EVS-EN 82304-1:2017

EN 82304-1 applies to the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware. It is intended for manufacturers and it covers the entire lifecycle including design, development, validation, installation, maintenance, and disposal of health software products.

For health software that can contribute to a hazardous situation, risk control is needed to prevent harm or reduce the likelihood of harm occurring. Testing of the finished product is not, by itself, adequate to address the safety of health software. Therefore, requirements for the processes by which the health software is developed are necessary.

EN 82304-1 also applies to health software products like medical apps or health apps intended to be used in combination with mobile computing platforms. The international standard has been approved in Europe as EN 82304-1:2017 without any changes.