Registration of radiotherapy apparatus
Ionising radiation apparatus used for radiotherapy or the planning of radiotherapy
DECC has prepared this document to help explain the process and procedures for the registration of your apparatus.
The Radiation Control Act 1990 and the Radiation Control Regulation 2003 prescribe the registration of radiation apparatus and the requirements of registration. The purpose of registration is to:
- Ensure that radiation apparatus comply with the specified minimum standards. These standards aim to optimise the protection of individuals and the environment from exposure to ionising radiation.
- Enable the keeping of up-to-date records of ownership and location of radiation apparatus.
DECC registers radiation apparatus for reasons of public safety, community and professional concerns, setting standards, and achieving best practice.
Changes have been made to legislation regarding the registration of ionising radiation apparatus used for radiotherapy and the planning of radiotherapy. These requirements are part of the Radiation Control Regulation 2003.
The registration of radiotherapy apparatus used or intended to be used for radiotherapy or radiotherapy planning purposes commenced on 1 February 2004. If the apparatus is not intended to be used for radiotherapy or the planning of radiotherapy planning purposes, then registration is not required. In this case, the apparatus must be stored or labelled so that it is not used for radiotherapy purposes. If the apparatus is later needed for radiotherapy or the planning of radiotherapy, it must be registered before it can be used.
Registration relates to the apparatus, not a person, and the operator needs a licence to use the apparatus.
A licence is required to:
- use radiotherapy apparatus
- possess radiotherapy apparatus
- sell radiotherapy apparatus
- buy radiotherapy apparatus
An application for the registration of ionising radiation apparatus used in radiotherapy or the planning of radiotherapy can be downloaded regtherapyappln.pdf (55kb, requires Adobe Acrobat).
Summary of requirements
Apparatus used for radiotherapy, or planning radiotherapy must be registered
Any apparatus used or intended to be used for radiotherapy, radiotherapy planning purposes (includes general x-ray and CT apparatus) must be registered with DECC. If the apparatus is sold or given away, the registration must be transferred using the appropriate application form.
DECC must be notified of the sale, give away or disposal (no longer of use) of ionising radiation apparatus used for radiotherapy, radiotherapy planning purposes
This includes new and used apparatus, registered or unregistered, that is sold, given away or disposed of privately or commercially. DECC must be notified using the appropriate form within 7 days of sale, disposal or being given away.
How to register your apparatus
- submit a completed registration application form or transfer application form with the required fee.
- a Certificate of Registration will be issued by DECC. The Certificate of Registration will include registration conditions. The conditions are mandatory requirements with which the owner must comply.
DECC requires all necessary information (and the application fee) to be provided with application forms. If all relevant information is provided, applications are processed on the day of receipt.
Licence numbers
For registration applications, the licence number of the owner must be used where a licence number is requested. The owner may be an individual, a company (not the company director), or a corporation such as an Area Health Service. Apparatus cannot be registered in the name of an employee or use an employee's licence number.
Serial numbers
You must provide model numbers and serial numbers on your forms.
Generator serial numbers
If your equipment is old and you cannot locate a serial number for the console/generator, you can use DECC registration number in place of a serial number. If your machine is not currently registered you must use a number that will uniquely identify your machine, such as an equipment inventory number issued by your organisation. This number should be replaced with DECC registration number once the apparatus is registered. In all cases, the number must be permanently marked on the apparatus (for example by engraving) and must uniquely identify it.
X-ray tube housing and tube insert serial numbers
In some cases these may not be visible or are worn or faded. A registration will be accepted in these cases, but numbers must be provided if available. When physically possible, the tube housing must be identified by an equipment inventory number, DECC apparatus registration number, or some other means of unique identification. The tube insert serial numbers must be provided if the tube is physically accessible. In all cases, the number must be permanently marked on the apparatus (for example by engraving) and must uniquely identify it.
Conditions of registration
These are requirements imposed on the owner that will depend on the specific situation, e.g. the type of apparatus being registered. The conditions form part of the Certificate of Registration.
Buying additional apparatus
You must apply to register any new apparatus, and each radiotherapy apparatus must be registered separately. You must register each apparatus with DECC before it is used for radiotherapy or radiotherapy treatment planning purposes.
Suppliers of new apparatus
You do not need to register the apparatus with DECC prior to the sale. DECC must be notified of the sale (as required by the conditions of the licence to sell radiation apparatus) using the form Notification of sale or give away - Ionising Radiation Apparatus (rasale.pdf, 50kb).
Apparatus on loan
If you loan out your apparatus but are not receiving any money from the loan, you are still the legal owner and must register the apparatus. Each time the apparatus registered location changes you must inform DECC of the new location using the form Renewal and notification of change of registration details - Ionising radiation apparatus used in diagnostic imaging, radiotherapy and planning of radiotherapy (changedetails.pdf, 85kb).
Certification of Compliance (all apparatus excluding computed tomography apparatus used for radiotherapy treatment planning purposes)
At this time there are no mandatory registration requirements for radiotherapy apparatus or apparatus used for the planning of radiotherapy (except for computed tomography apparatus). In future mandatory registration requirements will be developed for these radiotherapy apparatus and a compliance certification program will be instigated.
Computed tomography apparatus used for radiotherapy treatment planning purposes
Computed tomography apparatus used for radiotherapy treatment planning purposes must comply with the same registration requirements as computed tomography apparatus used for diagnostic imaging apparatus. Computed tomography apparatus used for radiotherapy planning purposes must be registered with a certificate of compliance. The certificate of compliance must be issued by a DECC accredited Consulting Radiation Expert.
The registration requirements are set out in Radiation Guideline No. 6 - Registration requirements & Industry best practice for ionising radiation apparatus used in diagnostic imaging (DEC 2004), Part 5 Computed Tomography and Bone Mineral Densitometry. Copies of the guideline can be purchased from DECC Pollution Line on 131 555.
Once registered, a certificate will be issued that will allow the computed tomography apparatus to be used for both diagnostic imaging and radiotherapy treatment planning purposes.
To register computed tomography apparatus, you must complete the diagnostic imaging apparatus registration application form (diaapplication.pdf, 84kb). For more information on the compliance certification program for computed tomography apparatus refer to registration of x-ray machines.
Renewal of registration
Duration of registration
Registrations are valid for two years. Your Certificate of Registration will show the date when the registration expires and is due for renewal.
Renewing a registration
DECC will send a renewal notification six weeks prior to the registration expiry. The renewal notification will need to be returned with the fee.
Transfer (sell or give away) of registration
Whenever registered apparatus is sold (see the definition of 'sell') or given away, the registration must be cancelled or transferred into the name of the new owner.
Transfer applications must be made on the appropriate form and accompanied by the transfer application fee. The licence number of the current registered owner (i.e. the seller) should be given on the form. The owner must have a licence to sell ionising radiation apparatus. A licence to use such apparatus is not appropriate to sell the apparatus. The purchaser must also have a valid licence to use or licence to sell radiation apparatus (if an individual), or a licence to sell/possess (if an organisation).
Definition of 'sell'
'Sell' means 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.
Selling or giving away apparatus
Selling
If you wish to sell your apparatus and you do not have a licence to sell, you will need to apply to DECC for a licence to sell radiation apparatus. You must notify DECC of the sale 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 registration is to be transferred.
If the Certificate of Registration has been surrendered or the apparatus is new and not registered use the form Notification of sale or give away - Ionising Radiation Apparatus (rasale.pdf, 39kb).
Giving away
You must hold either a licence to sell or a licence to use if the apparatus is being given away, and you must complete a registration transfer application or a notification form as above.
In both cases, you can only sell or give to a company that has a licence to sell/possess radiation apparatus, or to a person who is a sole trader and has an appropriate licence to use radiation apparatus or licence to sell that particular type of apparatus. If the apparatus is registered and you wish to transfer registration to the new owner, both the transfer application form and transfer fee must be provided (see below for details on how to transfer registrations).
If you do not wish to transfer the registration, you must surrender the Certificate of Registration to DECC and the registration will be cancelled. DECC must be notified (as required by the conditions of the licence to sell radiation apparatus) using the form Notification of sale or give away - Ionising Radiation Apparatus (rasale.pdf, 39kb).
Transferring a registration
The current owner must apply to DECC for a transfer 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). The current owner must also pay the transfer application fee and ensure that information such as licence details of the new owner are correct.
On receipt of the transfer application, DECC will confirm the transfer details with the new owner. If the transfer application is approved, DECC will issue a registration certificate to the new owner.
In all cases:
- The new owner must not use the apparatus for radiotherapy or radiotherapy planning purposes until a new Certificate of Registration has been issued. The registration number of the apparatus will remain the same.
- If the apparatus is being sold the owner must have a licence to sell/possess ionising radiation apparatus. A licence to use such apparatus is not appropriate to sell the apparatus.
- If the apparatus is being given away, the giver (i.e. old owner) must hold either a licence to use or a licence to sell/possess ionising radiation apparatus.
- The purchaser must have a valid licence to use or licence to sell radiation apparatus (if an individual), or a licence to sell/possess (if an organisation).
Surrender of registration
If you no longer wish to use your apparatus for the purposes of radiotherapy or radiotherapy planning, you can surrender the registration. Notify DECC of the surrender in writing and return the Certificate of Registration to DECC.
Disposal
If you wish to dispose of your apparatus you must first render the apparatus permanently inoperable as outlined on your Certificate of Registration. After disposal you must notify DECC 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 both registered and unregistered apparatus.
Further information
For further information contact NSW DECC Hazardous Materials and Radiation Section on 131 555.