International Standards and Conformity Assessment for all electrical, electronic and related technologies

 

Project

Reference EN 62304:2006
Title Medical device software - Software life-cycle processes
Project Number 16632
Abstract/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.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2006-07-12
Current Stage code deadline 2007-03-01
Deadline date for vote  

Legal

Directive(s) MDD (93/42/EEC), AIMD (90/385/EEC), IVD (98/79/EC)
Mandate(s) M/432
Order Voucher  

Details

IEC Technical Body IEC/SC 62A
Reference Document IEC 62304:2006 (EQV)
ICS 11.040 - Medical equipment
Keywords Software; Medical; Life-cycle process
Note Corrigendum to EN issued November 2008
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2006-07-12 2007-03-01 export to doc file  EN  FR  DE
5099 2006-06-01 2006-08-01  
5060 2006-04-20 2006-05-04 export to doc file  EN
5020 2006-02-10 2006-04-14  
4099 2005-09-23 2005-12-31  
4020 2004-12-03 2005-05-13  
3099 2004-11-30 2005-04-30  

Implementation Dates

date of Ratification (DOR) (1) 2006-06-01
date of Availability (DAV) (2) 2006-07-12
date of Announcement (DOA) (3) 2006-09-01
date of Publication (DOP) (4) 2007-03-01
date of Withdrawal (DOW) (5) 2009-06-01

Relations

Supersedes  
Superseded by  
Normative reference (6) EN ISO 14971:2012

(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved


(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat


(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level


(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement


(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn


(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.