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Midstate Mold & Engineering

Precision Plastic Injection Molders

ISO Standards

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Medical Plastic Parts: Injection Molding Cleanroom

Cleanroom door.

The medical industry has many requirements and specifications when it comes to the manufacturing and assembly of its parts. Having sterile medical devices, especially single-use items like needle housing or pacemaker parts, is vital. Today, instead of focusing on the importance of great quality assurance or the right medical-grade plastic, let’s talk about the need for an injection molding cleanroom in your manufacturing process.

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Injection Molding: What Are the ISO Standards for Medical Devices?

ISO 13485 on a doctor's clipboard next to medical equipment.

When it comes to making medical products, the functionality of your devices is literally a balance of life and death. That’s why the medical industry relies on standards that govern design, safety, and materials used. Let’s go over the four most common ISO standards for medical devices you should take into consideration during design and manufacturing, as well as the ISO standards and other manufacturer standards you should look for in an injection molding company that will be helping you create the parts for it.

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