Registration of diagnostic imaging (x-ray) radiation apparatus

DECC has prepared the following information to help answer common questions relating to registration and certification of your apparatus, and to explain to you the procedures for registration, and how compliance inspection works.

The Radiation Control Act 1990 provides for the registration of radiation apparatus and for conditions of registration to be imposed. The Radiation Control Regulation 2003 prescribes that all diagnostic imaging (x-ray) apparatus used for medical, dental and veterinary purposes must be registered.

The owner of x-ray apparatus is responsible for ensuring that apparatus is registered.

DECC registers x-ray apparatus so that it knows what equipment is being used, where it is located, to whom it belongs, and to ensure that it complies with safety standards.

Registration and periodic testing of x-ray apparatus helps to minimise exposure of occupationally exposed persons and the general public to harmful radiation, and promotes best practice.

The mandatory requirements for registration of x-ray apparatus and recommendations for radiation safety are in Radiation Guideline 6: Registration requirements & industry best practice for radiation apparatus used in diagnostic imaging, first published by the EPA in 1999.

Radiation Guideline 6 was updated in 2004 and is available online at no cost or hard copies may be purchased from Environment Line by calling 131 555.

To ensure that x-ray apparatus meets the minimum registration requirements, a Certificate of Compliance from an DEC-accredited Consulting Radiation Expert must be provided with all registration applications and renewals.

In addition to the registration requirements for apparatus, a person must hold a current licence under the Radiation Control Act 1990 to:

use diagnostic imaging apparatus
possess diagnostic imaging apparatus
sell diagnostic imaging apparatus
buy diagnostic imaging apparatus

Summary of requirements

Radiation apparatus used for diagnostic imaging must be registered by its owner.
Registration must be renewed every two or five years depending on the type of apparatus.
There are separate registration requirements for apparatus used for radiotherapy or radiotherapy planning.Refer to Registration of radiotherapy apparatus.
X-ray apparatus must be regularly inspected by an EPA-accredited Consulting Radiation Expert.
A Certificate of Compliance is required with all new registration applications and renewals.
The owner must notify DECC of any relocation, transfer of ownership or disposal of x-ray apparatus.

The owner must notify DECC within 7 days of any relocation, transfer of ownership (whether by sale or giving away), or disposal of apparatus using the appropriate form.

This applies to private and commercial transactions involving prescribed apparatus, whether it is new or used, registered or unregistered.

Ownership of radiation apparatus

The definition of 'owner' in relation to apparatus in the Radiation Control Act 1990 includes a lessee or one who takes apparatus on hire.

If the owner of radiation apparatus is a corporation (including a statutory corporation – for example, an Area Health Service) the corporation must hold a licence to sell/possess radiation apparatus, in addition to registration requirements.

If the owner is an individual person who also uses the apparatus (for example, a sole trader) they must have a licence to use x-ray apparatus with conditions appropriate to the apparatus. An individual's licence to use x-ray apparatus includes the right to possess for use. Therefore, an individual owner does not require a separate licence to sell/possess, unless the owner decides to sell the apparatus.

Further information relating to ownership and licensing in particular situations contact DECC, Hazardous Materials and Radiation Section on 131 555.

Registration requirements: Radiation Guideline 6

Radiation Guideline 6 sets the minimum standards for registering x-ray apparatus (in Schedule 1 of Parts 1-5) and offers owners best practice recommendations.

Part 6 of the Guideline, Test protocols for parts 2-5, is used by Consulting Radiation Experts to assess registered apparatus, except mammography apparatus.

Mammography apparatus (which is covered by Part 1 of the Guideline) is assessed using the Royal Australian and New Zealand College of Radiologists' Mammography Quality Control Manual (2002).

The guideline is available in pdf format (requires Acrobat Reader 5.0):

Part 1 - Mammography (mammography.pdf, 207kb)
Part 2 - Fluoroscopy & radiography (radiotherapyreginfo.pdf, 276kb)
Part 3-Dentistry (including maxillofacial) (dentistry.pdf, 233kb)
Part 4-Veterinary science (veterinary.pdf, 262kb)
Part 5-Computed tomography & bone mineral densitometry (ct_bmd.pdf, 224kb)
Part 6-Test Protocols for parts 2-5 (test_protocols.pdf, 265kb)

Radiation Guideline 6 Parts 1-6 may be purchased as individual booklets from Environment Line by calling 131 555.

Registration procedures

The owner must submit a completed registration application or transfer application form, as appropriate, with a Certificate of Compliance and the required fee.

The Certificate of Registration issued by DECC includes registration conditions. These conditions are mandatory requirements with which the owner must comply.

Conditions of registration may be different depending on the type of apparatus and the purpose for which it is used, and may be varied by DECC from time to time.

Licence numbers

The licence number of the owner must be used where a licence number is required on a registration application or other form. The registered owner may be an individual or a company (but not a director of the company). An application may not be in the name of an employee or use an employee's licence number, where the owner's licence number is required.

Serial numbers

Where they are required on a form, generator/console, tube housing and tube insert serial numbers must be provided if they are available.

If a required serial number is not available (for example, where it is inaccessible or worn), the EPA registration number may be used. If the apparatus is not currently registered the owner must provide a number that will uniquely identify the apparatus (for example, an equipment inventory number).

Once the apparatus is registered, if a required serial number is not available, the EPA registration number must be provided on forms in the future. In all cases, the number must uniquely identify the apparatus and must be permanently marked on the apparatus in English.

Duration of registration

A registration is valid for two or five years depending on the type of apparatus, as shown in the table below.

Duration of registration for diagnostic imaging apparatus

Category	Duration of registration
Dental radiography (fixed and mobile)	5 years
Radiography (fixed and mobile)	5 years
Fluoroscopy (fixed and mobile)	2 years
Radiography/fluoroscopy (fixed and mobile)	2 years
Mammography (fixed and mobile)	2 years*
Computed tomography (includes dental apparatus classified as computed tomography)	2 years
Panoramic radiography (with/without cephalometry)	5 years
Bone mineral densitometry	5 years

*Note: mammography apparatus must be inspected annually by a Consulting Radiation Expert to measure the mean glandular dose. The owner of registered mammography apparatus must send a copy of a Certificate of Compliance annually to DECC for the mean glandular dose measurement.

Renewal of registration

The Certificate of Registration shows the date when a registration expires and is due for renewal, in accordance with the registration durations listed in the table above.

DECC will send a renewal notification approximately six months before the registration expires.

If the owner intends to continue to use the apparatus, it must be assessed by a Consulting Radiation Expert within six months before the expiry date expires. The owner must return the renewal notification with the prescribed fee and a photocopy of the Certificate of Compliance issued by the Consulting Radiation Expert. It is the owner's obligation to ensure that the apparatus is assessed and certified compliant by a CRE before the renewal falls due.

Suppliers of new apparatus

New apparatus is not required to be registered before it is sold. However, DECC must be notified of the sale using the form Notification of sale or give away - Ionising radiation apparatus (rasale.pdf, 50kb).

Buying additional apparatus

An owner must register each new x-ray apparatus that comes into their possession. New apparatus must be registered with DECC before it is used for diagnostic imaging. The owner must have the apparatus inspected by a Consulting Radiation Expert and submit an application form to DECC with a Certificate of Compliance, verifying that the apparatus complies with the registration requirements, and the prescribed fee.

A person who intends to purchase apparatus should make the necessary inquiries of the supplier to ascertain whether the apparatus meets the registration requirements.

Relocated apparatus

Mobile x-ray apparatus may be moved as necessary.

If fixed apparatus is relocated and the ownership of the apparatus remains the same, a Consulting Radiation Expert must inspect the apparatus in the new location and certify that it complies with regulatory requirements.

The owner must notify DECC using the on-line form Renewal and notification of change of details - Ionising radiation apparatus used in diagnostic imaging, radiotherapy and planning of radiotherapy with the prescribed fee and a copy of the Certificate of Compliance issued by the CRE before the apparatus may continue to be used for diagnostic imaging.

If the apparatus has been relocated due to being sold or given away, the registration is cancelled. The owner (seller) must notify DECC using the form Notification of sale or give away - Ionising radiation apparatus (rasale.pdf, 50kb).

The new owner must have the apparatus inspected by a Consulting Radiation Expert and submit a Certificate of Compliance, verifying that the apparatus complies with registration requirements, with the form Registration application - Ionising radiation apparatus used in diagnostic imaging (diaapplication.pdf, 84kb) and the prescribed fee, before the apparatus may be used for medical, veterinary or dental diagnostic imaging.

Apparatus on loan

If the registered owner loans out apparatus but is not receiving any money from the loan, they are still the legal owner and are still responsible for keeping the apparatus registered.

If fixed apparatus on loan is relocated, a Consulting Radiation Expert must inspect the apparatus and certify that it complies with regulatory requirements before it may continue to be used for diagnostic imaging. The owner must notify DECC, using the on-line form Renewal and notification of change of registration details - Ionising radiation apparatus used in diagnostic imaging and radiotherapy and planning of radiotherapy (changedetails.pdf, 85kb) and provide a copy of the Certificate of Compliance.

If apparatus on loan is relocated and the purpose for which it is used changes (for example, from medical to veterinary) the registration is cancelled. The apparatus must be inspected by a Consulting Radiation Expert and the owner must submit a Certificate of Compliance, verifying that the apparatus complies with registration requirements for the intended use, with the form Registration application - Ionising radiation apparatus used in diagnostic imaging (diaaplication.pdf, 84kb) and the prescribed fee, before it may be used for medical, veterinary or dental diagnostic imaging.

Unused apparatus

X-ray apparatus that is not intended to be used for medical, veterinary or dental diagnostic purposes is not required to be registered, for example, apparatus that is in storage. The apparatus must be stored or labelled in such a way to prevent it being used for medical, veterinary or dental diagnostic imaging.

If the owner decides to use the apparatus for medical, veterinary or dental diagnostic imaging, the apparatus must be registered with DECC before it can be used.

Consulting Radiation Experts

A Consulting Radiation Expert (CRE) is a person accredited by DECC on behalf of the EPA under the Radiation Control Act 1990 to carry out certain activities relating to radiation apparatus, radioactive substances and premises on which radioactive sources are kept or used.

CREs are not EPA or DECC employees or contractors. The price of a compliance inspection varies according to the market.

Registered x-ray apparatus must be periodically inspected to ensure that safety and performance meet the mandatory requirements in Schedule 1 of Radiation Guideline 6.

Only an EPA-accredited Consulting Radiation Expert may assess apparatus and issue a Certificate of Compliance, verifying that the apparatus complies with the mandatory requirements for registration.

List of accredited Consulting Radiation Experts.

Accreditation of Consulting Radiation Experts

The type of the apparatus that a Consulting Radiation Expert (CRE) may assess depends on the conditions of accreditation that the person has been issued by DECC, based on their qualifications.

A CRE may be accredited to assess mammography, general diagnostic or dental apparatus. General diagnostic imaging accreditation includes medical, veterinary and chiropractic radiography, fluoroscopy, and computed tomography and bone mineral densitometry.

Please contact the DECC Hazardous Materials and Radiation Section for information on the prerequisites for gaining accreditation in all areas, except mammography.

Certification in Mammography Testing by the Australasian College of Physical Scientists and Engineers in Medicine (ACPSEM) is required to obtain accreditation to inspect mammography apparatus.

Compliance inspection

Following an inspection for compliance certification the Consulting Radiation Expert must:

within 21 days, provide the owner with a Certificate of Compliance declaring whether or not the apparatus complies with regulatory requirements, and
within a reasonable time, provide a full report, including readings and calculations, and details of non-compliance with any mandatory requirements.

Failure at inspection

If an apparatus fails compliance inspection in relation to a minor or easily repairable requirement, a Consulting Radiation Expert may exercise their discretion to allow the apparatus to continue to be used (for a maximum period of three months) while the necessary repairs are carried out or a replacement part is obtained.

If you require further advice about minor or easily repairable faults, contact DECC, Hazardous Materials and Radiation Section on 131 555.

Inspection of apparatus by non-Consulting Radiation Experts

A person who is not a Consulting Radiation Expert, for example, an employee, supplier or maintenance contractor, may inspect apparatus for compliance with Radiation Guideline 6 requirements in the course of regular servicing or quality assurance.

However, only a Consulting Radiation Expert with the relevant accreditation can certify that apparatus complies for registration purposes.

Certificate of Compliance

X-ray apparatus must comply with mandatory requirements relating to performance, quality and safety in Schedule 1 of the relevant part of Radiation Guideline 6 before it can be registered or an existing registration can be renewed.

A Certificate of Compliance is an approved form issued by a Consulting Radiation Expert to an owner that declares whether the apparatus meets the registration requirements.

A Certificate of Compliance may only be issued by a CRE who is appropriately accredited by DECC.

When a Certificate of Compliance is required

A Certificate of Compliance is required for initial registration of x-ray apparatus and must be submitted with all renewals, every two or five years depending on the type of apparatus (see Duration of registration).

A Certificate of Compliance is also required:

when fixed apparatus is relocated
after annual 'mean glandular dose' assessment (mammography apparatus only).
when apparatus is modified (for example, a tube insert is replaced)when the purpose for which apparatus is used changes (for example, from medical to veterinary)
following any service that may affect patient x-ray dose

Certification of mammography apparatus

Mammography apparatus must be certified at least every two years. In addition, mammography apparatus must be assessed annually for 'mean glandular dose' by a Consulting Radiation Expert and the owner must send a copy of a Certificate of Compliance to DECC.

If an owner fails to provide an annual 'mean glandular dose' certificate for mammography apparatus the registration may be cancelled, in which case, the apparatus must be assessed by a CRE and re-registered before it a may be used.

Modifications to apparatus

If an apparatus is modified (for example, a tube is replaced) it must be inspected and certified by a Consulting Radiation Expert as complying with registration requirements.

The owner must notify DECC of the details of the modifications (for example, serial no., make and model of new tube) and send a copy of the Certificate of Compliance before it may be used for medical, veterinary or dental diagnostic imaging

Change of purpose or use

If the purpose for which apparatus is used changes (for example, from medical to veterinary) the registration is cancelled and the apparatus must be inspected by a Consulting Radiation Expert and certified as complying with the registration requirements applicable to the new purpose.

The owner must obtain a new registration using the form Registration application - Registration application - Ionising radiation apparatus used in diagnostic imaging (diaapplication.pdf, 84kb) with a copy of the Certificate of Compliance and the prescribed fee, before the apparatus may be used for medical, veterinary or dental diagnostic imaging.

Transfer of apparatus/registration and disposal of apparatus

Definition of "sell"

In the Radiation Control Act 1990 "sell" means to sell by wholesale or retail, and includes barter, supply for profit, lease, let out on hire, offer or expose for sale, receive for sale, have in possession for sale, send, forward or deliver for sale, and cause, suffer or allow to be sold, offered, or exposed for sale.

Transfer (sell or give away) of apparatus

When x-ray apparatus is sold (under the definition of 'sell' in the Act) or given away, the registration is either cancelled or must be transferred into the name of the new owner, depending on the circumstances.

The person who is selling or giving away the apparatus must have a licence to sell/possess radiation apparatus. The new owner (if a company) must have a licence to sell/possess radiation apparatus or (if an individual) a licence to sell/possess or a licence to use the relevant type of radiation apparatus.

Transfer of registration applications must be made using the appropriate form and be accompanied by a transfer application fee. The licence number of the registered owner (seller) and the new owner is required on the form.

Selling or giving away apparatus

Selling

If a person intends to sell radiation apparatus and does not have a licence to sell/possess radiation apparatus, they must obtain a licence from DECC before they may sell the apparatus. This applies to a company and to an individual who possessed the apparatus under their licence to use.

If the apparatus is registered and the registration is to be transferred on sale, the owner (seller) must notify DECC using the form Application for transfer of registration and notification of sale or give away- Ionising radiation apparatus used in diagnostic imaging, radiotherapy and planning of radiotherapy (diatransfer.pdf, 49kb).

If the apparatus is not registered (for example, because the Certificate of Registration has been surrendered or the apparatus is new) the owner (seller) must notify DECC using the form Notification of sale or give away - Ionising Radiation Apparatus .

Giving away

An owner must hold either a licence to sell/possess or licence to use radiation apparatus if they intend to give away radiation apparatus, and must complete a registration transfer application or a notification form, as appropriate.

If the apparatus is registered, the owner may transfer the registration to the new owner with the apparatus (subject to the Circumstances in which a registration cannot be transferred). In this case both a transfer application form and transfer fee are required. (See below for further details on how to transfer a registration).

If an owner does not wish to transfer the registration when giving away apparatus, the owner must surrender the Certificate of Registration to DECC and the registration will be cancelled. The owner must notify DECC using the form Notification of sale or give away - Ionising Radiation Apparatus (rasale.pdf, 39kb).

Circumstances in which a registration cannot be transferred

A registration cannot be transferred with radiation apparatus that is sold or given away if:

modifications have been made to the apparatus that affect its ability to comply with the registration requirements
a fixed apparatus has been physically relocated
the intended use of the apparatus has changed (for example, from medical to veterinary).

Transferring a registration

To transfer a registration the owner must apply to DECC using the form Application for transfer of registration and notification of sale or give away - Ionising radiation apparatus used in diagnostic imaging radiotherapy, and planning of radiotherapy (diatransfer.pdf, 49kb), accompanied by the prescribed transfer application fee.

It is the obligation of the person who is transferring the apparatus to ensure that the information on the form, including the licence details of the new owner, is correct.

On receiving the transfer application, DECC will confirm the transfer details with the new owner. If the transfer application is approved, DECC will issue a Certificate of Registration to the new owner.

If the circumstances do not permit a registration to be transferred with the apparatus, the registration will be cancelled.

If the new owner intends to use the apparatus for medical, veterinary or dental diagnostic purposes, they must make a new registration application, including a copy of a Certificate of Compliance issued by a Consulting Radiation Expert and the registration fee.

In all cases:

The new owner must not use the apparatus for medical, veterinary or dental diagnostic imaging before a Certificate of Registration has been issued.
If the apparatus is being sold, the seller must have a licence to sell/possess ionising radiation apparatus; a licence to use radiation apparatus alone is not sufficient to sell apparatus.
The new owner must have a licence to sell/possess radiation apparatus (if an company) or a licence to sell/possess or an appropriate licence to use radiation apparatus (if an individual).
If the apparatus is being given away, the owner giving away the apparatus must hold either a licence to use or a licence to sell/possess ionising radiation apparatus.

Surrender of registration

If an owner no longer wishes to use registered apparatus for medical, veterinary or dental diagnostic imaging, the owner may surrender the registration, by returning the Certificate of Registration to DECC and the registration will be cancelled.

Disposal

If an owner wishes to dispose of diagnostic imaging apparatus, the apparatus must first be rendered permanently inoperable, in accordance with the Conditions attached to the Certificate of Registration.

The owner must notify DECC of the disposal using the form Notification of disposal - Ionising radiation apparatus used in diagnostic imaging, radiotherapy and planning of radiotherapy (diadispose.pdf, 42kb). This requirement applies to registered and unregistered apparatus.