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

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 modelPI (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.

Marking on stainless steel

Laser marking process: Annealing

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 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.