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

 

Project

Reference EN 60601-1:2006/A1:2013
Title Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Project Number 23401
Abstract/Scope  
Status
Published

Status

Current Stage code 6060
Current Stage code date 2013-10-04
Current Stage code deadline 2014-06-24
Deadline date for vote  

Legal

Directive(s) MDD (93/42/EEC), AIMD (90/385/EEC)
Mandate(s) M/295; M/432
Order Voucher  

Details

IEC Technical Body IEC/SC 62A
Reference Document IEC 60601-1:2005/A1:2012 (EQV)
ICS 11.040 - Medical equipment
Keywords Medical equipment; Essential performance; Safety
Note D145/C144: extension to DOW to December 2018
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2013-10-04 2014-06-24 export to doc file  EN  FR  DE
5099 2013-09-24 2013-11-24  
5091 2012-08-18    
5099 2012-08-17 2012-09-14  
5060 2012-07-02 2012-07-23 export to doc file  EN
5020 2012-04-27 2012-06-29  
3090 2011-08-26 2012-04-30  
5060 2011-08-16 2011-09-06 export to doc file  EN
5020 2011-03-11 2011-08-12  
1090 2011-03-08 2011-03-11  

Implementation Dates

date of Ratification (DOR) (1) 2013-09-24
date of Availability (DAV) (2) 2013-10-04
date of Announcement (DOA) (3) 2013-12-24
date of Publication (DOP) (4) 2014-06-24
date of Withdrawal (DOW) (5) 2018-12-24

Relations

Supersedes EN 60601-1:2006/A11:2011
Superseded by  
Normative reference (6) ISO 780
ISO 1853
ISO 2878
ISO 2882
ISO 3746
ISO 3864-1:2002
ISO 5349-1
ISO 7000:2004
ISO 7010:2011
ISO 9614-1
ISO 10993 series
ISO 11135-1:2007
ISO 11137-1:2006
ISO 13857:2008
EN ISO 14971:2012
ISO 15223-1:2012
ISO 17665-1:2006
ISO 23529:2010
EN 60065:2002
corr. March 2006
corr. August 2007
A1:2006
A2:2010
A12:2011
A11:2008
EN 60068-2-2:2007
EN 60079-0
EN 60079-2
EN 60079-5
EN 60079-6
IEC 60083
EN 60085
EN 60086-4
EN 60112
EN 60127-1
IEC 60227-1:2007
IEC 60245-1:2003
EN 60252-1
EN 60320-1
EN 60335-1:2012
corr.
HD 60364-4-41
EN 60384-14:2005
EN 60445
EN 60447
EN 60529:1991
corr. May 1993
A1:2000
EN 60601-1-2
EN 60601-1-3
EN 60601-1-6
EN 60601-1-8
EN 60664-1:2007
EN 60695-11-10
EN 60730-1:2011
EN 60825-1:2007
EN 60851-3:2009
EN 60851-5:2008
EN 60851-6:1996
A1:1997
IEC 60884-1
EN 60950-1:2001
corr. April 2004
corr. December 2007
A11:2004
EN 61058-1:2002
:
A1:
A2:2008
EN 61558-2-1
EN 61672-1
EN 61672-2
EN 61965
EN 62133
EN 62304:2006
corr. November 2008
EN ISO 80000-1:2013


(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.