Medical parts are essential components of medical devices and equipment. Medical injection molded parts are medical components made of plastic materials manufactured by injection molding. They can be used for a variety of purposes, including diagnosis, treatment, and monitoring of patients. Most of these parts and components are made of medical grade plastics, which are characterized by excellent chemical resistance (acids, alkalis, corrosion), biocompatibility, and wear resistance.
Injection molding is a widely used manufacturing process in the medical industry, providing many advantages for a variety of applications. Medical grade plastic injection molding is used in medical devices, components, laboratories, and facilities. The key advantage of the injection molding process is that it can meet the strict regulatory and supervisory needs of the medical industry. We will discuss in detail the precautions for medical device injection molding below.
Considerations for injection molding of medical devices
Plastic injection molding of medical devices is a critical process in which the risk of failure is very high. Therefore, several factors must be considered during the design, planning and manufacturing process. These include:
Raw material selection
- Biocompatibility: Select materials that meet medical device standards to ensure that the product is harmless to the human body, such as polypropylene (PP), polycarbonate (PC) and special materials such as PEEK.
- Quality stability: Material suppliers should have relevant certifications and provide necessary documentation support to ensure the stability and reliability of material quality.
Mold design and manufacturing
- Precision requirements: The mold design must meet the specifications and performance requirements of the product to ensure that no defects will occur during the injection molding process. Mold manufacturing should be precise to improve the dimensional accuracy and appearance quality of the product.
- Maintenance and inspection: Regularly maintain and inspect the mold to prevent wear and damage and ensure the long-term performance of the mold.
Quality inspection
- Comprehensive inspection: Each production batch must undergo quality inspection, including appearance inspection, dimensional measurement, material composition analysis and performance testing.
- Standard compliance: Establish appropriate inspection plans and standards to ensure the accuracy and reliability of inspection results. At the same time, international and domestic standards such as ISO, ASTM, and GB must be followed.
Production environment
- Dust-free or low-microbial environment: Keep the production environment clean and sanitary to prevent microbial contamination and ensure the sterility of the product. This is the minimum requirement for any medical component, whether it is a device housing in a facility or part of a device that interacts directly with the human body. The material must be resistant to contamination and sterilized to prevent harm to people who come into contact with it.
- Temperature and humidity control: Control the temperature and humidity in the production workshop to prevent the material from getting damp or deforming.
Regulatory compliance
- Certification and standards: Ensure that the product meets international standards in the medical device industry, such as ISO 13485 quality management system certification, FDA certification, and CE certification.
- Risk management: Perform risk management in accordance with standards such as ISO 14971 to assess and manage potential risks of medical devices and ensure product safety.
Production and precautions of injection molds for medical products
Injection molds for medical products are very different from those required for ordinary electronic products, automotive products, and consumer products. Medical molds need to consider reliability, stability, and cleanliness. In addition, it is necessary to ensure that there is no oil pollution and optimization of mold structure during the injection molding production process.
During the development of medical injection molds, many medical products are not on the market or are still in the research and development stage. Most customers habitually think that the cost of developing medical molds is to save money. This habitual thinking also leads to many medical products spending more development time and development costs in the development process. We all know that getting things right once is the most cost-effective, but this simple idea requires more experience. Therefore, Elimold recommends not wasting time and money on unnecessary places, but spending funds more efficiently on more valuable places. Rather than saving on necessary investments.
The development process of medical injection molds does require experience in the mold industry, including the selection of steel materials and the optimization of mold structure, but if you find a reliable partner, this will save you more time and reduce the overall development cost when developing products.
Inspection standards for injection molded parts of medical devices
Physical performance inspection
Includes tests on indicators such as size, appearance, tensile strength, bending strength, and impact strength. Size and appearance are basic quality requirements, and it is necessary to ensure that the injection molded parts meet the design specifications and have no obvious defects and damage. The tests of mechanical properties such as tensile strength, bending strength, and impact strength are carried out by equipment such as universal testing machines to evaluate the stability and durability of injection molded parts under stress.
Chemical performance inspection
Mainly involves indicators such as processing stability, thermal stability, oxidation resistance, and chemical resistance. The test of processing stability includes the measurement of parameters such as the melt index and mass loss rate of plastics before and after injection molding. Thermal stability is evaluated by means such as thermogravimetric analysis to ensure that injection molded parts can maintain stable performance in high temperature environments. In addition, oxidation resistance and chemical resistance tests are also necessary to verify the stability and safety of injection molded parts in chemical environments.
Biocompatibility inspection
Since medical devices are in direct contact with the human body, it is necessary to ensure that injection molded parts are harmless to the human body. Biocompatibility inspection mainly includes tests of indicators such as cytotoxicity, local tissue irritation, and allergic reactions. These tests are usually performed using a combination of in vitro and in vivo testing to fully evaluate the biocompatibility of injection molded parts.
Benefits of Injection Molding for Medical Devices
Elimold Corporation has found that plastic injection molding medical parts, components, and devices is one of the most effective ways to cost-effectively achieve the quality and specifications required. The plastic injection molding medical component process can be applied to almost any medical field that requires high-volume production of durable, easily sterilizable, and precision-produced components. When using injection molding, medical industry suppliers and manufacturers can gain multiple benefits inherent to the process and available materials. These benefits include:
- Cost-Effectiveness: The nature of injection molding makes it one of the more cost-effective manufacturing processes, especially in high-volume production. Injection molding is almost always the most cost-effective choice when producing medical parts, components, and devices in large quantities.
- Superior Precision: Close tolerance production is critical in medical device manufacturing, and a millimeter or micron can make or break the successful performance of a component. Skilled plastic injection molding equipment can produce a large number of components and devices with a high degree of precision and negligible variation between parts.
- Material Selection: Plastic injection molding has one of the widest material selections of any manufacturing process. While medical-grade requirements certainly narrow this range, the number of materials available to meet these critical specifications is still large. We will list common material choices in the medical field later in this article.
- Durability: Many plastics used in injection molding have excellent strength and durability, and can withstand harsh environments, vibration, and blunt force without cracking, breaking, or shattering. Many injection molded plastics are also heat resistant and can be sterilized repeatedly through autoclaves and other means.
- Contamination resistance: Plastic materials used in medical device injection molding are designed to resist contamination and be easily sterilized. What’s more, the injection molding process itself can easily meet FDA and other requirements.
Medical Device Injection Molding Material Selection
Now that you understand the benefits of plastic injection molding for medical components and devices and the specific requirements these components must meet, we will look at some specific materials that meet the requirements. In general, plastics outperform other materials in terms of design flexibility, overall cost-effectiveness, and production speed.
- Silicone: Silicone is often the material of choice for components and parts where flexibility is a key requirement. It has excellent durability and biocompatibility and is very cost-effective in mass production.
- Polycarbonate (PC): This is one of the strongest materials with high impact and vibration resistance. Polycarbonate is ideal for high-visibility components because it can be made almost completely transparent. It also has strong heat and UV resistance.
- Polyethylene (PE): Polyethylene has a high molecular weight and is well suited for use as a surface for prosthetics and wearable devices due to its appearance, durability, and relative smoothness. It is strong and low cost, but cannot be sterilized in an autoclave.
- Polypropylene (PP): Due to its high heat resistance, this material is ideal for components that must be repeatedly sterilized in an autoclave. It also exhibits significant radiation resistance. With these skills, you will be able to make an informed decision about the materials and processes that are best suited for the manufacturing of your medical device or component.
- Polystyrene (PS): This is a strong plastic with little to no elasticity. It is inflexible and exhibits high levels of impact resistance and processability. It is primarily used for easily customizable surfaces with good dimensional stability and aesthetics.
- Polyetheretherketone (PEEK): It is a thermoplastic known for its high performance and excellent mechanical properties. It has high levels of resistance to wear, radiation, tracking, and thermal degradation.
- Silicone: This is a material of choice when flexibility is the primary need for medical device components. Its ability to make parts extremely durable and biocompatible is second to none in the industry. It is also affordable and reduces costs in high-volume production.
Summary
During the medical injection molding process, attention should be paid to raw material selection, mold design and manufacturing, process control, quality inspection, production environment, and regulatory compliance. Only by comprehensively considering these factors can the quality and safety of medical injection molded products be ensured to meet the strict requirements of the medical industry.
By following the above precautions, injection molds are very important tools in the medical industry and play a vital role in the manufacturing process of medical devices. The design and use of medical precision injection molds require special considerations to ensure that the produced medical devices are of high quality and accuracy.
Medical precision injection molds can ensure the manufacturing quality and production efficiency of medical device injection molding. The medical industry has very high requirements for product quality and safety, so in the design, manufacturing and use of molds, it is necessary to pay attention to details at all times and ensure that every link is strictly operated in accordance with the requirements. Only in this way can better manufacturing results and higher market competitiveness be obtained. It can be said that as long as the quality and precision of injection mold development and manufacturing are not a problem, the injection molding production of medical products will not have too many problems. If you need to carry out medical product injection molding production or injection mold development and manufacturing, you can contact Elimold to serve you.