| AS/NZS 3551:2012 defines a medical device as “Any instrument, apparatus or appliance, including software, whether used alone or in combination, together with any accessories necessary for correct operation, which makes physical or electrical contact with the patient, or transfers energy to or from the patent, or detects such energy transfer to or from the patient, or is intended to diagnose, treat or monitor the patient."
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| The Standard is called up under Sections 25 and 91 of the Electricity (Safety) Regulations 2010.
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| DHBs, private hospitals, medical clinics, rest homes/hospitals and health entities often have a range of medical devices that are subject to the Standard.
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| What is the Standard about? |
| AS/NZS 3551:2012 covers the requirements for management of medical devices and includes: |
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Procurement |
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Acceptance process |
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Safety and performance testing |
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Disposal |
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| Correct performance verification is critical to ensure safe use of the medical device for the patient and the operator. |
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| Key Parameters
A. Physical Inspection
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| B. Functional Testing |
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Device Inputs and Outputs |
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Alarms |
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Safety Cutout and Protective Functions |
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Radiation |
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Mechanical |
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Gas and/or Liquids |
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| C. Electrical Testing |
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Protective Earthing |
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Insulation Resistance |
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Touch Current |
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Earth Leakage Current |
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Patient Leakage Current |
| Parameters are determined at time of device acceptance in accordance with manufacturers' specification. |
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