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NSAI
I.S. EN 50527-1:2016

I.S. EN 50527-1:2016

Current

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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2016

Publisher

National Standards Authority of Ireland

Preview

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.


Dates of withdrawal of national standards are available from NSAI.

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 45502-2-1:2003 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

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