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

 

Project

Reference FprEN 60601-2-27:2011
Title Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
Project Number 22194
Abstract/Scope IEC 60601-2-27:2011 applies to electrocardiographic monitoring equipments used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. This particular standard also applies to ECG telemetry systems used in a hospital environment. Electrocardiographic monitoring equipments intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply for those environments of use. This standard is not applicable to electrocardiographic monitors for home use. However, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use. Ambulatory ('Holter') monitors, fetal heart rate monitoring, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of this particular standard. The aim of this third edition is to bring this particular standard up to date with reference to the third edition of the general standard through reformatting and technical changes.
Status
Approval stage

Status

Current Stage code 5091
Current Stage code date 2011-11-03
Current Stage code deadline  
Deadline date for vote  

Legal

Directive(s) MDD (93/42/EEC)
Mandate(s) M/295
Order Voucher  

Details

IEC Technical Body IEC/SC 62D
Reference Document IEC 60601-2-27:2011 (EQV) + corrigendum May 2012 (EQV)
ICS 11.040.50 - Radiographic equipment
Keywords Medical equipment; Electrocardiograph; Monitoring; Safety
Note Publication editing allocated to svandriessche@cencenelec.eu * Will supersede EN 60601-2-27:2006
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
5091 2011-11-03    
5060 2011-03-14 2011-04-04 export to doc file  EN
5020 2011-01-07 2011-03-11  
3090 2010-04-16 2010-10-31  
5060 2009-06-22 2009-07-06 export to doc file  EN
5020 2009-01-16 2009-06-19  
3090 2009-01-13 2009-01-16  

Implementation Dates

date of Ratification (DOR) (1)  
date of Availability (DAV) (2)  
date of Announcement (DOA) (3) -
date of Publication (DOP) (4) dor + 6 months
date of Withdrawal (DOW) (5) -

Relations

Supersedes EN 60601-2-27:2006
EN 60601-2-27:2006/corrigendum Dec. 2006
Superseded by  
Normative reference (6) EN 60601-1-2:2007
corr. March 2010
EN 60601-1-8:2007
corr. March 2010
EN 60601-2-2:2009
A11:2011
IEC 60601-2-25:2011
IEC 60601-2-49:2011

(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.