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

 

Project

Reference EN 60601-1:1990/A2:1995
Title Medical electrical equipment - Part 1: General requirements for safety
Project Number 4205
Abstract/Scope This is the major revised and updated baseline of standards for the safety of all medical electrical equipment used by or under the supervision of qualified personnel in the general medical and patient environment. lt also contains certain requirements for reliable operation to ensure safety. Note the change of title from the first (1977) edition. (For particular requirements see series 601-2 below.)
Status
Published

Status

Current Stage code 6060
Current Stage code date 1995-06-16
Current Stage code deadline 1996-03-01
Deadline date for vote  

Legal

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

Details

IEC Technical Body IEC/SC 62A
Reference Document IEC 60601-1:1988/A2:1995 (EQV) + corrigendum Jun. 1995 (EQV)
ICS 11.040 - Medical equipment
Keywords Medical equipment; Safety
Note EN following parallel vote * Incorporates and supersedes A11 and A12
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information
6.8.2.j Waste - Hazardous waste Disposal B2B, B2C

History

Stage
Date
Deadline Date
Documents
6060 1995-06-16 1996-03-01 export to doc file  EN
5099 1995-03-06 1995-04-06  
5060 1995-03-02 1995-06-02  
5020 1994-10-14 1995-02-15  
1090 1994-10-14 1995-02-15  
3092 1994-06-13 1994-12-13  
3020 1992-12-15 1993-04-30  

Implementation Dates

date of Ratification (DOR) (1) 1995-03-06
date of Availability (DAV) (2) 1995-06-16
date of Announcement (DOA) (3) 1995-06-01
date of Publication (DOP) (4) 1996-03-01
date of Withdrawal (DOW) (5) 2012-06-01

Relations

Supersedes  
Superseded by EN 60601-1:2006
Normative reference (6) ISO 471:1983
ISO 1000:1981
ISO 1853:1975
ISO 2878:1987
ISO 2882:1979
ISO 8185:1988
ISO R 32:1977
ISO 10993-1:1992
EN 60065:1993
corr. November 1993
corr. September 1997
A11:1997
EN 60068-2-2:1993
HD 354 S2:1987
IEC 60079-2:1983
IEC 60079-5:1967
IEC 60079-6:1968
HD 566 S1:1990
HD 214 S2:1980
HD 109 S3:1983
HD 21.1 S2:1990
A8:1994
A6:1991
A7:1992
A5:1990
A9:1993
A12:1993
A15:1995
A13:1994
A16:1995
A14:1997
IEC 60241:1968
HD 22.4 S2:1992
A6:1992
IEC 60252:1975
EN 60320-1:1987
corr. November 1993
A11:1994
IEC 60328:1972
IEC 60335-1:1970
IEC 60364-4-41:1982
IEC 60384-14:1993
HD 243 S12:1995
corr. October 1995
HD 241 S2:1977
HD 331 S1:1977
IEC 60513:1994
EN 60529:1991
corr. May 1993
HD 366 S1:1977
HD 395.1 S2:1988
A1:1993
EN 60601-1-1:1993
EN 60601-1-2:1993
corr. December 1997
EN 60601-1-3:1994
EN 60601-1-4:1996
IEC 60664:1980
IEC 60695-1-1:1982
HD 441 S1:1983
EN 60742:1995
IEC 60878:1988
ISO R 407:1983
ISO R 780:1985

(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.