Testing and Verification guidelines for owners of Autoclave used in Medical and Dental Clinics
Your autoclave is designed to sterilise reusable instruments used medical and dental surgical procedures. As an owner and user of an autoclave it is your responsibility to ensure safe provisions are in place for the use of sterile healthcare products. Confirmation that the autoclave has been verified and is performing accurately, reliably and within the manufacturer’s specifications and service intervals, is also your responsibility. As a guide, the Australian Standard, AS4815 & AS4817, is used by operators, manufacturers and service providers, as the industry standard for office based medical and dental facilities.
As a responsible service provider, U-Tech Medical works within the guidelines of this standard, plus the manufacturer’s preventative maintenance/service requirements, to ensure that your autoclave is accurate, reliable and able to meet the Australian Standards and accreditation requirements.
How we can help?
- We can review your autoclave make and model, and then provide you with a recommendation for verification, preventative maintenance and on-site repairs as needed.
- With our calibrated test equipment we can provide accurate and traceable test cycle verification results, as required by AS4815 & AS4817 and by independent accreditation groups.
- We can advise on the age and condition of your autoclave and recommendation on the expected life, so you can plan a replacement program before the autoclave becomes non-serviceable.
Frequently asked questions and answers
Q. What tests are performed during the verification of my autoclave?
A. Temperature versus time during a complete sterilization cycle, at 3 temperature points, using test loads. Confirmation of cold spot temperature, pressure leakage test, water/air filters inspection/replacement, biological testing, dry cycle temperature testing. Electrical safety testing and tagging is included on the reports.
Q. How many tests cycles are performed during verification testing?
A. One temperature/pressure cycle and 3 biological cycles, depending on option selected.
Q. What happens if the verification or calibration test fails?
A. The process will stop when a failure or error message occurs and the corrective action will be discussed with the on-site manager or owner. No additional work will be carried out without approval.
Q. How often does my equipment need to be tested?
A. Validation shall be repeated annually and every time significant changes are made. Changes in packaging or loading specification, which would provide a greater challenge to the sterilization process.
Q. If my equipment comes with manufacturers extended service warranty, do I still need validation and preventative maintenance?
A. Yes. The warranty of equipment is not related to the validation and PM. Validation is also a requirement after completion of repairs or after any re-calibration.
Q. Do I need to purchase a copy of the Australian Standards?
A. This is not required, however if you prefer to keep a copy, it is available on-line at: http://infostore.saiglobal.com/store/ and type “AS/4815” in the search window.
Q. How do I select the best autoclave service company for optimum performance and repairs?
A. There are a number of factors to consider when choosing the correct service company. U-Tech Medical has developed a “Service Provider Evaluation Checklist” which can be downloaded from our homepage or the top of this page or simply ask one our customer service team members on 1300 4 UTECH, (1300 488324).
- Cold spot verification cycle needs to be performed by technician only once for each autoclave. Next verification service will not incur any cost relating to cold spot measurement.
- Two additional biological test cycles must be performed during the validation process. This may be performed by the U-Tech Medical Service Technician, (at an additional cost), or by a suitable qualified practice member.