jQuery Mobile Framework
Search Home >> Standards Wordwide >> International Electrotechnical Commission (IEC) >> IEC 62304 Ed. 1.0 Medical device software - Software life cycle processes

IEC 62304 Ed. 1.0 Medical device software - Software life cycle processes

Standard Number:  IEC 62304 Ed. 1.0
Title:  Medical device software - Software life cycle processes
Language:  English and French
Replaced by Standard:  IEC 62304 Ed. 1.1

Adopted International Standard:  AAMI SW68 Ed. 1 (2001) Identical
AAMI IEC 62304-2006 Identical
OVE/ONORM EN 62304-200
Status:  Current
International Classification for Standards (ICS)HEALTH CARE TECHNOLOGY>>Medical equipment
Publisher:  International Electrotechnical Commission (IEC)
Price:  
Number of Pages:155  

Description: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 English-language version is derived from the original bilingual publication by leaving out all French-language pages. Missing page numbers correspond to the French-language pages.  
File Format:  PDF(Acrobat Reader) or Word version doc Document
File Size:  256KB
Tile in English:  Medical device software - Software life cycle processes

Full Text Information

Related

Top 10

New 10

PC Version