The design requirements for medical molds are extremely strict, because the injection molded parts they produce will be directly applied to the medical field, which is related to the health and safety of patients. The following are the main requirements for medical mold design:

1. Material selection and design considerations

Biocompatibility: Medical injection molded parts directly contact human tissues or body fluids, so the selected plastic materials must have good biocompatibility to ensure that they will not cause toxicity, allergic reactions or other adverse effects on the human body. For example, polyether ether ketone (PEEK), medical grade polycarbonate (PC) and other materials have been widely used in the medical field after rigorous biosafety testing. When designing molds, you must fully understand the characteristics of these materials, such as fluidity, thermal stability, etc., in order to optimize the mold structure and injection molding process parameters, ensure that the performance of the material is not damaged during the molding process, and maintain good biocompatibility.

High purity: Medical-grade plastic materials require high purity and the impurity content must be strictly controlled at extremely low levels. This is because even trace amounts of impurities can affect the performance and safety of medical devices, such as triggering an inflammatory response or causing a decline in material properties. Mold designers need to work closely with material suppliers to ensure that the selected materials meet the high purity standards of the medical industry, while considering how to avoid contamination of materials during injection molding, such as enclosed injection molding systems and clean Mold cavity design.

2. Dimensional accuracy and stability

Precision structure: Medical products usually have precision structures and strict dimensional tolerance requirements. For example, some micro-medical devices have components that may be in the millimeter or even micron level, with very small tolerance ranges such as ±0.01mm or narrower. This requires that when designing the mold, the dimension calculation of the cavity and core must be accurate, and the shrinkage rate of the plastic material must be fully considered. The value of the shrinkage rate must be based on the actual production data and accurate analysis of material characteristics to ensure the injection molded parts After forming, it can meet the assembly and use requirements of medical products.

Long-term stability: Not only should the initial dimensional accuracy be ensured, but the size of injection molded parts can be maintained stable under different usage environments and conditions. For example, some implantable medical devices need to maintain their shape and size for a long time in the physiological environment of the human body, which requires the mold design to consider the long-term stability of the material and the impact of the injection molding process on the internal structure of the material to avoid changes in size due to size This leads to medical accidents.

3. Mold structure and injection molding process

Partition surface design: The design of the parting surface should ensure that the medical injection molded parts can be successfully demolded without affecting their appearance and function. For medical devices with complex shapes and internal structures, such as some components with tiny holes or inverted structures, it is necessary to skillfully select the parting surface and combine it with sliders, oblique tops and other mold release mechanisms to achieve complete and non-destructive Removal.

Gate design: The location and form of gates have an important impact on the quality of medical injection molded parts. For example, for some high-precision medical testing equipment components, the use of point gates or latent gates can reduce the generation of weld marks and improve the strength and accuracy of the product. At the same time, the size of the gate should be accurately calculated based on factors such as the flowability of the plastic material and the wall thickness of the injection molded parts to ensure that the melt can fill the cavity smoothly and there will be no obvious gate marks after being demolded. Impacts the appearance and quality of the product.

Exhaust design: Exhaust design of medical molds is also critical. Due to the complex structure of medical injection molding parts, gas trapping is prone to occur during the injection molding process. If the exhaust is not smooth, it will lead to incomplete filling, surface defects, internal bubbles and other problems. These problems may affect the performance and reliability of medical devices and even endanger the patient's life safety. Therefore, it is necessary to arrange the exhaust system reasonably in mold design, such as opening exhaust slots and exhaust holes in appropriate locations in the mold cavity, or using materials such as breathable steel to improve the exhaust effect.

4. Temperature and pressure control

Temperature control: The injection molding temperature includes barrel temperature, mold temperature, etc., which has a significant impact on the fluidity, molding quality and product performance of the plastic material. For medical injection molded parts, temperature control is particularly important because inappropriate temperatures can cause changes in material properties or defects. For example, excessively high barrel temperature may decompose medical plastics, release harmful substances, affecting the biocompatibility of medical devices; while excessively low mold temperature may cause uneven cooling of injection molded parts, creating internal stress, and affecting their dimensional accuracy and mechanical properties.

Pressure and speed control: The reasonable setting of injection molding pressure and speed is crucial to the molding quality of medical precision injection molding parts. Too much injection molding pressure may cause flashes and overflow on the mold parting surface, resulting in product size exceeding the difference, and may also cause damage to the mold; if the pressure is too small, it cannot ensure that the plastic melt can fully fill the cavity, which is easy to Defects such as material shortage and shrinkage occur. The injection molding speed is too fast, which makes the plastic melt appear in a turbulent state in the cavity, resulting in quality problems such as flow marks and bubbles on the surface of the product; the speed is too slow, the plastic melt will pass through the cavity. Early cooling affects the filling effect and product integrity.

5. Cleaning, disinfection and quality testing

Easy to clean: The surface treatment and structural design of the mold should be easy to clean, such as smooth cavity surfaces, avoiding blind spots and gaps, and providing easy removal and cleaning components. In addition, the manufacturing materials of the mold should have good corrosion resistance to prevent corrosion by chemical reagents during the cleaning process, which will affect the accuracy and service life of the mold.

Adaptable disinfection process: Considering that medical injection molded parts may need to be disinfected, the mold design should consider its adaptability to the disinfection process. For example, some high-temperature and high-pressure disinfection methods may have an impact on the material performance and structure of the mold. Therefore, when designing the mold, it is necessary to select materials that can withstand the corresponding disinfection conditions, and optimize the structure of the mold to ensure that the mold does not occur during the disinfection process. Deformation, damage or performance deterioration may occur. At the same time, the sealing performance of the mold must be good to prevent disinfection media from entering the mold, affecting its normal operation and service life.

Quality inspection and verification: Injection molded parts produced by medical precision molds must undergo strict quality inspection, and the inspection standards are usually higher than those of general industrial products. In addition to conventional testing items such as dimensional accuracy, appearance quality, and mechanical properties, testing for special projects such as biocompatibility testing, sterility testing, and chemical stability testing are also required.

To sum up, the design requirements of medical molds involve multiple aspects, including material selection, dimensional accuracy and stability, mold structure and injection molding process, temperature and pressure control, cleaning, disinfection and quality testing, etc. These requirements are designed to ensure that injection molded parts produced by medical molds can meet the strict standards and regulations of the medical industry, thereby ensuring the health and safety of patients.

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