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Medical Devices
The Standard and Legislation
Any person or organisation that uses or maintains medical devices is subject to the Standard AS/NZS 3551:2004 -“Technical management programs for medical devices”.
AS/NZS 3551:2004 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."
The Standard is mandatory in New Zealand and is called up under Section 46 of the Electricity Act 1997.
DHBs, private hospitals, medical clinics, rest homes/hospitals and health entities often have a range of medical devices that are subject to the Standard.
What is the Standard about?
AS/NZS 3551:2004 covers the requirements for management of medical devices and includes:
- Procurement
- Acceptance process
- Safety and performance testing
- Disposal
Correct safety and performance testing is critical to ensure safe use of the medical device for the patient and the operator.
Key safety parameters
A. Electrical safety “covers”
| Protective earthing
Insulation resistance test
Earth leakage
Applied part leakage
Mains contact |
B. Performance
Parameters are determined at time of device acceptance.
Examples relevant to various health care providers include:
Electric bed: | Verify patient lockout switches
Verify movement only when switches actuated |
Infusion pumps: | Air detection
Delivery rate
Occlusion pressure
Bolus accuracy |
Syringe driver: | Delivery rate
Occlusion pressure
Bolus accuracy
End of stroke detection
Alarms |
Ensure you get the right Service Technician
Medical devices are a specialist area which is subject to particular Standards and Legislation.
Ensuring you get the right Service Technician is critical to ensure correct compliance.
Testing of medical devices is normally undertaken by a professional biomedical technician. The technician will typically have an extensive electronics background, knowledge of medical devices and be fully conversant with the Standard AS/NZS 3551:2004. The technician will maintain the full suite of testing equipment to ensure that all necessary tests are undertaken for both electrical safety and performance (checking that the devices work correctly).
Electricians and other service technicians normally test to a different Standard (AS/NZS 3760:2003 Domestic Appliances). The testing they do is normally suitable for fridges and microwaves but not for medical equipment. Your organization, staff and patients/clients may be subject to safety risk if your medical devices have not been tested to the correct Standard. Compliance risk also exists where not all required electrical and performance tests have been completed.
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Contact us by phone or email, or simply fill in the call request form below and we will call you.
P: 04 529 8453
E: support@biomed.co.nz
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