| Publication CODE |
Title |
| NBN EN 60601-1-6:2010 (2010-04) |
MEDICAL ELECTRICAL EQUIPMENT
PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
25.00 €
|
4 P. |
Description
Specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical electrical equipment. This usability engineering process assesses and mitigates risks caused by usability problems 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. If the usability engineering process detailed in this collateral standard has been complied with and the acceptance criteria documented in the usability validation plan have been met (see 5.9 of IEC 62366:2007), then the residual risks, as defined in ISO 14971, associated with usability of me equipment are presumed to be acceptable, unless there is objective evidence to the contrary (see 4.1.2 of IEC 62366:2007). The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. This document cancels and replaces the second edition of IEC 60601-1-6 which has been technically revised. It was revised to align with the usability engineering process in IEC 62366. To allow for equipment manufacturers and testing organizations to make products and to equip themselves for conducting revised tests in accordance with this third edition, it is recommended by SC 62A that the content of this document not be adopted for mandatory implementation earlier than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production.
|
| Class |
C74
(EQUIPMENT USING ELECTRICAL POWER RADIOLOGY AND SIMILAR ELECTRICAL APPLIANCES AND THEIR ACCESSORIES)
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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 60601-1-6:2010.
For the series NBN EN 50XXX, the standards are however complete.
|
EN version
|
FR version
|
DE version
|
|
| Status |
Registered trilingual Belgian standard EN or FR or DE |
| Situation |
Currently active
Replaces
NBN EN 60601-1-6:2007
|
|
| Committee |
TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
|
| Responsible |
De heer VAN HECKE Luk
|
| BEC Approval |
2010-04-01 |
| NBN Approval |
2010-07-30 |
| Belgian Official Journal |
2010-08-19 |
| Registration |
106949 |
| Numbers identifying the european directives |
90/385/EEC
(Active implantable medical devices)
93/42/EEC
(Medical devices)
|
| ICS-Code (International Standards Classification) |
11.040
|
| NBN Status |
Adapted |
|
| Date of ratification (d.o.r.) |
2010-04-01 |
| Date of availability (d.a.v.) |
2010-04-16 |
| Date of announcement (d.o.a.) |
2010-07-01 |
| Date of publication (d.o.p.) |
2011-01-01 |
| Date of withdrawal former edition (d.o.w.) |
2013-04-01 |
| Date of cessation of conformity (d.o.c.) |
2013-04-01 |
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