(a)

1. (1) When using equipment specially designed for human breast milk pasteurization, the:

   1. (A) Procedures for the use of the machine are followed; and
   2. (B) Machine is calibrated and maintained per manufacturer's guidelines.
2. (2) Documentation that equipment is maintained per manufacturer's guidelines is required.

(b)

1. (1)

   1. (A) When pasteurizing using manual equipment (reciprocal shaking water baths), thermometers used in control bottles to record the temperature of breast milk during heating and cooling phases should be:

(i) National Institute of Standards and Technology-certified; or

1. (ii) Calibrated no less often than quarterly using a National Institute of Standards and Technology-certified reference thermometer.

   1. (B) The breast milk bank must keep records of calibration.

2. (2) In addition to the quarterly calibration, thermometers should be calibrated if:

   1. (A) Dropped;
   2. (B) Damaged; or
   3. (C) At any time their accuracy is in question.

3. (3)

   1. (A) Thermometers used to monitor the heat processing and cooling of donor breast milk using manual equipment should have as small a standard deviation range as is practical.
   2. (B) Thermometers with a standard deviation of plus or minus two-tenths of one degree Celsius (0.2°C) or less are recommended.