ISO 13485 Quality: At the Heart of Ventilator PCBs - Nexlogic
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Covid-19 continues to dominate the news around the world.  Medical experts aren’t sure when this deadly virus will subside or whether or not it’ll return again even stronger.  But one critical fact remains.   There continues to exist a great demand for medical ventilators, not just for now, but also in the future to effectively deal with a possible Covid-19 rebound.

Given the severity of the coronavirus, quality is at the top-most requirement for this emerging flood of new life-saving ventilators. How does the ventilator OEM determine how to look for and gauge quality, repeatability, and reliability for PCBs, which are a ventilator product’s underpinnings?

The short answer is partnering with an EMS provider or contract manufacturer that is ISO 13485:2016 and ISO 9001:2015 compliant.   An array of advanced systems and equipment ensures ISO 13485 quality and reliability.  For example, x-rays provide assurances that all joints are proper, Fig. 1, and automated optical inspection (AOI) ensures consistency. 

Check out our SMT007 column to learn more about these key subjects as the basis for properly selecting your ventilator PCBs.   In the meantime, here are some tips and hints to get you better acquainted with ISO 13485 and its quality and reliability requirements. 

  • It’s a specific ISO standard serving as a comprehensive management system for the design and manufacture of medical devices like ventilators.
  • A correct thermal profile is crucial and major part of ventilator PCB assembly. It must be correctly designed and implemented. 
  • A properly defined stencil design and solder paste dispensing are equally as important as a correct thermal profile.
  • ISO 13485 demands considerable traceability. PCBs must be serialized and allocated in batches; products can then be traced by lot and batch codes. 
  • ISO 13485 requires inspection documentation and process validation for medical products like ventilators.
  • Vitally important is knowing that ventilator PCB assembly requires a different set of criteria than commercial PCBs.

The bottom line is the EMS provider or CM should maintain a constant check on its assembly processes and procedures in order to produce high-quality, highly reliable ventilator PCBs that meet or exceed ISO 13485 requirements.