Regulations for the Coloring and Labeling of Medical Instruments

The guide explains the core standards for medical device color coding, including design principles, material selection, and quality control points, to help manufacturers optimize the color-coding process and ensure that it meets industry standards and guarantees safe usage.The content focuses on practical scenarios, and provides implementable suggestions.

Why are color-coded labels so important for medical equipment?

The colored labels on the medical equipment we use every day, whether surgical instruments or diagnostic devices, are not just decorative.The models are like silent instruction manuals, able to quickly inform medical personnel of the uses of the equipment, its limitations, and even how it should be disinfected.For instance, red labels might be used to mark "high-risk operation zones," while green labels might be used to mark "reusable parts." If the colors are mixed up, it could cause a treatment delay, or even an accident.So, accurately and firmly marking the colors is a top priority in the production process.

These are the three principles that must be closely followed in the design stage.

The color contrast must be strong enough to "grab the eye.

Don't just think that bright colors will do! The lights in operating rooms tend to be cool, while those in hospital wards are warmer.For example, a combination of dark blue and bright yellow is much more reliable than black and gray.If possible, it is suggested that the product be tested in a simulated environment.

The dimensions of the symbol cannot be "reduced.

The symbols on small instruments like dental drills or microsurgical tools must be at least 2 millimeters high.Some manufacturers have made the labels very ornate and fancy, but the result is that medical personnel wearing their protective goggles can't see them at all.

The material has to withstand the "torture.

Disinfectant solutions, high-temperature autoclaving, repeated friction .... These routine procedures are all tests for labels.Epoxy resin ink is more resistant to corrosion than ordinary pigments, but it is also more expensive.He suggests that the frequency of use of a tool is a good indicator of the type of material it should be made of.

The most common pitfalls in the production line.

Don't rely on the human eye for color calibration.

A master craftsman might say, "I've been doing this for 10 years and have never made a mistake," but the human eye can be affected by fatigue.The Pantone color card is just the starting point; the key is to see how the colors actually look on the material.

Adhesion tests can't be taken lightly.

Randomly checking two or three items on the assembly line is not enough! I recommend that you do at least 20 simulated sterilization cycles on each batch.There was one instance in which a brand of catheter had labels that fell off and blocked a patient's blood vessel, forcing the company to recall the entire batch of products. The cost of the recall was much higher than the cost of testing.

Do not ignore the clarity of the small print.

The small print, such as the date of manufacture, is the easiest to smear.Although laser marking is very precise, some plastics can warp when heated.UV ink-jet technology is very popular these days, and can print on irregular surfaces without damaging the equipment. It is especially suitable for printing small labels on precision equipment.

These are key actions in daily maintenance.

Even if the process of engraving is perfect, the signs will inevitably be damaged by use.It is suggested that hospitals check the completeness of the labels on commonly used equipment every quarter. If the labels have faded, the equipment should be taken out of service immediately.If manufacturers can offer a repair service, that would be a big plus, as it would both extend the product's lifespan and increase customer loyalty.