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Laser solutions for the medical industry SISMA offers an articulated and advanced series of production solutions, specifically developed for the medical sector, with particular attention to the creation of economic advantages in terms of productivity. Internally produced in our plants, they represent the ideal solution for professionals looking for quality and reliability in the processing of plastics and metals.

Medical marking applications Most medical equipment usually goes through a process of chemical passivation, creating a surface film over the equipment that enhances its inherent corrosion resistance, preventing corrosion while also making it less susceptible to germs. One of the major benefits of medical laser marking technology is that it can mark instruments without causing any harm to the chemical coating. The marked surface retains its corrosion resistance even after being continually used, cleaned and sterilized for years. Marking of medical equipment is necessary to ensure that the...

UDI hints In order to enhance the effectiveness of the post-market surveillance of all medical devices, both the United States and the European Union have adopted geographically-delimited unique device identification (UDI) regulations. In compliance with said standards, each tool must, then, be labeled with HRI (human readable interpretation) and AIDC (automatic identification and data capture) identifiers (the last one being mandatory), unless otherwise specified. Owing to strict clinical and operational requirements of the medical-grade steel equipment, UDI identifiers must meet, at...

Black marking on medical devices

CO2 and UV laser applications Medical instruments or implants can be manufactured from a diverse range of materials. It is possible to use a laser to mark medical devices made from a variety of materials such as cardboard, paper, glass, ceramic… SISMA’s CO2 laser markers are the ideal solution for marking medical device packaging such as cases, boxes, blisters, etc. The configuration of the lasers allows a wide range of cardboard substrates to be coded. Our Lasers, with their ability to leave an indelible mark on the product, are the perfect tools for direct coding of medical devices...

SISMA turnkey solution for UDI medical marking In order to be able to track all relevant information about the product and to increase the safety of medical devices, each medical instrument has to be marked in the form of a unique, machine-readable data matrix code. To help you implement the UDI guidelines, the SLC3 control software for Sisma laser machines allows marking devices to be seamlessly integrated into the UDI process. SISMA medical laser process in medical technology The UDI code is generated through manual or automated input, while the software constantly dialogues with the...

Process validation and qualification of laser system solutions: DQ, IQ, OQ, PQ, MQ In the highly-regulated pharmaceutical, medical devices, and clinical industries, even tiny inconsistencies can compound into serious issues without the proper qualification and validation protocols in place. As a component of quality assurance, equipment validation is absolutely critical to producing consistent, high-quality products. One of the key sets of protocols within equipment validation is Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Maintenance...

SISMA S.p.A. High precision laser systems, chain making machines and additive manufacturing. SISMA is a worldwide reference in the design and production of extremely high precision machinery and laser systems. Headquartered in Italy, SISMA can count on a worldwide network and subsidiaries in Mexico, Spain, Turkey and USA. Established in 1961, SISMA can boast an extensive experience with more than 150 models of automatic chain making machines. Today at the forefront in the development of laser solutions, SISMA has been able to extend its know-how to marking, welding, cutting, engraving and...