Sterilization Validation

Sterilization is defined as using steam, dry heat, hydrogen peroxide, ethylene oxide, or radiation to render a device free from viable microorganisms. The level of sterilization is defined by Sterility Assurance Level (SAL), which is the probability that a device is not sterile. For example, an SAL of 10-6 indicates a 1 in 1 million possibility that the device is non-sterile.

Sterilization Validation is used to help manufacturer establish appropriate sterilization parameters for health care processing instructions, and confirm the pertinent SAL, dry time and thermal profiling of the medical device. For non-critical devices (those that do not penetrate the body), the sterilization process is considered to be validated if the SAL is 10-3, while for critical devices, the SAL should be 10-6. Based on the data obtained through testing, the manufacturer will be able to provide health care facilities with validated sterilization parameters.

STEMart helps manufacturer test and validate the labeling claims for sterilization of reusable medical devices in a health care facility.

Applicable Standards

• AAMI TIR12 Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities
• AAMI ST58 Chemical Sterilization and High-Level Disinfection in Health Care Facilities
• AAMI ST77 Containment Devices for Reusable Medical Device Sterilization
• AAMI ST79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities
• ISO 11135 Sterilization of Health-Care Products-Ethylene Oxide-Requirements for the Development, validation and Routine Control of a Sterilization Process for Medical Devices
• ISO 17664 Processing of Health-Care Products-Information to Be Provided by the Medical Device Manufacturer for the Processing of Medical Devices
• ISO 17665 Sterilization of Health-Care Products-Moist Heat-Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices

Test Capabilities

• High temperature sterilization (moist heat (gravity or prevacuum)/steam or dry heat)
• Low temperature sterilization (ozone)
• Chemical sterilization (liquid sterilants, hydrogen peroxide)
• Gas sterilization (ethylene oxide)
• Radiation sterilization (gamma, e-beam)

STEMart provides adequate testing to demonstrate the efficacy of recommended sterilization instruction. If you want to learn more detail about our service, or would like to consult with the experts at STEMart, please feel free to contact us.