It celebrates the day 'technical Appearances of hygiene in new machines and into use'
19 December 2013
The rule of machines, so much the one who affects to the manufacturer of the new machine like which affects to the user, is changing constantly, thing that easily can happen unobserved. Although the two legal norms, the directive 2006/42/CE for the manufacturer of the machine and the directive 2006/104/CE (whose transposition to the internal juridical legislation Spanish is the royal decree 1215/1997) for the user are relatively stable, the norms harmonised that they support them vary to a frantic rhythm. It is known that the essential requirements and the minimum disposals are knowingly ambiguous, reason whereby is unavoidable to interpret them through the technical norms harmonised.
The most recent changes emanate of four main sources:
- The entrance in force of the directive of machines 2006/42/CE;
- The withdrawal of the Norm IN 954-1 and his definite replacement by the norm IN ISO 13849;
- The publication of the Norm IN ISO 14119:2013 on the enclavamientos associated to resguardos;
- The publication, in November of 2011, of the last version of the Guide of application of the RD 1215/1997.
The directive 2006/42/CE includes two very significant changes: it admits explicitly the use of the software in functions of hygiene and incorporates the definitions of manufacturer and of group of machines, that turn into manufacturer, now already of way indubitable, to the user that does significant changes to a machine or together machines to automate the productive process and do that several machines that worked loose happen to do it coordinated, like an alone machine, forming a “group of machines”. This forced assumption of the paper of manufacturer, with the inherent obligations of marked CE, technical file, etc., is due to that, according to the directive, this group of machines is a new machine, different of each one of the individual machines and, as it is not frequent that the user of the machine have of a “manufacturer” in the classical sense of the term, that accept his responsibility delivering the corresponding statement CE of compliance of the conjoint “machine of machines”, applies the definition of manufacturer: “In absence of a manufacturer in the sense indicated, will consider manufacturer any physical or juridical person that commercialise or put in service a machine or a cuasi machine covered by the present Managerial”.
The possibility to use the software in functions of hygiene is carrying to modify substantially the new machinery, that does an extensivo use of the servos and adjustable speed drives of hygiene (“drives” in the technical literature English) as well as all a range of components of hygiene (relays of hygiene, PLCs of hygiene, photoelectric curtains, …) that support in electronics equipment dealers equipment dealers and software instead of in electromechanical components. The reliability of all they and of the functions of hygiene that entrust them justifies by means of the PL (performance level, level of provision) of the norm IN ISO 13849-1, or by means of the SIL (safety integrity level, level of integrity of the hygiene); both are a quantification of the probability of failure along an hour. The norm IN ISO 13849 is much more complicated that his substituted, the norm IN 954-1, that was purely qualitative.
But what happens with the ancient machinery, into use, subject to the RD 1215/1997? It affects him of some way all the previous? The publication by the National Institute of hygiene and Hygiene in the Work in November of 2011 of the new version of the Guide of application of the RD 1215/1997 clears it in his page 157 in which, referring to the norm IN ISO 13849 says that “…it is the (norm) that uses at present for the offer of devices of protection or other subsystems of control specifically developed to realizar functions of hygiene and, therefore, would have to take into account in the case that it was necessary to implant said devices or subsystems in machines used”. A lot of more hygiene for the user… but a lot of more complexity!!
