Risk assessment in the light of the Legislative Decree 1° August 2016 n. 159: operational criteria and critical issues


  • Rosaria Falsaperla INAIL – Dipartimento Medicina, Epidemiologia, Igiene del Lavoro e Ambientale- Roma
  • Iole Pinto Azienda Sanitaria USL Toscana Sud Est – Laboratorio di Sanità Pubblica- Siena




Occupational Exposure to EMF, Legislative Decree 81/08, Risk assessment, Physical Agents Portal, Workers bearing active implantable medical devices.


Directive 2013/35/EU has introduced remarkable innovations in the protection of workers from the risks arising from electromagnetic fields, particularly with regard to exposure to low frequency fields. The directive were transposed in Italy by the Legislative Decree n. 159 of 1 August 2016, which amended Chapter IV of Title VIII of the Legislative Decree 81/2008. The Decree 159/2016 fully adopts the system of protection of the directive introducing at the same time few more stringent measures aimed at greater protection of workers. Compared to the first formulation, the current Chapter IV introduces greater complexity in the management of risks arising from exposure to electromagnetic fields (eg, the derogations system). On the other hand, the decree introduces some novelties to carry out the risk assessment aimed at simplify it whenever possible. Indeed the articulation of Article 209 provides that the employer may use, at least in the first instance, operational references such as the European Commission's non-binding Practice Guide, relevant European and Italian technical standards as well as information available at INAIL or regional databases, taking into account also the information provided by the manufacturers for a safety use of the equipment. This formulation therefore qualifies the Physical Agents Portal and validate its content. Risk assessment  becames more complicated if it is not possible to establish with certainty that Exposure Limit Values (VLE) are respected on the basis of easily accessible information. In this cases it is necessary to carry out measurements and/or calculations. This articulation of the risk assessment process is aimed at supporting small and medium-sized enterprises (SMEs), for which the outlined path avoids, in most exposure conditions, heavy burdens related to measurements and/or to dosimetric evaluations. The news introduced in the risk assessment do not substantially alter the approach for the workers with active implantable medical devices whose susceptibility to the electromagnetic fields requires specific criteria and operational measures.
The aim of the present work is provide employers with useful information to carry out a proper risk assessment whit regard also to the workers bearing active implantable medical devices. Critical situations derived from experience or pointed out from users of the Physical Agents Portal are also presented and discussed.


Coordinamento Tecnico per la sicurezza nei luoghi di lavoro delle Regioni e delle Province autonome, INAIL, ISS, “Decreto Legislativo 81/2008 Titolo VIII, Capo I, II, III, IV e V sulla prevenzione e protezione dai rischi dovuti all’esposizione ad agenti fisici nei luoghi di lavoro. Indicazioni operativeâ€, (2014).


EN 50499, Procedure for the assessment of the exposure of workers to electromagnetic fields, European Commitee for Standardization, Bruxelles, 2008.

EN 50527-1, Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices. Part 1: General, European Commitee for Standardization, Bruxelles, 2010.

EN50527-2-1, Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices Part 2-1: Specific assessment for workers with cardiac pacemakers, European Commitee for Standardization, Bruxelles, 2011.

EN45502-1, Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer, European Commitee for Standardization, Bruxelles, 2015.

European Union, “Non-binding guide to good practice for implementing Directive 2013/35/EU Electromagnetic Fields - Volume 1: Practical Guideâ€, Luxembourg: Publications Office of the European Union (2015); ISBN 978-92-79-45869-9; doi:10.2767/961464.