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

 

Project

Reference EN 60601-1-8:2004
Title Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Project Number 15244
Abstract/Scope The object of this collateral standard is to specify 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.
Status
Withdrawn

Status

Current Stage code 6060
Current Stage code date 2004-01-30
Current Stage code deadline 2004-09-01
Deadline date for vote  

Legal

Directive(s) MDD (93/42/EEC)
Mandate(s) M/023; M/432
Order Voucher  

Details

IEC Technical Body IEC/SC 62A
Reference Document IEC 60601-1-8:2003 (EQV)
ICS 11.040.01 - Medical equipment in general
Keywords Medical equipment; Collateral standard; Alarm system; Safety
Note Superseded by EN 60601-1-8:2007
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2004-01-30 2004-09-01 export to doc file  EN
5099 2003-12-02 2004-02-01  
5062 2003-10-01 2003-12-02  
5061 2003-08-25 2003-10-01  
5020 2003-05-09 2003-07-11  
4099 2002-12-13 2003-05-30  
4020 2002-06-07 2002-11-08  
3099 2002-06-04 2002-06-07  

Implementation Dates

date of Ratification (DOR) (1) 2003-12-02
date of Availability (DAV) (2) 2004-01-30
date of Announcement (DOA) (3) 2004-03-01
date of Publication (DOP) (4) 2004-09-01
date of Withdrawal (DOW) (5) 2006-12-01

Relations

Supersedes  
Superseded by EN 60601-1-8:2007
Normative reference (6) ISO 3744:1994
ISO 7000:1989
EN 60601-1:1990
corr. July 1994
A1:1993
A2:1995
A11:1993
A12:1993
A13:1996
EN 60601-1-1:2001
EN 60601-1-6:2004
EN 60651:1994
A1:1994
A2:2001
IEC 60417-DB:2002

(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.