IEC 62304

IEC 62304 is a standard published by the International Electrotechnical Commission which provides a framework for the life cycle processes with activities and tasks necessary for the safe design and maintenance of medical software. The standard is harmonized by the European Union (EU) and the United States (US), and compliance with this standard is often required by regulatory authorities.

Overview

The IEC 62304 standard applies to the development and maintenance of medical device software when the software itself is a medical device or when it is part of a medical device. The standard defines the life cycle requirements for medical device software and provides a framework of processes and activities, each with associated tasks and outcomes.

Structure

The standard is divided into five main sections:

• Scope - This section outlines the applicability of the standard.
• Normative references - This section lists the standards that are referenced in the document.
• Terms and definitions - This section provides definitions for terms used in the document.
• General requirements - This section outlines the general requirements for medical device software.
• Software development process - This section describes the software development process, including software development planning, software requirements analysis, software architectural design, software detailed design, software unit implementation and verification, software integration and integration testing, and software system testing.

Compliance

Compliance with IEC 62304 is often required by regulatory authorities in the EU and US. The standard is harmonized under the Medical Device Directive (MDD) and the Medical Device Regulation (MDR) in the EU, and under the Food and Drug Administration (FDA) in the US.

See also

• Medical Device Directive
• Medical Device Regulation
• Food and Drug Administration
• International Electrotechnical Commission

References

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