"Governed by numerous standards ensuring the reliability of its components, the medical sector has implemented numerous traceability processes over the last few years," said an SIC Marking USA spokesperson. "With markings applied to the various components, it is possible to obtain information about the manufacturer, component reference number or expiration date. All this data complies with the Unique Device Identification (UDI) and Medical Device Regulation (MDR) standards, which are essential for exporting devices to the USA and Europe. "The components to be marked are as diverse as the professions that make up the medical sector. These include surgical instruments such as scalpels or bistouries; prosthetics or orthoses made of steel, cobalt, ceramics or biomaterials; dental implants, often made of titanium; hearing aids; and pacemakers."
The spokesperson continued, "In order to ensure optimal identification throughout their distribution and use, these multiple devices must contain a machine-readable barcode or Datamatrix as well as several alphanumeric codes that can be identified by humans. Quite often a logo is applied."
In addition, there may be constraints linked to the complexity of the marked components and the sector of activity. "For example, the materials with which the various devices are made can be complex and varied (steel, titanium, stainless steel, ceramics, various alloys, biomaterials, etc.) and require technical expertise when marking," said the spokesperson. "Precision objects and medical tools are often small and leave very little space for marking. Despite the small marking windows, the identifiers must be contrasting and visible. Another challenge is not to weaken the part nor to change its surface state. It is also important to take into account all the surface treatments and sterilization cycles that medical instruments undergo."
Benoit Massel, Specialist of Laser Marking Technology at SIC Marking, said, "All the difficulty of permanent marking by laser technology on medical parts lies in the ability to obtain a contrasting result without affecting the surface state of the material, which must resist passivation treatments. The technology must also be able to mark on a variety of materials. All of these constraints make the traceability of medical tools a real technical challenge. This is why SIC Marking is committed to providing the most appropriate marking solutions to meet all the challenges faced by the medical sector."
SIC Marking's latest generation technology consists of emitting radiation from a source, amplifying it and directing it towards the part to be marked. The beam creates a chemical reaction on contact with the workpiece. "This traceability solution offers flexibility of use and is able to mark barcodes, Datamatrix codes, alphanumeric characters and logos while adapting to any material," said the spokesperson. "The high-contrast and durable result obtained allows perfect reading over time for optimal traceability. Laser marking does not weaken the part and does not degrade its hygiene, a crucial factor in the medical sector."
The SIC Marking Laser product range can be adapted for serial or single marking. It consists of lasers that can be integrated with various options:
- 3D function for marking on complex shaped parts, different heights, curves or angled faces
- Integrated Vision function for fast reading of barcodes and Datamatrix codes
- Rotary D-axis for marking cylindrical workpieces around the diameter.
The range is completed by three marking stations, L-Box, XL-Box and the new XXL-Box. SIC Marking provides a feasibility study before each project.
For more information contact:
SIC Marking USA
137 Delta Dr., O'Hara TWP
Pittsburgh, PA 15238
877-742-9133
info@sicmarkingusa.com
www.sic-marking.com