🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
BS EN 50527-1:2016:2017 Edition

BS EN 50527-1:2016:2017 Edition

$167.15

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices – General

Published By Publication Date Number of Pages
BSI 2017 38
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Category:

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

This European Standard provides 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. It describes how a general risk assessment should be performed and determines whether it is necessary to carry out a detailed risk assessment. NOTE 1 This European Standard does not cover indirect effects caused by non active implants. NOTE 2 The risk of human exposure to EMF considered is only due to malfunctioning of AIMD. Possibilities of AIMD contribution to the risk, e.g. local modification of the distribution of EMF produced by external source or production of own EMF, are covered by the respective product standards for the AIMD. Based on specific workplace standards it can be determined whether preventive measures/actions need to be taken to comply with the provisions of Directive 2013/35/EU. The work situation covered is considered to be under normal working conditions including normal operation, maintenance, cleaning and other situations being part of the normal work. The frequencies covered are from 0 Hz to 300 GHz. The European Parliament and Council Directive 2013/35/EU will be transposed into national legislation in all the EU member countries. It is recommended that users of this standard consult the national legislation related to this transposition in order to identify the national regulations and requirements. These national regulations and requirements may have additional requirements that are not covered by this standard and take precedence. NOTE 3 Performance requirements with respect to active implantable medical devices are excluded from the Scope of this standard. These are defined in the relevant particular standards for active implantable medical devices. The risk assessment described in this standard is only required if an AIMD-Employee is present. Active Implantable Medical Devices (AIMDs) are regulated by Directive 90/385/EEC and the amendments to it. NOTE 4 Product standards EN 45502-1 and of the EN 45502-2-X series describe the product requirements for different kinds of AIMDs. Different kinds of AIMDs are e.g. pacemaker (EN 45502-2-1), implantable cardioverter defibrillators (EN 45502-2-2), cochlear implants (EN 45502-2-3), implantable neurostimulators (ISO 14708-3), implantable infusion pumps (ISO 14708-4). In situations where the risk assessment following this standard does not lead to a conclusion, complementary provisions for the assessment of workers exposure for different kinds of AIMDs are given in particular standards for these specific AIMDs (see Figure 1). (…) Figure 1 – Structure of the EN 50527 family of standards

PDF Catalog

PDF Pages PDF Title
4 Contents Page
6 European foreword
8 1 Scope
Figure 1 — Structure of the EN 50527 family of standards
9 2 Normative references
3 Terms and definitions
10 4 Risk assessment
4.1 Risk assessment procedure
4.1.1 Introduction
11 4.1.2 Workplace equipment
4.1.3 Previously uninfluenced behaviour
12 4.1.4 Specific warnings
13 Figure 2 — Risk assessment process
4.2 Documentation and information for the AIMD-Employee
14 4.3 Maintaining the risk assessment
5 Equipment at workplaces
5.1 General approach
15 5.2 Equipment with recommendations restricting use
5.2.1 General recommendations
5.2.2 Compliant workplaces and exceptions
Table 1 — Compliant workplaces and equipment with exceptions
19 6 Special cases
7 AIMD-Employees with more than one AIMD
8 Documentation
20 Annex A (normative) Specific risk assessment
A.1 General
A.2 Non-clinical approach
A.2.1 Assessment of the exposure situation
A.2.2 Assessment of the AIMD immunity
A.2.3 Assessment of the compatibility
21 A.2.4 Assessment of the risk of incompatibility
A.3 Clinical approach
A.4 Documentation of the specific assessment
22 Annex B (informative) Documenting the risk assessment
B.1 Introduction
B.2 Workplace compliance documentation form
B.2.1 General
23 B.2.2 Assessment
B.2.3 Conclusion
24 B.3 Previously uninfluenced behaviour
B.3.1 General information
B.3.2 Assessment
25 B.3.3 Conclusion
B.4 Documenting the detailed risk assessment
B.4.1 General information
B.4.2 Assessment
26 B.4.3 Exposure situation (see A.2.1)
B.4.4 Compliance demonstration
27 Annex C (informative) Specific electromagnetic environments
C.1 Railways
C.2 Workplace power transmission and distribution
C.2.1 General
C.2.2 Field levels in public exposure situations
28 Table C.1 — Summary of maximum field values beneath high-voltage overhead lines at 1 m above ground
C.2.3 Sensitivity of AIMDs to 50 Hz fields
C.2.4 Risk assessment in occupational situations
C.3 Broadcasting
29 Annex D (informative) Theoretical considerations
D.1 Introduction
D.2 Brief summary of exposure limits for persons without implant
30 Figure D.1 — Field strength – Distance ratio
Figure D.2 — Near field – far field transition for sources smaller than half wavelength in size
D.3 General considerations about electromagnetic fields
31 D.4 General considerations about AIMDs
D.4.1 General
D.4.2 Devices with sensing leads
D.4.3 Devices with stimulating leads
D.4.4 Devices without leads
D.4.5 Devices using RF or inductive coupling
32 D.4.6 Considerations for minimizing transient exposure
D.5 Description of electromagnetic interference effects
D.6 Model to assess the possibility of induction of AIMD response
Figure D.3 — Entire model to assess the possibility of induction of AIMD response
33 Figure D.4 — Simplified model to assess the possibility of AIMD response in special cases
D.7 Possibility of induced AIMD response
34 D.8 Possible AIMD responses to interference
36 Bibliography

Related products

BS EN 50527-1:2016
$167.15