Five Industry Standards for Laser Engraving on Medical Instruments

Medical laser engraving must strictly adhere to five standards: material compatibility, permanence of the mark, sterile adaptability, traceability of information, and operator qualification.From choosing equipment that meets the requirements of the ISO 13485 standard to recording operating parameters, every step directly affects the safety and compliance of the medical devices, ensuring that product labels are still legible after sterilization, so that they can be traced for more than 20 years.

Why does laser etching for medical use require special standards?

Medical instruments come into direct contact with the human body, and the information etched on them is not only for product identification, but also for tracing safety.Unlike ordinary industrial products, laser marking on medical devices must be clear and long-lasting, while at the same time not contaminating the material or damaging its performance.

They must adhere to a core set of standards.

Testing of material compatibility

Different materials (like titanium and high polymers) react very differently to laser energy.Before the laser is used, experiments must be carried out to confirm the parameters, to ensure that the etching does not damage the structure of the material or affect its biocompatibility.

Permanent markers are required.

According to ISO 15223-1 standards, UDI (unique device identification) on medical devices must remain legible for 20 years.The laser etchings must be able to withstand alcohol wiping and high-temperature sterilization tests.

Aseptic compatibility.

In clean rooms, the laser marking machines must meet GMP standards, and be equipped with dust-proof sealed devices.For certain implants, the marking process must not leave any particles behind, so as to avoid the risk of secondary pollution.

Traceability of information.

The parameters for each piece of equipment must be automatically recorded and tied to the production batch.If a product quality problem occurs, it is possible to quickly retrieve information about the etching power and speed, making it easier to track down the source of the problem.

Certification of operators.

The operators of medical laser equipment must hold a certificate of training in the Good Manufacturing Practice (GMP) standard for medical devices, be familiar with the characteristics of materials, and be well prepared to handle emergencies, so as to avoid product failure caused by human error.

A guide to choosing equipment.

When purchasing a laser marking machine, it is important to check if the equipment has passed ISO 13485 certification.They suggest that consumers ask the manufacturer to provide a test sample of the same material to see if the edges of the markings have been carbonized and if the surface of the material has oxidized and changed color.