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Software Standards

Authors:
Geoffrey Hunter
Geoffrey Hunter
Published On:
Jul 11, 2024
Last Updated:
Jul 11, 2024

IEC 62304

IEC 62304 is a standard aimed at medical device software. It defines software lifecycle processes that must be applied during the development and maintenance of software that will be used in medical devices.

There are three safety classes:

  • Class A: No injury or damage to health is possible.
  • Class B: Non-serious injury is possible.
  • Class C: Death or serious injury is possible.

SOUP is an acronym used frequently with IEC 62304. It stands for “Software Of Unknown Provenance”. It refers to existing software that is then used in a medical device, but has not been developed under the IEC 62304 standard. For example, if you choose to use FreeRTOS in your medical device or incorporate a ADC IC driver library you found on GitHub, you would need to treat these as SOUP.

Topics:

  • Risk management (must conform to ISO 14971)

Documents:

  • Software development plan
  • Software requirements specification
  • Software architecture
  • Configuration
  • Test documentation
  • Problem reports

IEC 62304 enforces that the manufacturer of the software implements and documents a software development plan. The plan has to detail the processes, deliverables, traceability and problem resolution. The standard also enforces that system/software requirements are defined and documented.