Enters into force a new edition of the safety standard of electro-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 the trials that must be an electrómedico team before its marketing
-the SEEIC experts believe that, “ thanks to this new Edition, you can count on safer equipment â€
-the new text delves into the errors of use for try to reduce them, associated with a clinical practice increasingly technique
Madrid, June of 2012- health technology is becoming increasingly more efficient, but also more complex. This complexity has led to errors in use have increased exponentially. Therefore, it is need a revision and updating of the regulations governing.This kind of technology.
this sense, 1 June introduced an important novelty in this field: the entry into force of the new edition of the standard important for the electro-medical equipment, the ‘ UNE EN 60601-1: 2008. Teamselectro-medical. Part 1: General requirements for basic safety and essential functioning ’. This privacy policy details the General requirements forthe safety and essential equipment performance and must be included in the Declaration of conformity to provide equipment.
“ this last edition (the third) has increased its extension 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 â€, explains XavierCanals, Member of the Spanish society of Electromedicine and clinical engineering(SEEIC).
other relevant sections are, for example, the inclusion of computer programs that are included and control equipment ofhealth technology, as well as the treatment in depth of systems electro-medical bringing together several health products.
“ thanks to this new regulation will have teams more secure that, through a process of risk management, they have been analysed trials to those who are to be submitted. In particular, teams that will be they try to avoid human error â€, ensures Canals.
“ the new text delves into risk management and theusability to try to reduce the risks associated with clinical practice increasingly 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 â€, 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 the public and private bodies, management and professional standardization ofstandards and requirements necessary for the correct application of the electromedical equipment.
is a pioneer in Spain society, whose members they carry out their activity in companies, health centers and other organizations and institutions related to technology electromédica.
the challenges of this scientific society aimed at short-termtowards the launching of the certificates of professionalism throughout the country, and to the definition of aOwn degree the competent authorities so far formally non-existent, to respond to a training and regulation of the Electromedicine and clinical engineering in Spain sector and the consolidation of the relevant professional categories within the public 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 the security 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 the Electromedical equipment, the company has own training programs that They cover different technical and management issues related to its scopeaction.
