What is the standard process for customizing injection molded parts for medical devices?

What is the standard process for customizing injection molded parts for medical devices?

The standard process for customizing injection molded parts for medical devices is a meticulous and rigorous process that involves multiple links from raw material preparation to final product testing.

The standard process for customizing injection molded parts for medical devices mainly includes the following 6 aspects:

(1) Raw material preparation
It is crucial to select suitable plastic materials, such as ABS, PP, PE, PVC, PC, etc. These materials must meet the biocompatibility and safety requirements of medical devices. When selecting materials, factors such as mechanical properties, processing properties and cost must also be considered.

(2) Plastic heating
Plastic particles are fed into the barrel of the injection molding machine and gradually melt and become fluid under the heating of the electric heating coil. This process requires precise control of the heating temperature and time to ensure that the plastic is completely melted and not overheated.

(3) Injection molding
When the plastic is completely melted, it is injected into the pre-designed mold through the screw or piston rod of the injection molding machine. The design of the mold must be accurately calculated based on the product shape, size and functional requirements to ensure the quality of the injection molded parts.

(4) Cooling and curing
The plastic in the mold forms a predetermined shape during the cooling and curing process. This step requires controlling the cooling speed and temperature to avoid defects such as shrinkage and deformation of the product.

(5) Post-processing
When the plastic is completely cured, the mold is opened and the product is taken out. At this time, some post-processing may be required, such as removing burrs on the product and performing surface treatment to improve the appearance quality and performance of the product.

(6) Mold inspection and product quality inspection
Mold inspection includes inspections of dimensional accuracy, surface quality, wear resistance, etc. to ensure the stability and reliability of the mold. Product quality inspection includes appearance inspection, performance testing, etc. to ensure that the product meets the relevant standards and regulations for medical devices.

Throughout the customization process, quality control and monitoring are carried out throughout. By strictly controlling each link, the quality and safety performance of medical device injection molded parts are ensured to be optimal. In addition, in order to meet the special needs of customers, such as dust-free or low-microbial environment production, the use of medical-grade plastic materials, etc., the customization process needs to be adjusted and optimized accordingly.

In short, the standard process for customizing medical device injection molded parts is a complex and delicate process involving multiple links and quality control points. By strictly following this process, high-quality, safe and reliable medical device injection molded parts can be produced to meet the needs of the medical industry.