In the medical field, it is generally considered an industry with minimal chances of errors, and this is also applicable to the production of medical components. This is because the field involves human lives; even a tiny mistake could lead to life-threatening situations or even death. Therefore, when producing medical components, the machining technology used by CNC workers must be able to meet strict tolerances and high precision specifications.
 

Prerequisites for CNC machining of medical parts：
When machining parts for the medical industry, it differs from machining parts for other industries. Medical components must adhere to additional standards, not just complying with the ISO 9001 quality management standard, as it involves the medical field.

According to the International Organization for Standardization (ISO), companies involved in designing, developing, machining, processing, distributing, implementing or servicing medical devices and related services must be able to demonstrate their ability to regularly meet the requirements of customers and applicable government regulators.

Your medical components need to meet the following qualification requirements before they can be put into use:

• ISO 13485: This is a specific qualification standard for the medical industry, emphasizing production process control, including process validation, risk mitigation, and quality control.
• ISO 9001: This is the industry standard for quality assurance and production management, controlling every manufacturing process, making the company more easily to develop and ensuring compliance with standards.
• ISO 5001: Energy management standard, helping manufacturers improve energy usage efficiency and reduce manufacturing costs.
• ISO 14001: Environmental management standard, combined with ISO 5001, to reduce overall energy consumption and waste output and increase competitiveness.

Medical Component CNC Machining Standards:
The CNC machining workshop aims to achieve success in machining medical components. In this case, they need to take extra measures to meet requirements and obtain certification. Indeed, the success or failure of machining these parts may directly impact the lives of real humans.

Here are some basic requirements for medical CNC machining:

• Due to their small size, many medical components require strict tolerances, especially invasive devices. Proper dimensions can help patients recover faster while minimizing invasion. Therefore, medical device manufacturing necessitates strict tolerances.
• Certain medical components require complex geometric shapes and forms, necessitating machines with higher cutting flexibility for fairness. To achieve this extra cutting flexibility, CNC machine tools with four or five-axis motion are the best choice.
• As many of these materials come into contact with humans, machinists must maintain exceptional cleanliness throughout the manufacturing process.
• Various materials are used, including stainless steel and PEEK. Essentially, the range of raw materials for producing CNC medical components extends from metals to plastics. CNC machine tools must successfully cut all these materials during manufacturing.
• Highly precise surface finishing capabilities are crucial.

Example of CNC Machining in Medical Device Production：
Mechanics opt for computer numerical control (CNC) medical machining due to its compliance with industry standards. This includes crafting precise medical components, such as:

1. Medical implants
Manufacturing body implants (like knee and hip joint replacements) is a key application of machining medical parts. In most cases, the limited quantity of implants needed by doctors makes injection molding methods economically impractical. This is because mold production would needlessly raise costs. Conversely, in CNC medical machining, mechanics can reuse tools, keeping manufacturing costs in check.

These implants are crafted from various materials, ranging from plastics (PEEK) to metals (titanium), etc. Therefore, CNC machining stands out as a suitable choice for its ability to handle diverse materials effectively in medical device production.

2. Surgical instruments
In addition to producing biological implants, CNC machining can also manufacture surgical equipment used by medical professionals throughout the entire surgical process. Surgical scissors, biopsy tubes, knife handles, cutting tools, forceps, implant scaffolds, sheet metal benders, and other metal components may fall into this category.

These surgical devices and instruments must adhere to additional safety standards and must be carefully and accurately manufactured. One requirement is that they are easy to sterilize.

Due to the high precision requirements, medical device manufacturers can use CNC machining to produce these surgical instruments. Some tools and instruments can only be produced in limited quantities, and some are even customized based on the specific conditions of individual patients. Therefore, CNC machining will be the most efficient and cost-effective way to manufacture these components.

CNC machining allows for a wide range of surface treatment processes for precision medical components, helping to ensure that the surfaces are free of defects.

 


Machined components for healthcare electronic products
Surgical equipment typically consists of two metal components. However, CNC machines can manufacture more complex device components, such as electrocardiograms and heart rate monitors, as well as MRI and X-ray machines. These high-value products are sometimes composed of hundreds or thousands of discrete elements, many of which may be produced using CNC machine tools.

Switches, knobs, levers, and larger components (such as display casings) are examples of machined parts for medical devices. Since medical equipment often needs to be moved from one room to another, all components must be of high quality to prevent machine failures.

The difference between these components and implants or surgical devices is that the former may not need to have biocompatibility, as they may never come into contact with patients. Therefore, materials suitable for CNC machining can be used more widely.

For precise application results, electronic medical device components need to be machined with the highest precision, especially for the following equipment:

• Diagnostic devices

• Monitors

• Lighting

• Ultrasound equipment

• MRI scanners

• CT scanners

4. Microfabrication
The production of extremely small medicinal components is the focus of this activity. In most cases, this is used for manufacturing implantable devices, exploratory surgical instruments, drug delivery technologies, etc. These small tools typically pack a high level of complexity into a very small footprint.

Therefore, their production requires a very high level of expertise. It is for this reason that methods such as CNC medical machining are a good choice, as they can support a high degree of accuracy. The characteristic dimensions of these components may be far less than 50 micrometers.



Typical micro-machined components for medical devices:

• Optical switch components
• Fiber optic assemblies
• Ultrasonic nozzles
• Micro gears
• Micro shafts
• Micro fittings
• Electron microscope components
• Micrometer surgical scissors
• Bone surgery saw guide plate

5. Medical Device Prototyping
The production of medical device prototypes is an important step to ensure product safety and efficacy. CNC machining, due to its fast and cost-effective nature, has become the ideal choice for manufacturing medical device prototypes. Through rapid iterative design, engineers can thoroughly test and optimize the equipment to ensure it meets safety and regulatory requirements. In the medical device industry, rapid market entry is key to competition, and CNC machining supports small-batch prototype production, reducing waste and lowering development costs.


6. Dental tools and implants
CNC machining plays a crucial role in the field of dentistry, as it is used to manufacture customized dental tools and implants to provide high-quality dental care. Dentists worldwide rely on CNC technology for precise treatments and the production of robust instruments such as probes and drills. These instruments need to be durable to withstand the sterilization process and ensure patient safety. CNC machining provides quality control and repeatability, ensuring that the tools consistently meet standards. The manufacturing of dental implants also depends on CNC technology, offering precision and customization to provide accurate and personalized implants for each patient. Additionally, CNC technology enables the precise use of materials such as titanium and zirconia, effectively utilizing them in various applications.


7. Customized prosthetics
In the field of prosthetics, the importance of customization is self-evident, as prosthetics require precise matching to the unique anatomical structure of each patient. Traditional manufacturing methods often fail to meet these needs. However, the emergence of CNC machining has changed this situation, as it can create custom devices that meet the individual physiological characteristics of each patient. Through 3D scanning and CAD modeling, CNC machines can produce prosthetics with complex details and precise dimensions, allowing patients to enjoy the best comfort and functionality.


8. Small orthopedic hardware
In the field of medicine, orthopedic components such as screws, plates, and rods play a crucial role in repairing or replacing injured bones and joints, so they must be manufactured with extremely high precision and quality. The production of orthopedic components relies on CNC machining, as it can process complex geometries with high accuracy and handle a variety of biocompatible materials such as titanium and stainless steel.


In conclusion
Medical device processing requires high precision and accuracy, which can be achieved through CNC machining. However, having the right personnel is also crucial. Janee is a reliable manufacturer of critical medical components, specializing in surgical instruments, tools, and medical equipment prototype design. With over 20 years of experience, we are dedicated to producing parts with extreme precision and tight tolerances. Our skilled machinists can provide customized machining part designs for all aspects of the medical industry. Feel free to submit your CNC machining project quote request to Janee. （