Hivatkozási szám

MSZ EN 50527-1:2010

Dokumentumazonosító

149971

Cím

Eljárás az aktív beültethető gyógyászati eszközöket viselő dolgozók elektromágnesestér-expozíciójának értékelésére. 1. rész: Általános előírások

Angol cím

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices. Part 1: General

Alkalmazási terület

The scope of this European Standard is to provide 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. It specifies how to perform a general risk assessment and to determine 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 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 must be taken to comply with the provisions of Directive 2004/40/EC. 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. NOTE 3 The European Parliament and Council Directive 2004/40/EC 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 4 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. NOTE 5 This standard is written under mandate M/351 and relates to the exposure limits as specified in the Directive 2004/40/EC which is intended to protect workers from risks to their health and safety arising or likely to arise from exposure to electromagnetic fields (0 Hz to 300 GHz) during their work. However, this and other directives may include additional measures for the protection of specific groups of workers and/or specific workplaces for which the employer is required to investigate other protective measures as a part of the overall risk assessment. 2 Relationship to other standards This European Standard complements the workers exposure assessment standard EN 50499. It provides the general methodology for doing the risk assessment for employees bearing an AIMD at the workplace. AIMDs are regulated by Directive 90/385/EEC amended by Directive 2007/47/EC. NOTE 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/PRF 14708-3), implantable infusion pumps (ISO/PRF 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). Ábra

ICS

11.040.40 Sebészeti implantátumok, protézisek és ortézisek

13.100 Munkavédelem. Ipari egészségügy

13.280 Sugárvédelem

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2010-07-01

A visszavonás napja

2019-07-04

Forrás

idt EN 50527-1:2010

Előd

Utód

MSZ EN 50527-1:2017

Módosítás

SZK-közlemények

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