AI Assurance DirectoryStandard · IEC TC 62/SC 62A
IEC 62304 (medical device software — software life cycle processes)
Life-cycle requirements for medical device software when the software is itself a medical device or is embedded in one. Does not cover validation and final release of the medical device.
- Status
- Published 9 May 2006 (edition 1.0); consolidated with Amendment 1, 26 June 2015
- Last reviewed
- Last verified
- Industries
- Medical devices
What it is
IEC lists IEC 62304:2006, Medical device software — Software life cycle processes, published 9 May 2006, from TC 62/SC 62A. The catalog defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes.
It applies to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device. The consolidated edition IEC 62304:2006+A1:2015 consists of the first edition (2006) and its amendment 1 (2015).
What it does not cover
The same catalog sentence is explicit: This standard does not cover validation and final release of the medical device, even when the medical device consists entirely of software. We have not found an official IEC catalog sentence that says IEC 62304 is an AI-specific standard or that it is a PCCP.
How it relates to other frameworks
- FDA AI-DSF / PCCP. US marketing-submission recommendations for AI-enabled device software functions. Different issuer.
- EU MDR + AI Act. Union device and AI-system rules. IEC 62304 is a software life-cycle standard, not those regulations.
Primary sources
Read the catalog entries at IEC 62304:2006 and the 2015 consolidated version. IEC sells the full text.