The field of medicine is inherently associated with minimal margin for error. This principle extends to the production of medical components, emphasizing the need for precision and adherence to strict standards. CNC machining has emerged as a key technology in this domain, offering ease of operation and the potential for mechanization and automation.
When machining medical components for the healthcare sector, the standards differ compared to machining parts for other industries. The production of medical components must comply with additional standards beyond the common ISO 9001 quality management requirements.
As outlined by the International Organization for Standardization (ISO), companies involved in the design, development, processing, treatment, distribution, implementation, or servicing of medical components must demonstrate their ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Medical components must meet the qualification requirements before use, including compliance with:
ISO 13485: A specific qualification standard for the medical industry, delving into details related to ISO 9001 standards relevant to the medical sector. It emphasizes process control during manufacturing, covering stages such as process validation, risk mitigation, and quality control.
ISO 9001: An industry standard for quality assurance and production management. While not limited to any specific sector, it indicates that ISO 9001 standards control every manufacturing process, aiding in cost savings, business development, and ensuring compliance with established norms.
ISO 50001: A standard focused on energy management, providing guidelines for manufacturers to enhance their energy efficiency using specific medical components, ultimately improving overall competitiveness and reducing manufacturing costs.
ISO 14001: Comparable to ISO 50001 but more comprehensive, this quality standard emphasizes sustainable energy utilization. It enables medical component manufacturers to reduce overall energy consumption and waste output. Any business meeting this quality standard is likely to implement ISO 50001 in its daily operations.
CNC machining workshops aiming for success in processing medical components must take additional measures to meet requirements and obtain certification. The success or failure of these machined components can directly impact human lives, making it imperative to ensure compliance with stringent standards.
Some fundamental requirements for CNC machining of medical components include:
Strict Tolerances: Many medical components, due to their small size, require stringent tolerances, especially for devices that invade the body. These tight tolerances help patients recover faster while minimizing invasion.
Complex Geometries: Certain medical components necessitate complex geometries and forms, requiring machines with higher cutting flexibility. CNC machines with four or five-axis motion provide the necessary flexibility.
High Cleanliness Standards: Given that many materials used in medical components might need to be acquired by humans, maintaining exceptionally high cleanliness throughout the manufacturing process is crucial.
Material Range: Various materials, including stainless steel and PEEK, are used for producing CNC medical components. CNC machines must successfully cut all these materials during the manufacturing process.
Surface Finishing Capability: High precision in surface finishing is of paramount importance.
Mechanics employ Computer Numerical Control (CNC) medical machining as it aligns with many standards required in this sensitive industry. These requirements include the manufacturing of precision medical components, such as:
Medical Implants: The production of bodily implants, including knee joint replacements and hip joint implants, is one of the most effective applications of machining medical components, making it a crucial use of this technology.
In conclusion, CNC machining has become an indispensable tool in the production of medical components, ensuring compliance with rigorous standards and contributing to the advancement of healthcare technology. The precision, versatility, and adherence to stringent regulations make CNC machining an integral part of the medical manufacturing landscape.
Implants Manufacturing
In most cases, the quantity of implants required by doctors is limited. Therefore, methods like injection molding make little economic sense. This is because the unnecessary cost of mold production is incurred. On the other hand, during CNC medical machining, machinists can repetitively use the same tools without affecting manufacturing costs.
These implants are manufactured using various materials, ranging from plastics (such as PEEK) to metals (like titanium). Hence, when considering which machining method to use, CNC machining stands out as a viable choice due to its ability to handle a variety of materials, making it an excellent option for such manufacturing processes.
Typical Machined Implants
Spinal Implants
Knee Joint Implants
Hip Joint Implants
Materials Suitable for Machining Implants
Stainless Steel (for temporary implants)
Titanium Alloys like Ti6Al4V
Polyetheretherketone (PEEK)
Cobalt Chromium Alloys like CoCr28Mo6
Surgical Instruments
Beyond producing biological implants, CNC machining is also employed to manufacture surgical instruments used by medical specialists throughout surgical procedures. Instruments such as surgical scissors, biopsy tubes, blade fixtures, cutting tools, forceps, implant supports, plate benders, and other metal components are included.
These surgical instruments must adhere to additional safety standards and must be manufactured with precision and care. One of the requirements is their ease of sterilization.
Given the high precision requirements, medical equipment manufacturers can utilize CNC machining to produce these surgical instruments. Some tools and instruments can only be produced in limited quantities, and some are even tailored for specific patients. Therefore, CNC machining proves to be the most efficient and cost-effective method for manufacturing these components.
Typical Machined Surgical Instruments
Forceps
Holders
Clamps
Washers
Handles
Cutting Tools
Saws
Materials Suitable for Machining Surgical Instruments
Titanium Alloys
Stainless Steel, especially surgical-grade steel (AISI 316L)
Machined Components for Healthcare Electronics
Instances where surgical equipment involves two metal pieces are not uncommon. However, CNC machines can manufacture components for more complex devices, such as electrocardiograms, heart rate monitors, MRI machines, and X-ray machines. These high-value items sometimes consist of hundreds of discrete components, many of which can be produced using CNC machines.
Examples of machined equipment parts include switches, knobs, levers, and larger components like monitor casings. As medical equipment often moves from one room to another, all components must be of high quality to prevent machinery failure. CNC machining allows for extensive application of surface treatment procedures for precision medical components, ensuring there are no surface defects.
In the realm of medical devices and equipment, the distinction lies between components, implants, and surgical instruments. Unlike implants and surgical instruments, components may not require biocompatibility, as they might never come into direct contact with patients. Therefore, a broader range of materials applicable to CNC machining can be employed.
Surgical Monitoring Devices
Precision machining of electronic medical equipment components ensures accurate application results. These components include:
Diagnostic equipment
Monitors
Lights
Ultrasound devices
Magnetic Resonance Imaging (MRI) scanners
CT scanners
The machining of medical devices is a process that demands a high level of precision and accuracy. High precision is crucial in the medical industry, where components require durability and reliable performance. We manufacture and supply investment castings and precision machined parts extensively used in various medical instruments and equipment. These parts find applications in diagnostic devices, surgical instruments, pathology analysis equipment, patient transport equipment, as well as prosthetics and orthopedic implants. We provide critical components to industry leaders and have earned their trust through long-term partnerships. Thanks to our comprehensive one-stop service capabilities, we can offer clients rapid delivery and high-quality products,provide professional cnc machining service to customers.
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