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

CLC/TC 62

Electrical equipment in medical practice

 

Project

Reference EN 60601-1-1:2001
Title Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
Project Number 7350
Abstract/Scope Applies to the safety of medical electrical systems, as defined as follows: combination of items of equipment, at least one of which must be medical electrical equipment and inter-connected by functional connection or use of a multiple portable socket-outlet. Describes the safety requirements necessary to provide protection for the patient, the operator and surroundings. Cancels and replaces the first edition published in 1992 and its amendment 1 (1995) and constitutes a technical revision.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2001-04-09
Current Stage code deadline 2001-10-01
Deadline date for vote  

Legal

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

Details

IEC Technical Body IEC/SC 62A
Reference Document IEC 60601-1-1:2000 (EQV)
ICS 11.040.01 - Medical equipment in general
Keywords Medical equipment; Collateral standard; Safety
Note EN following parallel vote
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2001-04-09 2001-10-01 export to doc file  EN
5099 2000-12-01 2001-04-01  
5061 2000-10-26 2000-12-01  
5020 2000-08-04 2000-10-16  
4099 2000-07-31 2000-08-04  
4020 1999-06-04 1999-11-15  
3099 1999-05-31 1999-06-04  
1000 1997-01-31    
1000 1995-12-15    

Implementation Dates

date of Ratification (DOR) (1) 2000-12-01
date of Availability (DAV) (2) 2001-04-09
date of Announcement (DOA) (3) 2001-04-01
date of Publication (DOP) (4) 2001-10-01
date of Withdrawal (DOW) (5) 2003-12-01

Relations

Supersedes EN 60601-1-1:1993
EN 60601-1-1:1993/A1:1996
Superseded by EN 60601-1:2006
Normative reference (6) ISO 7767:1997
ISO 8185:1997
ISO 8359:1996
ISO 9918:1993
EN 60065:1998
corr. June 1999
IEC 60083:1997
EN 60335-1:1994
corr. October 1994
corr. January 1995
corr. July 2009
A1:1996
A11:1995
A12:1996
A13:1998
A16:2001
A15:2000
A14:1998
EN 60529:1991
corr. May 1993
EN 60601-1:1990
corr. July 1994
A1:1993
A2:1995
A11:1993
A12:1993
A13:1996
EN 60601-1-4:1996
A1:1999
EN 60825-1:1994
corr. February 1995
A1:2002
A11:1996
IEC 60884-1:1994
EN 60950:2000
corr. February 2002
IEC 60989:1991
EN 61010-1:1993
:
A2:1995
ISO 10079-1:1991

(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.