Medical devices & Pharmaceutical



CAUSE
Irradiation inactivates micro-organisms by means of damaging their genetic material through breaking their DNA chains.
EFFECT
This damage to the DNA impedes the reproduction of micro-organisms.
STERILIZATION
The theoretical probability that micro-organisms are present in the product after the sterilization treatment is equal or les than 10-6.
STERILITY ASSURANCE
Sterility Assurance Level, SAL=10-6.
ADVANTAGES
  • Physical method which does not generate chemical or toxic residuals.

  • A fast and flexible method that is compatible with most materials.

  • Complete traceability with process documentation for each product treated.

  • No need for quarantine allowing the product to be available for immediate use.

  • Simple and reliable validation process.

  • It is a process which uses moderate temperatures, is clean and valid for most types of products and packing materials.

  • Intrinsically safe.

  • The process is economic and efficient.

  • A detailed certificate is issued with each treatment.

  • Ionisos Ibérica supports their customers in the acquisition of the CE approval for medical and sanitary products.


  • APPLICABLE STANDARD
    UNE EN ISO 9001:2000
    UNE EN ISO 13485:2004
    UNE EN ISO 11137:2006
    GMP

    APPLICATIONS
    Dressings
    Clinical implants
    Gloves
    Surgical sets
    Theatre packs
    Dialysis filters
    Disposable laboratory materials
    Syringes
    Dental prostheses
    Ophthalmologic packaging and products for the eyecare & contact lenses
    Brushes, disinfectants for medical devices
    Surgical gowns & drapes
    Petri plates & culture medium
    Sutures