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



Reference EN 60601-1:1990
Title Medical electrical equipment - Part 1: General requirements for safety
Project Number 4201
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.)


Current Stage code 6060
Current Stage code date 1990-08-09
Current Stage code deadline 1991-01-01
Deadline date for vote  


Directive(s) AIMD (90/385/EEC), MDD (93/42/EEC)
Mandate(s) M/432
Order Voucher BC/CLC/09-89


IEC Technical Body IEC/SC 62A
Reference Document IEC 60601-1:1988 (EQV)
ICS 11.040 - Medical equipment
Keywords Medical equipment; Safety
Note Supersedes HD 395.1 S2 * Corrigendum to EN issued July 1994 * Superseded by EN 60601-1:2006
Special National Condition(s)  


Categories - Aspects
Product Life Cycle


Deadline Date
6060 1990-08-09 1991-01-01 export to doc file  EN
5099 1990-06-11 1990-07-11  
5020 1989-12-20 1990-03-31  
1599 1989-09-11 1990-01-11  
1520 1989-04-28 1989-08-31  
1000 1988-07-06 1989-04-01  

Implementation Dates

date of Ratification (DOR) (1) 1990-06-11
date of Availability (DAV) (2) 1990-08-09
date of Announcement (DOA) (3) 1990-09-01
date of Publication (DOP) (4) 1991-01-01
date of Withdrawal (DOW) (5) 2012-06-01


Supersedes HD 395.1 S2:1988
HD 395.1 S2:1988/A1:1993
Superseded by EN 60601-1:2006
Normative reference (6)  

(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.