Medical Device Requirements for High Reliability PCBA Designs

High-reliability PCBA design is critical in the medical device field, where products require extreme stability, reliability and safety. Here are some requirements and considerations about high reliability PCBA design in medical field:

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1、Temperature Range And Environmental Requirements:

In the medical device field, PCBAs may be exposed to different clinical environments, including high humidity, corrosive liquids and high sterilisation environments. Therefore, PCBAs need to be protected accordingly.


2、Selection of High-Reliability Components:

It is important to select electronic components with high reliability and long life. This may include industrial or military grade components.

Use high quality, reliable connectors, capacitors, inductors and other components to reduce the risk of component failure.


3、Power Supply And Backup:

Provide a stable and redundant power supply to ensure that the system will function in the event of a power failure.

Backup power supplies and batteries are used in critical systems to maintain continuous operation.


4、Signal Integrity And EMI Suppression:

Ensure signal integrity to avoid electromagnetic interference (EMI) and radioactive interference (RFI).

Use shielding and filters to minimise EMI.


5、Harness and Layout Design:

Perform a well-planned harness design to reduce the risk of circuit noise, cross-talk, and malfunction.

Avoid cross-talk between high and low current paths.


6、Maintainability And Traceability:

Design the PCBA for ease of maintenance and troubleshooting, including labelling components, providing wiring diagrams and troubleshooting tools.

Traceability is required so that problems can be traced back to specific PCBA lots and components.


7、System Testing and Validation:

Rigorous system-level testing and validation, including functional, temperature, vibration, and EMI/RFI testing, is performed to ensure the reliability of the PCBA under real-world conditions of use.


8、Regulations and Compliance:

Compliance with applicable regulations and standards, including relevant regulations and quality standards for the medical device industry.


9、Fault Tolerance and Backup:

Consider fault tolerance in system design so that essential functions can still be provided in the event of a failure.

Backup circuits and backup systems are provided to ensure system continuity.

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In the medical device field, high reliability PCBA design is not only about product performance, but also about people’s lives and safety. Therefore, sufficient time and resources need to be invested to ensure that PCBAs are designed, manufactured and tested to the highest standards.

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