HIGHPOWER’s test methodology is based on methods outlined in the United States Pharmacopeia/National Formulary and in the ANSI/AAMI/ISO 11138 and ANSI/AAMI/ISO 11140 series of standards.

Testing can also take into consideration the FDA guidance documents “Guidance for Industry and FDA Staff Biological Indicator (BI) Premarket Notification [510(k)] Submissions and Guidance for Industry and FDA Staff Premarket Notification [510(k)] Submissions for Chemical Indicators”.

HIGHPOWER can verify and/or validate the performance requirements of all class 1, 2, 4, 5 and 6 chemical indicators as listed in ISO 11140-1 standard. Our management staff has over 25 years’ experience in the designing, testing and validating of chemical indicator products considered to be class II medical devices by the United States FDA.

HIGHPOWER can verify and/or validate the performance requirements of all types of biological indicators used in healthcare and industrial sterilization processes. Our management staff has over 25 years’ experience in the designing, testing and validating of biological indicator products considered to be class II medical devices by the United States FDA.

All of HIGHPOWER’s test equipment meets the performance requirements listed in the ISO 18472 standard for steam, ETO, dry heat, steam formaldehyde and hydrogen peroxide resistometer’s.

Tests:

  • Chemical Indicator Shelf life
  • Class 1 Process Indicator Testing
  • Class 2 BD Indicator Testing
  • Class 4 Multi-parameter Indicator Testing
  • Class 5 Integrating Indicator Testing
  • Class 6 Emulating Indicator Testing
  • Chemical Indicator Post Processing Signal Color Retention
  • D-value Analysis
  • Z-value Analysis
  • Biological Indicator Survive/Kill Testing
  • Biological Indicator Population Assay Testing
  • Biological Indicator Purity Testing
  • Biological Indicator Reduced Incubation Time Testing

We’re constantly adding new test to meet our customer’s expectations. If you don’t see your required test listed, please contact us at info@highpowervtls.com with your inquiry.