivation processes, with a subsequent verification of material oxidation through a 24-hour salt spray cycle. In this way, we can guarantee that the specific laser we use to carry out the tests maintains the quality and functionality of our customers’ products unaltered.

Picosecond laser marker: no reflection

Picosecond laser, a unique fiber laser technology, has gained renown in the medical industry for its unrivalled results on metal components. The main advantage is the total absence of reflection on the laser marking, no matter what the angle of light. Moreover, the Picosecond laser is three times faster than the traditional fiber laser in terms of production.
The ultra-short pulse duration allows the Picosecond laser to mark materials where traditional nanosecond infrared lasers can’t. Its almost cold ablation also makes it suitable for a wide range of materials and applications, virtually eliminating heat transmission on components.

A customized solution for implants, designed by LASIT

Implants are extremely delicate. This factor, together with the demand for multi-sided marking, made it necessary to create a laser marker with an anthropomorphic robot to take the parts from the template and position them under the laser head at all the required angles.

The exact centering and positioning of each component by the robot under the laser offers not only an aesthetic value for the marking of alphanumeric codes, but also a functional value: alignment notches, which are essential for correct insertion of the prostheses in the operating room, were also marked on the implant.

Since the same machine marks all three components, the laser marking machine is equipped with a multi-magazine and a fully automatic pick-up and positioning system.

Once the pallets have been loaded into the magazine, the laser marker works without the need for an operator: the software identifies the type of component through a specific Datamatrix code, sets the corresponding marking, and starts the cycle.

Watch our video of the FlyRobot marking process.

Our advantages

Sole supplier

No intermediary,
from design to realization

Interface

PROFIBUS protocols,
PROFINET and PROFIsafe

Integration

Integrations with
MES / ERP systems

Industry 4.0

Business database interaction
for industry 4.0

Vision system

Automatic centering, 2D code verification and grading, OCR recognition

Laser system

For every application and integration
in production chains