Back

IEC 62304:2006+AMD1:2015 CSV

Medical device software - Software life cycle processes

General information
Valid from 26.06.2015
Directives or regulations
None
Standard history
Status
Date
Type
Name
IEC 62304:2006+A1:2015 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. This consolidated version consists of the first edition (2006) and its amendment 1 (2015). Therefore, no need to order amendment in addition to this publication.
*
*
*
PDF
867.72 € incl tax
Standard monitoring
Customers who bought this item also bought
Main

ISO 14971:2019

Medical devices -- Application of risk management to medical devices
Newest version Valid from 10.12.2019
Main

ISO 13485:2016

Medical devices -- Quality management systems -- Requirements for regulatory purposes
Newest version Valid from 25.02.2016
Main

IEC 62366-1:2015

Medical devices - Part 1: Application of usability engineering to medical devices
Newest version Valid from 24.02.2015
Main

ISO 15223-1:2016

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements (Corrected version 2017-03)
Withdrawn from 06.07.2021