Reusable Medical Device Testing

To address regulatory and liability concerns, manufacturers of medical devices that are intended for reuse and sterilization in health care facilities must provide specific cleaning, disinfection and/or sterilization instructions to their customers. To insure that reliable cleaning, disinfection and/or sterilization will result, the instructions must be validated. For more information, refer to AAMI TIR 12: 1994 Design, testing and labeling of reusable medical devices of reprocessing in health care facilities – A guide for device manufacturers.

SGS can simulate most conventional hospital cleaning and sterilization procedures. Fees for the cleaning and sterilization validation studies will vary depending on the validation protocol. Please contact us or submit our Request for Quotation Form to discuss your requirements. We can perform testing according to our protocol or prepare a protocol in consultation with you.

• Cleaning, Disinfection and Sterilization Validation Protocols
• Cleaning Validation Studies
• DisinfectionValidation Studies
• Sterilization Validation Studies
  • Ethylene Oxide
  • Steam Sterilization at 121°C or 132°C
  • Flash, Gravity and High Vacuum Cycles
  • Liquid Chemical Sterilization
  • Dry Heat Sterilization and Depyrogenation
  • VHP (Hydrogen Peroxide Gas)

Please contact us about Sterrad hydrogen peroxide gas plasma sterilization or Steris System 1 Processor Sterilization