Health software – Part 1: General requirements for product safety

This standard applies to the safety and security of health software products that are designed to operate on general computing platforms without dedicated hardware. The document sets out the requirements for manufacturers over the entire product life cycle, including design, development, validation, installation, maintenance, and disposal of health software products.

Main sections:

· Scope

· Normative references

· Terms and definitions

· Health software product requirements

· Health software life cycle processes

· Health software product validation

· Health software product identification and accompanying documents

· Postmarket activities for the health software product