What is the regulation of black spots for injection parts of medical devices?

What is the regulation of black spots for injection parts of medical devices?

The provision of black spots for injection parts of medical devices is an important part of ensuring product quality, and these provisions are usually based on strict industry standards and quality requirements.

Medical device injection parts of the black spot provisions include 5 aspects, the following is a detailed explanation of the medical device injection parts of the black spot provisions:

(1) First of all, the size of the black spot is the primary consideration.
In the medical device injection parts, the size of the black spot is strictly controlled to ensure the appearance and performance of the product. In general, the diameter of the black spot should be less than a certain percentage of the overall size of the product, and the specific value may vary according to different standards or product requirements. Such regulations help to avoid the adverse impact of black spots on the appearance of the product, while ensuring the safety of the use of the product.

(2) Secondly, the distribution of black spots is also key.
The black spots should be evenly distributed, and there should be no dense, continuous black spots. This distribution requirement helps ensure the overall beauty and stability of the product. At the same time, black spots must not appear in the important functional areas of the product, such as the key part, the light transmission part, etc., to ensure the functionality and safety of the product.

(3) In addition, the color of the black spots is also an important consideration.
The color of the black spot should be similar to the color of the surrounding material, and should not be too prominent or contrast. Such regulations help to maintain the overall tonal consistency of the product and improve the beauty of the product. At the same time, the color of the black spots should be uniform, and there should be no different shades to ensure the appearance quality of the product.

(4) In the medical device industry, the standard for black spots of injection parts may vary by product, use and manufacturer. But in general, these regulations are designed to ensure the quality, safety and reliability of injection molded parts for medical devices. Strict compliance with these regulations helps to enhance the market competitiveness of products and win the trust of consumers.

(5) It should be noted that the black spots may come from a variety of factors such as raw materials, processing processes or molds. Therefore, in the production process, it is necessary to strictly control the quality of raw materials, optimize the processing technology, and regularly maintain the mold to reduce the generation of black spots. At the same time, for the black spots that have been generated, it is necessary to take effective treatment measures, such as polishing, repairing or replacing parts, to ensure that the product meets the specified requirements.

To sum up, the provision of black spots for injection molding parts of medical devices is an important link to ensure product quality and safety. By strictly controlling the size, distribution and color of the black spots, it can improve the appearance quality and performance stability of the product, and provide a strong guarantee for the safe use of medical devices.