Guidelines for the Use of Laser Marking Machines in the Medical Devices Industry

Laser marking machines are ideal for use in the medical device industry, as they can satisfy the strict requirements of UDI traceability, and are also environmentally friendly.Accurate parameter settings, regular machine calibration, and complete production records allow for compliance with GMP and ISO 13485 standards, which are especially suitable for permanent markings on high-precision medical products such as surgical instruments and implants.

Why does the medical equipment industry need laser marking?

Clear labeling is a "lifeline" for medical safety, whether for surgical instruments or implants.Lasers can permanently mark stainless steel, titanium alloys and even ceramics, and these "engraved" marks can withstand high-temperature sterilization and will not fade from chemical disinfection. This solves the problem of traditional ink markings easily coming off.

The three major advantages of laser marking machines.

The company also meets strict demands for traceability.

Nowadays, medical regulations around the world emphasize "traceability." For example, there is the UDI, or unique device identification number.Laser marking can easily produce QR codes and serial numbers with precise engraving, and the success rate for scanning is 30 % higher than for the traditional method.

Strong adaptability to materials.

Different medical devices require different parameters for marking. Titanium alloy is used for orthopedic joints, while cobalt-chromium alloy is used for stents.A good laser system is like an "auto-focus" smart pen that can adjust the wavelength and power according to the characteristics of the material, so as to avoid damaging the surface of the instrument.

It eliminates the risk of pollution.

Traditional chemical etching produces waste liquids, whereas laser engraving is a purely physical process.Many medical instrument makers report that after switching to laser technology, their costs for environmental protection have fallen by 40 %.

A practical guide to applying IT in the health care industry.

Parameters must pass through a "double gate.

First they use the same batch of scrap to do test runs, then confirm the clarity of the marking, and finally use a three-dimensional measuring machine to check the depth of the engraving.Don't go directly to the finished product. We have seen manufacturers that have had whole batches of tubes scrapped because of a parameter deviation.

Don't be lazy.

We recommend that you use standard calibration plates to check marking accuracy every quarter, especially if you are frequently switching between product lines.One customer insisted that the laser heads be maintained, and after five years of use, the equipment still maintained an accuracy of within ± 0.05 mm.

The records need to "keep pace.

Every time a label is applied, the system records the equipment parameters, the operator, and the time stamp.Last year, at a site where an ISO inspection was taking place, the auditor randomly checked the production records of three years ago. The complete and intact data allowed the enterprise to pass the inspection smoothly.

Solutions to common problems.

If the marker is yellowing or fading, it may be because the material contains too much carbon, and you should try lowering the frequency and increasing the scanning speed.If stainless steel surgical instruments show slight deformation after laser marking, try using a green laser with a shorter pulse width.These are the fruits of our experiences with over 20 medical enterprises.