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



Reference EN 60601-1-8:2007
Title Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Project Number 20488
Abstract/Scope Specifies basic safety and essential performance requirements and tests for alarm systems in medical electrical equipment and medical electrical systems and to provide guidance for their application. This is accomplished by defining alarm categories (priorities) by degree of urgency, consistent alarm signals and consistent control states and their marking for all alarm systems.


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 60601-1-8:2006 (EQV)
ICS 11.040.01 - Medical equipment in general
Keywords Medical equipment; Collateral standard; Alarm system; Safety
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 2007-04-11 2007-08-01  
5062 2006-12-01 2007-04-11  
5061 2006-10-26 2006-12-01  
5060 2006-07-21 2006-10-13 export to doc file  EN
4099 2006-07-14 2006-10-06  
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) 2007-04-11
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 60601-1-8:2004
EN 60601-1-8:2004/A1:2006
EN 60601-1-8:2004/A1:2006/corrigendum Oct. 2006
Superseded by  
Normative reference (6) ISO 3744:1994
ISO 7000:1989
EN 60601-1:2006
corr. March 2010
EN 60601-1-2:2007
corr. March 2010
EN 60601-1-6:2007
corr. March 2010
EN 60651:1994
IEC 60417-DB

(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.