AAMI TIR12:2004 -- Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers:
 4.3.5 Test data and user verification The device manufacturer should provide users, on request, with a summary and interpretation of test data or other information that verifies the efficacy of the manufacturer's recommendations for cleaning agents and cleaning procedures.

AAMI TIR12:2004 -- Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers:
 4.3.5 Manufacturers should strive to develop and validate test procedures that can be replicated easily in a health care facility and that can help users recognize whether cleaning was effective for all device surfaces. Such tests would be particularly important for devices with components that cannot be readily inspected for cleanliness (e.g., spring hinges, lumens, porous materials, crevices).

AAMI TIR12:2004 -- Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers:
 5.4 Criteria for selecting an appropriate chemical disinfectant: c) Bioburden. The disinfectant has been tested against a known number of microorganisms; therefore, the efficacy of the process depends on the cleanliness of the items to be processed (i.e., the bioburden on the device after patient use might differ from that used by the manufacturer in simulated-use testing).

AAMI TIR12:2004 -- Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers:
 4.3.5 If all surfaces of the device cannot be visually inspected (as in the case of some devices with lumens and some hinged instruments), manufacturers should provide users with rapid test methods that can be used as part of quality assurance to ensure that the cleaning process has been effective. Such test methods may apply to automated cleaning equipment or to a specific medical device.

AAMI TIR12:2004 -- Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers:
 4.3.5 Using scientifically valid methods, the manufacturer should show that the recommended cleaning process is effective in removing the simulated soil from all surfaces of the device that could come into contact with the patient or that are accessible to tissue, blood, body fluids, and other organic material. Testing should be adequate to ensure that the process can be successfully duplicated in the hospital environment.

AAMI TIR12:2004 -- Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers:
 4.3.5 Simulated soiling is generally performed in laboratory testing. The soil selected should be that which most closely simulates the contamination in actual clinical use.

AAMI TIR12:2004 -- Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers:
5.8 Test data and user verification: Device manufacturers should provide test data and other information supporting the efficacy of the recommended disinfectant products and procedures. Such information should include any test procedures that can be easily replicated in the health care facility and that can help users determine whether the disinfecting process was effective in rendering the device safe for patient use.

AAMI TIR12:2004 -- Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers:
5.7 Furthermore, manufacturers must show that the rinsing procedure provides adequate removal of residual disinfectant after disinfection is achieved. Testing should be adequate to ensure that the process can be successfully duplicated in the hospital environment.

AAMI TIR12:2004 -- Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers:
5.7 Efficacy of the process: Device manufacturers must show that recommended disinfection procedures ensure that all device surfaces (including internal channels) that will either come in direct contact with the patient or physician or be soiled with blood, body fluids, and other organic material will be in contact with the disinfectant solution.... Testing should be adequate to ensure that the process can be successfully duplicated in the hospital environment.

AAMI TIR12:2004 -- Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers:
6.5 Sterilization efficacy testing: Sterilization efficacy testing must be performed by the device manufacturer. The objective is to show that the recommended cycle parameters are capable of producing the desired SAL for the device (typically 10⁶).

AAMI TIR12:2004 -- Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers:
6.5 Sterilization efficacy testing: Microbiological challenges should be placed in the most difficult-to-sterilize, accessible locations of the device. If it is not possible to reach these areas of the device with a biological indicator, then the device may be inoculated with the specified microbiological challenge by using a liquid suspension.