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Category: Reusable Device Studies
Nelson Laboratories validates product-specific cleaning, sterilization and disinfection procedures for reusable devices. By simulating clinical use, we assist our sponsors in developing reliable procedures for cleaning and disinfecting or sterilizing their devices between patient use. We can design comprehensive validation programs, complete with biocompatibility evaluations and multiple simulated reprocessing.
Tests available for Reusable Device Studies
Sterilization validation for device & trays ISO 11134, ISO 17665, AAMI ST77
These are the methods to be used in evaluating recommended gravity and prevacuum steam sterilization methods for a reusable device. Methods of gravity and prevacuum steam sterilization will be validated to a sterility assurance level (SAL) of 10-6 using the biological indicator overkill method.
Cleaning validation AAMI TIR 12, AAMI TIR 30
Nelson Laboratories offers a full range of services to evaluate reusable devices, including inoculation, sterilization, disinfection, cleaning, AAMI TIR 12 and TIR 30 evaluations, and post-reprocessing biocompatibility tests.
As part of a reusable device validation, product inoculation is an important component. The method of inoculation is dependent on the product. Clients should consult their FDA reviewer or regulatory consultant for their specific product and test requirements.
With the increased awareness of the potential dangers of residual manufacturing materials on medical devices, the FDA often requests documentation of a thorough validation of the cleaning processes used to remove residual materials from newly manufactured devices.
Disinfection of resuable/reprocessed devices
Disinfection study prices are per device area or component evaluated to simulate manufacturer cleaning instructions which generally require that each device or component is cleaned separately.