Medical Device Plastic Injection Molding Considerations
Plastic injection molding for medical devices is a critical process where the stakes of failure are very high. As such, several considerations must be taken into account during the design, planning and manufacturing processes. These include:
FDA regulations — As mentioned above, FDA regulations for cleanliness and sterility are a prime consideration for medical components, both in the parts themselves and in the manufacturing process. Ensure that the material you select meets those standards and that your manufacturing partner is able to pass an audit or other regulatory requirement for medical-grade approval.
ISO certification and compliance — ISO regulations govern processes and outputs across numerous industries, including the medical industry. At a minimum, a facility producing medical components must meet ISO 13485:2003 standards with further compliance to Class I, II or III required, depending on the products being manufactured. Standards for biocompatibility, such as ISO 10993, may also be required, in addition to other application- or product-specific standards. Be sure that you or your manufacturing partner is aware of the standards related to your application and that the facility is able to meet and sustain compliance via audit.
Material properties — The material chosen for medical components and devices must display specific physical properties in order to be suitable for these applications. These include:
Ability to be sterilized — This is a minimum requirement for any medical component, whether equipment housing in a facility or part of a device that interacts directly with the human body. Materials must be contaminant-resistant and able to be sterilized in order to prevent harm to those with whom they interact.
Suitability for extreme environments — Bio-implants must be able to handle the difficult environment of the human body, including reliable operation and durability when exposed to heat, liquid, corrosives, vibration and other movement, and more. Fortunately, many plastics used in injection molding meet those requirements.
Durability — Easily breakable materials just aren’t practical in the medical industry, where they are as much a danger as they are an inconvenience. Ensure that your selected material offers the shatter and breakage resistance necessary in the medical field.
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