Clinical Transportable Non Vacuum Steam Steriliser: Automatic Control Test

Step 1

Place a test load (as BS EN 13060) into the chamber

Step 2

Start a routine cycle and stopwatch

Step 3

If the steriliser does not have a recording device fitted, note the time taken for all of the key cycle stages.

Step 4

At the mid-point of the cleaning cycle, note the length of time elapsed and the indicated temperature.

Step 5

During the cycle attempt to open the lid/door. As this is a pressure vessel, this should only be undertaken by a competent and trained person.

Step 6

During the cycle observe if there are any anomalies, mechanical or otherwise.

Step 7

Ensure the cycle complete notification is evident

Procedure Comparison with Other Standards

The differences between standards are highlighted below:

HTM 2010 Part 3 Validation & Verification

Manual Method During Daily & Weekly Periodic Testing

• No test Load (as BS EN 13060) required.
  
• Ideally needs the Sterilisation cycle with the highest temperature that the test pack is compatible with.

Manual Method During Quarterly & Yearly Periodic Testing

• Resquires sensors in place from thermometric testing and the cycle under test should be independently logged using a validated data recorder.
  
• Requires a test pack applicable to the machine being tested into the chamber. The test pack should be in the centre of the chamber, raised 10cm to 20cm from the chamber floor.
• Ideally needs the Sterilisation cycle with the highest temperature that the test pack is compatible with.

BS EN 13060 and BS EN ISO 17665

• Test method not provided by either document.

Criteria 1

Within Holding Time

• Time, temperature and pressure are within the stated validation parameters as specified by the manufacturer for the appropriate sterilisation band.

Criteria 2

During the Cycle

• The lid/door could not be opened during the cycle.
• There were no observed anomalies or mechanical failures.

Criteria 3

End of Cycle

• The steriliser presented a cycle complete indication.
• If any failure is noted, inform the user immediately.

Pass/Fail Criteria Comparison with Other Standards

The differences between standards are highlighted below:

HTM 2010 Part 3 Validation & Verification

Manual Method During Daily & Weekly Periodic Testing

• Presents no differences in criteria.

Manual Method During Quarterly & Yearly Periodic Testing (within Plateau Period)

• The difference is temperature between the sterilisers own display (indicated) and the cycle print-out/data file or independent instrumentation (recorded) is +/-2°C.
  
• The difference in pressure between the sterilisers own display (indicated) and the cycle print-out/data file or independent instrumentation (recorded) is not greater than 0.1 bar.

BS EN 13060 and BS EN ISO 17665

• Test criteria not provided by either document.

Step 1

For an unwrapped instruments and utensils steriliser, the chamber should be empty for this test other than the furniture.

Step 2

Start a sterilisation cycle and a stopwatch. Ideally choose a cycle with the highest temperature that the test pack is compatible with.

Step 3

Any recording device fitted to the steriliser should initiate a process log.

Step 4

Note the time taken using the stopwatch, and visually the temperatures and pressures indicated by the sterilisers own display for all of the key cycle stages.

Step 5

At the mid-point of the plateau period, note the length of time elapsed and the indicated temperature and pressure.

Step 6

During the cycle attempt to open the lid/door.

Step 7

During the cycle observe if there are any anomalies, mechanical or otherwise.

Step 8

Ensure the cycle complete notification is evident.

Step 1

The test should be performed with the sensors in place from thermometric testing and the cycle under test should be independently logged using a validated data recorder.

Step 2

Place a test pack applicable to the machine being tested into the chamber. The test pack should be in the centre of the chamber, raised 10cm to 20cm from the chamber floor.

Step 3

Start a sterilisation cycle and a stopwatch. Ideally choose a cycle with the highest temperature that the test pack is compatible with.

Step 4

Any recording device fitted to the steriliser should initiate a process log. 

Step 5

Note the time taken using the stopwatch, and visually the temperatures and pressures indicated by the sterilisers own display for all of the key cycle stages.

Step 6

At the mid-point of the plateau period, note the length of time elapsed and the indicated temperature and pressure.

Step 7

During the cycle attempt to open the lid/door.

Step 8

During the cycle observe if there are any anomalies, mechanical or otherwise.

Step 9

Ensure the cycle complete notification is evident

Procedure Comparison with Other Standards

The differences between standards are highlighted below:

HTM 01-05

• Does not state differences between Daily/Weekly Testing to Quarterly/Yearly Testing.

BS EN 13060 and BS EN ISO 17665

• Test method not provided by either document.

Criteria 1

Within Holding Time:

• Time, temperature and pressure are within the stated validation parameters as specified by the manufacturer for the appropriate sterilisation band.

Criteria 2

During the Cycle:

• The lid/door could not be opened during the cycle.
• There were no observed anomalies or mechanical failures.

Criteria 3

End of Cycle:

• The steriliser presented a cycle complete indication.
• If any failure is noted, inform the user immediately.

Criteria 1

Within Plateau Period:

• The difference in temperature between the sterilisers own display (indicated) and the cycle print-out/data file or independent instrumentation (recorded) is +/-2°C.
• The difference in pressure between the sterilisers own display (indicated) and the cycle print-out/data file or independent instrumentation (recorded) is not greater than 0.1 bar.

Criteria 2

Within Holding Time:

• Time, temperature and pressure are within the stated validation parameters as specified by the manufacturer for the appropriate sterilisation band.

Criteria 3

During the Cycle:

• The lid/door could not be opened during the cycle.
• There were no observed anomalies or mechanical failures.

Criteria 4

End of Cycle:

• The steriliser presented a cycle complete indication.
• If any failure is noted, inform the user immediately.

Pass/Fail Criteria Comparison with Other Standards

The differences between standards are highlighted below:

HTM 01-05

• Measurements during the Plateau Period are not required.

BS EN 13060 and BS EN ISO 17665

• Test criteria not provided by either document.

BS EN 13060 does not reference this test.

BS EN ISO 17665 states that routine testing of the automatic controller should be carried out (BS EN ISO 17665:1 Section 10.3 (C)) however does not provide a method of test.

Use relevant test procedure from either HTM 01-05 or HTM 2010:3

BS EN 13060 specifies that the following is a suitable test load for a Solid Load, unwrapped.

Austeninitic Stainless Steel Bolts (EN 10088-1), hexagon head M12 x 100mm (EN ISO 4017), which have been degreased/cleaned/dried.

Click here to find out more about EN 10088-1 >

Click here to find out more about EN ISO 4017 >

The manufacturer should specify how many bolts are required to create the test load.

Procedure Comparison with Other Standards

The differences between standards are highlighted below:

HTM 01-05

• Test method provided.

HTM 2010 Part 3 Validation & Verification

• Test method provided.

No specific pass or fail criteria is provided in either document.

Pass/Fail Criteria Comparison with Other Standards

The differences between standards are highlighted below:

HTM 01-05

• Criteria provided.

HTM 2010 Part 3 Validation & Verification

• Criteria provided.