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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

Pricing/Quote

Test Price Request Quote
RSC130 - Sterilization Cycles (Repeat): Chemical Immersion
Per test1+Quote
Add
RSC140 - Sterilization Cycles (Repeat): Pasteurization
Per test1+Quote
Add
RSC150 - Sterilization Cycles (Repeat): Manual Cleanings
Per test1+Quote
Add
RSC160 - Sterilization Cycles (Repeat): STERRAD100S
Per test1 - 49
50+
Quote
Quote
Add
RSC180 - Sterilization Cycles (Repeat): Automatic Washer/Disinfector
Per test1 - 99
100+
Quote
Quote
Add
RVS110 - Sterilization Validation (Reuse): Steam
Per test1+Quote
Add
RVS130 - Sterilization Validation (Reuse): Steam Tray Study
Per test1+Quote
Add
RVS140 - Sterilization Validation (Reuse): Ethylene Oxide
Per test1+Quote
Add
RVS145 - Sterilization Validation (Reuse): Ethylene Oxide for Trays
Per test1+Quote
Add
RVS150 - Sterilization Validation (Reuse): Liquid Chemical
Per test1+Quote
Add
RVS160 - Sterilization Validation (Reuse): Chemiclave
Per test1+Quote
Add
RVS170 - Sterilization Validation (Reuse): Dry Heat
Per test1+Quote
Add
RVS180 - Sterilization Validation (Reuse): STERRAD
Per test1+Quote
Add
RVS185 - Sterilization Validation (Reuse): STERRAD for Trays
Per test1+Quote
Add
RVS190 - Sterilization Validation (Reuse): STERIS VHP
Per test1+Quote
Add
RSC130 - Sterilization Cycles (Repeat): Chemical Immersion
Per test1+Quote
RSC140 - Sterilization Cycles (Repeat): Pasteurization
Per test1+Quote
RSC150 - Sterilization Cycles (Repeat): Manual Cleanings
Per test1+Quote
RSC160 - Sterilization Cycles (Repeat): STERRAD100S
Per test1 - 49
50+
Quote
Quote
RSC180 - Sterilization Cycles (Repeat): Automatic Washer/Disinfector
Per test1 - 99
100+
Quote
Quote
RVS110 - Sterilization Validation (Reuse): Steam
Per test1+Quote
RVS130 - Sterilization Validation (Reuse): Steam Tray Study
Per test1+Quote
RVS140 - Sterilization Validation (Reuse): Ethylene Oxide
Per test1+Quote
RVS145 - Sterilization Validation (Reuse): Ethylene Oxide for Trays
Per test1+Quote
RVS150 - Sterilization Validation (Reuse): Liquid Chemical
Per test1+Quote
RVS160 - Sterilization Validation (Reuse): Chemiclave
Per test1+Quote
RVS170 - Sterilization Validation (Reuse): Dry Heat
Per test1+Quote
RVS180 - Sterilization Validation (Reuse): STERRAD
Per test1+Quote
RVS185 - Sterilization Validation (Reuse): STERRAD for Trays
Per test1+Quote
RVS190 - Sterilization Validation (Reuse): STERIS VHP
Per test1+Quote

Turn Around Time

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product.

Code Test TAT
RVS110 Sterilization Validation (Reuse): Steam 0
RVS130 Sterilization Validation (Reuse): Steam Tray Study 0
RVS140 Sterilization Validation (Reuse): Ethylene Oxide 0
RVS145 Sterilization Validation (Reuse): Ethylene Oxide for Trays 0
RVS180 Sterilization Validation (Reuse): STERRAD 0
RVS185 Sterilization Validation (Reuse): STERRAD for Trays 0
Code TAT
RVS110 0
RVS130 0
RVS140 0
RVS145 0
RVS180 0
RVS185 0

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.