Steriliser Validation
Compulsory every 12 months according to Australian Standards AS5369:2023

Performance Qualification includes calibration and chamber profiling as well as further testing to ensure that your steriliser is capable of sterilising the most challenging load that you process in your practice.

Stages of Validation

1. Installation Qualification (IQ)

undertaken to demonstrate that the Sterilizer has been supplied and installed in accordance with manufacturer specifications.
IQ is performed at installation of equipment.

2. Operational Qualification (OQ)

undertaken to demonstrate the capability of the equipment to deliver the sterilization process that has been defined in equipment specifications.
OQ is performed immediately after installation or relocation of reprocessing equipment, when a service is changed or delivering a new process and when introducing new RMD’s or loading configurations to ensure performance is consistent with original OQ or after a repair and prior to equipment being put back into service.

3. Performance Qualification (PQ)

undertaken to demonstrate that the sterilizer consistently operates in accordance with predetermined criteria and parameters and the sterilization meets the specified requirements.
PQ shall only be performed by a competent person and in accordance with the National or International Standards and shall be performed immediately after IQ and OQ for a newly installed or relocated machine; when repairs are made or a service is changed; and when introducing new devices, packaging or loading configurations unless equivalence to a previously qualified reference load can be demonstrated. PQ shall be performed using RMD’s that are representative of the range of devices identified as the most difficult to process in use in your facility. PQ shall be performed annually.

The yearly Performance Qualification (PQ) consists of Physical Performance Qualification (PPQ) and Microbiological performance Qualification (MPQ) which are conducted concurrently.  PPQ determines attainment of the specified critical physical parameters and MPQ demonstrates the microbiological lethality of the process.

Our reporting process and performance Qualification Certificate confirms your compliance with mandatory Obligations under the Australian Standards.

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Electrical Safety Test and Tag

Biomedical equipment testing exceeds the standard office equipment electrical safety testing and must be carried out by a qualified biomedical technician with the appropriate test equipment that ensures every piece of equipment is electrically safe to use for both the patient and the user.

AS/NZS 3760 – 2010 In-Service safety inspection and testing of electrical equipment carried out by a general Electrician states in 1.1.7 This Standard does not apply to medical electrical equipment nor any equipment connected to medical electrical equipment in a medical electrical system as defined in AS/NZS 3551.

NOTE – Test and inspection requirements for this equipment are contained in AS/NZS 3551.

Our test and tag service incorporates functional testing and electrical safety using the highest quality fluke test equipment specifically for use on biomedical equipment. This will ensure that the electrical safety testing and compliance documentation will meet all regulatory audits and allow for practice accreditation.

We perform this electrical safety testing to comply with AS/NZS:3551 and will provide the relevant compliance reports, including asset logs and test equipment certification to ensure your practice passes safety accreditation.

Comprehensive Quoting

Whether you currently use Medical Dental Solutions or not, we can provide you with a comprehensive and competitive quote prior to any work being completed. If you are interested in a quote on any of our services, please contact one of our friendly staff.