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Biomedical Electrical Testing And Why It's Vital To Get It Right

MegaTest, Biomedical, GP, 3003, 3551, Do

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 electromedical 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

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  • GP Practices

  • Medical/ Health Facilities

  • Private Hospitals

  • Retirement Homes with Hospital Facilities

  • Physiotherapist Clinics

  • Dentist

  • Radiology Facilities

 

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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.

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Legislation & Standards
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The Health and Safety at Work Act 2015, together with the Electricity (Safety) Regulations 2010, make the Directors and Shareholders of healthcare practices responsible for ensuring a safe environment for both patients and staff.


We strongly recommend that all Owners and users of medical electrical equipment need to be aware that under New Zealand law all electrical equipment in your practice must be tested yearly. Failure to do so may result in fines being imposed.

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Let MegaTest work with your team to reduce workplace interruptions, compliance costs and to ensure the safety of your workplace environment. 

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Call us to day we will help you get it right first time.

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MegaTest

info@megatest.co.nz

027 22 33 446

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Practicing Certificates  (Kevin)

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An Overview of the Standards affecting the Medical fraternity include:

(as taken from Standards New Zealand with online links as referenced below)

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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.

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  • Electricity (Safety) Regulations 2010- Summary                                                                                                                                            The main purpose of ESR is to promote the health and safety of members of the public, and promote the prevention of damage to property, around    the supply and use of electricity in New Zealand.

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