Printed circuit boards are used everywhere in various industries. Today we mainly talk about medical-related content. With the use of high-tech technology, the exploration of life sciences has gradually deepened. More and more diseases are being cured in the upgrading revolution of medical research and treatment methods, among which the role of medical equipment plays an important role. This is reflected in the intelligence of the medical electronic pcba.

There is no doubt that when the patient's life is at stake, these devices are the key to the race against death. Therefore, medical PCBA processing needs to follow strict guidelines.

These standards specify which processes are to be carried out from the relevant links of PCB design, smt processing, assembly, testing and inspection. Although medical equipment is diverse and has a wide range of uses, and requires specific standards and regulations related to its use, the main standards are as follows:

Medical-PCB

IPC-A-600: This is related to the acceptability of the circuit board.

Medical grade circuit board

IPC-A-6012: This relates to PCB performance specifications.

Medical printed circuit board

IPC-A-610: This standard is related to the acceptability of electronic components. Below this, there are different standards: wire, welding, housing, cable.

Printed circuit board assembly

ISO9001: A well-known standard, it stands for the International Organization for Standardization. There are several standards in this series related to the quality of circuit board design, manufacturing and testing. Generally, CM is certified to one of the ISO 9001 standards, of which ISO 9001 is the most common.

Medical printed circuit board manufacturer

FDA: 21 CFR 820, introduced by the US Food and Drug Administration, is a quality system regulation. Medical device OEMs need to pass relevant certifications to perform their manufacturing and control processes. This ensures that their products meet the necessary requirements.

Medical grade PCB

This is another very important standard for circuit board manufacturers. This standard is consistent with the ISO 9001 series and specifies the quality and reliability of medical products. According to this standard, manufacturers have established specific standards for documented processes and tracking materials. Some important aspects of ISO 13485 include: The certification requires a clear record of all manufacturing stages in order to manufacture products in accordance with regulations, and it also ensures that risk management and design control processes are in place. Manufacturers also need to develop an audit system to track their own performance throughout the process.

ISO 13485 certification also means that contract manufacturers understand and promote other regulatory requirements. By doing so, the requirements of regulatory agencies can be met.

With these standards, regulators and customers can be assured that manufacturers are fully committed to quality and have the necessary systems and processes.

This of course means that in order for your medical requirements to comply with the necessary regulatory standards, you need to work with contract manufacturers that comply with these standards. If you have been looking for contract manufacturers that provide medical PCB prototypes that meet the highest standards, then your search will end at FASTPCBA. Not only have we obtained the highest industry standard certification, but we also have a well-trained team with the necessary experience and expertise in medical printed circuit board assembly. In fact, we are also equipped with industry best practices. When you work with us, you can rest assured that you will get medical equipment PCBA circuit boards that meet strict requirements.