medical Hand held testing equipment enclosure

Medical-Grade Plastic Enclosure Injection Molding

Yixing Plastic factory supplies medical-grade plastic parts with sterilization capabilities after injection and packaging. Our facility ensures compliance with stringent industry standards for cleanliness and sterility.

Key Considerations for Medical Device Molding

Plastic injection molding for medical devices is a critical process where failure is not an option. The following factors are essential during design, planning, and manufacturing:

FDA Regulations

FDA regulations for cleanliness and sterility are a prime consideration. Ensure selected materials meet those standards and that your manufacturing partner can pass audits for medical-grade approval.

ISO Certification & Compliance

ISO regulations govern processes across the medical industry. Facilities must meet ISO 13485:2003 standards with further compliance to Class I, II, or III as required. Biocompatibility standards such as ISO 10993 may also apply.

Material Properties

Materials for medical components must display specific physical properties:

• Ability to be sterilized — Minimum requirement for contaminant resistance and sterilization to prevent harm.
• Suitability for extreme environments — Bio-implants must handle heat, liquid, corrosives, vibration, and movement.
• Durability — Shatter and breakage resistance is essential in the medical field.

Commonly Used Materials

• Silicone
• Polycarbonate (PC)
• Polyethylene (PE)
• Polypropylene (PP)

Contact Yixing Plastic for more information about getting a quote, placing an order, or finding solutions for your application.