What materials are commonly used for medical-grade molds?

What materials are commonly used for medical-grade molds?

Medical-grade molds require materials that meet strict biocompatibility, sterilization resistance, and regulatory standards (e.g., FDA, ISO 13485). Common materials include:

1.Stainless Steel (316L or 17-4 PH)

 Resists corrosion, withstands repeated sterilization (autoclaving, chemical disinfectants), and ensures long-term durability.

Applications: High-precision molds for syringes, surgical tools, and implantable devices.

2.Aluminum (7075-T6 or 6061-T6)

Lightweight, excellent thermal conductivity, and cost-effective for prototyping or low-volume production.

Limitations: Less wear-resistant than steel; often coated for enhanced longevity.

3.Tool Steel (H13, P20, or S7)

High hardness and heat resistance, ideal for high-volume injection molding of medical components like IV connectors or housings.

4.Nickel Alloys (e.g., Inconel)

Exceptional resistance to extreme temperatures and corrosive environments, used for molds in specialized applications.

Medical-Grade Silicone (for soft molds)

Flexible and biocompatible, suitable for prototyping or creating soft medical components (e.g., seals, gaskets).