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Publication details

Publication CODE Title
NBN EN 82304-1:2017 (2017-09) HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY
 
Price Excl. VAT Total number of pages, tables and drawings
25.00 € 3.
Description
IEC 82304-1:2016 applies to the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for manufacturers. It covers the entire lifecycle including design, development, validation, installation, maintenance, and disposal of health software products.
Class  C
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 82304-1:2016. 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 2016-12-01
NBN Approval 2017-10-25
Registration 177196
Numbers identifying the european directives 90/385/EEC  (Active implantable medical devices)
93/42/EEC  (Medical devices)
98/79/EC  (In vitro diagnostic medical devices)
ICS-Code (International Standards Classification) 35.240.80
NBN Status New
Date of ratification (d.o.r.) 2016-12-01
Date of availability (d.a.v.) 2017-09-01
Date of announcement (d.o.a.) 2017-12-01
Date of publication (d.o.p.) 2018-03-01
Date of withdrawal former edition (d.o.w.) 2020-09-01
Correspondences with international standards
Relation International standard Date
is identical to EN 82304-1:2017 2017-09-01
is identical to IEC 82304-1:2016 2016-10-27
Relations to belgian/foreign publications
Type Origin Code Date
Standard Belgium NBN EN 62304:2007
Standard Belgium NBN EN 62304:2007/A1:2015