Views: 0 Author: Site Editor Publish Time: 2025-05-26 Origin: Site
Medical device manufacturers can use laser markers to mark trademarks, serial number marks and traceable marks on products to improve brand awareness and product image, and help consumers confirm the source and authenticity of the products. The US FDA introduced the requirements for device identification ( 2015UDI ) in 2018 as a standard for tracking and identification of medical devices. UDI is a permanent logo that needs to be engraved on the implant device or otherwise attached to the device. This helps the FDA to regulate and track medical devices more effectively, ensuring public health and safety. In 20182019, the FDA further clarified that it is required to have UDI markings on reusable medical devices . For example, orthopedic surgery robot positioning tools can be reused after high temperature autoclave. To ensure cleaning, disinfection and tracking after each use, UDI applications become very important. UDI identification must meet the following criteria: 1. High contrast and dark black : enables medical professionals to easily identify and read relevant information. At the same time, the satisfaction can be clearly visible in various light and backgrounds; 2. Corrosion-resistant, non-fading, and long-lasting: UDI logos should have corrosion resistance and non-fading properties to ensure that they are kept clearly visible during multiple use, cleaning and disinfection; 3. shallow marking, small surface undulations, prevent bacterial accumulation : UDI marking should be printed shallowly or attached to medical devices, with small surface undulations to reduce the possibility of bacterial accumulation. Helps ensure the cleanliness and hygiene of medical devices and reduces the risk of infection; 4. Machine-readable: UDI identifiers should be able to be read by machines, so the design and encoding should comply with relevant regulations so that they can be correctly parsed and read by the FDA's UDI database and other related systems. It helps to achieve automated identification and tracking of medical devices.
The three most common types of marking on medical devices are:
1
QR code for UDI identification;
2
A scale mark engraved on the catheter and ruler to indicate depth;
3
The pattern, color or logo marked on the surface of the instrument.
Traditional laser black marking
Nanosecond infrared ( IR ) fiber lasers and nanosecond ultraviolet diode pumped solid ( DPSS ) lasers are now widely used in achieving black marking. Although nanosecond lasers can achieve black marking, their processing windows are very narrow, so they cause a lot of troubles to the reliability, stability and consistency of processing, and it is difficult to meet the requirements of UDI marking, because repeated disinfection in medical environments will corrode, fade or fade.
There are challenges and problems in the application of nanosecond laser marking in the medical field. Due to the thermal effect, the mass of marking is not only affected by the working principle of the laser, but also by the geometry of the parts and the alloy used. The heat generated by thermal effect marking will cause an oxide layer to form a surface of the part, resulting in cracks that will cause the mark to fade and the mark will disappear completely during the passivation process.
In order to maintain the integrity of the mark in production practice, weak acid passivation or second blunt ( 5-10 seconds ) are often used to restore the degraded or removed chromium oxide layer during laser marking, so that the surface of the laser marking still has corrosion resistance and rust resistance. However, the implementation of this method is still extremely unstable. No matter how lean the operation is, the risk of laser marking surface fading and rusting cannot be completely avoided, and the requirements of UDI marking or high quality cannot be met at all. The current proportion of such risks is very high and is common in the medical industry.
When reused medical devices are cleaned, disinfected and sterilized, the laser marking parts will fade and rust, which not only affects the integrity and readability of the marking, but also reduces the use experience and intended use of the medical devices.
Corrosion-resistant laser black marking
Corrosion-resistant laser black marking machine lasers have the characteristics of short pulse width (3-4 orders of magnitude shorter than nanosecond laser pulse width) and high peak power, which makes the thermal effect on the surface of the material very small during laser engraving, with almost no damage and will not form a brittle oxide layer. The laser-acting area forms characteristics similar to 'light trap' and has anti-reflection properties, making the laser-acting area appear distinctly dark black. Even after multiple high-temperature autoclave and disinfection, it can still remain dark black, not fade, not discolored, and not corroded. The advantages and engraving effect achieved by corrosion-resistant laser black marking are fully in line with the requirements of the US FDA for UDI marking.
'Good Doctor Medical' upholds the spirit of craftsmanship, insists on breakthroughs and transcendence, constantly identify the risks in the production process of medical devices and take measures to effectively control them. In response to the pain points and confusions of laser marking of medical devices, good doctors pay special attention and actively seek breakthrough solutions, and carry out countless verifications and innovations from the two aspects of source technology and lean technology, and ultimately obtain a perfect solution that is stable, reliable and consistent.
'Good Doctor Medical' now implements corrosion-resistant laser black marking process that breaks through the traditional laser black marking process and fully meets the requirements of the US FDA for medical product identification . This has very important practical significance and promotes the development of the international market by Liang Doctor's partners.
Good doctors have been working hard to help orthopedic surgery robot partners succeed.
