HTM 01-05 Air Leakage Test

What is it?

This test ensures that the vacuum stage of the cycle does not draw in air from outside of the chamber. It is only required for Type S and Type B vacuum sterilisers. It is not performed on a non-vacuum Type N steriliser.

HTM 01-05

Air Leakage Test

The test is performed to ensure that during vacuum stages, the rate of air leakage back into the chamber is at the required tolerance.

Air that is drawn into the chamber as a result of the vacuum will hamper sterilisation.

Any air that leaks into the chamber from the outside also poses a risk of load contamination.

This test is only performed by the User if the steriliser has an automatic test cycle that performs the air leakage test.


What Equipment and Materials are Required?

  • Benchtop Steriliser Log Book
 D = Day | W =Weekly | Q = Quarterly | Y = Yearly | CP(D) = Competent Person (Decontamination) | ENG = Engineer

When is it Performed, and by Who?

Document Specific Title Reference Installation & Commission Periodic Testing
HTM 01-05 Air Leakage Table on page
56 Refers to
MDA DB 2002(06)





What is the Procedure, and Pass/Fail Criteria

Document Test Procedure Pass or Fail Criteria
HTM 01-05

Weekly Method by the User

HTM 01-05 references to MDA DB 2002(06) which references to MD DB 9804 (section A.3.1).

This test is only performed by the User if the steriliser being tested has an automatic test cycle that performs the test and indicates values at the end for the User to note.

Although generic instructions are provided here, the specific instructions provided from the manufacturer should be used.

1. Select and start the appropriate Air Leakage Test cycle.

The test is a pass if the following criteria are met at the completion of the test cycle:

  • The steriliser indicates a clear pass result.

  • The indicated pressure provided for the end of the vacuum stage is as required by manufacturer recommendations.

  • The indicated pressure rise was below 1.3 mbar/minute.

Test results should be shown on the steriliser display.