Understanding medical electrical safety rules in New Zealand

The following is a brief Explanation of Medical Electrical Safety Regulations in New Zealand.

This information should be read in conjunction with New Zealand Electrical (Safety) Regulations 2010 and AS/NZS 3551:2012. This information is provided as a general introduction and does not in any way constitute legal advice. The opinions expressed here are entirely those of the authors. We welcome any comments on this page via our ‘Contact Us’ page.

Electrical (Safety) Regulations 2010

According to the New Zealand Electrical (Safety) Regulations 2010, Section 91 (1):

91 Periodic assessment of electrical medical devices
(1) The owner of an electrical medical device must ensure that the device is periodically assessed in accordance with AS/NZS 3551 to determine whether it is electrically safe and complies with that standard.
(2) The results of each periodic assessment must be recorded in accordance with AS/NZS 3551, and the owner must retain the record.
(3) The person who completes the assessment must—

1. give the record of the assessment to the person who requested the assessment; and
2. keep a copy of it for at least 3 years, or send a copy to WorkSafe

(4) A person who owns an electrical medical device commits an offence and is liable on conviction to a level 1 penalty if the device is not assessed in accordance with subclause (1).
(5) A person who owns or operates an electrical medical device commits an offence and is liable on conviction to a level 1 penalty if the person uses, or allows another person to use, the electrical medical device knowing that it has not been assessed as required by this regulation, unless, because of an emergency, use of the device is justified in the circumstances

AS/NZS 3551:2012

AS/NZS 3551:2012 states that a medical device must have:

1. Marketing authorisation.
   1. Evidence of regulatory compliance. In New Zealand, this evidence shall include a copy of the sponsor’s entry into the WAND database operated by MedSafe and a copy of either:
      1. The ARTG Inclusion Certificate
      2. The declaration of conformity, in accordance with the requirements of the European Council Directive 93/42/EEC on medical devices.
2. Medical Equipment Markings:
   1. The name of the manufacturer
   2. The name of the supplier
   3. Supply voltage and ratings
   4. Other specific markings as per standard
3. Performance Verification: This includes but is not limited to:
   1. Electrical Safety
   2. Physical Inspection
   3. Non-Electrical Tests
   4. Identification of medical equipment
   5. Test Status.

Performance Verification:

Performance Verification shall be performed:

1. Prior to placing new equipment into service.
2. Following work that could affect the safety of the equipment.
3. At routine intervals (In New Zealand, 12 Monthly unless otherwise determined).

Performance Verification consists of:

1. Functional Testing
2. Physical Inspection
3. Electrical Testing

Review and Recording of results:

Following any performance verification repairs or preventative maintenance activities, the equipment shall be appropriately labelled.

The label shall include the following:

1. Date when retesting is due
2. Identification of the testing entity
3. Electrical / Physical / Functional tests in accordance with AS/NZS3551:2012
4. Identification of tests carried out

If the power cord is detachable, a label shall be affixed to the power supply cable.