Medical Consulting has always had a strong presence on the Italian, European and International markets, with certifications that guarantee the compliance of our products and services, in addition to the high quality standards of specialized supplies, of medical devices and technical assistance for the maintenance of systems.
The continuous monitoring of the effectiveness and efficacy of our business processes makes Medical Consulting one of the main international reference points in the field of specialized supply distribution, equipment and medical gases for healthcare facilities, both private and public.
Below are the main current laws and regulations about the production of the above-mentioned systems.
These conditions are set by the entry into force of the following regulations:
- European Directive 93/42/CEE – “Medical Devices” of 14/06/93 as amended and restated by Directive 2007/47/CE
- Legislative Decree February 1997 No 46/97: implementation of the Directive 93/42/CEE about medical devices, as amended and restated by Legislative Decree 37/2010
- UNI EN ISO 7396-1 Norm: about Medical high-pressure gas and vacuum distribution systems
- UNI EN ISO 7396-2 Norm: about anesthetic gas evacuation systems
- UNI CEI EN ISO 14971:2009 Norm: about the risk management of medical gas systems.
According to the above listed regulations, medical gas systems must be designed and completed, from plants to final users, with the issuing of a Declaration of Compliance and “Medical Device” CE marking, in accordance with Directive 93/42/CEE.
Therefore, in order to produce and deliver any “Medical Device” system, it will be necessary to define the executive project, to analyze and assess risks according the UNI CEI EN ISO 14971:2009 Norm, to perform testing, write down the Technical File, all according to the above listed regulations and others that have not been quoted here.
For systems and components that are considered medical devices, moreover, it is essential that the compliance with the said European regulations can be verified; therefore according to the Annex to the above mentioned Legislative Decree the Producer of the medical device must be authorized to set a CE marking on his systems by means of certifications issued by the Notified Body from the Ministero della Salute; accordingly a Quality Management System certification is mandatory, issued by a Certification Body following the UNI EN ISO 9001, UNI EN ISO 13485 Norms. Since the entry into force of such a Decree, then, medical high-pressure gas, vacuum distribution systems and anesthetic gas evacuations systems must be CE marked as medical devices. The harmonized reference standards are those included in the UNI EN ISO 7396 series.
It is important to underline that any extension of medical gas distribution systems is considered as a new systems itself and needs to have a CE marking to be put into service.
Besides, part of the components (e.g. terminal units and reducers) that are built on that system are to be considered as “medical device”, therefore need the “CE” marking.
Medical gas design also follows the D.P.R. (Presidential Decree) 14/1/97 “Approval of structural, technological and organizational basic requirements to perform healthcare activities for private and public facilities” (Accreditation).
Finally, and for safety reasons, medical gas systems must also consider the fire-prevention compartmentalization pattern of the premises where installation is to be performed.
The D.M. (Ministerial Decree) of 18 September 2002, “Approval of technical regulations for fire prevention in hospital, clinics building and operation”, drafted by Vigili del Fuoco, points to some basic requirements that medical gas systems need to meet as for compartmentalization and fire-prevention.