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:
1. FDA regulations for medical injection molding
FDA cleanliness and sterility regulations are a top consideration for medical parts, both in the part itself and in the manufacturing process. Make sure the materials you choose meet these standards and that your manufacturing partners can pass audits or other regulatory requirements for medical-grade approval.
2. ISO certification and compliance for medical injection molding
ISO regulations govern processes and outputs across numerous industries, including the medical industry. At a minimum, facilities producing medical components must comply with the ISO 13485:2003 standard, and further comply with Class I, II or III requirements, depending on the product manufactured.
Biocompatibility standards such as ISO 10993 may be required in addition to other application or product specific standards. Make sure you or your manufacturing partner understand the standards relevant to your application and that the factory can meet and maintain compliance through audits.
3. Material characteristics of medical injection molding
Materials selected for medical components and devices must have specific physical properties to be suitable for these applications.
4. Disinfection ability of medical injection molding
This is a minimum requirement for any medical component, be it a device enclosure in a facility or part of a device that directly interacts with the human body. Materials must be contamination-resistant and capable of being sterilized to prevent harm to those who come into contact with them.
5. Medical injection molding is suitable for extreme environments
Biological implants must be able to handle the harsh environment of the human body, including reliable operation and durability when exposed to heat, liquids, corrosion, vibration and other motion. Fortunately, many plastics used in medical injection molding meet these requirements.
6. Durability of medical injection molding
Fragile materials are not practical in the medical industry because they are both dangerous and inconvenient. Make sure the material you choose has the shatter resistance required in the medical field.
In general, plastics outperform other materials and processes in terms of design flexibility, overall cost-effectiveness, and production speed. Consider the following materials for your project:
1. Silicone
For components and parts where flexibility is a key requirement, silicone is often the material of choice. It has excellent durability and biocompatibility and is very cost-effective in high volume production.
2. Polycarbonate
This is one of the strongest materials with high shock and vibration resistance. Polycarbonate is ideal for high-visibility components because it can be made almost completely transparent. It is also highly heat and UV resistant.
3. Polyethylene
Polyethylene has a high molecular weight and is ideal for surfaces in prosthetics and wearables due to its appearance, durability and relative smoothness. It is strong and cost-effective, but cannot be sterilized by autoclaving.
4. Polypropylene
Due to its high heat resistance, this material is ideal for components that must be repeatedly sterilized by autoclaving. It also exhibits excellent radiation resistance.
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