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- Medical Device Marking: Challenges and Solutions
- How to create a reliable laser marking on medical stainless steel devices?
In view of its optimum compatibility with the identification requirements in medical technology,
laser technology represents the perfect solution for marking medical devices made of virtually
any material. However, the identification of stainless steel medical products poses its own
challenges for manufacturers: Are laser markings corrosionresistant? Does the passivation
influence legibility and contrast? Will the marking withstand the stresses of the product life-cycle?
What most do not know: It is possible to laser mark stainless steel reliably and in compliance with
medical standards. Especially with the comparatively low-priced fiber laser markers. What it needs
is the appropriate expertise and a specialist coordination of all laser parameters with the product-specific
requirements as well as the product life-cycle.
Patient safety is the utmost priority in the healthcare sector.Quality assurance and process
validation measures are implemented in order to minimize risks in medical treatment.
The identification of medical products is part of these measures, and crucial when it
comes to clear identification, reliable documentation of the product cycle and complete traceability.
Efforts to maintain patient safety are therefore firmly anchored in the production process of
medical devices and products.
In many regards, marking is a critical step in the production process of medical products. Only correctly marked medical products can be reliably traced and support flawless documentation during the entire product cycle. Alongside patient safety, manufacturers must also take into consideration a further critical point in the production process:
The efficiency of the production line. More and more products have to be marked more efficiently and cost-effectively. As the marking takes place at the end of the production cycle, scrap must be kept to a minimum and repeatable results and process stability are imperative. For a reliable identification, laser marking has become the chosen technology: It enables both a safe marking as well as a lean production.
- Which type of laser best suits the respective application depends on the marking quality requirements as well as on economic aspects. Concerning laser marking of stainless steel, there are decisive differences when it comes to these key factors..
Irrespective of the material: Marking tests must always be carried out to determine the suitable laser source and the appropriate laser parameters. If medical stainless steels are to be marked, all associated processes must also be taken into consideration..
For a long time, vanadate lasers were the preferred system for marking medical stainless steels. The disadvantage of these lasers: The acquisition costs are particularly high compared to fiber lasers, even though there are no significant advantages in view of the marking results. In most cases, the lowmaintenance fiber lasers are therefore the better choice for black marking medical steels: They ensure corrosion-resistant, permanent markings throughout the entire product life-cycle, and provide optimum marking results. However, perfect marking results are not always presupposed even when using fiber laser marking systems. In fact, various influencing factors should be considered. These include:
- requirements on marking content, contrast/color intensity, marking time
- corrosion-resistance of the marked areas
- production and product cycle, including passivation and cleaning procedures
- material (steel grade/alloy) and surface finish
- setting the optimum laser parameters
- Provided these factors are known and they are coordinated with one another, the fiber laser is generally the optimum and most efficient marking solution for medical stainless steel products.
Laser marking offers:
- Process reliability, efficient and lean production:
precision and repeatable identification; stable marking processes; short processing times
- Zero defect marking:
consistently high marking quality; precise positioning of the correct content on the right product; reduction of scrap and non-conforming parts
- Reliable traceability:
permanent, legible markings for dependable product identification; OCV (Optical Character Verification) and code reading
- Reliable markings according to medical standards:
biocompatible, sterilization- and cleaning-resistant markings; contact-free, hygienic procedure
In laser marking procedures, a distinction is made between ablative and oxidative marking.
Generally, both procedures can be used for marking medical stainless steel products,
irrespective of what type of marking laser is used.
|Ablative laser marking||Oxidative laser marking|
Would you like to learn how it’s possible to laser mark medical stainless steel products corrosion free? Will the passivation affect the contrast or legibility?
Then download the complete whitepaper “Lasermarking medical stainless steel” here.
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