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Department of Health

Department of Health

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03/13/2013

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DEPARTMENT OF HEALTHDIRECTORATE: RADIATION CONTROLCODE OF PRACTICE FOR USERS OF MEDICAL X-RAYEQUIPMENT(Code: Diagnostic Use)
WEB ADDRESS:
http://www.doh.gov.za/department/radiation/01.html
2
INDEX
Page no.
1. INTRODUCTION 32. ABBREVIATIONS AND DEFINITIONS 43. LICENSING 6
 Application for Licences
6
Installations
6
 Acceptance Tests
6
Disposal / modification of x-ray equipment
7
New / modified premises
7
Responsible person
7
Change of responsible person
74. RESPONSIBILITIES OF LICENCE HOLDER / RESPONSIBLE PERSON 8
Keeping of patient records
8
Keeping of equipment records
9
Submission of acceptance test results
95. OPERATORS 10
Operators of mammography units
106. RADIATION WORKERS 11
Pregnant radiation workers
11
 Appointment of a radiation worker 
11
Medical examinations
12
Monitoring
12
Termination of employment
13
 Appointment of radiation workers by a new employer 
13
Radiation Occurrences
137. RADIATION PROTECTION 14
Basic protection principles
14
Protection of patients
14
Protection of pregnant patients
15
Protection of women of reproductive capacity
15
Protection of paediatric patients
15
Protection of non-radiation personnel and public
16
Protection of persons holding patients
168. PREMISES REQUIREMENTS 17
 
9 RADIATION WARNING SIGNS, NOTICES AND LIGHTS 1710. ANNEXURE A 1811. CONTACT DETAILS 1912. REFERENCES 20
3
 
1. INTRODUCTION
This Code sets out requirements and recommendations for radiationsafety associated with the use of medical diagnostic x-ray equipment.The Hazardous Substances Act, 1973 (Act 15 of 1973) andRegulations(No R1332 of 3 August 1973) govern the safe use of medical x-rayequipment in South Africa.Requirements from the Act and Regulations are incorporated in thisCode. Further requirements are taken from source material listed inthesection of References.Whenever compliance with a requirement in this Code is mandatedtheword
must / shall
is used. The word
should
indicate a practice thatisrecommended but not mandatory at this stage.Where a given technology or practice is not specifically covered bythisCode, guidance in matters of radiation protection should be soughtfromthe Department of Health: Radiation Control.The Licensee shall be responsible for ensuring that corrective actiontakes place on items of non-compliance with this Code.The Act does not allow any person to use radiation equipment unlesshe/she holds a licence under the Act for that purpose.This Code does not cover the use of x-rays for dental and veterinarydiagnosis.This Code must be read in conjunction with DOH Guidelinedocumentsas listed in Annexure A of this Code.
 
 All forms and guidelines are available at:
http://www.doh.gov.za/department/radiation/01.html
 
Licensing.
 
DOH Guideline documents: http://www.doh.gov.za/department/radiation/01.html
C
odes ofPractice
E
lectronicproducts
I
onising Radiation
4
 
2. ABBREVIATIONS
ACT
Hazardous Substances Act, 1973 (Act 15 of 1973)
DOH
Department of Health
HPCSA
Health Professions Council of South Africa
IER
Individual Equipment Record
mSv
milliSievert
TLD
Thermo Luminescent Dosimeter 
NTP
Nuclear Technology Products
PRMD
Personal Radiation Monitoring Device
SABS
South African Bureau of Standards
SANAS
South African National Accreditation System
SDR
Supplementary Diagnostic Radiographer 
QA
Quality Assurance
QC
Quality Control
DEFINITIONS
Actinic marking
Permanent transfer of patient data / identification on tothe film prior to processing
ALARA A
s
L
ow
A
s
R
easonably
A
chievable
Controlled area
 A controlled area is a limited access area in which theoccupational exposure of personnel to radiation is under the supervision of an individual in charge of radiationprotection. This implies that access, occupancy andworking conditions are controlled for radiation protectionpurposes
Department
Department of Health
Diagnostic QC
Requirements for licence holders with respect to QualityControl Test for diagnostic x-ray imaging systems
5
 
Inspection Bodies
 An organisation approved by the Department of Healthto perform acceptance and QC tests on diagnostic x-rayequipment
Radiation worker 
 Any person who is potentially exposed as a result of his/her occupation to more than three tenths of theoccupational dose limit
Regulations
Regulations relating to the Control of Electronic Products(No R1332 of 3 August 1973)
X-ray unit
 An electronic product that is designed, manufactured or assembled with the primary purpose of producing x-rays
6
 
3. LICENSING
3.1
The Regulations concerning to the Control of Electronic Products require thata jointproduct and premises licence be obtained for x-ray equipment
b
efore
it may beinstalled and commissioned.(a) Licences are not transferable and are issued:
 
To a specific person or institution;

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