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Publication details

Publication CODE Title
NBN EN 62304:2007 (2006-07) MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES
 
Price Excl. VAT Total number of pages, tables and drawings
25.00 € 3 P.
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.
Class  C90  (TELECOMMUNICATIONS - ELECTRONIC GENERAL)
Available files
ATTENTION: Belgian registered standards (NBN EN or NBN HD) are generally only available in English or French. Only the cover page is translated and the document itself is in English or in French.

Very important notice: 98% of the text of the NBN EN 55XXX, NBN EN 6XXXX comes from the IEC text which is NOT included. This text can be ordered here: IEC 62304:2006. For the series NBN EN 50XXX, the standards are however complete.

DE version
EN version
FR version
Status
Status Registered trilingual Belgian standard EN or FR or DE
Situation Currently active
Origin
Committee TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2006-06-01
NBN Approval 2007-01-31
Registration 75178
Numbers identifying the european directives 98/79/EC  (In vitro diagnostic medical devices)
93/42/EEC  (Medical devices)
90/385/EEC  (Active implantable medical devices)
ICS-Code (International Standards Classification) 11.040
NBN Status Adapted
Date of ratification (d.o.r.) 2006-06-01
Date of availability (d.a.v.) 2006-07-12
Date of announcement (d.o.a.) 2006-09-01
Date of publication (d.o.p.) 2007-03-01
Date of withdrawal former edition (d.o.w.) 2009-06-01
Correspondences with international standards
Relation International standard Date
is identical to EN 62304:2006 2006-07-12
is identical to EN 62304:2006/corrigendum Nov. 2008 2008-11-14
is identical to IEC 62304:2006/ed. 1.0 2006-05-01
Relations to belgian/foreign publications
Type Origin Code Date
Standard Belgium NBN EN ISO 14971