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Sterilization Validations for Device or Trays

Sterilization Validations for Device or Trays

A sterilization validation test confirms the appropriate Sterility Assurance Level (SAL) of the medical device.  The testing establishes the pertinent sterilization parameters for healthcare reprocessing instructions.  Based on the data obtained through testing, the manufacturer will be able to provide healthcare facilities with validated sterilization parameters.  Nelson Laboratories can validate using steam (gravity or prevacuum), ethylene oxide (EO), STERRAD® or dry heat. 

ANSI/ASMI ST79, ANSI/AAMI ST77 and AAMI TIR12 are guidelines for testing reusable medical devices.    Nelson Laboratories has the equipment and qualified personnel to help guide you through the process.  Our experts will provide individualized consultation and are here to help simplify the complex regulatory and standard recommendations. 

Applicable Standards

  • AAMI TIR 12
  • ISO 17665
  • ISO 17664
  • ISO 11135

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.

Code Test TAT (days) Request Quote
RVS111 Sterilization Validation (Reuse): Steam - 2 Parameters 35 Add
RVS112 Sterilization Validation (Reuse): Steam - 3 Parameters 42 Add
RVS113 Sterilization Validation (Reuse): Dry Time Testing Only 14 Add
RVS132 Sterilization Validation (Reuse): Steam Tray Study - 3 Parameters 42 Add
RVS141 Sterilization Validation (Reuse): Ethylene Oxide with Residuals 45 Add
RVS181 Sterilization Validation (Reuse): STERRAD with Residuals 45 Add
RVS111 - Sterilization Validation (Reuse): Steam - 2 Parameters
TAT: 35 days
RVS112 - Sterilization Validation (Reuse): Steam - 3 Parameters
TAT: 42 days
RVS113 - Sterilization Validation (Reuse): Dry Time Testing Only
TAT: 14 days
RVS132 - Sterilization Validation (Reuse): Steam Tray Study - 3 Parameters
TAT: 42 days
RVS141 - Sterilization Validation (Reuse): Ethylene Oxide with Residuals
TAT: 45 days
RVS181 - Sterilization Validation (Reuse): STERRAD with Residuals
TAT: 45 days

Sample Specifications

RVS111: Minimum 3 devices required
RVS112: Minimum 3 devices required
RVS113: Minimum 3 devices or 1 tray/kit required
RVS132: Minimum 1 tray/kit required
RVS141: Minimum 3 devices required (9 preferred to hit TAT) or Minimum 1 tray/kit (3 preferred to hit TAT)
RVS181: Minimum 3 devices required (9 preferred to hit TAT) or Minimum 1 tray/kit (3 preferred to hit TAT)

Study Outline

Steam sterilization sterility assurance level testing: The testing validates the recommended gravity and/or prevacuum steam sterilization parameters for the medical device. Nelson Laboratories validates individual devices, implants, trays, kits or other reusable devices.  Typically, a Sterility Assurance Level (SAL) of 10-6 is validated using the biological indicator overkill method.  Depending on the specific device, other testing such as dry time validations or internal temperature mapping may be appropriate. Dry time testing ensures that after the sterilization cycle the packaging and device are not wet.  Moisture may compromise the sterile properties of the packaged device.  Temperature mapping profiles the temperature inside the containment device and demonstrates the heating properties of the device.
 
Nelson Laboratories validates individual devices, implants, trays, kits, reusable devices or other devices reprocessed at a healthcare facility.
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