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 |
|
|
