IEC 62304:2006
Medical device software - Software life cycle processes
Note: a more recent version of this publication exists
IEC 62304:2006+AMD1:2015 CSV
Abstract
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. 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. This standard does not cover validation and final release of the medical device, even when the medical device consists entirely of software.
Additional information
Publication type | International Standard |
---|---|
Publication date | 2006-05-09 |
Edition | 1.0 |
Available language(s) | English, English/French, French, Spanish |
TC/SC | TC 62/SC 62A - Common aspects of medical equipment, software, and systemsrss |
ICS | 11.040.01 - Medical equipment in general |
Stability date | 2026 |
Pages | 155 |
File size | 2331 KB |
The following test report forms are related:
More information
Share this page
Share your publications
Learn how to share your publications with your colleagues, using networking options.
Payment information
Our prices are in Swiss francs (CHF). We accept all major credit cards (American Express, Mastercard and Visa, JCB and CUP), PayPal and bank transfers as form of payment.
Keep in touch
Keep up to date with new publication releases and announcements with our free IEC Just Published email newsletter.
Contact customer services
Please send your enquiry by email or call us on +41 22 919 02 11 between 09:00 – 16:00 CET Monday to Friday.