Autoclave Performance Qualification Process and Compliance

Autoclave Performance Qualification Process and Compliance
August 26, 2021 Vividus Admin

Instrument sterilisation is a critical step in infection control. One of the key components in the infection control chain is instrument sterilisation via an autoclave. Like any equipment, the autoclave must be maintained to ensure proper operation. But not only does the autoclave need to be maintained it must also operate within specific parameters.

How does the operator know that the equipment is operating between those parameters? The process of confirming the autoclave is operating within the designated parameters is called the Performance Qualification. The Performance Qualification process is detailed in Australian Standard AS/NZS: 4815:2006 Office-based health care facilities – Reprocessing of useable medical and surgical instruments and equipment, and maintenance of the associated environment.

Performance qualification is defined in the Standard as the Process of obtaining and documenting evidence that the equipment, as installed and operated in accordance with operational procedures, consistently performs in accordance with pre-determined criteria, and thereby yields a product meeting its specification. The Performance Qualification will be conducted over three cycles.

Parameters tested during each cycle of a Performance Qualification on Autoclaves (Class B) include steam, pressure and time to ensure the sterilisation process is successful. Performance Qualification must determine that all gauges (displays of measurement) are indicating accurately.

Frequency of Testing is detailed in the Standard and states that all benchtop autoclaves are tested at the completion of the commissioning, annually or when the load arrangement changes, or new items/packing is introduced.

The Test Report is your evidence that the tests conducted met the Standard and provide all the relevant supporting data. Failure to obtain a Statement of Compliance and the supporting data may void the Performance Qualification and waste time and money and potentially expose the Practice to potential liability.

Performance Qualification conducted in accordance with the Standard shall:

  • Be completed over three cycles measuring all parameters in each cycle.
  • Include Challenge Load photos as part of the report.
  • Include Data Loggers and Biological Indicators (SAL 10-6) in all three cycles.
  • Include the measurement parameters of each cycle.
  • Details the results of the Biological Indicators testing.
  • Identify the Measuring Equipment used by the supplier which must have established traceability to a National Standard.
Instrument-Traceability-W&H Lisa

A Compliant Test Report should contain:

  • Test Parameters of each cycle, both values and graphically.
  • Challenge Load photographs.
  • Biological Indications test results both on-site and at our service centre.
  • Statement of Compliance
  • Details of Measuring Equipment used.
  • Date of Test and when next Due.

Dental Depot Performance Qualifications

Dental Depot conducts Performance Qualifications in accordance with the Standard AS/NZS 4815:2006 and in conjunction with the customers best practice methods ensuring the machine operates as intended. Utilising the latest data logger technology, recording temperature and pressure of the chamber throughout the sterilisation cycle. In addition, Dental Depot supplies the biological indicators required, sterility assurance level (SAL) 10-6. Once these are processed in the three consecutive cycles, the biological indicators are returned and incubated at the Dental Depot Service Centre.

1. AS/NZS: 4815:2006 Para 1.3.38
2. AS/NZS: 4815:2006 Appendix F4(e)
3. AS/NZS: 4815:2006 Para
4. AS/NZS: 4815:2006 Para 7.9.4.(b)
5. AS/NZS 4815:2006 Para