Frequently Asked Questions

Frequently Asked Questions

Who should have medical electrical safety testing performed?

Safety Testing is required because?

What does testing involve?

Which equipment has to be tested?

What is Performance Verification?

What is the correct standard to use when testing medical electrical appliances?

A Medical Practitioner has an appliance that was not specifically designed as a medical appliance that is used for patient treatment. Does it still need to be tested and to what standard?

What is a Body Protected Area?

Our treatment rooms are not Body Protected Areas. What should we do?

Is electrical safety testing compulsory for healthcare facilities?

What will happen if we don't have our equipment tested?

We need to have our equipment and installation tested for accreditation. Will the service offered by EMTaC be acceptable?

How frequently are tests required?

Why do medical appliances need clear top plugs?

How long do tests take?

Who can undertake Medical Electrical Safety Testing?

What is the difference between Medical Electrical Safety Testing and safety testing of other appliances?

When can we get our testing done?

Is it acceptable to have a medical grade portable RCDs instead of getting the sockets set up (internally) with the RCDs?

Who should have medical electrical safety testing performed?

Anyone who uses electrically powered equipment for the medical treatment, diagnosis or monitoring of patients, e.g. hospitals, physiotherapy clinics, medical practices and health centres, dental practices, and radiology facilities

Safety Testing is required because?

Electrical appliances will become susceptible to wear and tear when in regular use and as a result faults may develop that could be injurious to an operator or patient. Even when not in use, deterioration can still occur. These faults may not be readily apparent without the use of measuring instruments or a biomed trained engineer to identify potential hazards. Routine safety testing is carried out to identify faults and hazards before they cause injury.

Patients in medical care may be more susceptible to the effects of electric shock. They may be unable to move away from the source of the electricity, they may be unwell or frail and they may have lowered skin resistance due to perspiring, the application of agents such as ECG or ultrasound gel, or the use of needles and surgical instruments. For this reason medical electrical appliances must meet special mandatory requirements and be tested regularly as laid out in AS/NZS3551. In New Zealand testing must be made at least annually.

What does testing involve?

Testing covers both individual items of medical equipment (appliances) or medical systems, and the facilities in which they are used (installation).

Appliance tests include a physical check of equipment condition, electrical measurements of earthing integrity, insulation resistance and leakage currents, as well as an operational check known as performance verification. Installation tests check the correct operation of residual current devises (RCD’s) in Body Protected areas and the condition of electrical fittings.

Which equipment has to be tested?

Any electrical equipment that is used, under medical supervision, to diagnose, treat or monitor a patient must be tested. Examples of such appliances would be: examination lamp, nebuliser, diathermy, ultrasound, ECG. Ultrasounds, interferentials, Hilo beds.

Although battery operated equipment comes under the definition, this does not generally require safety testing unless it is capable of harming a patient or operator in the event of a fault. Such items may still require performance verification (e.g. a tympanic thermometer or sphygmomanometer). Appliances such as sterilisers, heaters, electric fans, radios and computers are not considered medical appliances, but if they are located within a Body Protected Area, they must also be tested to the medical standard (AS/NZS3551).

What is Performance Verification?

Performance verification is a test that an appliance is working as intended. Only basic tests that can be performed on site are undertaken and in some cases it may be recommended that critical appliances are returned to the service agent for a detailed test and calibration. EMTaC very strongly recommend that Sphygmomanometers and tympanic thermometers also be tested. This is based on our years of experience.

What is the correct standard to use when testing medical electrical appliances?

AS/NZS3551 is the correct standard for testing medical electrical appliances. This should not be confused with AS/NZS3760, which is used by electricians and test and tag companies for general appliance testing. When obtaining prices for electrical safety testing, it is essential that the correct standard be used.

A Medical Practitioner has an appliance that was not specifically designed as a medical appliance that is use for patient treatment. Does it still need to be tested and to what standard?

Any electrical appliance used for medical treatment, diagnosis or monitoring must be tested to AS/NZS3551 regardless of whether it was originally designed for medical use. If it does not pass the relevant tests it may not be used.

What is a Body Protected Area?

A Body Protected Area is an area within a medical facility where patients are treated, diagnosed or monitored using medical electrical appliances. There are a number of requirements for such areas including that electrical outlets are protected by a 10mA RCD (a special safety switch). Body Protected Areas must be certified every 12 months.

Our treatment rooms are not Body Protected Areas. What should we do?

Firstly, check with EMTaC. Most facilities can be successfully retrofitted and we are happy to recommend the best way to our customers. We will most likely recommend that any work needed is completed by your normal electrician, or we can refer you to a suitably experienced contractor to do this for you.

Is electrical safety testing compulsory for healthcare facilities?

Yes, but only for areas where patients are treated, diagnosed or monitored using medical electrical appliances. The requirements for this are stated in the Electricity Regulations 2010, which calls on three standards to describe what is required. These are:

  • AS/NZS2500 Guide to the safe use of electricity in patient care
  • AS/NZS3003 Electrical installations - patient areas
  • AS/NZS3551 Management programs for medical equipment

At this time the Energy Safety (part of Work Safe NZ) does not actively police this section of the Electricity Regulations, but instead take the stand that ignorance of the law does not provide an excuse for not complying with it. It is the responsibility of medical practices to be aware of such laws that may affect the running of their business. Occupational Safety and Health regulations also call for a safe workplace for both staff and patients.

What will happen if we don't have our equipment tested?

If you knowingly or unknowingly operate an unsafe appliance, someone may be hurt or even killed. As a result any or all of the following may occur:

  • You may face legal action by the Energy Safety (part of Work safe NZ)
  • Your insurance may be invalidated
  • Your ACC levies may be increased
  • There may be a police inquiry in the event of a death and you could be charged with manslaughter
  • You may receive bad publicity from the media
  • The cost of defending legal action and meeting any penalty imposed is likely to be substantial in terms of money, time and lost income.

We need to have our equipment and installation tested for accreditation. Will the service offered by EMTaC be acceptable?

Because the testing procedures used by EMTaC conform to AS/NZS3551, they will meet the requirements of all New Zealand accreditation programmes. In some cases where a traceable full calibration check is required for accreditation, this must be undertaken as a separate procedure by the relevant service agency. Likewise some radiology or audiology equipment will require specialised checks by the appropriate agencies.

How frequently are tests required?

In New Zealand AS/NZS3551 testing is at least annually. In some cases it may be more frequent, depending on the environment in which they are used.

Why do medical appliances need clear top plugs?

Each time an appliance is tested, the connections to the mains cord must be checked to make sure that the wires go to the correct pins of the 3-pin plug. To avoid dismantling the plug each time, either transparent top plugs or moulded (non-Rewireable) plugs are used. This is now a requirement of AS/NZS3551.

How long do tests take?

Some equipment takes longer than others. A simple double-insulated appliance can normally be tested in about 8 minutes. An ECG may take 20 minutes.

Who can undertake Medical Electrical Safety Testing?

Safety testing can only be performed by a registered electrical/electronic technician, a registered electrician, or a registered electrical engineer or electrical inspector. These people must be properly trained in the testing of medical electrical appliances. EMTaC engineers are properly qualified and trained. All are Registered Engineering Associates or Registered Electrical Engineers.

What is the difference between Medical Electrical Safety Testing and safety testing of other appliances?

The testing requirements for medical electrical appliances under AS3551 are more stringent and extensive than for appliances in general use (which are tested to AS3760). There is also a requirement that measurements observed during testing be documented. General appliance testing is insufficient for fulfilling the obligations for medical practices. Many electricians unfortunately are simply not aware of this.

When can we get our testing done?

To make it easier for a busy practice, EMTaC engineers will work quietly during the practitioner’s lunch breaks or after hours. We will not make you come back on a Saturday or stay late if there is an alternative. You make the date and time and we will be there.

Is it acceptable to have a medical grade portable RCDs instead of getting the sockets set up (internally) with the RCDs?

Under the revised Royal NZ College of General Practitioners this June, these are allowed. HOWEVER it does not say that if one of these is hardwired into a machine we will not be able to do the annual testing with our test meter. Our recommendation is NOT to wire the portable RCD into a cable which is hard wired into the machine. Plug the machine such as a diathermy or hyfrecator into an RCD wall socket. However it is perfectly ok to wire the portable RCD  into a detachable power cable.