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QI Medair is the medical air service produced through compressors and done according to the specifications set in the current legislation. To provide this service, Linde Healthcare implements:
The design of the entire production plant to meet the requirements both of regulation UNE EN ISO 7396-1 at the industrial level standard and the risk andlysis requirements of the CE mark of medical products (RD 1591-2009).
The installation of the medical air unit with three independent supply sources with CE mark medical products, according to the provisions of Directive 93/42/EEC.
Maintenance of the system ensuring maximum performance of the equipment and installations and maintaining an adequate level of safety. To do this the following actions are performed:
Perform necessary technical assistance in accordance with the manufacturer's specifications.
Schedule preventive inspections to locate and prevent equipment failures in advance.
Carry out technical-legal maintenance demanded by the current legislation.
Analysis of gas quality to guarantee compliance of the GMP standards, of the Royal Spanish Pharmacopoeia and the European Pharmacopoeia.
Adaptation to the actual needs of the client providing various service models depending on the type of use and duration of contract.
Pharmaceutical quality of medical gas is assured.
The system consists of three safety levels that minimise potential unwanted stoppages or stoppage due to breakdown.
CE Mark medical product, according to Directive 93/42/EEC, of the medical air unit.
Exclusive design based on vast experience of implementing this system in hundreds of medical centres.
System designed for the future that allows us adapt to new technologies. At Linde Healthcare we have an RDI vocation, are always inclined to develop special solutions, maintaining the reliability typical of a standard and medical system.
The quality of medical air is considerably better than that required in pharmacopoeia parameters (see the table).
Comprehensive solution. Initial investment is not required. There is no risk of costs from unexpected failures.