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Publication details

Publication CODE Title
NBN EN 60601-1-6:2007 (2013-04) 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 € 5 P.
Description
This international standard specifies requirements for a process to analyse, design, verify and validate the usability, as it relates to basic safety and essential performance of medical electrical equipment, hereafter referred to as ME equipment. this collateral standard addresses normal use and use errors but excludes abnormal use.
Class  C74  (EQUIPMENT USING ELECTRICAL POWER RADIOLOGY AND SIMILAR ELECTRICAL APPLIANCES AND THEIR ACCESSORIES)
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 60601-1-6:2006. For the series NBN EN 50XXX, the standards are however complete.

EN version
FR version
DE version
Status
Status Registered trilingual Belgian standard EN or FR or DE
Situation Withdrawn
Replaced by  NBN EN 60601-1-6:2010
Replaces  NBN EN 60601-1-6:2005
Origin
Committee TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2007-05-01
NBN Approval 2007-12-19
Registration 85103
Numbers identifying the european directives 93/42/EEC  (Medical devices)
ICS-Code (International Standards Classification) 11.040
NBN Status New
Date of ratification (d.o.r.) 2013-04-01
Date of availability (d.a.v.) 2013-04-01
Date of announcement (d.o.a.) 2007-08-01
Date of publication (d.o.p.) 2008-02-01
Date of withdrawal former edition (d.o.w.) 2012-06-01
Date of cessation of conformity (d.o.c.) 2012-06-01
Correspondences with international standards
Relation International standard Date
is identical to EN 60601-1-6:2007 2007-07-31
is identical to EN 60601-1-6:2007/corrigendum Mar. 2010 2010-03-05
is identical to IEC 60601-1-6:2006/ed. 2.0 2006-12-01
Relations to belgian/foreign publications
Type Origin Code Date
Standard Belgium NBN EN 60601-1
Standard Belgium NBN EN 60601-1-8
Standard Belgium NBN EN ISO 14971