What Are The Criteria for Medical PCBA Chip Processing Assembly?

The use of printed circuit boards is ubiquitous in various industries. Today we mainly talk about medical-related content. As mankind utilizes high and new technology to gradually deepen the exploration of life sciences. More and more diseases in medical research and treatment methods to upgrade the revolution was cured, in which the role of medical equipment is pivotal. This is again reflected in the degree of intelligence of medical electronic pcba.

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

Medical Electronics PCBA SMD

These standards specify what processes are to be carried out from PCB design, smt processing, assembly, testing and inspection related aspects. Although medical devices are varied and their uses are extensive and require specific standards and regulations related to their use, some of the main standards are listed below:

1. Medical-PCB

IPC-A-600: This relates to the acceptable level of quality control of the board.

2.Medical-grade circuit boards

IPC-A-6012: This relates to the performance specification of the PCB.

3.Medical Printed Circuit Boards

IPC-A-610: This standard relates to the acceptability of electronic components. Under this, there are different standards: wires, soldering, enclosures, cables.

4. Printed circuit board assembly

ISO 9000: A well known standard which stands for International Organization for Standardization. Under this series there are several standards related to the quality of board design, smt placement and testing. Typically, CMs are certified to one of the ISO9000 standards, of which ISO9001 is the most common.

5. Medical Printed Circuit Board Manufacturers

FDA: 21CFR 820, introduced by the U.S. Food and Drug Administration, is a quality system regulation that medical device OEMs need to be certified to perform their manufacturing and control processes. This ensures that their products meet the necessary requirements.

ISO 13485: QMS for Medical PCBs

This is another very important standard for circuit board manufacturers. Medical PCBA SMT Processing.


Post time: Sep-19-2023

Send your message to us: