62304

ISO 62304, also adopted as IEC 62304, is an international standard that specifies the life cycle requirements for software used in medical devices. It applies to software that is part of a medical device or software that is developed for use in a medical device, including off‑the‑shelf software integrated into the device. The standard emphasizes safe design, development, and maintenance of medical device software and is intended to help manufacturers meet regulatory expectations.

Software safety classification is a core element. Based on hazard analysis and risk management performed per ISO 14971, software is classified into safety classes A, B, or C. Class A indicates no influence on safety, while Classes B and C denote increasing potential impact on patient or user safety, with corresponding requirements for development rigor and documentation.

The standard organizes software lifecycle processes into several areas: software development, software maintenance, risk management, configuration management, problem resolution, and software release. The development process covers activities from software requirements analysis through design, implementation, integration, verification, and validation. The maintenance process addresses post‑release changes and defect handling. Documentation and traceability are emphasized throughout the lifecycle, ensuring that requirements, design decisions, verification and validation results, and changes can be tracked across the project.

ISO 62304 is widely used by medical device manufacturers to structure software engineering activities and to demonstrate compliance with regulatory requirements related to software safety. It is commonly referenced in regulatory frameworks and harmonization efforts to ensure consistent safety practices in medical device software development and maintenance.