Publication details
| Publication CODE |
Title |
| NBN EN 62366-1:2015 (2015-04) |
MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
25.00 €
|
3 P.. |
Description
Specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS permits the MANUFACTURER to assess and mitigate RISKS associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE.
Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process.
It strengthens links to ISO 14971:2007 and the related methods of risk management as applied to safety related aspects of medical device user interfaces.
Part 2 contains tutorial information to assist manufactures in complying with Part 1, as well as offering more detailed descriptions of usability engineering methods that can be applied more generally to medical devices that go beyond safety-related aspects of medical device user interfaces.
|
| 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 62366-1:2015.
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
Partly replaces
NBN EN 62366:2008
|
|
Origin
| Committee |
TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
|
| Responsible |
De heer VAN HECKE Luk
|
Approval
| BEC Approval |
2015-03-31 |
| NBN Approval |
2015-06-19 |
| Belgian Official Journal |
2015-07-03 |
| Registration |
158400 |
| Numbers identifying the european directives |
93/42/EEC
(Medical devices)
98/79/EC
(In vitro diagnostic medical devices)
|
| ICS-Code (International Standards Classification) |
11.040
|
| NBN Status |
Adapted |
|
| Date of ratification (d.o.r.) |
2015-03-31 |
| Date of availability (d.a.v.) |
2015-04-24 |
| Date of announcement (d.o.a.) |
2015-07-01 |
| Date of publication (d.o.p.) |
2015-12-31 |
| Date of withdrawal former edition (d.o.w.) |
2018-03-31 |
|
Correspondences with international standards
| Relation |
International standard |
Date |
| is identical to |
EN 62366-1:2015
|
2015-04-24 |
| is identical to |
IEC 62366-1:2015/ed. 1.0
|
2015-02-24 |
Relations to belgian/foreign publications
| Type |
Origin |
Code |
Date |
| Standard |
Belgium |
NBN EN ISO 14971 |
|
|
