STERIS Corporation Device Testing Program (DTP)
Since 1988, the STERIS Corporation Device Testing Program (DTP) has evaluated device conformance, material compatibility, and microbial efficacy of thousands of reusable medical devices after numerous cycles in STERIS Corporation Processors. Our material compatibility and efficacy testing are endorsed by many leading device manufacturers.
The goal of DTP is to provide customers and/or manufacturers assurance that their medical devices can be safely and repeatedly sterilized or high level disinfected by STERIS processors.
Currently, DTP conducts testing in the SYSTEM 1® Processor and the Reliance™ Endoscope Processing System. The SYSTEM 1 Processor provides sterile processing and the Reliance EPS provides high level disinfection of reusable medical devices.
The requirements of medical devices for testing are that they are reusable, submersible, and heat tolerant to 56°C. For SYSTEM 1, devices with lumens require the development of special adaptors that direct flow of sterilant through them. For Reliance, devices having lumens that are not open on the control handle will also need to have special connectors developed. If your device requires a connector, STERIS Corporation has a team of engineers who can help develop appropriate adapters for your device. Please use this link to inquire about development of adaptors for a device.
DTP has three main forms of testing:
- Device Conformance Testing: Determines the specific tray/container for device reprocessing (if applicable for processor type tested) and ensures a proper fit of the device in the processor.
- Material Compatibility Testing: Verifies the chemical use dilution is compatible with the device's materials and processes of construction.
- Microbial Efficacy Testing: Confirms that the medical device can be repeatedly sterilized or high level disinfected by STERIS processors.
When testing is completed the customer is supplied with a report stating the results of their testing.
Test Guide Lines
All DTP testing is performed in the STERIS Corporation Corporate R&D Laboratories. STERIS Corporation is ISO 9001 and ISO 13485 certified. Testing is in accordance with Good Laboratory Practices (GLPs) as outlined by U.S. regulatory agencies, and employs a method adopted as a standard test method by the American Society for Testing Materials (ASTM #E1766-95 Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices ). Established protocols, standard operating procedures, and data recording systems maintain consistency and traceability of all tests that are conducted.
Pricing and Protocols
E-mail us to request testing or for more information.
Device Conformance Testing:
During Device Conformance Testing, a device is placed in all the applicable trays and/or containers for the processors being tested to determine fit. This will determine if a device is capable of being processed in a specific processor based only on size conformance. If there is more than one tray/container that the device is compatible with, a recommended one is decided on.
Material Compatibility Testing:
During Material Compatibility Testing, a device or material is repeatedly processed in order to expose it to the chemical use dilution of the processor under test. The customer and/or manufacturer will decide on the number of cycles that a device or material is exposed to. It is recommended that the number of cycles be based on the minimum expected life of the device or material. This test determines if the device or material is degraded in any way by the processor’s chemical use dilution and determines whether the device or material is still functional.
Microbial Efficacy Testing:
For sterile efficacy testing, a device is inoculated with a Geobacillus stearothermophilus spore suspension so that the total microbial load of the device is at least 106 cfu and less than 107 cfu. For high level disinfection efficacy testing, a device is inoculated with a microbial suspension of Mycobacterium terrae totaling greater than 106 cfu. The device is then run through a “worst case” cycle of the applicable processor. The device is harvested and the samples are provided opportunity to grow for 7 or 14 days respectively. This test is repeated five times and determines whether a device is capable of being sterilized or high level disinfected in the appropriate processor.
Price List:
Testing |
SYSTEM 1 |
Reliance EPS |
Material Compatibility ≤ 100 cycles |
$500.00 |
$750.00 |
Material Compatibility 101 – 400 cycles |
$1250.00 |
$1500.00 |
Material Compatibility 401 – 700 cycles |
Not Applicable |
$2250.00 |
Material Compatibility 401 – 1000 cycles |
$2000.00 |
Not Applicable |
Sterile Efficacy Testing |
$3000.00 |
Not Applicable |
High Level Disinfection Efficacy Testing |
Not Applicable |
$3500.00 |
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