The area considered as a controlled area in a diagnostic imaging department would be: - The room where radiographic or fluoroscopic examinations are performed using x-ray equipment. - This is because specific protection measures and safety provisions are required in this room to control normal occupational exposures to workers and prevent the spread of contamination during normal working conditions. Protective measures such as lead shielding, personal protective equipment etc. are needed. - The area would need to be clearly demarcated with appropriate warning signs to indicate it as a controlled area where radiation exposures are possible. Access to this area would need to be restricted as per regulatory requirements.

1. ACT 304 AND RELATED
REGULATORY REQUIREMENTS
IN
DIAGNOSTIC RADIOLOGY
Muhammad Khalis Bin Abdul Karim
Radiation Health and Safety Unit
Johor State Health Department
Ministry of Health Malaysia

2. Contents
Background
Atomic Energy Licensing Act 1984
(Act 304)
Subsidiary regulations under Act 304
Regulatory and Licensing
Requirements in Diagnostic Radiology

3. Part I
Background

4. Legislation Hierarchy
1 Act
Regulations Legally
2 Bound
Circulars/ Standards
3 & Code*
Local Rules,
4 Guidelines, Voluntary
Instructions Manual
* Not regulatory by itself but becomes regulatory if linked to Regulations/Acts

5. In the numbers
(1)
6,570 radas

6. Malaysian Legislation
Radioactive Substance Act 1968
- First legislation regulating the use of
ionising radiation.
- MOH control the use of ionising radiation
for medical and non-medical
Atomic Energy Licensing Act 1984 (Act 304)
- Replaces and supersedes Radioactive
Substance Act 1968.
- Act under MOSTI

7. Cont..
• Act 304 was gazetted under the purview of
Ministry of Science, Technology and Innovation
Malaysia (MOSTI).
• The Director-General of Health where the activity
to be licensed under this Act is in respect of the
use of ionizing radiation for medical purpose as
determined in Section 15 (2) Act 304.
• RHSS, MOH is entrusted as the secretariat for
the D-G of Health, in all activities that related to
the use of ionising radiation for medical
purposes.

8. Regulatory Authority
Atomic Energy Licensing Board (AELB)
(Regulatory Authority)
Authority
Medical Non-Medical
Ministry of Health Ministry of Science, Tech and
Malaysia Innovation (MOSTI)
Director General of Health Executive Secretary to the
(Regulatory Authority)
Authority Board
Secretariat: Secretariat :
Radiation Health & Safety Section AELB (Dept)
(RHSS), MoH

9. Malaysian Legislation
Main Act
Atomic Energy Licensing Act 1984 (Act 304)
Subsidiary Regulations
 Radiation Protection (Licensing) Regulations
1986
 Atomic Energy Licensing (Basic Safety
Radiation Protection (Basic Safety Standard)
Radiation Protection) Regulations 2010
Regulations 1988
 Radiation Protection (Transports)
Regulations 1989

10. Malaysian Legislation
Guidelines/Circulars
 Malaysian Standards (MS 838) : Code of Practice
For Radiation Protection (Medical X-Ray Diagnosis)
- 1985 (1st Revision, 2007)
 Circular on Employment of Trained X-Ray
Operators By Private General Practitioners - 1993
 Guidelines To Obtain Class C License Under the
Atomic Energy Licensing Act 1984 - 1994
 Guidelines For Medical Diagnostic Procedures
Using X-ray For Women of Childbearing Potential -
1998

11. Malaysian Legislation
Continue..
 Circulars on Licensing Requirements Under Act 304
For Specialized Diagnostic Radiology Services
Provided by Private Hospitals/ Radiology Clinics –
1999
 Circulars on Licensing Requirements Under Act 304
For Specialised Diagnostic Radiology Services
Provided by GP Clinics - 1999
 Circulars to TKPK(Medical), TKPK(Public Health) &
Pengarah Perancang & Pembangunan – 2001
 Guidelines On The Use of Mobile X-ray Machines -
2005

12. Part II
Atomic Energy
Licensing Act (Act 304)

13. Atomic Energy Licensing Act 1984
Contents
Atomic Energy Licensing Board, functions, powers
• Control and licensing
• Cancellation, Suspension and Renewal of Licenses
• Health and Safety
• Disposal of Radioactive Waste
• Power of seizure and Arrest, Offences and
Forfeiture
• Liability for Nuclear Damage

14. Act 304
Appropriate Authority
a) The Director-General of Health
where the activity to be licensed or
licensed under this Act is in respect of
a medical purpose
b) The Board where the activity to be
licensed or licensed under this Act is
in respect of a purpose other than a
medical purpose
Sec 2 of Atomic Energy Licensing Act 1984

15. Act 304
Control and licensing
12.(1) Without prejudice to the requirements
of any other law, no person shall :
a) site, construct or operate a nuclear
installation
b) deal in, possess or dispose of any
radioactive material, nuclear material,
prescribed substance or irradiating
apparatus
unless he is the holder of a valid license

16. Act 304
12.(3) A licence for using any any
radioactive material, nuclear material,
prescribed substance or irradiating
apparatus for diagnostic or therapeutic
purposes may be issued ONLY to a
registered medical practitioner,
registered veterinary surgeon,
radiologist, radiotherapist or registered
dentist

17. Act 304
Condition of Licenses
17(1) Licenses issued under this Act
shall be subjected to such conditions as
may, be imposed by the appropriate
authority which may in respect of the
conditions imposed by it, add to, vary
or revoke such conditions at any time.

18. Act 304
Cancellation, Suspension and
Renewal of Licenses
22(1) The appropriate authority may at any time
under any of the following circumstances in its
discretion cancel, or suspend any license ;
a) Where the licensee has committed an offence
under this Act
b) Where the licensee has committed a breach of
any of the conditions of the license
c) Where the licensee ceases to work or operate the
nuclear installation in respect of which the license
was issued
d) Where in the opinion of the appropriate authority
it would be in the public interest so to do

19. In the numbers
(2) 660
radas penyinaran

20. In the numbers
(3) 279
premis swasta

21. Act 304
Health and Safety
25 (1) Every licensee shall comply with all
such directives as the appropriate authority
may issue…, including :
a) Conditions of exposure
b) Dose limitation
c) Occupation exposure
d) Medical exposure
e) Exposure of members of the
public
f) Accidental exposure
g) Emergency exposure

22. Act 304
25 (2) If the appropriate authority has reasonable
cause to believe that any workers has been or
likely to be exposed …, licensee shall :
a) provide and require such worker to wear
approved personnel monitoring devices
b) keep records of dose and type of ionizing
radiation
c) install or use monitoring devices in work
places to record the amount of ionizing
radiation present
d) provide medical examination for such worker

23. Act 304
Disposal of Radioactive Waste
26 (1) No person shall dispose of or
cause to be disposed any radioactive
waste without the prior authorization in
writing of the appropriate authority

24. Act 304
Powers of Seizure and Arrest,
Offences and Forfeiture
33 (1) & 34 (1) Senior Public Officer authorize
to, with or without warrant :
a) Enter the premises, site, nuclear installation or
conveyance and there to search and seize such
radioactive material, nuclear material, prescribed
substance, irradiating apparatus, book or document;
b) Arrest any person being in or on the premises, site,
nuclear installation or conveyance in whose
possession or under whose control such radioactive
material, nuclear material, prescribed substance,
irradiating apparatus, book or document is found;

25. Act 304
33(2) Senior Public Officer may if necessary,
with or without assistance:-
• Break open any door or window or part of the
premises, site, nuclear installation or conveyance and
there to have ingress thereinto;
• Forcibly enter the the premises, site, nuclear
installation or conveyance
• Remove by force any obstruction to entry, search,
seizure and removal as he is empowered to effect
d) Detain every person found in or on the
premises, site, nuclear installation or
conveyance until the premises, site, nuclear
installation or conveyance has been searched

26. Act 304
38(1) Any radioactive
material, nuclear material,
prescribed substance,
irradiating apparatus or
radioactive waste in respect
of which an offence under
this Act is committed, or any
book, document or
conveyance connected with
such offence is liable to
forfeiture

27. Act 304
Offences
39 – Specific offences [(a) – (i)] under this
Section is, on conviction, liable to
imprisonment for a term not exceeding 5
YEARS or a fine not exceeding RM10,000 or
BOTH
40(2) Any person who commits an
offence under this Act is liable to
imprisonment for a term not exceeding
10 YEARS or a fine not exceeding
RM100,000 or BOTH

28. Part III
Subsidiary Regulations
under Act 304
 Radiation Protection (Licensing)
Regulations 1986
 Atomic Energy Licensing (Basic Safety
Radiation Protection) Regulations 2010
 Draft Radiation Protection (Medical, Dental
and Veterinary Usage of Radiation)
Regulations 201__

29. Radiation Protection (Licensing)
Regulations 1986
Contents
 Classification of licenses
 General Conditions for Obtaining a
License
 Application for, Amendment and
Renewal of License
 License fees
- Review fees and application forms – one form for all
type of application, etc
– still in JKK of LPTA

30. Classification of Licenses
A license to manufacture, trade in, produce, process,
Class A purchase, own, possess, use, transfer, handle, sell or
store radioactive material
A license to manufacture, trade in, ..… or store nuclear
Class B material
A license to manufacture, trade in, ….. or store irradiating
Class C apparatus
A license to transport radioactive material, nuclear material,
Class D prescribed substances or their waste
A license to export or import radioactive material, nuclear
Class E material, prescribed substances, irradiating apparatus or
their waste

31. Cont..
A license to site, to construct or to operate a nuclear
Class F installation
A license to
• dispose of radioactive material, nuclear
Class G materials, prescribed substances or their wastes
• store of radioactive material, nuclear materials,
prescribed substances or their wastes prior to
their disposal
• Decommission a milling installation, nuclear
installation, waste treatment facility, irradiating
apparatus or sealed sources apparatus
A license to control of activities not covered by classes
Class H A to G

32. General Conditions For
Obtaining a Licenses
12 (a) The applicant shall employ a person or persons
having the necessary knowledge, skill and
training to ensure that the activities sought to
be licensed are carried out in such manner as to
protect the health of workers and members of
the public
(b) The applicant’s proposed equipment, facilities
and procedures shall be adequate to protect the
health of workers and member of the public and
to minimize danger to life, property and the
environment

33. License & Application Fees
Category/Type of Irradiating
License fee per year in RM
Apparatus
Dental X-ray units, mobile & RM100 for the first apparatus
1 fixed medical x-ray units,
mobile veterinary X-ray units RM20 for every additional apparatus
X-ray therapy units not RM300 for the first apparatus
2
operable above 500kVp RM60 for every additional apparatus
CT Scanner units, RM1000 for the first apparatus
3 Accelerators, X-ray therapy
units operable above 500kVp RM200 for every additional apparatus
Application Fee RM15
Reg 15 of Rad. Protec (Licensing) Regulations 1986

34. Cont..
Category of Sealed Source License fee per year in RM
1
RM100 for the first source
Any sealed source with activity not greater
RM20 for every additional source
than 40MBq
2
RM200 for the first source
Radiation gauges and other sealed
RM40 for every additional source
sources not specified in this Schedule
3
RM300 for the first source
Medical therapy sources with activity not
RM60 for every additional source
greater than 400MBq, etc
4
Medical therapy sources with activity RM1000 for the first source
greater than 400MBq, irradiation cell for RM200 for every additional source
sterilization purposes, etc
Reg 15 of Rad. Protec (Licensing) Regulations 1986

35. In the numbers
(4) 21
CT Scan

36. Atomic Energy Licensing (Basic
Safety Radiation Protection)
Regulations 2010
15 February 2010

37. OLD NEW
Radiation Atomic Energy
Protection (Basic VS
Licensing (Basic
Safety Standard) Safety Radiation
Regulations 1988 Protection)
Regulations 2010
 Based on ICRP 26,  Based on ICRP 60,
1977 1990
 56 provisions  80 provisions
 Medical Exposure – 5  More provisions on
provisions Medical Exposure –
18 provisions

38. Interpretation
“medical exposure” means the exposure
exposure
incurred by :
(a) a patient as part of his medical or dental
investigative or diagnostic procedures or
treatment;
(b) a person who knowingly assists in the
support and comfort of patients, other than
a person who is occupationally exposed; or
(c) a volunteer in a medical research
programme that involves radiation
exposure;
Reg. 3

39. Atomic Energy Licensing (Basic Safety Radiation
Protection) Regulations 2010
ARRANGEMENT OF REGULATIONS
PART I - PRELIMINARY
PART II - SYSTEM OF RADIATION PROTECTION
PART III - OCCUPATIONAL EXPOSURE
PART IV - MEDICAL EXPOSURE
Specific provisions in diagnostic radiology
• Requirements for irradiating apparatus and equipment
using sealed sources for diagnostic radiology
• Operational consideration for diagnostic exposure
• Clinical dosimetry
• Quality assurance for medical exposure
• Guidance levels
• Investigation, notification and reporting of accidental
medical exposure

40. Cont..
ARRANGEMENT OF REGULATIONS
PART V - PUBLIC EXPOSURE
PART VI - POTENTIAL EXPOSURE AND SAFETY OF RADIATION
SOURCES
PART VII - INTERVENTION
PART VIII - SUBMISSION OF DOCUMENTS
PART IX - CESSATION OF OPERATIONS, DECOMMISSIONING OR
ABANDONMENT OF LICENSED FACILITIES
PART X - GENERAL

41. PART I - PRELIMINARY
Working Area
Classification of Clean Areas, Supervised Areas
Working Areas : and Controlled Areas
“clean area” - an area where the annual dose received by a
area
worker
is not likely to exceed the dose limit for a member of the public;
“controlled area” - area in which specific protection measures and
area
safety provisions are required for controlling normal exposures or
preventing the spread of contamination during normal working
conditions, and preventing or limiting the extent of potential
exposures;
“supervised area” - an area for which occupational exposure
area
conditions are kept under review even though specific protective
measures and safety provisions are not normally needed;
Reg. 3

42. PART III - OCCUPATIONAL EXPOSURE
Classification of Working
Area
Supervised Areas and Controlled
Areas have to clearly demarcated
and appropriate legible notices
and warning signs bearing the
radiation symbol are posted
conspicuously in strategic places.
Question
Where is the area considered as controlled
area in a diagnostic imaging department ??

43. PART II - SYSTEM OF RADIATION PROTECTION
Dose Limit for Workers &
Member of Public
Whole Body Exposure
Dose Limit (mSv/year)
BSS 1988 BSS 2010
Public 1 1
Radiation Workers 50 20*
Foetus 10 1
* The maximum effective dose on the worker averaged over a
period of 5 consecutive years shall not exceed 20mSv
Reg. 8 & 9

44. Question
What is the patient dose limit ?
A: 1 mSv/year Public
B: 20 mSv/year Radiation workers
(new BSS Regulations
– 2010)
C: 50 mSv/year
D: 150 mSv/year Radiation workers (old
BSS Regulations 1988)
ANS: NO LIMIT
Lens of the eyes

45. Personnel Monitoring
(1) The licensee shall be responsible for arranging the
assessment of the occupational exposure of workers
(2) The licensee shall carry out personnel monitoring for all
workers who normally work in a controlled area, and
workers who occasionally work in a controlled area but
may receive significant occupational exposure.
(3) Personnel monitoring shall not be required for any
worker who normally works in a supervised area, or
area
who enters a controlled area only occasionally, but the
occupational exposure of the worker shall be
assessed on the basis of the results of work place
monitoring
Reg. 22

46. PART IV - MEDICAL EXPOSURE
Responsibilities of licensee or
employer
To ensure that :
(a) no patient is administered with a diagnostic or
therapeutic medical exposure unless the exposure
is prescribed by an approved registered medical
practitioner;
(b) an approved registered medical practitioner is
assigned with the primary task and obligation of
ensuring overall patient protection and safety in the
prescription of, and during the delivery of,
diagnostic or therapeutic medical exposure to the
patient;
Reg. 41

47. Cont…
(c) an appropriate healthcare professional who is
adequately trained to discharge assigned tasks to
the patients in the conduct of the diagnostic or
therapeutic procedures that the approved registered
medical practitioner prescribes, is available;
(d) for diagnostic uses of radiation, the quality
assurance programme specified by the appropriate
authority is conducted by or under the supervision
of a qualified expert in medical physics;

48. Operational consideration for
diagnostic exposure
(1) For diagnostic radiology practices, the licensee
shall ensure:
(a) the exposure of patients is at the minimum level
required in order to achieve the intended diagnostic
objective;
(b) the relevant information from previous examinations
is taken into account in order to avoid unnecessary
additional examinations; and
(c) the relevant guidance levels as specified in the Sixth
Schedule is taken into account.
Reg. 48

49. Cont…
The licensee shall ensure that …
the diagnostic procedure chosen to produce the
minimum exposure to patient is consistent with the
acceptable image quality and the clinical purpose of the
examination.
the portable and mobile radiological equipment is used
only for examinations where it is impractical or not
medically acceptable to transfer patients to a stationary
radiological installation, and only after proper attention
has been given to the radiation protection measures
that are required in its use.

50. Cont…
The licensee shall ensure that …
any radiological examination causing exposure to the
abdomen or pelvis of women who are pregnant or
suspected to be pregnant is avoided, unless there are
avoided
strong clinical indications for such examinations.
any diagnostic examination of the abdomen or pelvis of
women of reproductive age is planned to deliver the
minimum dose to the ovary or to any embryo or foetus
that might be present.
whenever feasible and appropriate, shielding of
radiosensitive organs such as gonads, lens of the eye
and thyroid is provided.
provided

51. Clinical dosimetry
For clinical dosimetry, the licensee shall ensure
that the following items are determined and
documented:
documented
(a) in radiological examinations, the
representative values for typical sized adult
patients of entrance surface doses, dose-area
products, dose rates and exposure times, or
times
organ doses;
doses
52. (1)(a)

52. Quality assurance for medical
exposure
53. (1) The licensee shall establish a comprehensive QAP
for medical exposure with the participation of appropriate
qualified experts in the relevant fields as specified by the
appropriate authority.
(2) The quality assurance programmes for medical
exposure shall include:
(a) the measurement of the physical parameters of the irradiating
apparatus, imaging devices and irradiation installations at the
time of commissioning and periodically after the commissioning;
(b) verification of the appropriate physical and clinical factors used
in patient diagnosis or treatment;
(c) written records of relevant procedures and results;
(d) verification of the appropriate calibration and conditions of
operation of dosimetry and monitoring equipment

53. Guidance levels for Medical
Exposure
• As a guide by approved registered medical
practitioners, in order that :
(a) corrective action is taken as necessary if doses or
activities fall substantially below the guidance
levels and the exposures do not provide useful
diagnostic information and do not yield the
expected medical benefit to patients; and
(b) review is considered if doses or activities exceed
the guidance levels as an input to ensuring
optimized protection of patients and maintaining
appropriate levels of good practice.
Reg. 54 (1)

54. Tables I of the Sixth Schedule
GUIDANCE LEVELS FOR DIAGNOSTIC RADIOLOGICAL PROCEDURES
Guidance levels of dose for diagnostic radiography for a typical adult patient
Examination Projection ESD per radiograph *
(mGy)
Lumbar spine AP 10
LAT 30
LSJ 40
Abdomen, intravenous, urography AP 10
and cholecystography
Pelvis AP 10
Hip joint AP 10
Chest PA 0.4
LAT 1.5
Thoracic spine AP 7
LAT 20
Dental Periapical 7
AP 5
Skull PA 5
LAT 3
In air with back-scatter. 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

55. Tables II of the Sixth Schedule
Dose guidance levels for computed tomography for a
typical adult patient
Examination Multiple scan average dose
(mGy)
Head 50
Lumbar spine 35
Abdomen 25

56. European Guidance Levels for Computed
Tomography for a Typical Adult Patient and Children
Reference levels
CTDIw (mGy) DLP (mGycm)
Adults (typical value)
Chest 30 650
Chest high resolution 35 280
Abdomen 35 780
Pelvis 35 570
Head 60 1050
Children age <15y (typical value)
Chest 30 600
Chest high resolution 50 100
Abdomen 30 800
Pelvis 30 500
Head 70 750

57. Investigation, notification and
reporting of accidental medical
exposure
(1) The licensee shall notify the appropriate
authority of all accidental medical
exposures within 24 hours after the
occurrence of such accidental medical
exposures.
Reg. 57 (1)

58. Cont…
(2) The licensee shall immediately investigate
the following accidental medical exposures:
(b) diagnostic exposure substantially greater
than intended or resulting in doses
repeatedly and substantially exceeding the
established guidance level as specified in
the Sixth Schedule;
(c) any equipment failure, accident, error, mishap
or other unusual occurrence with the potential
for causing a patient exposure significantly
different from that which is intended.
Reg. 57 (2)

59. Cont…
(3) The licensee shall, with respect to any
investigation carried out under subregulation (2)
(a) calculate or estimate the doses received and their
distribution within the patient;
(b) indicate the corrective measures required to prevent
recurrence of such an incident;
(c) implement all the corrective measures that are under
his responsibility;
(d) submit a written report within 30 days after the
completion of the investigation stating the cause of the
accidental medical exposure to the appropriate
authority, and
authority
(e) inform the patient and the approved registered medical
practitioner about the incident.

60. Records
58. (1) The licensee shall keep for a period as
may be specified by the appropriate authority
and make available, when required, the
following records:
(a) in diagnostic radiology, necessary
information to allow retrospective dose
assessment, including the number of
exposures and the duration of fluoroscopic
examinations;

61. Prevention of accidents
The licensee shall make suitable arrangements to prevent any
accident that could reasonably be foreseen for any radiation source
and to limit the consequences of any accident that occurs.
(a) adequate procedures are established for the control of the radiation
source and of any potential accident that is reasonably
foreseeable;
(b) the system, components and equipment which are important for
safety are inspected and tested for any degradation that could lead
to abnormal conditions or inadequate performance;
(c) appropriate maintenance, inspection and testing are carried out
without undue occupational exposure;
(d) appropriate automatic systems for safely shutting off or reducing
radiation output from the radiation source when the operating
conditions exceed the operating ranges are provided; and
(e) provide a system which can detect and respond immediately to
abnormal operating conditions that can significantly affect the
protection or safety and to allow for timely corrective action to be
taken, is provided. Reg. 67

62. Notification of theft, loss or
sabotage
The licensee shall, upon discovering any theft, loss or
sabotage of any radiation source in his possession or
under his control :
(a) notify the appropriate authority of such theft, loss
or sabotage within 24 hours after discovering the
theft, loss or sabotage; and
(b) submit a complete report of the theft, loss or
sabotage in writing within 30 days after the
notification to the appropriate authority.
71. (1)

63. Notification of theft, loss or sabotage…
cont
The report shall contain :
(a) where appropriate, a description of the radiation source, including
its kind, quantity and its chemical and physical forms;
(b) a description of the circumstances under which the theft, loss or
sabotage occurred;
(c) a statement of the location or probable location of the radiation
source;
(d) the possible radiation exposure to individuals, circumstances under
which the exposures may occur, and the extent of potential hazard
to members of the public;
(e) the actions which have been taken, or will be taken, to recover the
radiation source;
(f) the procedures or measures which have been or will be adopted to
prevent a recurrence of the theft, loss or sabotage of the radiation
source; and
(g) any other information as the licensee deems necessary.

64. Submission of Documents
The appropriate authority may require the licensee to submit any or
all of the followings:
(a) a report on area monitoring;
(b) a report on environmental monitoring;
(c) a report on radioactive discharge;
(d) a report on personnel monitoring;
(e) a report on accidental exposures and emergency exposures;
(f) a report by approved registered medical practitioners;
(g) operational procedures, instructions and manuals;
(h) emergency plans and procedures;
(i) training programmes;
(j) physical protection measures; and
(k) other reports and records as the appropriate authority deems
necessary.
Reg. 77

65. PART X - GENERAL
Transitional provisions
A person who holds a licence issued under
the Act in relation to activities involving
ionizing radiation that is still in force at the
date of commencement of these Regulations
shall, within 2 years from the date of
commencement, comply with the
requirements under these Regulations.
Reg. 79

66. Draft Radiation Protection (Medical,
dental and veterinary Usage of
Radiation) Regulations 20__
- More comprehensive regulation to control
the use of ionizing radiation in medicine
under the purview of MoH
- the draft regulations for medical usage were
prepared with IAEA technical assistance
- Approved by Radiological Advisory Committee
(RAC)
- To be reviewed & discussed in JKK of MoH

67. Cont..
Contents
Establishment of Radiation Protection Programme
Radiation Protection Committee
Role of Radiation Protection Officer
Implementation of Quality Assurance Programme (QAP)
Radiation Protection Survey
Notification, Reports and Records of Reportable Events
Additional requirements for general radiography,
fluoroscopy, CT, mammography, dental radiology &
veterinary (RADIOLOGY)
Additional requirements for Radiotherapy
Additional requirements for Nuclear Medicine

68. In the numbers
(5) 238
radiografi am

69. Part IV
Regulatory & Licensing
Requirements in Diagnostic
Radiology

70. Circular to Private Hospital/GP’s
Clinics Issued on 21 Oct 1999
Requirements Effective date
• Only Trained Personnel (GP’s Clinic) – 1.1.2000
• At least 1 qualified radiographer – 1.1.2000
(Private Hosp)
Training of New Applicants – 1.1.2000
Implementation of QAP:
- QC of Equipment, Processor – 1.1.2000
& Associated Facilities
- CME Annually – 1.1.2002
- Film Reject Analysis – 1.1.2002
- Audit of X-Ray Radiographs – 1.1.2002
(GP Clinic only)

71. Circular to TKPK (Medical) and
TKPK (Public Health) – 15.1.2001
All plans for facilities under Act
304 to be submitted and approved
by Radiation Health and Safety
Branch, Engineering Services
Division before commencement of
installation/renovation
All related equipment and facilities to be
tested, commissioned and verified to conform
to safety and performance standards before
clinical use

72. Cont…
Implementation of QAP
• Quality control (QC) of equipment,
processors and associated facilities
• Monitoring and analysis of film
reject rate
• Continuous Professional Education
(CME)

73. Procedures To Apply For A License
(Private) or Getting Approval (Public)
STEP 1
Requirements to BUY &
STOR Irradiating Apparatus
STEP 2
Requirements to USE
Irradiating Apparatus

74. Step 1
Documents required to apply for BUY & STORE
Irradiating Apparatus
 Application form (private) or letter of intent
(public)
 Application/Licence fee (private)
 Copy of current APC
The address of practice stated in APC shall be the same
as the address of where apparatus is to be stored or used
 Layout plan of the premises
 Detailed plan of the room where the
apparatus will be located
 Description of irradiating apparatus

75.  FACILITIES
Layout plan of premises
Layout plan of premises shall indicate
- Location of the x-ray room, darkroom &
occupied area in the premise
- All plan shall be in technical drawings &
the scale shall be in metric (S.I) unit
Note:
No licence will be issued for X-ray practice in
free standing laboratory where there is no
doctor practicing in the premise

76.  FACILITIES
Detailed Plan of X-ray Room & Dark Room
Detailed Plan of X-ray room shall clearly
specify the following :
i. Dimension of the x-ray room
ii. Material used and thickness of the wall, ceiling
and floor
iii. Position, size & material used for the windows,
doors and other openings
iv. Position of the apparatus in the x-ray room
v. Position of the operating console/control area
vi. Warning light/sign at the door of the room

77.  X-RAY ROOM- Layout and Dimension
Type of Equipment
General X-Ray * Fluoroscopy
Plan Spec.
Dimension of the room 3.0 m x 4.0m 6.0 m x 4.0m
Thickness of Shielding at the 2.0mm Pb eq 2.0mm Pb eq
Doors and Walls
Dimension & Thickness of Lead 1.2m x 1.2m x 1.2m x 1.2m x
at the Chest Wall 2.0mm Pb eq 2.0mm Pb eq
Dimension & Thickness of Lead 35cm x 30cm x 100cm x 50cm x
Glass Observation Window 2.0mm Pb eq 2.0mm Pb eq
Dimension & Thickness of Lead 1.2m x 2.5mx 1.2m x 2.5mx
at the Floor (upper floor) 2.0mm Pb 2.0mm Pb
* Control panel outside with examination table
Cont….

78.  X-RAY ROOM- Layout and Dimension
Type of Equipment
Mammography CT Scanner
Plan Spec
Dimension of the room 2.5 m x 3.0m 5.5 m x 4.0m
Thickness of Shielding at the 1.0mm Pb eq 2.0mm Pb eq
Doors and Walls
Dimension & Thickness of Lead NA NA
at the Chest Wall
Dimension & Thickness of Lead NA 100cm x 50cm x
Glass Observation Window 2.0mm Pb eq
Dimension & Thickness of Lead NA 1.2m x 2.5mx
at the Floor (upper floor) 2.0mm
NA - Not applicable
Cont….

79.  X-RAY ROOM- Warning Signs
- All entrances to x-ray
rooms shall be marked R
with a warning sign
- Consist of a three-
blade design using the
radiation caution
colours, that is black
for the design and
yellow for the
background.
1.5 R

R is the radius of theis correct ?
Which one inner 5R
circle and 5R is not less than
7.5 cm
MS 838:1985 Cont….

80. New Radiation Symbol ????
New Symbol launched to warn public about radiation
dangers - supplementary symbol aims to help reduce
needless deaths and injuries, IAEA – 15 February 2007

81.  X-RAY ROOM- Warning Light
All entrances to x-ray rooms
shall have a light that is
illuminated prior to exposure
or when fluoroscopy is in
progress
The warning light should be
red in colour (yellow or amber
may also be used)
MS 838:1985
Cont….

82.  DARKROOM- Dimension & Location
Minimum Dimension of = 1.5m x 2.0m
Darkroom
Location of darkroom
shall not be in the
direction of the
useful beam.
MS838:2007

83. Step 2
Requirements to STORE & USE Irradiating
Apparatus
• Personnel & Licensee/Org Yg Bertanggungjawab
Training Supervisor
RPO
Operators
• Facility X-ray Room
Dark room
• Equipment X-ray Machine
Processor/cassette/Viewer, etc
• Procedures Local rules, etc

84. Requirements to STORE & USE Irradiating
Apparatus
 Licensee/Org Yg Bertanggungjawab :
GP clinics/Non X-ray Sp. Clinics/Health
Clinics
Registered Medical Doctor
undergo 40 credit hours training program (new
applicant)
Hospital/Radiological Clinic
Registered Med. Doc/Pengarah@ Radiologist
Attend continuous professional education (CME)
program

85. Requirements to STORE & USE Irradiating
Apparatus
 Supervisor :
GP clinics/Non X-ray Sp. Clinics/Health
Clinics
Registered Medical Doctor
Attend yearly continuous professional education
(CME) program
Hospital/Radiological Clinic
Radiologist
Attend yearly continuous professional education
(CME) program

86. Requirements to STORE & USE Irradiating
Apparatus
 Radiation Protection Officer (RPO) :
GP clinic/Non X-ray Specialist Clinic
Registered Medical Doctor or radiographer
Attend yearly continuous professional education
(CME) program
Hospital/Radiological Clinic
Med. Physicist/Radiologist/radiographer
Attend yearly continuous professional education
(CME) program

87. Requirements to STORE & USE Irradiating
Apparatus
 X-ray Operator :
GP clinic/Non X-ray Sp. Clinic
undergo 50 credit hours training program
(new operator);
Attend continuous professional education
(CME) program yearly
Having a personnel monitoring devices
do a medical surveillance once in 3 years

88. Training Syllabus For New Licensees &
New Operators
Doctors applying for new licences and newly employed
operators are required to undergo the following courses
before they are permitted to use the x-ray equipment
Mod. 1: Radiation Safety Awareness 9 cr. hrs
Mod. 2: X-ray Equipment and Associated 10 cr. hrs
facilities
Mod. 3: Clinical Practices 31 cr. hrs
Mod. 4: Radiographic Techniques and QAP 21 cr. hrs
TOTAL : (Module 1, 2 & 3 – for operators) 50 cr. hrs
(Module 1, 2 & 4 – for doctors) 40 cr. hrs

89. Existing X-ray Operator*
1. X-ray operators currently employed in the clinics
and have been trained in the Orientation
Programme conducted by the College of General
Practitioners X-Ray Society of Malaysia or ANM
2. Workers trained in programme approved by the
Licensing Authority – the training syllabus and
facilities would be vetted before approval is given
3. Medical practitioners
* Subjected to do chest & extremities only

90. Requirements to STORE & USE Irradiating
Apparatus
Hospital/Radiology clinic
Employment of at Least 1 Radiographer
Mammography procedures shall be
performed by a qualified female radiographer
trained in mammography
Attend continuous professional education
(CME) program yearly
Having a personnel monitoring devices
Do a medical surveillance once in 3 years

91. Medical
Surveillance
(Buku LPTA/BM/5)
Nota: Pemeriksaan x-ray dada hanya perlu Question:
dibuat utk jangkamasa lima (5) tahun
sekali; atau apabila difikirkan perlu oleh Do you require to
pengamal perubatan berdaftar yang do chest x-ray for
diluluskan. medical check-up
every time?

92.  CME All personnel
All personnel/operators (include licensees) are
required to attend CME programme to update their
knowledge in order to keep abreast of the current
practices in radiology annually.
The training programme may include one of the
following :
• Radiation protection pertaining to the use of x-ray
equipment
• Radiographic techniques
• Image quality criteria and requirements
• X-ray reporting
• Management of QAP
• Film processing
• Update in radiology imaging

93.  CME
All personnel
The above may be
achieved :
 By attending courses organized by other
agencies/ organizations/ societies/ ect
 Peer reviewed educational programmes/
distance learning programmes available
either on the internet or through posts

94.  FACILITIES & X-RAY EQUIPMENT
Safety and Performance Standard
QC of Equipment and Associated Facilities:
 Tested & certified by consultant medical
physicist approved by MoH – Class H
(certification)
 Submit certificate with summary report
and full report to MoH

95.  FACILITIES & X-RAY EQUIPMENT
Safety and Performance Standard
Facility/
Parameter Optimum Achievable Std
Equipment
Machine
Irradiating
performance As specified in the Standard 
Apparatus
parameter
Exp. rate at every occupied
outside the x-ray room and at the
X-Ray Room Scattered Radiation position normally occupied by the
operator at the control area shall
not exceed 10mR in one week
Condition of the
Dark Room No light leakage
dark room
No light leakage
Condition of all the
Cassettes Film and screen should be in good
cassettes contact

96.  ADDITIONAL REQUIREMENTS
Monitoring & analysis of film reject rate
 Monitoring and Analysis of Film Reject Rate
A report of monitoring and analysis of film
reject rate shall be submitted every year. It
should include the following:
i. Monitoring Period
ii. No. of film used
iii. No. of film rejected and percentage
• Corrective action taken when reject rate > 10%

97.  ADDITIONAL REQUIREMENTS
Audit of X-Ray Radiographs
 Audit of X-ray Radiographs*
i) Film Audit by Radiologist
10 x-ray radiographs selected randomly from GP’s clinics
will be audited by radiologist based on established
criteria and standard under circular issued on
21-10-1999.
For each radiograph a minimum score of 7 is required to
pass the audit. At least, 7 out of 10 films audited should
meet the minimum score of 7 before they are considered
to have pass the overall audit
* For GP’s Clinic/Sp. Clinic only

98.  ADDITIONAL REQUIREMENTS
Audit of X-Ray Radiographs
ii) Letter from Fomema (for Fomema panel’s
clinics)
Letter from Fomema to confirm that clinics are
participating regularly in the X-ray Quality Control
Programme of Fomema and x-ray films taken are
satisfactory and adhere to the SOP

99. Question
Does ‘radiation leave’ cover
under Act 304 or subsidiary
regulations ?
Answer
NO
Perintah Am Bab C – 47 Cuti tugas khas perubatan
(14 hari) 

100. SUMMARY
Documents required to BUY/ STORE
Irradiating Apparatus
Documents Required Private Public
Completed Borang LPTA/BP/3 or letter
of intent  
Application fee & License fees 

Copy of current APC  
Layout plan of the premises  
Detailed plan of the X-ray room
where the apparatus will be located  
Catalogue/detailed of the apparatus to
be licensed & copy of supplier license  

101. Cont..
Documents required to STORE/USE
Irradiating Apparatus
Documents Required Private Public
QC of Equipment Certificates  
Licensee/supervisor/RPO – CME 

Operators – Med. check up/Film badge/
CME  
FRRA Report  
Audit Film Report *  
* GP Clinics

102. Summary
OVERALL
Protection &
Image Quality
Safety

103. Thank You For Your
Attention

104. PERINTAH-PERINTAH AM
BAB C: CUTI
47 Cuti Khas Perubatan
Kelayakan :
(i) Pegawai yang menjalankan tugas x-ray sepenuh masa
dan terdedah kepada pancaran x-ray
(ii) Pegawai di pusat-pusat perubatan tertentu di mana
jenis- jenis tugas yang dijalankan adalah atau tidak
digemari. Pusat-pusat perubatan ini hendaklah seperti
yang diluluskan oleh Ketua Pengarah Perkhidmatan
Awam dari masa ke semasa
TEMPOH : 14 hari setahun. Tidak boleh dikumpul dan
hendaklah diambil dalam tahun yang ianya
diperolehi
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105.  X-RAY EQUIPMENT
Safety and Performance Standard (General X-ray)
OPTIMUM ACHIEVABLE REMEDIAL SUSPENSION
PARAMETERS
STANDARD LEVEL LEVEL
1. X-Ray Generator
ii) Accuracy of kVp Max. Deviation ± 5% >5% > 20 %
or ± 5kV whichever is
smaller.
ii) Accuracy exposure time Maximum Deviation :
a) for time ≥ 0.1sec ± 10% > 10 % > 25 %
b) for time < 0.1 sec ± 20% > 20 % > 30 %
Maximum deviation ± > 10 % or >30 % or
iii) Exposure baseline
10% baseline
reproducibility >50 %
> 20 %
iv) Exposure linearity Maximum deviation :
10% > 10 % or > 30 % or
baseline baseline
>20 % >50 %

106.  X-RAY EQUIPMENT
Safety and Performance Standard (General X-ray)
OPTIMUM ACHIEVABLE REMEDIAL SUSPENSION
PARAMETERS
STANDARD LEVEL LEVEL
2. X-Ray Beam Limitation
ii) Beam Collimation Max. misalignment 1
o o o
>1 >3
of SID on any side
o o o
ii) Beam perpendicularity Less than 2 >2 >3
3. X-Ray Beam Filtration mm Al mm Al
Below 50 kVp 30 0.3 < 0.3
40 0.4 < 0.4
50 to 70 50 1.2 < 1.2
60 1.3 < 1.3
70 1.5 < 1.5
> 70 80 2.3 < 2.3
100 2.7 < 2.7
130 3.5 < 3.5
Cont….

107.  X-RAY EQUIPMENT
Safety and Performance Standard (General X-ray)
OPTIMUM
REMEDIAL SUSPENSION
PARAMETERS ACHIEVABLE
LEVEL LEVEL
STANDARD
4. Image Quality
i) Resolution Please specify Baseline ±
the resolution 2 group
ii) Contrast and contrast and
-
attach test film
5. Leakage Radiation
Exposure from the leakage 0.1mGy (10mR) > 0.1mGy > 1.0 mGy
radiation at 1m from the x-ray (10mR) (100 mR)
tube in an hour at every rating
specified by the manufacturer.
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