Standard Swedish standard · SS-EN 62304

Medical device software - Software life-cycle processes

Status: Valid

· Corrected by: SS-EN 62304 C 1 , SS-EN 62304 T 1 Amended by: SS-EN 62304 A 1
Buy this standard

Standard Swedish standard · SS-EN 62304

Medical device software - Software life-cycle processes
Subscribe on standards - Read more Dölj
Price: 2 839 SEK
standard ikon pdf

PDF

Price: 2 839 SEK
standard ikon

Paper

Show more Show less
Scope
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.

Subjects

General (11.040.01)


Buy this standard

Standard Swedish standard · SS-EN 62304

Medical device software - Software life-cycle processes
Subscribe on standards - Read more Dölj
Price: 2 839 SEK
standard ikon pdf

PDF

Price: 2 839 SEK
standard ikon

Paper

Show more Show less

Product information

Language: English

Written by: SEK SVENSK ELSTANDARD

International title:

Article no: STD-3332735

Edition: 1

Approved: 3/26/2007

No of pages: 79