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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.

Code Test TAT (days) Request Quote
RSC130 Sterilization Cycles (Repeat): Chemical Immersion Add
RSC140 Sterilization Cycles (Repeat): Pasteurization Add
RSC150 Sterilization Cycles (Repeat): Manual Cleanings Add
RSC160 Sterilization Cycles (Repeat): STERRAD100S Add
RSC180 Sterilization Cycles (Repeat): Automatic Washer/Disinfector Add
RVS110 Sterilization Validation (Reuse): Steam 0 Add
RVS130 Sterilization Validation (Reuse): Steam Tray Study 0 Add
RVS140 Sterilization Validation (Reuse): Ethylene Oxide 0 Add
RVS145 Sterilization Validation (Reuse): Ethylene Oxide for Trays 0 Add
RVS150 Sterilization Validation (Reuse): Liquid Chemical Add
RVS160 Sterilization Validation (Reuse): Chemiclave Add
RVS170 Sterilization Validation (Reuse): Dry Heat Add
RVS180 Sterilization Validation (Reuse): STERRAD 0 Add
RVS185 Sterilization Validation (Reuse): STERRAD for Trays 0 Add
RVS190 Sterilization Validation (Reuse): STERIS VHP Add
RSC130 - Sterilization Cycles (Repeat): Chemical Immersion
Standard TAT not available for this product
RSC140 - Sterilization Cycles (Repeat): Pasteurization
Standard TAT not available for this product
RSC150 - Sterilization Cycles (Repeat): Manual Cleanings
Standard TAT not available for this product
RSC160 - Sterilization Cycles (Repeat): STERRAD100S
Standard TAT not available for this product
RSC180 - Sterilization Cycles (Repeat): Automatic Washer/Disinfector
Standard TAT not available for this product
RVS110 - Sterilization Validation (Reuse): Steam
0 days
RVS130 - Sterilization Validation (Reuse): Steam Tray Study
0 days
RVS140 - Sterilization Validation (Reuse): Ethylene Oxide
0 days
RVS145 - Sterilization Validation (Reuse): Ethylene Oxide for Trays
0 days
RVS150 - Sterilization Validation (Reuse): Liquid Chemical
Standard TAT not available for this product
RVS160 - Sterilization Validation (Reuse): Chemiclave
Standard TAT not available for this product
RVS170 - Sterilization Validation (Reuse): Dry Heat
Standard TAT not available for this product
RVS180 - Sterilization Validation (Reuse): STERRAD
0 days
RVS185 - Sterilization Validation (Reuse): STERRAD for Trays
0 days
RVS190 - Sterilization Validation (Reuse): STERIS VHP
Standard TAT not available for this product

Sample Specifications

RVS110: Minimum 3 devices required
RVS130: Minimum 1 tray/kit required
RVS140: Minimum 3 devices required
RVS145: Minimum 1 tray/kit; 3 preferred
RVS180: Minimum 3 devices required
RVS185: Minimum 1 tray/kit; 3 preferred

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.