The medical industry is an industry known for its little chances for errors. This same rule also applies when producing medical parts. This is because the industry involves human life, and little errors can lead to deadly health issues or even death. Therefore, machinists’ machining process in producing medical parts has to be one that can accommodate tight tolerances and high precision measurements.
Of all machining processes, CNC machining is the best which can meet these requirements. Apart from its ability to machine a wide variety of materials, it can also accommodate those requirements mentioned earlier. To learn about various ways machinists apply CNC machining to producing medical parts, stay glued to this article!
Qualifications for Making CNC Machined Medical Parts
Machining medical parts for the medical industry is not like making parts for other industries. Whereas most ordinary metal parts must meet ISO 9001 quality management requirements, medical parts must meet further standards.
According to the International Standards Organization, companies involved in the design, development, production, storage, distribution, installation, or servicing of medical parts must demonstrate their “ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.”
To get your medical parts approved for use, they have to pass these standards of qualification:
- ISO 13485:This is the medical industry-specific qualification standard. It expands on the finer details of the ISO 9001 standard related to the medical industry, emphasizing the regulation of production processes. It regulates production stages such as process validation, risk management, and quality control. Compliance with this standard makes it easier for any company to bring its products to the international market.
Apart from this, other additional qualification standards used in judging the quality of medical precision parts include:
- ISO 9001: This is the general standard used for quality control manufacturing management. However, it is not specific to any industry. This means the ISO 9001 standard actually governs every production process. It helps to minimize costs, facilitate company growth while establishing compliance to set standards.
- ISO 5001: This quality standard is based solely on the management of energy. It offers a guideline which medical parts manufacturers can utilize to increase their efficiency in energy utilization. This way, they can further bring down the costs of production.
- ISO 14001: This is a similar but broader quality standard compared to ISO 5001. It also emphasizes energy sustainability in coalition with ISO 5001; medical parts manufacturers can cut down on energy consumption and waste production. Any company that has this quality standard in place will definitely have incorporated ISO 50001 into its operations.
At RapidDirect, we ensure to follow all these standards strictly.
Requirements for Making CNC Machined Medical Parts
Besides meeting standards and obtaining certifications, CNC machine shops must take other steps if they are to succeed in machining medical parts. After all, human lives may depend on the success or failure of these machined components.
Basic requirements for medical CNC machining include:
- Precision machining to tight tolerances (as tight as 0.0001” inches for some parts): Many of these medical parts requires extra tight tolerances due to their small intended size. This applies especially to those meant for intrusion into the human body. Their small size will help to minimize intrusion and help patients heal faster. Hence, the machines used for medical instrument machining must be able to accommodate tight tolerances.
- 4-axis and 5-axis machining for complex geometries: Some medial parts require complex shapes and geometries; hence, machines with extra cutting flexibility can do justice to this. 4-axis and 5-ais CNC machines are the perfect choices to achieve this extra-cutting maneuverability.
- Ultra-high level of cleanliness, especially for an implant manufacturer: Many of these materials might need to enter the human body; hence, machinists should maintain a high level of cleanliness during production.
- A wide material selection that includes stainless steel and medical-grade plastics such as PEEK: Making CNC medical parts involves using different types of raw materials, ranging from metal to plastic. The CNC machine must be able to cut through these different materials during production.
- High-level surface finishing capabilities
Example of CNC Machined Medical Equipment
Due to its compatibility with many of the requirements needed in this delicate industry, machinists apply CNC medical machining in making medical precision parts such as:
1. Medical Implants
One of the most important uses of machining medical parts is the production of bodily implants such as knee implants and hip replacements.
Most times, medical practitioners only need implants in small quantities. This means a process like injection molding will be uneconomical to use. This is because mold production will increase the production costs unnecessarily. However, with CNC medical machining, the machinists can use the tools used repeatedly. This way, they do not affect production costs.
These implants are made from various metals ranging from metals (e.g., titanium) to plastics (e.g., PEEK). This makes CNC machining a feasible machining process to use. This is due to its compatibility with a wide variety of materials. Hence, it is perfect for such production processes.
Common Machined Implants
- Hip implants
- Spine implants
- Knee implants
Common Materials Used for Machined Implants
- Titanium alloys such as Ti6Al4V
- Cobalt-chrome alloys such as CoCr28Mo6
- Stainless steels (for temporary implants)
- Polyether ether ketone (PEEK)
2. Machined Surgical Instruments
Apart from creating bodily implants, CNC machining can create surgical instruments used by medical professionals during operations. These metal components may include surgical scissors, biopsy tubes, blade handles, cutters, saws, forceps, implant holders, clamps, spacers, plate benders, and more.
These CNC machined surgical tools and instruments must be made with care and precision and are subject to extra safety requirements such as ease of sterilization.
Medical device manufacturers may favor CNC machining for these surgical tools because the demand for precision is high. Some tools and instruments must be manufactured in small production runs. Some are even fabricated for individual patients. Hence, CNC machining will be perfect the perfect economical method for producing these parts.
With CNC machining, medical precision parts can also be subjected to comprehensive surface finishing treatments to ensure no surface defects.
Common Machined Surgical Instruments
Common Materials for Surgical Instruments
- Stainless steels, particularly surgical steel (AISI 316L)
- Titanium alloys
3. Machined Parts for Electronic Medical Equipment
Surgical instruments are simple devices often consisting of one or two metal parts. But CNC machines can create parts for much more complex pieces of equipment, e.g., heart rate monitors, MRI scanners, and X-ray machines.
These expensive pieces of equipment may comprise hundreds or thousands of individual parts, and many of these parts can be fabricated with CNC machines.
Machined equipment parts can include small components like switches, buttons, and levers and larger items such as monitor housings.
These components must be high standards to eliminate any chance of machine failure, especially since medical equipment is regularly wheeled from room to room around a hospital.
However, unlike implants and surgical tools, these parts may not need to be biocompatible or bio-safe since they may never make direct contact with a patient. As such, a much wider variety of CNC machining materials can be used.
Electronic Medical Equipment Commonly Fitted With Machined Parts
- Ultrasound equipment
- MRI scanners
- CT scanners
- Diagnostic equipment
Just as the name implies, this involves the making of extra small medical parts. This is mostly used in making implantable devices, exploratory surgical tools, drug-delivering technologies, etc. These devices usually have very high sophistication packed into their small sizes. Hence, they require a high level of expertise to make. This is why a process like CNC medical machining is a perfect fit. This is because it accommodates high precision levels. Feature sizes of these components may be well under 50 microns.
In the medical instrument machining industry, machinists apply micromachining for the production of stents, catheters, pacemaker components, drug delivery systems, ophthalmic devices, miniature screws for implants and devices, tiny plastic tubes, and more.
Common Micromachined Medical Equipment
- Pacemaker parts
- Drug delivery systems
Medical instrument machining is a process that requires precision and accuracy, hence the suitability of CNC machining for the process. However, the process used won’t matter if the right personnel does not handle the job.
At RapidDirect, we have experts skilled in the CNC machining field who can deliver top-notch work promptly. Our parts always satisfy our clients as we make high-quality parts that exactly fit the requirements given. Would you like to try out our services? Click on the link below to get a quote from us. We’ll be waiting!