For your sterilizer to be safely marketed, it is vital that it can perform as intended. With many different sterilizers on the market, healthcare professionals need to know that they are using a sterilizer that has been validated to be safe and effective. Sterilizers, or autoclaves, must be validated to the manufacturer’s performance standard as well as meet regulatory guidelines before they can be legally sold/purchased in the US marketplace. HIGHPOWER has been performing traditional and non-traditional sterilizer validations for over 30 years and is truly the expert in the industry. We have written portions of the current American National Sterilizer standards and validated sterilizers from the size of a small tabletop unit used in a dental office to extremely large hazardous waste sterilizers located in healthcare facilities.
Test methodologies for sterilizer validations are typically performed following the FDA’s Sterilizer 510(k) Guidance document or the applicable American National Sterilizer Standard such as AAMI ST-55 or ST-08 (Association for the Advancement of Medical Instrumentation). With up-to-date knowledge of FDA regulations, HIGHPOWER can ensure that your sterilizer meets the needs of the dental and medical markets and has the appropriate testing for clients to receive an FDA 510(k) clearance. HIGHPOWER particularly has experience with both traditional and non-traditional sterilizer validations.
We also validate mechanical washers to the American or International Standard (ANSI/AAMI 15883 or ISO 15883) standards.
Tests Available by Test Code:
| Test Code | Test Name |
|---|---|
| VAL-ST55 | AAMI ST-55 Steam Table-Top Sterilizer Validation |
| VAL-ST8 | AAMI ST-08 Steam Hospital Sterilizer Validation |
| SIM-USE | Simulated Use Testing |
| IN-USE | In Use Testing |
| VAL-WD | Washer Disinfector Validation |
If you are in need of premium sterilizer equipment validation services, HIGHPOWER is the team of experts for you. Our list of testing options is expansive so that we can accommodate a series of distinct needs depending on the type of sterilization process (steam, EtO, H2O2, Ozone, NO2, etc.) that you are trying to bring to market. If you don’t see your required test listed, please contact us at clientservices@highpowervtls.com with your inquiry.
