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 |
|
|
