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

 

Project

Reference EN 50527-2-1:2011
Title Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-1: Specific assessment for workers with cardiac pacemakers
Project Number 16682
Abstract/Scope This European Standard provides the procedure for the specific assessment required in Annex A of EN 50527 1:2010 for workers with implanted pacemakers. It offers different approaches for doing the risk assessment. The most suitable one shall be used. If the worker has other AIMDs implanted additionally, they have to be assessed separately. The purpose of the specific assessment is to determine the risk for workers with implanted pacemakers arising from exposure to electromagnetic fields at the workplace. The assessment includes the likelihood of clinically significant effects and takes account of both transient and long-term exposure within specific areas of the workplace. NOTE 1 This standard does not address risks to workers bearing a pacemaker from contact currents. The techniques described in the different approaches may also be used for the assessment of publicly accessible areas. The frequency range to be observed is from 0 Hz to 3 GHz. Above 3 GHz no interference with the pacemaker occurs when the exposure limits are not exceeded. NOTE 2 The rationale for limiting the observation range to 3 GHz can be found in Clause 5 of ANSI/AAMI PC69:2007.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2011-05-27
Current Stage code deadline 2012-05-02
Deadline date for vote 2009-12-31

Legal

Directive(s) EMF (2004/40/EC)
Mandate(s) M/351
Order Voucher  

Details

IEC Technical Body  
Reference Document  
ICS 11.040.40 - Implants for surgery, prosthetics and orthotics
17.240 - Radiation measurements
Keywords EMF assessment; Active; Implantable; Medical device; Cardiac pacemaker
Note 2011-03-29 - Publication editing allocated to cpalagi@cencenelec.eu * Numbering scheme analogue to EN 45502-2-1
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2011-05-27 2012-05-02 export to doc file  EN  FR  DE
5099 2011-05-02 2011-05-30  
5060 2011-03-28 2011-04-18 export to doc file  EN
5020 2011-01-21 2011-03-25 export to doc file  EN  FR  DE
4090 2010-11-10    
4060 2010-09-27 2010-10-19 export to doc file  EN
4020 2010-05-07 2010-09-24 export to doc file  EN  FR  DE
3099 2010-02-24 2010-06-01  
2020 2007-03-28    
1099 2004-12-07 2005-06-07  

Implementation Dates

date of Ratification (DOR) (1) 2011-05-02
date of Availability (DAV) (2) 2011-05-27
date of Announcement (DOA) (3) 2011-11-02
date of Publication (DOP) (4) 2012-05-02
date of Withdrawal (DOW) (5) 2014-05-02

Relations

Supersedes  
Superseded by  
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.