Calibrating Digi-Stem® Systems for use as Food Processing TID's

The United States Food & Drug Administration is "...responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation."  As a part of this mission, the FDA regulates the thermal processing of low acid canned foods in hermetically sealed containers under part 113 of the Code of Federal Regulations.

Thermometers used as a Temperature Indicating Device for low acid canned foods applications consist of (1) a sensor (probe) and (2) a display (meter). Our DST600 Series Digi-Stem® meters and probes are most commonly used for this purpose.

When calibrating or re-calibrating DST600 series thermometers used as a temperature indicating devices (TID) as defined in 21CFR Part 113.40(a)(1), NIST traceable calibration must be performed on the TID system  as defined in the standard as "Each temperature indicating device shall have a sensor and a display".  This prohibits NIST calibration of a "Probe (sensor) only" or "meter (display) only", as this data would not comply with the requirements of 21CFR Part 113.40(a)(1).

When returning your DST600s for calibration, please return the entire system (probe + meter) for system NIST calibration.