Biomedical Electrical Testing And Why It's Vital To Get It Right
At MegaTest our focus is to help you achieve compliance to the relevant Legal Standards. In addition to verifying compliance of your equipment and/or workplace we also supply a variety of useful Reports. MegaTest do this by using the latest in electrical testing equipment and software programming. For further peace of mind, we also monitor your expiry dates so you can be reassured that your equipment and site safety is always up to date.
MegaTest ensures that our technicians are qualified to test and certify your electrical equipment to the appropriate Legal Unit Standards. This minimizes impact on both your staff and your clients, and ensures your workplace meets its legal obligations of compliance - so you can focus on the running of your business practice.
Medical Device Definition – AS/NZS 3551: 2012
Any instrument, apparatus, or appliance (including software) whether used alone or in combination with any accessories necessary for correct operation that:
Makes physical or electrical contact with the patient
Transfers energy to or from the patient
Detects such energy transfer to or from the patient
Is intended to diagnose, treat or monitor a patient
This includes items of equipment not originally designed as medical equipment but which are:
Supplied as part of or interfaced with other medical equipment
Considered to be themselves part of a medical electrical system
Subject to the requirements of AS3551.
Types of businesses affected by this requirement include
Medical/ Health Facilities
Retirement Homes with Hospital Facilities
Medical Device Definition - AS/NZS 3003
Specifies requirements for new electrical installations and for alterations and repairs of patient areas, where the organization/entity responsible has determined that low voltage medical electrical equipment will be used on a patient.
Classification of patient areas need to be based on the medical procedures undertaken in each area; this includes special patient areas such as homecare installations and transportable vehicles.
NOTE: Guidance on the classification of medical procedures enabling the decisions made by the responsible organization in determining patient areas in NZ may be found in AS/NZS 2500.
Patient Location/ Environment Definition
Patient areas may consist of either a single patient location or multiple patient locations. If the area consists of multiple patient locations which form a single clinical operational unit (e.g. recovery) the patient area will enclose all of these patient locations.
Where adjacent patient environments overlap, the combined area is deemed one patient environment - therefore a patient environment may contain one or more patient locations.
Where the location of a patient is likely to vary for different occasions (e.g. in some operating theaters) the patient location extends laterally to the entire room.
The boundary extends to the walls enclosing the patient location(s) or, if such walls are incomplete (e.g. an entryway without a door) to the boundary formed if such walls or projections were extended.
The update to the Act in 2018 made various changes to the operation, wiring and use of medical equipment which could impact on your practice.
Furthermore there are significant differences between New Zealand and Australia within the Standard as follows:
All AS/NZS 3003 RCD Body/ Cardiac Protected Areas need to have their electrical outlets protected by a 10mA RCD (Residual Current Device).
Any electrical equipment within the AS/ NZS 3003 Patient Environment needs to be tested to the AS/NZS 3551 Standard regardless of its use – this includes but is not limited to such general items as computers and monitors, printers, battery chargers, and fans, etc
A general rule of thumb is that all equipment that is 25V AC or 60V DC or above, that either touches, is used on or near a patient, requires testing to AS/NZS 3551 Standard by qualified personnel using certified test equipment. Your equipment may include:
This equipment might include:
Electrical items outside of the AS/NZS 3003 RCD Body/ Cardiac Protected Area do not usually require testing to AS/NZS 3551 Standard - there are some exceptions that apply (your MegaTest Technician will advise), however most items only legally require testing to AS/NZS 3760. These may be certified by various Test and Tag companies and/or Electricians who are competent up to this qualification.
MegaTest Technicians are qualified to the higher Standard of AS/NZS 3003 and AS/NZS 3551 and can guide you through the various testing standards and correct fulfillment/accurate compliance of your legal requirements.
Let MegaTest work with your team to reduce workplace interruptions, compliance costs and to ensure the safety of your workplace environment.
Call us to day we will help you get it right first time.
Practicing Certificates (Kevin)
An Overview of the Standards affecting the Medical fraternity include:
(as taken from Standards New Zealand with online links as referenced below)
Provides a guide to the safe use and application of electricity operated equipment used in health care. In addition to providing protection against electric shock to patients and staff, provision to safeguard against hazards such as thermal, radiant and mechanical, are also included. Measures required to provide and maintain patient and operator safety, including specification of the class of equipment and electrical installation to be employed for particular medical procedures, are also included.
Outlines procedures required to develop management programs for medical equipment. These include protocols and procedures for procurement, acceptance, maintenance activities throughout the service life of the medical equipment, and finally disposal of medical equipment.
Specifies particular requirements for electrical installations in patient areas. These requirements are additional to those specified in AS/NZS 3000 and the New Zealand Electricity (Safety) Regulations 2010. This standard sets out the requirements for areas in new electrical installations and for alterations and repairs of patient areas in existing electrical installations where the organization/entity responsible for that electrical installation has determined that low-voltage medical electrical equipment will be used on a patient. It covers special patient areas, including homecare installations and transportable vehicles. It also contains requirements for identification, inspection and testing of patient areas.
This Standard is a revision of AS/NZS 3760:2003, and specifies procedures for the safety inspection and testing of low voltage single phase and polyphase electrical equipment, connected to the electrical supply by a flexible cord and/or connecting device, which is new equipment placed into service for the first time, is already in-service, has been serviced or repaired, is returning to service from a second-hand sale, or is available for hire.