Medical PCBs have high standards and must meet requirements such as electrical safety, environmental adaptability, EMC, high precision, and medical regulations to ensure product quality and safety. Customized design, isolation protection, and easy maintenance and replacement meet the special needs of medical equipment. In the field of electronic device manufacturing, especially in the field of medical equipment, PCB, as one of the core components of the equipment, its quality standards and requirements far exceed those of ordinary electronic devices.
1、 Electrical safety standards
The particularity of medical equipment determines its high requirements for electrical safety. Medical PCBs must meet international electrical safety standards such as IEC60601.
2、 Environmental adaptability requirements
Medical equipment often needs to operate in various complex environments, such as operating rooms, wards, emergency rooms, etc. Therefore, medical PCBs need to have strong environmental adaptability. This includes characteristics such as high temperature resistance, corrosion resistance, and radiation resistance.
3、 EMC and anti-interference ability
EMC is one of the important performance indicators of medical equipment. Medical PCBs must have good EMC performance to ensure normal operation in electromagnetic environments without causing interference to the surrounding environment and other devices.
4、 High precision and stability
Medical devices require extremely high precision in data collection and processing, therefore medical PCBs must have a manufacturing process with high precision and stability.
5、 Compliant with medical industry standards and regulations
The PCB of medical equipment must comply with a series of medical industry standards and regulations, such as ISO 13485 Medical Device Quality Management System Certification, FDA Certification, etc. These standards and regulations impose strict requirements on the design, manufacturing, testing, and use of medical PCBs to ensure product quality and safety.
6、 Material selection and supply chain management
The material selection of medical PCBs is also extremely crucial. PCB materials used for medical equipment must comply with relevant standards such as FDA and RoHS to ensure that they do not pose a threat to human health. At the same time, materials also need to have characteristics such as high temperature resistance, corrosion resistance, and radiation resistance to adapt to special medical environments.
7、 Customized design and isolation protection
For different types of medical devices, medical PCBs often require customized design to meet specific needs.
8、 Maintainability and replaceability
Medical equipment usually requires long-term use, so timely repair and replacement of PCBs are necessary when malfunctions occur. The design and manufacturing of medical PCBs should consider the characteristics of easy maintenance and replacement, in order to facilitate later maintenance and repair work.
