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::President Midial Spa::
Midial SpA, is a Company that has been operating in the medical and biomedical field for over twenty years, producing and distributing medical devices for dialysis and for various infusion therapies.

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  Validations

Validations

Midial S.p.A has a well equipped laboratory for chemical-biological analysis and is able to offer its Customers, a complete assistance consisting of:
  1. Drafting of validations with elaboration of relative protocols.
  2. Analysis connected with the sterilization process (Chemical and Biological).
  3. Controls of the production areas.

The validation protocol is elaborated following the guidelines put in place by the normative hereunder:

  • UNI EN 550 Sterilization of the medical devices. Method for the validation, and systematic control of ethylene oxide sterilization.
  • ISO 11135 Medical devices. Validation, and systematic control of ethylene oxide sterilization.
  • UNI CEI EN 46002 Medical devices. Special requirements for the application of EN ISO 9002.
  • UNI EN 556 Sterilization of the medical devices. Requirements for the medical devices that carry the “STERILE” sign.
  • UNI EN ISO 10993-7 Biological assessment of the medical devices. Residues from the sterilization by ethylene oxide.
  • ISO11737-1 Sterilization of the medical devices. Microbiological method. Part 1: Assessment of the micro organism population on the product.
  • UNI EN 1174-1 Sterilization of the medical devices. Assessment of the population of micro-organism on the product.
Flow regulator
Spikes
Infusion Pumps
Midial S.P.A - Via Vincenzo Baviera, 5 - 91100 Trapani - Italy - Tel. +39 0923. 444001 - Fax.+39 0923.444072