I.S. EN 50527-1:2016
Current
The latest, up-to-date edition.
PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL
Hardcopy , PDF
English
01-01-2016
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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National Foreword
European 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
Gives a procedure 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.
DocumentType |
Standard
|
Pages |
40
|
PublisherName |
National Standards Authority of Ireland
|
Status |
Current
|
Standards | Relationship |
EN 50527-1:2016 | 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 |
PREN 50527-2-2 : DRAFT 2017 | PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: SPECIFIC ASSESSMENT FOR WORKERS WITH CARDIOVERTER DEFIBRILLATORS (ICDS) |
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 45502-1 : 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 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 |
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) |
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