Design of new systems or extension/updating of existing systems is done in full compliance with applicable standards and in conformity with the UNI EN ISO 9001:2000 and UNI CEI EN ISO 13485 standards in order to ensure appliance supply with guarantee of operation continuity in the event of single faults and accidents or exceptional situations.
Installation of the systems for the production and distribution of medical gases, vacuum and Anaesthetic Gas Evacuation, inasmuch as Medical Devices subject to CE marking, is performed by Berman in accordance with:
• The 93/42/EC Directive on Medical Devices which came into force on 14/06/1998 and was transposed in Italy with Legislative Decree 24/02/1997
• Official Italian Pharmacopoeia
• Harmonized UNI EN ISO 7396-1-2 Standards
• The Decree of the Ministry of the Interior dated 18/09/2002 on fire prevention
Maintenance of medical gas systems, consisting in the effective maintenance of the operartion and safety of production and distribution systems by means of preventive and corrective measures (routine and special maintenance): thanks to speedy and effective intervention and well tested personalized and specifically-planned maintenance programs which at the same time ensure the traceability of the jobs done, Berman is able to keep medical gas systems in perfect running order and safe condition.