BS EN 50527-1:2016 – TC:2020 Edition
$217.84
Tracked Changes. 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 | 2020 | 87 |
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 |
|---|---|
| 53 | Contents Page |
| 55 | European foreword |
| 57 | 1 Scope Figure 1 — Structure of the EN 50527 family of standards |
| 58 | 2 Normative references 3 Terms and definitions |
| 59 | 4 Risk assessment 4.1 Risk assessment procedure 4.1.1 Introduction |
| 60 | 4.1.2 Workplace equipment 4.1.3 Previously uninfluenced behaviour |
| 61 | 4.1.4 Specific warnings |
| 62 | Figure 2 — Risk assessment process 4.2 Documentation and information for the AIMD-Employee |
| 63 | 4.3 Maintaining the risk assessment 5 Equipment at workplaces 5.1 General approach |
| 64 | 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 |
| 68 | 6 Special cases 7 AIMD-Employees with more than one AIMD 8 Documentation |
| 69 | 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 |
| 70 | A.2.4 Assessment of the risk of incompatibility A.3 Clinical approach A.4 Documentation of the specific assessment |
| 71 | Annex B (informative) Documenting the risk assessment B.1 Introduction B.2 Workplace compliance documentation form B.2.1 General |
| 72 | B.2.2 Assessment B.2.3 Conclusion |
| 73 | B.3 Previously uninfluenced behaviour B.3.1 General information B.3.2 Assessment |
| 74 | B.3.3 Conclusion B.4 Documenting the detailed risk assessment B.4.1 General information B.4.2 Assessment |
| 75 | B.4.3 Exposure situation (see A.2.1) B.4.4 Compliance demonstration |
| 76 | 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 |
| 77 | 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 |
| 78 | Annex D (informative) Theoretical considerations D.1 Introduction D.2 Brief summary of exposure limits for persons without implant |
| 79 | 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 |
| 80 | 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 |
| 81 | 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 |
| 82 | Figure D.4 — Simplified model to assess the possibility of AIMD response in special cases D.7 Possibility of induced AIMD response |
| 83 | D.8 Possible AIMD responses to interference |
| 85 | Bibliography |
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