It can be said that CNC machining parts in the medical industry have high requirements, and the machining of medical parts requires high-precision measurement and strict tolerances. Throughout the entire CNC machining manufacturing industry, only CNC machining can meet all the requirements of the medical industry. If you want to understand the application of CNC machining parts in the medical industry, please read it together with the article.
What qualifications are required for CNC machining of medical parts?
CNC machined metal parts must meet the requirements of ISO9001 quality management, but medical CNC machined parts need to meet more standards. The particularity of the medical industry will therefore have more standards. According to the regulations of the International Standards Organization, all relevant certificates must be possessed during the production process or service of medical CNC machining parts.
In order for medical CNC machined parts to be approved for use by the International Organization for Standardization, CNC machined parts must pass the following qualification standards:
Medical devices-Quality management systems (Medical devices-Quality management systems) that meet regulatory requirements: ISO 13485
ISO 13485 is a specific qualification standard for the medical industry. Effectively improve and guarantee the quality level of CNC machining parts, and more effectively emphasize the supervision of the production process. For example, risk control management and quality control, process verification, etc.
Quality Management System (QMS) International Standard: ISO 9001
ISO 9001 is a general standard for quality control manufacturing management:
The ISO9001 standard is not a specific industry quality management, but the actual management of each production process. It helps to minimize the cost of CNC machined parts, promote company development, and establish compliance to set standards.
Energy Management System Standard: ISO 5001
ISO 5001 is an energy management system standard that can help organizations to organically integrate multiple energy management tasks such as original energy-saving planning, energy-saving technological transformation, statistics, measurement, and energy job training, to form a complete system. In order to better achieve the goal of energy saving and emission reduction, improve the economic efficiency and market competitiveness of the organization.
Environmental Management System Certification: ISO 14001
ISO 14001 is an organization planned and coordinated management activities, including standardized operating procedures and documented control mechanisms. It is implemented through an organizational structure with clear responsibilities and obligations, with the purpose of preventing adverse effects on the environment.
The basic requirements for medical CNC parts machining are as follows:
1. The tolerances of high-precision CNC machined parts must be strictly controlled, which is conducive to the application of CNC machined parts. This applies especially to parts that are intended to invade the human body. Help minimize invasion and help patients recover faster.
2. It must conform to the appearance design of the medical CNC machined parts, which is conducive to helping patients recover faster.
4. Wide selection of materials: including stainless steel and medical grade plastics (such as PEEK): manufacturing medical CNC parts and machining different types of raw materials, from metal to plastic. CNC machining machines must be able to cut these materials during the production process.
5. Surface finishing: CNC machining has a high level of surface finishing ability.
6. Complicated geometric shapes CNC machining parts: some complex CNC machining parts require CNC machining machines with extra cutting flexibility. 4-axis and 5-axis CNC machining machines are the perfect choice.
7. Ultra-high cleanliness: For medical CNC machining parts, many materials may need to enter the human body. Therefore, technicians should maintain a high degree of cleanliness during the production process.
What types of applications are there for medical CNC machining parts?
Medical CNC parts machining is extremely demanding, and it needs more compatibility for the CNC precision machining industry. Therefore, when machining CNC precision medical parts, machinists need to control the compatibility of the manufacturing. They can be divided into the following parts:
1. Electronic medical equipment CNC machining parts
CNC machining can process complex equipment parts, such as heart rate monitors, MRI scanners, and X-ray machines. These expensive equipment may include hundreds or thousands of individual CNC machined parts, many of which can be manufactured by CNC machining.
2. Mechanical surgical instruments
CNC machining can also manufacture surgical instruments used by medical professionals during surgery. These metal parts may include surgical scissors, biopsy tubes, blade handles, cutters, saws, forceps, implant holders, clips, spacers, bending machines, etc.
3. Medical implants
One of the important uses of medical CNC machining parts is the production of body implants, such as knee implants and hip replacements. From metal (such as titanium) to plastic (such as PEEK). This makes CNC machining a viable machining process. This is due to its compatibility with multiple materials. Therefore, it is very suitable for this type of production process.
4. Micro machining equipment
It adapts to the high-precision level. The feature size of these components may be well below 50 microns. Medical CNC machining is used in the production of stents, catheters, pacemaker components, drug delivery systems, ophthalmic equipment, micro screws for implants and equipment, micro plastic tubes, etc.
In conclusion
Medical CNC machining parts is a process that strictly requires precision and accurate tolerances. It is also a CNC machining project that must strictly require standards. If you have not found a suitable CNC machining parts manufacturer, you can contact us immediately.