IEC 62304, Draft of the 2nd Edition: Optimized safety classes, extended scope for healthcare software and AI

Date

February 7, 2025

Category

Other Regulations

Description

The draft of the second edition of the IEC 62304 will introduce key changes focused on simplifying software classification and expanding the scope of the standard to include healthcare software. The original three software safety classes (A, B, and C) will be replaced by two software process accuracy levels (I and II), which is more consistent with the IEC 81001-5-1. Level I essentially replaces software safety class A, and Level II replaces software safety classes B and C.

The updated standard emphasizes the use of the term "harm" instead of "harm to patients, operators, or other persons" to align with the ISO 14971, which addresses damage to property and the environment. The updated standard omits the term "dangerous situation."

One key addition is the inclusion of AI process planning for devices that incorporate AI, machine learning, or deep learning. This includes an AI development lifecycle (AIDL) with specific phases and considerations. The standard extends its scope to healthcare software, which affects requirements and terminology.