Interpreting Medical Certification Standards for Laser Marking Machines

Medical laser marking must meet both the standards of permanent marking and of biological safety, and there are special requirements for material compatibility and precision.The ISO 13485, FDA, and CE certification systems not only regulate the production process, but also set strict standards for the traceability of marking.Understanding the specifics of these certifications can help medical device companies effectively avoid quality risks and speed up the process of getting their products to market.

The core role of medical laser marking.

The medical industry's requirements for laser marking are not something that can be met with a casual response.After all, these markings are on products that come directly into contact with the human body, and must be able to withstand high-temperature sterilization and chemical corrosion.

The first hurdle is material compatibility.

For instance, when marking a metal implant like a titanium alloy orthopedic screw, it is important to ensure that the marking is deep enough, yet not so deep as to damage the strength of the material.Some manufacturers have been burned by this--the markings may look nice, but the surface of the materials may develop fine cracks, which can cause the entire product to be scrapped.

The accuracy is comparable to surgery.

If the UDI is off by even 0.1 millimeters, it may cause the scanning equipment to fail to read it.We've had customers who demanded that the precision of the marking be within ± 5 microns. That's one-tenth the diameter of a human hair.

There are four main standards.

ISO 13485 quality management system.

This certification is like a medical passport for the industry, requiring that every step from the procurement of raw materials to the testing of finished products be recorded and traceable.Important reminder: Don't forget to keep a record of the calibration of your laser marking equipment. It will be checked during the audit.

FDA 21 CFR Part 11.

The US market in particular emphasizes the integrity of electronic records.For example, if your laser engraving machines can record data, then these electronic records must be tamper-proof, just like bank ledgers.

CE MDR Certification Changes

After the new rules are implemented in 2021, even the biocompatibility of the printing ink will have to be certified.One company had to delay its product launch by six months because its auxiliary materials for the labels had not been tested for cytotoxicity.

Key points of GMP on-site inspections.

The auditors love to check the maintenance records.For example, a medical equipment factory was tripped up by incomplete records for laser lens cleaning. Even though the equipment was running normally, it still failed to meet the standard.