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Our team of test and tag experts take a closer look at testing and tagging in the medical industry, specifically with regards to what is considered medical equipment and what Standard it should be tested to.
Electrical testing of medical equipment is generally a lot more involved than testing of non-medical equipment and includes performance verification and tests that assess the risk to a patient should an electrical fault occur when connected or in contact with the patient. Test equipment that is appropriate for testing to AS/NZS 3760 will likely not be used to test to AS/NZS 3551. That is because the testing equipment tested to AS/NZS3551 have lower tolerances and limits and require additional functionality and safety tests.
Standards Australia defines medical equipment as:
“Any instrument, apparatus or appliance, including software, whether used alone or in combination, together with any accessories necessary for correct operation, that makes physical or electrical contact with the patient, or transfers energy to or from the patient, or detects such energy transfer to or from the patient, or is intended to diagnose, treat or monitor a patient.” is called medical equipment.
This or any other equipment located in the ‘Patient environment’ is required to be tested and tagged in accordance with AS/NZS 3551, merely testing to AS/NZS 3760 is not sufficient.
Expanding on what we exactly mean by patient environment:
Patient’s environment is defined as, “The space extending 1500mm around all possible patient locations” Ref: AS/NZS 3551:2012 - 1.4.29
Any equipment that is located outside of the patient’s environment but is physically connected to a piece of medical equipment located inside the patient’s environment (such as computers, printers etc) are deemed as medical equipment and should be tested as such. This is defined as a “Medical electrical system” Ref: AS/NZS 3551:2012 – 1.4.20
Within a medical facility, there will almost always be a combination of medical and non-medical equipment. This could include places such as private hospitals, general practices, dental clinics, laboratories, cosmetic clinics, allied health clinics etc.
Many companies that provide specialised testing of medical equipment in accordance with AS/NZS 3551 don’t offer standard testing to AS/NZS 3760 and therefore the testing of non-medical equipment may need to be done by someone else. If you are unsure about the medical equipment safety testing process, we would suggest that it’s worth getting advice from a medical testing specialist.
Coming back to why it's essential to test and tag medical equipment against the set medical equipment testing standards - it’s done to guarantee that the equipment is functioning properly and safely, thus decreasing the risk of injury to operators and patients.
A copy of AS/NZS 3551 can be purchased from www.standards.org.au.