IEC 62304:2006 - Software life-cycle processes

This international standard defines the lifecycle requirements for medical device software, establishing a structured framework for safe design and maintenance. It mandates specific processes for development, risk management, and configuration control to ensure the software functions reliably within a medical context.

Overview

Background

Published by the International Electrotechnical Commission (IEC), this document serves as the primary benchmark for software engineering within the healthcare sector. It is designed to integrate seamlessly with quality management systems like ISO 13485 and risk management frameworks such as ISO 14971. The 2015 amendment updated the original 2006 release to address evolving safety classifications and legacy software issues.

Applicability

This framework is essential for manufacturers developing standalone software as a medical device (SaMD) or software embedded within hardware components. It is harmonized for use within the European Union to meet Medical Device Regulation (MDR) requirements and is widely recognized by regulatory bodies globally, including the FDA in the United States.

Core Principles

Integration of risk management processes

Safety classification determines process rigor

Structured software development lifecycle

Architectural decomposition and safety inheritance

Controlled software maintenance and changes

Software configuration management controls

Formalized software problem resolution