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

CLC/TC 62

Electrical equipment in medical practice

 

Project

Reference EN 60601-1-2:2007
Title Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
Project Number 20576
Abstract/Scope This collateral standard applies to electromagnetic compatibility of medical electrical equipment and medical electrical systems. The object of this collateral standard is to specify general requirements and tests for electromagnetic compatibility of medical electrical equipment and medical electrical systems. They are in addition to the requirements of the general standard and serve as the basis for particular standards. This edition of IEC 60601-1-2 was revised to structurally align it with the 2005 edition of IEC 60601-1 and to implement the decision of IEC subcommittee 62A that the clause numbering structure of collateral standards written to IEC 60601-1:2005 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The principle technical changes are in Clause 4, which now recognizes that there is a general requirement for a risk management process in IEC 60601-1:2005.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2007-07-31
Current Stage code deadline 2008-02-01
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 60601-1-2:2007 (MOD)
ICS 11.040.01 - Medical equipment in general
33.100.10 - Emission
33.100.20 - Immunity
Keywords Medical equipment; Electromagnetic compatibility; EMC; 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 2007-07-31 2008-02-01 export to doc file  EN  FR  DE
5099 2007-04-11 2007-08-01  
5062 2007-04-02 2007-04-11  
5060 2007-02-15 2007-03-01 export to doc file  EN
5020 2006-12-08 2007-02-09  
5020 2006-12-05 2007-02-09  
4099 2006-09-08 2006-12-31  
5060 2006-07-10 2006-07-24 export to doc file  EN
5020 2006-02-03 2006-07-07  
1090 2006-01-31 2006-02-03  

Implementation Dates

date of Ratification (DOR) (1) 2007-04-11
date of Availability (DAV) (2) 2007-07-31
date of Announcement (DOA) (3) 2007-08-01
date of Publication (DOP) (4) 2008-02-01
date of Withdrawal (DOW) (5) 2012-06-01

Relations

Supersedes EN 60601-1-2:2001
EN 60601-1-2:2001/A1:2006
Superseded by FprEN 60601-1-2:2013
Normative reference (6) EN 55011:2007
EN 55014-1:2006
EN 55015:2006
EN 55016-1-2:2004
CISPR 22:2005
EN 60601-1:2006
corr. March 2010
corr.
A11:2011
EN 60601-1-8:2007
corr. March 2010
EN 61000-3-2:2006
EN 61000-3-3:1995
corr. July 1997
EN 61000-4-2:1995
EN 61000-4-3:2006
EN 61000-4-4:2004
EN 61000-4-5:2006
EN 61000-4-6:2007
corr. August 2007
:
:
EN 61000-4-8:1993
EN 61000-4-11:2004
IEC 60417-DB

(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.