PREN 50527-1 : DRAFT 2015

Superseded

PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL

Superseded date

01-12-2016

Published date

03-03-2015

Publisher

European Committee for Standards - Electrical

Foreword
1 Scope
2 Normative References
3 Terms and definitions
4 Risk assessment
5 Equipment at workplaces
6 Special cases
7 AIMD-Employees with more than one AIMD
8 Documentation
Annex A (normative) - Specific risk assessment
Annex B (informative) - Documenting the risk assessment
Annex C (informative) - Specific electromagnetic
environments
Annex D (informative) - Theoretical considerations
Bibliography

Provides a procedure in order to assess the risk to workers bearing one or more active implantable medical devices from exposure to electric, magnetic and electromagnetic fields at a workplace.

Committee	TC 106X
DocumentType	Draft
PublisherName	European Committee for Standards - Electrical
Status	Superseded
SupersededBy	EN 50527-1:2016

Standards	Relationship
15/30321267 DC : DRAFT FEB 2015	Identical
08/30191453 DC : DRAFT OCT 2008	Identical

EN 50500 : 2008 AMD 1 2015	MEASUREMENT PROCEDURES OF MAGNETIC FIELD LEVELS GENERATED BY ELECTRONIC AND ELECTRICAL APPARATUS IN THE RAILWAY ENVIRONMENT WITH RESPECT TO HUMAN EXPOSURE
2007/47/EC : 2007 COR 1 2015	DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE)
EN 45502-2-2 : 2008 COR 2009	ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)
ISO 14708-3:2017	Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators
ISO 14708-4:2008	Implants for surgery Active implantable medical devices Part 4: Implantable infusion pumps
EN 45502-1 : 2015	IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
EN 45502-2-1:2003	Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
EN 50413 : 2008 AMD 1 2013	BASIC STANDARD ON MEASUREMENT AND CALCULATION PROCEDURES FOR HUMAN EXPOSURE TO ELECTRIC, MAGNETIC AND ELECTROMAGNETIC FIELDS (0 HZ - 300 GHZ)
EN 50499:2008	Procedure for the assessment of the exposure of workers to electromagnetic fields
EN 45502-2-3:2010	Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems