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enters into force a new edition of the safety standard ofelectro-medical equipment
This is an important milestone for the sector
– the ‘ UNE EN 60601-1: 2008. Electro-medical equipment. Part 1:General requirements for basic safety and essential performance ’ enteredinto force on 1 June
-this standard is more demanding and provides more details on thetrials that must be an electrómedico team before itsmarketing
-the SEEIC experts believe that, thanks to this newEdition, you can count on safer equipment ”
-the new text delves into the errors of use fortry to reduce them, associated with a clinical practice increasinglytechnique
Madrid, June of 2012- health technology is becoming increasinglymore efficient, but also more complex. This complexity has led toerrors in use have increased exponentially. Therefore, it isneed a revision and updating of the regulations governingThis kind of technology.
this sense, 1 June introduced an importantnovelty in this field: the entry into force of the new edition of the standardimportant for the electro-medical equipment, the ‘ UNE EN 60601-1: 2008. Teamselectro-medical. Part 1: General requirements for basic safety andessential functioning ’. This privacy policy details the General requirements forthe safety and essential equipment performance and must beincluded in the Declaration of conformity to provide equipment.
this last edition (the third) has increased itsextension of 40 to400 pages, is much more prescriptive and, through risk management,It provides more details about trials that a team should beelectrómedico to ensure their safety and operation ”, explains XavierCanals, Member of the Spanish society of Electromedicine and clinical engineering(SEEIC).
other relevant sections are, for example, the inclusion ofcomputer programs that are included and control equipment ofhealth technology, as well as the treatment in depth of systemselectro-medical bringing together several health products.
thanks to this new regulation will have teamsmore secure that, through a process of risk management, they have been analysedtrials to those who are to be submitted. In particular, teams that will bethey try to avoid human error ”, ensures Canals.
the new text delves into risk management and theusability to try to reduce the risks associated with clinical practiceincreasingly more technical. From now on, we will have a new generation ofequipment technology is put to the service of the health professional,helping to improve patient safety ”, concludes this expert.
present and future of the SEEIC
the Spanish society of Electromedicine and clinical engineering(SEEIC) is a national scientific and technical institution constituted,among others, with the goal of being the partner to promote, before thepublic and private bodies, management and professional standardization ofstandards and requirements necessary for the correct application of theelectromedical equipment.
is a pioneer in Spain society, whose membersthey carry out their activity in companies, health centers and other organizationsand institutions related to technology electromédica.
the challenges of this scientific society aimed at short-termtowards the launching of the certificates of professionalism throughout thecountry, and to the definition of aOwn degree the competent authorities so farformally non-existent, to respond to a training and regulation of thethe Electromedicine and clinical engineering in Spain sector and theconsolidation of the relevant professional categories within thepublic and private hospitals in the country, and in the companies of the sector, with avery direct condition in the continuous improvement of healthcare quality and thesecurity in the implementation and use of systems and electro-medical equipment.
on the other hand, according to its objective of collaborating in thepreparation of the professionals who carry out tasks relating to theElectromedical equipment, the company has own training programs thatThey cover different technical and management issues related to its scopeaction.
