Artificial Test Soil (ATS2015) IFU

Artificial Test Soil with Bone (ATS2015-B) IFU

Blood Test Soil (BTS) IFU

Blood Test Soil (BTS) with Bone IFU

Dental Surgical Test Soil (DTS) IFU

Saliva Test Soil (STS) IFU


Blood Test Soil SDS

Saliva Test Soil SDS

Dental Surgical Test Soil SDS

BTS White Paper

Simulated-Use Testing Flexible Encoscopes

Simulated-Use Testing Biopsy Forceps

Simulated-Use Testing Laparoscopic Instruments

Simulated-Use Testing Detergents

Artificial Test Soil & Blood Test Soil Expiration Date Letter

ATS2015 (Artificial Test Soil) is just a Test Soil

According to AAMI, the FDA, CDC, CEN, Health Canada, CSA, NHS Estates and other regulatory agencies, validation of medical device cleaning, disinfection and sterilization should be done with “test soils” that are modeled on the soils the medical device is likely to be contaminated with during actual clinical use.

*Based on extensive scientific research
*Complies with regulatory requirements

What is ATS2015?

Formulated and based upon experimental data, Artificial Test Soil (ATS2015) simulates the "worst case" soil level from patient-used medical devices. ATS2015 is a standardized soil formulation that would be applicable to a wide range of medical device simulated-use testing and cleaning validation.

ATS2015 is composed of protein, carbohydrate, hemoglobin and optionally endotoxins, in proportion to the worst-case levels found in patient-used surgical instruments. FDA and AAMI Guidelines direct medical device manufacturers (MDM's) to use "worst case conditions" in their simulated-use testing. In addition, MDM's are directed to use an organic challenge that embodies the types of soil to which the device will be exposed during clinical use. Guidance documents also recommend "... that the bioburden challenge (organic and microbial) to the cleaning and or disinfection process of the washer and washer disinfectors be determined from clinically used devices.*"

Who Should Consider Using ATS2015?

ATS2015 can be used as a standardized test soil by:

Medical device manufacturers whose reprocessing protocols need to be developed and validated for users.

Third Party reprocessors of single-use medical devices needing to validate and challenge their reprocessing procedures.

Testing labs and research facilities conducting independent validation testing and research.

Manufacturers of sterile reprocessing equipment when testing equipment such as cleaner/disinfectors and sterilizers.

Manufacturers needing to perform simulated-use evaluations for comparative testing of detergents, disinfectants or sterilants for medical device reprocessing.