Medical device software - Software life cycle processes
Covers the software life cycle for medical device software, including software maintenance and configuration management.
The text of this standard is sold by IEC and is not reproduced here. This page gives the code, edition, scope and what each market says about it.
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
| Market | Status | Edition accepted | National code | Details |
|---|---|---|---|---|
| United States | Recognized | Edition 1.1 2015-06 (consolidated version) | - | Recognition number 13-79. Voluntary: a declaration of conformity to a recognized standard can be used in a submission. |
| European Union | Referenced | - | - | Named for information in EU cybersecurity guidance. It gives no presumption of conformity unless the standard is harmonised and published in the Official Journal. |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: YY/T 0664-2020, GB/T 25000.51-2016, JIS T 2304, IMDRF GMLP guiding principles, IEC 82304-1. See all standards.
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.
| United Kingdom | Recognized | EN 62304:2006 with corrigendum AC:2008 | - | Recognition number List row 270. Partial recognition. The list adds a note that the standard may not cover the requirements added to the Regulations in 2008, so manufacturers are advised to check that all relevant essential requirements are covered.. Voluntary: a device that conforms to a designated standard is treated as complying with the related essential requirement unless there are reasonable grounds to suspect that it does not. |
| Japan | Adopted | IEC 62304:2006 with amendment 1 (2015), identical JIS version | JIS T 2304:2017医療機器ソフトウェア―ソフトウェアライフサイクルプロセス | Effective November 25, 2017. Conformity with JIS T 2304 is treated as showing conformity with the software life cycle requirement of the Essential Principles. Other suitable international standards may be used with a justification. |
| China | National equivalent | - | YY/T 0664-2020Medical device software - Software life cycle processes | Effective September 1, 2021. Recommended industry standard on medical device software life cycle processes. A regulator's review specification for Class II standalone software lists it among its references. |
| Canada | Recognized | Latest version (the list gives no edition or year) | - | When a new version is published, both the newest and the previous version stay recognized for 3 years from the date the newest version was published.. Voluntary: a manufacturer meets the standard, meets an equivalent or better standard, or gives other evidence of safety or effectiveness. A Declaration of Conformity is submitted when a recognized standard is used. |
| Australia | Referenced | - | - | The TGA names no edition.. Voluntary. The TGA treats it as a way to show compliance with the Essential Principles but does not require it. The TGA says the standard applies to all medical device software. |