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

 

Project

Reference EN 60601-1-2:2001
Title Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
Project Number 7351
Abstract/Scope Specifies requirements and tests for electromagnetic compatibility of medical electrical equipment and medical electrical systems and serves as the basis of electromagnetic compatibility requirements and tests in Particular Standards. The existence of electromagnetic emission requirements is essential for the protection of: - safety services; - other medical electrical equipment and medical electrical systems; - non-medical electrical equipment (e.g. computers); - telecommunications (e.g. radio/TV, telephone, radio-navigation). The existence of electromagnetic immunity requirements is essential to assure safety of equipment and systems. The immunity test levels specified in this standard (EN 60601 test levels) represent the range found in the general medical use environment.
Status
Withdrawn

Status

Current Stage code 6060
Current Stage code date 2001-11-09
Current Stage code deadline 2002-08-01
Deadline date for vote  

Legal

Directive(s) EMC related (2004/108/EC), MDD (93/42/EEC)
Mandate(s) M/432
Order Voucher  

Details

IEC Technical Body IEC/SC 62A
Reference Document IEC 60601-1-2:2001 (EQV)
ICS 11.040.01 - Medical equipment in general
33.100.10 - Emission
33.100.20 - Immunity
Keywords Medical equipment; Electromagnetic compatibility; Requirement; Test; Safety
Note  
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2001-11-09 2002-08-01 export to doc file  EN
5099 2001-11-01 2002-03-01  
5061 2001-09-20 2001-11-01  
5020 2001-05-11 2001-07-13  
4099 2001-05-08 2001-05-11  
4020 2000-03-17 2000-07-17  
3099 2000-03-13 2000-03-17  
1090 2000-03-13 2000-03-17  
1000 1997-01-31    
1000 1995-12-15    

Implementation Dates

date of Ratification (DOR) (1) 2001-11-01
date of Availability (DAV) (2) 2001-11-09
date of Announcement (DOA) (3) 2002-02-01
date of Publication (DOP) (4) 2002-08-01
date of Withdrawal (DOW) (5) 2004-11-01

Relations

Supersedes EN 60601-1-2:1993
Superseded by EN 60601-1-2:2007
Normative reference (6) EN 55011:1998
EN 55014-1:2000
EN 55015:2000
CISPR 16-1:1999
EN 55022:1998
corr. August 1999
corr. July 2001
corr. July 2003
corr. March 2005
IEC 60050-161:1990
EN 60417-2:1999
EN 60601-1:1990
corr. July 1994
A1:1993
A2:1995
A11:1993
A12:1993
A13:1996
EN 60601-1-1:2001
EN 61000-3-2:2000
EN 61000-3-3:1995
corr. July 1997
EN 61000-4-2:1995
EN 61000-4-3:1996
EN 61000-4-4:1995
EN 61000-4-5:1995
EN 61000-4-6:1996
EN 61000-4-8:1993
EN 61000-4-11:1994

(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.