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



Reference EN 60601-1-6:2007
Title Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
Project Number 20485
Abstract/Scope 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. This collateral standard addresses normal use and use errors but excludes abnormal use. The object of this collateral standard is to specify general requirements that are in addition to those of the general standard IEC 60601-1 and to serve as the basis for particular standards.


Current Stage code 6060
Current Stage code date 2007-07-31
Current Stage code deadline 2008-02-01
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 60601-1-6:2006 (EQV)
ICS 11.040 - Medical equipment
Keywords Medical equipment; Collateral standard; Usability
Note Superseded by EN 60601-1-6:2010
Special National Condition(s)  


Categories - Aspects
Product Life Cycle


Deadline Date
6060 2007-07-31 2008-02-01 export to doc file  EN  FR  DE
5099 2007-05-01 2007-07-01  
5061 2007-03-27 2007-05-01  
5060 2006-11-14 2006-11-28 export to doc file  EN
5020 2006-09-08 2006-11-10  
4099 2006-07-14 2006-11-10  
5060 2006-06-20 2006-07-04 export to doc file  EN
5020 2006-01-13 2006-06-16  
1090 2006-01-10 2006-01-13  

Implementation Dates

date of Ratification (DOR) (1) 2007-05-01
date of Availability (DAV) (2) 2007-07-31
date of Announcement (DOA) (3) 2007-08-01
date of Publication (DOP) (4) 2008-02-01
date of Withdrawal (DOW) (5) 2012-06-01


Supersedes EN 60601-1-6:2004
Superseded by EN 60601-1-6:2010
Normative reference (6) EN ISO 14971:2000
corr. February 2002
EN 60601-1:2006
corr. March 2010
EN 60601-1-8:2007
corr. March 2010

(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.