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Regulatory


Regulatory Information
Facility Inspections on Ionising & Non-Ionising Radiation
Guidelines for Licence Application
Licences & Fees
Miscellaneous Fees




Regulatory Information

Introduction

The Centre for Radiation Protection and Nuclear Science
(CRPNS) is the national regulatory authority for radiation protection in Singapore.

CRPNS administers the RADIATION PROTECTION ACT and its subsidiary Regulations through a system of licensing, notification, authorisation, inspection, and enforcement on irradiating apparatus and radioactive materials.

 
Facility Inspections on Ionising & Non-Ionising Radiation
 
Regulatory Functions
(The complete text of these Regulations may be purchased from the Singapore National Printers)

Inspection

As part of the regulatory control, premises using radiation sources or storing radioactive materials are subject to inspections to ensure compliance with safety requirements.

Before a new radiation facility can be put to use, officers from the Centre for Radiation Protection and Nuclear Science (CRPNS) will inspect the premises to ensure that the Radiation Protection Act and Regulations are complied with. Routine inspections are conducted for existing facilities at least once a year or once in two years. The main checks during an inspection visit are to ensure that:

  • the radiation sources are all licensed, the details are correct and they are all properly maintained;
  • all the radiation sources are physically accounted for;
  • there is a suitably qualified person licensed to use the radiation source;
  • the radiation level outside the room housing the radiation source, at any location accessible to any individual, should not be more than 10 µSv/hr, when the irradiating apparatus is working at its maximum rating or when the radioactive source is exposed;
  • the radiation warning signs are prominently displayed; and
  • the interlock system for the door is functioning; and for medical facilities
  • that QA programs are in place, with proper documentation

For a work site in an open area, a barricade with the radiation hazard logo, has to be placed around the work area. The radiation level at this barricade should not be more than 25 µSv/hr.

  • Radiotherapy Centres

    QA checks are particularly important in radiotherapy as high doses of radiation are delivered to the patient. The aim of the QA Program is to ensure optimal accuracy in the delivery of prescribed radiation dose to the patient undergoing therapy treatment and to minimise the radiation risks to others. The Radiotherapy Centre's QA Program and its results must be documented and made available for auditing by CRPNS at any time.

    Records of the daily, monthly and annual QA checks performed are inspected. The daily QA checks done are:

    • laser alignment to isocentre;
    • accuracy of optical distance indicator;
    • x-ray output constancy at all energies;
    • electron output constancy; and
    • checking that the door interlock, warning light and audiovisual monitor are functioning properly.

    The monthly checks to be performed by physicists are:

    • laser alignment to isocentre;
    • gantry and collimator angle indicator;
    • field size indicator (for the whole range of field sizes);
    • light/radiation field congruence;
    • mechanical gantry isocentre;
    • collimator rotation axis;
    • cross-hair centre-ing;
    • jaw symmetry;
    • output calibration;
    • x-ray field flatness constancy;
    • x-ray field symmetry constancy;
    • electron beam field symmetry constancy;
    • x-ray beam energy constancy;
    • backup monitor constancy (MU1/MU2);
    • checking that the wedge/accessory interlock, electron cone/field size interlock,
    • treatment couch brake/lock, x-ray/electron interlock, and the collision device (if available) are all functioning.

    Annually, the service engineer should do all the mechanical and electrical tests recommended by the manufacturer to ensure that the machine is still in good working condition. The accuracy or constancy of all the above checks should be within 2-3%.

    In addition all patient treatment records, treatment planning and dose data should be properly maintained for auditing and inspections.

  • Medical Diagnostic and Dental X-ray Facilities
    QA Programs are also necessary for medical diagnostic and dental x-ray facilities.

    Although the dose given in medical diagnostic and dental x-rays is relatively low, almost every individual would have undergone this type of examination sometime in his/her lifetime. Collectively, we want to keep the dose to the population as low as possible so it is important that the correct dose be given for each radiograph. Guidance dose levels for medical diagnostic radiography for a typical adult patient, as recommended by the IBSS are given in the following table. The given doses should not be too low either because then, the radiograph may not show the requested diagnostic information and the patient will not get the expected medical benefit from the x-ray examination. There shall be proper documentation of all QA procedures.

Guidance dose levels for medical diagnostic radiography for a typical adult patient
Examination
Entrance surface dose per radiograph* (mGy)
Lumbar spine
AP
LAT
LSJ
10
30
40
Abdomen, intravenous urography and cholecystography-
AP
10
Pelvis
AP
10
Hip Joint
AP
10
Chest
PA
LAT
0.4
1.5
Thoracic spine
AP
LAT
7
20
Dental
Periapical
AP
7
5
Skull
PA
LAT
5
3

    Notes:
    PA: posterior-anterior projection
    LAT: lateral projection
    LSJ: lumbo-sacral-joint
    AP: anterior-posterior projection.

    * In air with backscatter. These values are for conventional film-screen combination in the relative speed of 200. For high speed film-screen combinations (400 - 600), the values should be reduced by a factor of 2 to 3.

    An inspection for a medical diagnostic facility would therefore include the general checks outlined above and checking the existence of a comprehensive QA Program which should include:

    • image quality assessment;
    • film-reject analysis;
    • patient dose evaluation;
    • measurements of the physical parameters of the radiation generators (e.g. kVp, mAs) and imaging devices (e.g. film processors) at the time of commissioning and periodically thereafter;
    • verification of the appropriate physical and clinical factors used in patient diagnosis;
    • written records of relevant procedures and results;
    • verification of the appropriate calibration and conditions of operation of dosimetry and monitoring equipment;
    • procedures for remedial actions, follow-up and result evaluation.

    QA measurements to check that the equipment continues to meet manufacturer's specifications, should be done annually. This should be done by a properly trained staff from the supplier.

  • Nuclear Medicine Facilities

    For nuclear medicine facilities and laboratories using radionuclides, in addition to the above general checks, the facilities for storage and dispensing of radionuclides will be inspected as well as the facilities for storage and disposal of radioactive waste.

    The QA Program for Nuclear Medicine should include QA for radiopharmaceuticals as well as QA for the equipment. For radiopharmaceuticals intended for administration to patients, there should be an acquisition protocol to ensure that it meets the clinical requirements and satisfies both radiation safety and pharmaceutical quality requirements. There shall be proper documentation of all QA and QC procedures.

    Proper records shall be maintained for types and quantities of radionuclides in stock and used. Patient records shall also be kept together with details of radionuclides and radiopharmaceuticals administered. Records shall also be maintained for storage of radioactive waste and their disposal.




 
Guidelines for Licence Application

Irradiating Apparatus And Radioactive Materials

What licences to apply for

Companies selling or dealing in ionising radiation (IR) irradiating apparatus, need to apply for the L1 type of licence. If the company is going to provide demonstration or maintenance of the equipment, individuals will have to apply for the L5 and R1 licences. Every consignment of IR irradiating apparatus to be imported/exported requires a consignment licence (L7a/L7b).

Companies selling or dealing in radioactive materials, need to apply for the L2 licence. Individuals may need to apply for L6 and R1 licences or the L6A licence to transport radioactive materials. Every consignment of radioactive materials imported/exported requires a consignment licence (L8a/L8b).

Companies selling or dealing in non-ionising radiation (NIR) irradiating apparatus, need to apply for the N1 licence. Individuals may need to apply for N3 licence if the company is going to provide demonstration or maintenance of laser apparatus. Every consignment of NIR irradiating apparatus imported/exported requires a consignment licence (N4A/N4B).

Owners of IR irradiating apparatus, will need to apply for a L3 licence for the possession of each irradiating apparatus owned by the company. There has to be at least one applicant for the L5 licence to be responsible for the safe use of the IR irradiating apparatus and any other person using the apparatus will have to apply for R1 registration to work under the supervision of the L5 licencee.

Owners of radioactive materials, will need to apply for a possession licence L4. There has to be at least one applicant for the L6 licence to be responsible for the safe use of the radioactive materials. Any other person using the radioactive materials will have to apply for R1 registration to work under the supervision of the L6 licencee.

Owners of NIR irradiating apparatus, will need to apply for a N2 licence for each of the NIR apparatus possessed by the company. If the NIR apparatus is a Class 3b or Class 4 laser the person(s) using the laser will have to apply for the N3 licence.

Freight forwarding companies will need to apply for a L6A licence to handle and transport radioactive materials.


How to apply for licences

Application forms for radiation licences can be downloaded from NEA’s website.

Click on the licence type that you want to apply for, to download the application form. Fill up the form and send it to the Centre for Radiation Protection and Nuclear Science together with relevant documents and the cheque, made payable to 'National Environment Agency'.

Some of the licences allow you to apply on line but you still have to mail your cheque and your documents to CRPNS.

You are encouraged to pay via GIRO. Please write down your GIRO account number on the application form.

Import and Export licences are applied for through the TradeNet system. The licence application is merged with the IE Declaration. If the establishment code from the L1, L2 or N1 licence is indicated on the import licence application, the application will be auto-processed.

For more information on the items under import & export control, please refer to the following links appended below:

http://www.customs.gov.sg/leftNav/trad/TradeNet/National+Environment+Agency+-+Centre+for+Radiation+Protection+and+Nuclear+Science+%28CRPNS%29.htm

http://www.customs.gov.sg/leftNav/trad/TradeNet/Appendix+C+-+Items+Under+Import+and+Export+Control.htm

For further enquiries, please find CRPNS contact information at the FAQ.


Other Requirements

Applicants for L5, L6, R1 and N3 licences need to go for a medical examination. The Medical Certificate form is attached to the application form.

Applicants for L5 and L6 licences must be knowledgeable in radiation safety. They must show their knowledge by documentary proof or sit for a test set by CRPNS.


 
Licences & Fees

Application forms for radiation licences can be downloaded from NEA’s website. The processing time for applications, submitted with complete information, is about 10 working days. Applications that require pre-licensing inspections or passing of tests will require a longer time. The licence fees are as shown below.

Ionising Radiation
Application Type
Fee (no GST)
L1 - to manufacture, possess for sale or deal in irradiating apparatus $210 p.a.
L2 - to manufacture, possess for sale or deal in radioactive materials $210 p.a.
L3 - to keep or possess an irradiating apparatus for use other than sale $155 p.a.
L4 - to keep or possess radioactive materials for use other than sale $155 p.a.
L5 - to use irradiating apparatus (other than sale) $145 p.a.
L6 - to use, handle and transport radioactive materials (other than sale) $145 p.a.
L6A - to handle and transport radioactive materials $155 p.a.
L7 - to import/export a consignment of irradiating apparatus $40 per consignment
L8 - to import/export a consignment of radioactive materials $40 per consignment
R1 - registration as a radiation worker $105 p.a.
 
Non-Ionising Radiation (NIR)
Application Type
Fee (no GST)
N1 - to manufacture or deal in the apparatus specified in Parts I, II and III below $210 p.a.
N2 - to keep or possess for use the irradiating apparatus specified in Parts II and III below $155 p.a.
N3 - to use the irradiating apparatus specified in Part III below $105 p.a.
N4A - to import the irradiating apparatus specified in Parts I, II and III below $40 per consignment
N4B - to export the irradiating apparatus specified in Parts II and III below $40 per consignment

* including medical examination certificate
 
Classification of NIR Irradiating Apparatus
Part I
Ultraviolet sunlamps, microwave ovens, fetal heart monitoring Doppler non-imaging ultrasound apparatus and other industrial ultrasound apparatus with power output of not more than 50 W, and any apparatus with any or combination of the above as part of the apparatus.
Part II
Medical diagnostic imaging ultrasound and therapeutic ultrasound, industrial ultrasound apparatus with power output of 50 W or more, and magnetic resonance imaging apparatus.
Part III
Entertainment lasers and Class 3b and Class 4 lasers.


 

Miscellaneous Fees

Item/Service Description Fee including GST
Licence Amendment $25.00 (no GST)
Certified copy of licence $42.00
TLD Card Monitoring Service
(per month, per item)
$15.75
TLD Ring Monitoring Service
(per month, per item)
$15.75
TLD Card + TLD Ring Monitoring Service
(per month, per item)
$31.50
TLD Card (2 element card) $47.25
TLD Card (4 element card) $84.00
TLD Card Holder (2-element) $25.20
TLD Card Holder (4-element) $31.50
TLD Ring $47.25
Label - Type 'A' Trefoil Symbol
(20 x 20 cm)
$2.00
Label - Type 'B' Trefoil Symbol
(8 x 8 cm)
$1.00
Label - Type 'C' Danger Radioactive
(8 x 8 cm)
$1.00
Label - Type 'D' Danger Radiation
(8 x 8 cm)
$1.00
Label - Type 'E' Vehicle Label $2.00
Package Label - Category I (White) $1.00
Package label - Category II (Yellow) $1.00
Package Label - Category III (Yellow) $1.00
Gamma Ray Analysis - Food Sample (per sample) $57.75
Survey Meter Calibration (per meter) $141.75
Sealed Sources leakage Test (per isotope) $57.75
QFE Dosimeter Calibration Service (per pair) $73.50
Amendment of Report (per report) $26.25
Addition Copy of Report (per copy) $10.50
Certification of True Copy of Report (per copy) $42.00


 
   
 
 

NEA Call Centre Hotline: 1800-CALL NEA (1800-2255 632) / Fax: 62352611 / Enquiry Email: Contact_NEA@nea.gov.sg
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