International Standards and Conformity Assessment for all electrical, electronic and related technologies



Reference EN 60601-1-6:2004
Title Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability
Project Number 15737
Abstract/Scope Medical practice is increasingly using medical electrical equipment for observation and treatment of patients. use errors caused by inadequate medical electrical equipment usability have become an increasing cause for concern. The usability engineering process is intended to achieve reasonable usability, which in turn is intended to minimise use errors and to minimise use associated risks. Some, but not all, forms of incorrect use are amenable to control by the manufacturer. The usability engineering process is part of the process of risk control. This Collateral Standard describes a usability engineering process, and provides guidance on how to implement and execute the process to provide medical electrical equipment safety. It addresses normal use and use errors but excludes abnormal use.


Current Stage code 6060
Current Stage code date 2004-11-05
Current Stage code deadline 2005-06-01
Deadline date for vote  


Directive(s) MDD (93/42/EEC)
Mandate(s) M/432
Order Voucher  


IEC Technical Body IEC/SC 62A
Reference Document IEC 60601-1-6:2004 (EQV)
ICS 11.040 - Medical equipment
Keywords Medical equipment; Collateral standard; Usability
Note Superseded by EN 60601-1-6:2007
Special National Condition(s)  


Categories - Aspects
Product Life Cycle
Annex A.2 Waste Disposal B2B, B2C


Deadline Date
6060 2004-11-05 2005-06-01 export to doc file  EN
5099 2004-09-01 2004-12-01  
5061 2004-06-28 2004-09-01  
5020 2004-03-19 2004-05-21  
4099 2003-11-28 2003-12-31  
4020 2003-03-28 2003-09-05  
3099 2003-03-26 2003-03-28  

Implementation Dates

date of Ratification (DOR) (1) 2004-09-01
date of Availability (DAV) (2) 2004-11-05
date of Announcement (DOA) (3) 2004-12-01
date of Publication (DOP) (4) 2005-06-01
date of Withdrawal (DOW) (5) 2007-09-01


Superseded by EN 60601-1-6:2007
Normative reference (6) EN ISO 14971:2000
corr. February 2002
EN 60601-1:1990
corr. July 1994
EN 60601-1-8:2004

(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved

(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat

(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level

(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement

(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn

(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.