Laser Tattoo Removal: Industry Standards and Regulations

Laser marking in the medical field is directly related to the safety of patients 'lives, and domestic and international standards make strict demands on the durability and traceability of the markings.When selecting equipment, it is important to pay attention to material compatibility certification and daily maintenance requirements. The equipment must meet international standards such as ISO 13485, as well as the specific requirements of GB/T 29490-2023, the latest standard issued in China.Medical devices made of different materials require different laser parameters. Complete documentation and regular calibration are essential to avoiding risk.

Why medical laser marking needs standards.

The marking of medical equipment is not as simple as just carving a few characters. For example, for equipment like heart stents or surgical instruments, which come into direct contact with the human body, if the markings fall off or become illegible, this can cause serious problems in tracking down the source of any problems.Last year, the recall of a certain type of orthopedic implant was caused by the fact that the serial numbers were not clearly marked, so it was impossible to trace the source of the problem.

Patient safety is the first red line.

Imagine a situation where a doctor is operating, and has to keep flipping through a catalog to find information on a particular product.To meet the requirements of ISO 13485, the permanent marking of medical devices is like a double insurance policy, because the marking must be able to withstand both high-temperature sterilization and wiping with chemical solvents.

The differences in the regulations of Taiwan and other countries.

The EU's MDR and the US's FDA differ in their requirements for etching depth, just as Chinese and Western cuisines differ. The EU requires a minimum depth of 0.05 mm, while the US is more concerned with the readability of the mark after it has been sterilized with gamma rays.The GB / T 29490-2023 standard that has just been released in Taiwan, on the other hand, is a hybrid that incorporates the FDA’s durability test and the EU’s visual inspection system.

The details of certification often go overlooked.

Many manufacturers fall at the hurdle of material compatibility testing. For instance, the parameters required for titanium alloy and cobalt-chrome alloy are completely different.Last year one company had to scrap a product because it had not done a test run with PEEK material and ended up burning the surface of the product.

How to choose a laser device that meets the standards.

Don't let the salesman fool you by saying that the equipment is "medical grade." Only equipment with the complete set of certification documents is truly compliant.I suggest you focus on three documents: the FDA 510 (k) clearance, the CE MDR certificate, and the most important one-the list of material compatibilities provided by the equipment supplier. This list should cover more than 80 % of your product types.

Hidden risks in routine maintenance.

The most extreme case I've seen was of a hospital using industrial alcohol to wipe the laser lens, which resulted in corrosion of the optical components.The maintenance record is not just something to look at. According to YY / T 0595 standards, monthly calibration is just as important as regular maintenance of a car.