16.1 When using equipment specially designed for human milk pasteurization, the procedures for the use of the machine are followed and the machine is calibrated and maintained per manufacturer's guidelines. Documentation that equipment is maintained per manufacturer's guidelines is required.

16.2 When pasteurizing using manual equipment (reciprocal shaking water baths): Thermometers used in control bottles to record the temperature of milk during heating and cooling phases should be NIST-certified or calibrated no less often than quarterly using an NIST-certified reference thermometer. The milk bank must keep records of calibration.

16.2.1 In addition to the quarterly calibration, thermometers should be calibrated if dropped, damage, or at any time the accuracy is in question.

16.2.2 Thermometers used to monitor the heat processing and cooling of donor milk using manual equipment should have as small a standard deviation range as is practical. Thermometers with a standard deviation of +/- 0.2° Celsius or less are recommended.