ADMINISTRATIVE ORDER  
No. 2021 - _______ ___   
 
SUBJECT:  “Basic Radiation Protection and Safety Standards on the Use of 
Radiation Devices in Planned Exposure Situations”  
 
 
I. RATIONALE  
 
In 2004, Administrative Order (AO) Nos. 149 and 164 and its Department of Health 
(DOH) Memorandum Circular 323 were issued to align with the 1996 International Basic 
Safety Standards (IBSS) No. 115.  In 2014, the International Atomic Energy Agency (IAEA) 
published General Safety Requirements (GSR) Part 3 and superseded IBSS No. 115.  
 
This Administrative Order is hereby issued repealing Administrative Order (AO) Nos. 
149 and 164 and its DOH Memorandum Circular 323, and other relevant Administrative Orders 
issued by the DOH to adopt relevant provisions of the IAEA GSR Part 3.  
 
The implementation and enforcement of this AO shall be consistent with the mandate 
of the Food and Drug Administration (FDA) through the Implementing Rules and Regulations 
(IRR) of the  Republic Act 9711 known as the “Food and Drug Act of 2009”.  It is also in line 
with the objectives and targets of the FOURmula One Plus for Health (F1+) strategy and the 
National Objectives for Health 2017 -2022 in ensuring high quality radiation devices,  facilities, 
and services through harmonization, benchmarking, and compliance to internationally accepted 
regulatory standards such as the IAEA.  
 
 
II. OBJECTIVES  
 
To ensure the protection of medical, occupationally exposed person and members of 
the public from the harmful effects of using ionizing radiation devices in planned exposure 
situations. Specifically:  
 
1. To update the current regulations and to align with the relevant provisions of the IAEA 
GSR Part 3.  
 
2. To prescribe implementing guidelines in accordance to the graded approach.  
 
 
 
 III. SCOPE AND COVERAGE  
 
This AO shall apply for the following practices:  
 
1. The use of ionizing radiation devices in medicine, dentistry, veterinary medicine, 
commerce and industry, education, training and research, anti -crime, security, 
including the use of associated equipment, software or devices where such use could 
affect exposure to radiation;  
 
2. The production, testing and supply of radiation devices including linear accelerators, 
and fixed and mobile radiography eq uipment;  
 
3. The operation of facilities/establishments using ionizing radiation devices for medical 
and non -medical purposes and to all establishments using electrical/electronic devices 
that emit x -ray radiation or as a by -product of its operation and  
 
4. All types of planned exposure situations specifically medical, occupational , and public 
exposure situations involving radiation devices exposure that is amenable to control.  
 
This AO does not apply to existing exposure situations, emergency exposure situations, 
except for emergency situations arising from the planned use of an ionizing radiation devices, 
and use of radiation devices with radioactive materials . 
 
 
IV. DEFINITION OF TERMS  
 
Terms used are shown in Annex A as a supplement to this A O. For the purpose of 
implementing this Order, the terms used shall have the same meaning as defined in RA 9711, 
its IRR, and related rules and regulations.   
 
 
V. GENERAL GUIDELINES  
 
1. No person or organization shall install, acquire, possess, use, operate, maintain, or 
repair an ionizing radiation device within a practice other than in accordance with the 
requirements of this AO.  
 
2. Registrants/licensees shall be responsible for complying with this AO to ensure that 
protection and safety are optimized , dose limits are applied, appropriate safety 
assessment and monitoring are conducted as required in this regulation.  
 3. Registrants/licensees shall establish preventive measures against accidents and 
appropriate mitigation plans. Preventive measures shal l be duly documented and shall 
be available for verification of the FDA and/or other relevant authorities.  
 
4. Parties with responsibilities for protection and safety shall ensure that the principles of 
radiation protection are applied on the use of radiat ion devices for planned exposure 
situations.  
 
5. The person or organization responsible for facilities and activities that give rise to 
radiation risks shall have the prime responsibility for protection and safety. Other 
parties shall have specified respon sibilities for protection and safety.  
 
6. The principal parties shall ensure that protection and safety are effectively integrated 
into the overall management system of the organizations for which they are responsible.  
 
7. The requirements of this AO shall be ap plied in accordance with the graded approach 
where the protective measures to be implemented are commensurate with the radiation 
hazard associated with the use of radiation devices.  
 
8. The notification, exemption, authorization process and requirements shal l be in a 
graded approach consistent with the manner and forms required by the FDA in other 
regulation.  
 
 
VI. SPECIFIC  GUIDELINES  
 
A. ROLES AND RESPONSIBILITIES  
 
1. Responsibilities of the Food and Drug Administration (FDA)  
 
The FDA through the Center for Device Regulation, Radiation 
Health and Research (CDRRHR), having defined functions and powers 
to regulate the use of radiation devices shall exercise its regulatory 
powers in the implementation and enforcement of this AO.  
 
2. Responsibilities for Radiati on and Safety  
 
a. The registrants and licensees responsible for facilities and 
activities that give rise to radiation risks shall have the prime 
responsibility for protection and safety, which cannot be 
delegated.  
 b. The principal parties  having the main respon sibilities for the 
application of these AO shall be:  
 
i. Registrants or licensees, or persons or organizations 
responsible for notified or authorized practices or 
radiation devices within practices;  
 
ii. Employers of workers, in relation to occupational 
exposure;  
 
iii. Radiological medical practitioners, in relation to medical 
exposure.  
 
c. Other parties  shall have specified responsibilities for the 
application of these A.O. These  parties may include, as 
appropriate:  
 
i. Suppliers of radiation device s, providers of equipment 
and software;   
 
ii. Radiation protection officers;  
 
iii. Referring medical practitioners;  
 
iv. Medical physicists;  
 
v. Radiologic/x -ray technologists;  
 
vi. Qualified experts or any other party to whom a principal 
party has assigned specific responsibilities;  
 
vii. Workers other than workers listed in (a) -(f); 
 
viii. Ethics committees.  
 
d. The general responsibilities of the principal parties  shall  include 
the following:  
 
i. Have in place operating procedures and arrangements for 
protection and safety that are subject to periodic review 
and updating under a management system . 
 ii. Established  procedures for reporting on and learning 
from accidents and other incidents . 
 
iii. Established  radiation protection and safety objectives in 
conformity with the rele vant requirements of these AO;  
 
iv. Develop ed, implement ed, and document ed a protection 
and safety program commensurate with the radiation 
risks associated with the exposure situation under their 
responsibility (graded approach) and sufficient to ensure 
compli ance with the requirements of these AO. This 
program shall include the following actions:  
 
1. Determining  and keep ing under  continued  
review , the measures needed to achieve the 
radiation safety objectives, to ensure that the 
radiation devices needed for their implementation 
are provided and regularly to verify that the 
radiation safety objectives are being achieved;  
 
2.Identify  and prevent, or pr omptly correct, any 
failures or shortcomings in the radiation safety 
measures;  
 
3.Facilitate consultation and co -operation among 
all relevant parties with respect to radiation 
safety ; 
 
4.Keep appropriate records regarding the discharge 
of their responsibilitie s. 
 
v. Principal parties shall ensure that:  
 
1.A radiation device is transferred only if the 
recipient possesses the necessary authorization;  
 
2.Radiation devices are shipped and received in 
accordance with FDA regulatory requirements;  
 
e. The relevant principal parties shall ensure that, in the 
implementation of the protection and safety program:  
 i. The measures and radiation devices that are necessary for 
achieving the objectives for protection and safety have 
been determined and are duly pro vided;  
 
ii. The program is periodically reviewed to assess its 
effectiveness and its continued fitness for purpose;  
 
iii. Any failures or shortcomings in protection and safety are 
identified and corrected, and steps are taken to prevent 
their recurrence;  
 
iv. Arrangeme nts are made to consult with interested 
parties;  
 
v. Appropriate records are maintained.  
 
vi. The relevant principal parties and other parties having 
specified responsibilities in relation to protection and 
safety shall ensure that all personnel engaged in activities 
relevant to protection and safety have appropriate 
education, training and qualification so that they 
understand their responsibilities and can perform their 
duties competently, with appropriate judgement and in 
accordance with procedures.  
 
vii. The relevant principal parties shall ensure that qualified 
experts are identified and are consulted as necessary on 
the proper observance of this AO.  
 
 
3. Responsibilities of Registrants and Licensees  
 
Registrants and Licensees shall:  
 
a. bear the responsibility for establishing and implementing the 
technical and organizational measures that are needed for 
ensuring protection, and safety for the practices using radiation 
devices for which they are authorized and for compliance with 
all applicable re quirements of these AO . 
 
b. may designate suitably qualified persons to carry out actions and 
tasks related to these responsibilities, but they shall retain the prime responsibility for protection and safety. Registrants and 
licensees shall document the names  and responsibilities of 
persons designated  
 
c. notify the regulatory body of any intention to introduce 
modifications to any practice or radiation devices for which they 
are licensed whenever the modifications could have significant 
implications for protecti on and safety, and they shall not carry 
out any such modification unless specifically authorized by the 
regulatory body  
 
d. establish clear lines of responsibility and accountability for 
protection and safety for the radiation devices for which they are 
autho rized, and shall establish organizational arrangements for 
protection and safety  
 
e. ensure that any delegation of responsibilities by a principal party 
is documented  
 
f. ensure that the relevant principal parties and other parties having 
specified responsibilit ies in relation to protection and safety shall 
ensure that all personnel engaged in activities relevant to 
protection and safety have appropriate education, training and 
qualification so that they understand their responsibilities and 
can perform their dut ies competently, with appropriate judgment 
and in accordance with procedures  
 
g. have in place operating procedures and arrangements for 
protection and safety that are subject to periodic review and 
updating under a management system  
 
h. establish procedures for  reporting on and   learning from 
accidents and other incidents  
 
i. ensure that structures, systems and components, including 
software, that are related to protection and safety for x -ray 
facilities and activities using radiation devices are designed, 
constructed, commissioned, operated and maintained so as to 
prevent accidents as far as reasonably practicable  
 
j. make suitable arrangements:  
 i. to prevent reasonably foreseeable accidents in the x -ray 
facility;  
 
ii. to mitigate the consequences of those  accidents that do 
occur;  
 
iii. to provide workers with the information, instruction, 
training and equipment necessary to restrict potential 
exposures;  
 
iv. to ensure that there are adequate procedures for the 
control of the facility and for the management of any 
reasonably foreseeable accidents ; 
 
v. to ensure that safety significant structures, systems and 
components, including software, and other equipment 
can be inspected and tested regularly for any degradation 
that could lead to abnormal conditions or inadequate 
performance;  
 
vi. to ensure that maintenance, inspection and testing 
appropriate to the preservation of the provisions for 
protection and safety can be carried out without undue 
occupational exposure ; 
 
vii. to ensure that abnormal operating conditions  that could 
significantly affect protection and safety are detected by 
systems that respond quickly enough to allow for 
corrective action to be taken in a timely manner to ensure 
that all relevant safety documentation is available in the 
appropriate languages  
 
k. Notify the FDA of any intention to introduce modifications to 
any practice or radiation devices for which they are authorized 
whenever the modifications could have significant implications 
for protection and safety, and they shall not carry out any such 
modificatio n unless specifically authorized by the FDA.  
 
4.Responsibilities of Radiation Protection Officers and Qualified 
Experts  
 a. Licensees shall arrange for qualified experts to be identified and 
made available for providing advice on the observance of these 
Regulations when so required by the FDA.  
 
b. The qualifications of qualified experts in radiation safety shall 
include a level of academic knowledge and of professional 
experience compatible with the levels of risks associated with 
the authorized practi ces or radiation devices within a practice.  
 
c. A radiation protection officer shall be technically competent in 
radiation protection matters relevant to a given type of practice. 
The radiation protection officer oversees the application of the 
requirements of these AO to that practice.  
 
d. Registrants and licensees may propose to use a radiation 
protection officer in place of a qualified expert in radiation safety 
on the basis of the relatively low risk of the practice.  
 
e. Licensees shall keep the FD A informed of the arrangements 
made with respect to paragraphs 1 and 2 above.  
 
B. SPECIFIC REQUIREMENTS  
Radiation protection requirements, management requirements and technical 
requirements are further group ed into PARTS as supplemental requirements of this AO. 
The FDA will issue a practice specific implementing guideline to support its 
implementation.  
Parts    Supplemental Requirements   
Part 1  Requirements for Radiation Protection  
Part 2  Verification of Safety  
Part 3  Human Imaging For Purposes Other Than Medical Medical Diagnosis, 
Medical Treatment Or Biomedical Research  
Part 4  Occupationa Exposure  
Part 5  Medical Exposure  
Part 6  Public Exposure   
Part 7  Radiation Device   
 
 
VII. TRANSITORY PROVISIONS  
 A period of three (3) years from the approval of this regulation shall be allowed to 
facilitate and strengthen the full implementation of the following provision of this AO.  
 
 
 
Relevant 
Provision  Details  Remarks  
Part 2.1  Conduct of Safety 
Assessment and 
submission of the same to 
FDA for review  Requirements shall be in the graded 
approach in specific regulations to be 
issued by the FDA  
Section VI. 
B.7 and D  Requirements for 
Qualified Experts  Harmonized National Policy in a  graded 
approach to be issued by the FDA  
Part 1.3; 
Part 5.6 and 
5.8 Establishment and Use of 
DRL’s and Dose 
Constraints  Harmonized National Policy on the 
Establishment and  Use to be issued by the 
FDA  
 
 
VIII.  SEPARABILITY CLAUSE  
 
If any of the provisions of these regulations is found by a court of competent 
jurisdiction to be void and unenforceable, in whole or in part, such provision shall be 
deemed deleted from these regulations but the remaining provisions thereof shall remain in 
full force a nd effect.  
 
 
IX. REPEALING CLAUSE  
 
All provisions of the Administrative Orders No. 149  s. 2004  and 164 s. 2004  its 
department circular  is hereby amended.  All other administrative orders and issuances that 
are inconsistent with this AO are hereby repealed, amen ded, or modified accordingly, 
provided that nothing in these regulations shall be deemed to modify the existing 
regulations issued to special laws implemented by the FDA . 
 
 
X. MANDATORY REVIEW  
 
This Order shall be reviewed by the FDA after three (3) years of its implementation.  
 
 
XI. PENALTY CLAUSE  
 
Any person or establishment found to violate any of the rules and regulations set 
herein shall be imposed with the penalty prescribed in the Republic Act 9711 and its 
Implementing Rules and Regulations.   
 
XII. EFFECTIVITY  
 
This Administrative Order shall take effect fifteen (15) days after its publication in 
at least two (2) national papers of general circulation and upon filing at the Office of 
National Administrative Register (ONAR) at the UP Law Center, Dilim an, Quezon City.  
 
 
 
 
FRANCISCO T. DUQUE III, MD, MSc.  
       Secretary of Health  
 
Office  Food and Drug 
Administration  Health Regulations Team  Health Policy 
Development and 
Planning Bureau  Office of the Secretary  
Initial   
 
ROLANDO ENRIQUE D. 
DOMINGO, MD  
Director General   
 
DR. GERARDO V. 
BAYUGO, MPH, CESO I  
Undersecretary of Health   
 
MS. FRANCES ROSE 
E. MAMARIL  
OIC – Director IV   
 
ATTY. FATIMA E. 
LAPERAL  
Head Executive Assistant  
Date      
 
Keywords  radiation protection and safety standards, radiation, planned exposure 
situations, radiation devices, radiation sources, radiation facilities, radiation 
activities, radiation regulation  
Related issuances, laws, directives  RA 9711, DOH AO 149 s. 2004, DOH DC 323 s. 2004, DOH AO 164 s. 20 04 
 
 
  Annex A  
 
DEFINITION OF TERMS  
 
 
Authorization  - The granting by the FDA of written permission for a person or 
organization to conduct specified activities. An authorization may take the form of a license 
or registration.  
 
Carers and comforters  - Persons who willingly and voluntarily help (other than in their 
occupation) in the care, support and comfort of patients undergoing radiological procedures 
for medical diagnosis or medical treatment.  
 
Controlled areas  - A defined area in which specific protection measures and safety 
provisions are or could be required for controlling exposures, and preventing or limiting 
the extent of potential exposures  
 
Defence in depth  - The application of more than a single protective measure for a given 
safety objective, such that the objective is achieved even if one of t he protective measures 
fails.  
 
Diagnostic reference levels  - A level used in medical imaging to indicate whether, in 
routine conditions, the dose to the patient in a  
specified radiological procedure is unusually high or unusually low for that procedure.  
 
Dose constraints  - prospective and source related value of individual dose (dose constraint) 
or risk (risk constraint) that is used in planned exposure situations as a parameter for the 
optimization of protection and safety on the use of radiation device, a nd that serves as a 
boundary in defining the range of options in optimization.  
 
Notes:  
1) For occupational exposure, a constraint on individual dose to workers established and used by 
licensees to set the range of options in optimizing protection and safety for the radiation device;  
2) For public exposure, the dose constraint is a source related value established or approved by FDA, 
with account taken of the doses from planned operations of all radiation devices under control. The 
dose constraint for each  particular use of radiation devices is intended, among other things, to 
ensure that the sum of doses from planned operations for all sources under control remains within 
the dose limit;  
3) For medical exposure, the dose constraint is a source related value u sed in optimizing the protection 
of carers and comforters of patients undergoing radiological procedures, and the protection of 
volunteers subject to exposure as part of a programme of biomedical research.  
 Emergency exposure situation  - A situation of exp osure that arises as a result of an 
accident, a malicious act or other unexpected event, and requires prompt action in order to 
avoid or reduce adverse consequences.  
 
Emergency procedures  - A set of instructions describing in detail the actions to be taken  
by response personnel in an emergency.  
 
Employer - A person or organization with recognized responsibilities, commitments and 
duties towards a worker in the employment of the person or organization by virtue of a 
mutually agreed relationship.  
 
Exemption  - The determination by the FDA that a radiation devices or practice need not 
be subject to some or all aspects of regulatory control on the basis that the exposure and the 
potential exposure due to the radiation devices or practice are too small to warrant the 
application of those aspects or that this is the optimum option for protection irrespective of 
the actual level of the doses or risks.  
 
Existing exposure situation  - A situation of exposure that already exists when a decision 
on the need for control ne eds to be taken. Existing exposure situations include exposure to 
natural background radiation that is amenable to control; exposure due to residual 
radioactive material that derives from past practices that were never subject to regulatory 
control or expo sure due to residual radioactive material deriving from a nuclear or 
radiological emergency after an emergency has been declared to be ended.  
 
Facilities and activities  – for purposes of this AO, a general term encompassing any human 
activity that may cau se people to be exposed to radiation risk arising from the use of 
radiation devices.      
 
‘Facilities’ includes: x -ray facilities; and any other places where radiation device is produced, used, or where 
radiation devices are installed on such a scale that consideration of protection and safety is required.  
  
‘Activities’  includes: the production, use, import and export of radiation devices for medical and non -medical 
application.  
 
Graded Approach  - is a regulatory system or a safety system, a process or method in 
which the stringency of the control measures and conditions to be applied is commensurate 
with the level of risk; potential magnitude of exposure and hazard of facilities and activities 
associated with the use of radiation devices.  
 
Health pro fessional  – An individual who has been formally recognized through 
appropriate national procedures to practice a profession related to health (e.g. medicine, dentistry, chiropractic, podiatry, nursing, medical physics, medical radiation technology, 
occupat ional health).  
 
Health screening program  - A program in which a health test or medical examination is 
performed for the purpose of the early detection of disease.  
 
Inspection imaging device  – An radiation device designed specifically for imaging 
persons or cargo conveyances for the purpose of de tecting concealed objects on or within 
the human body or within cargo or a vehicle.  
 
Interested party  - A person, company, etc., with a concern or interest in the activities and 
performance of an organization, business, system, etc.  
 
License  - A legal docu ment issued by the FDA granting authorization to perform specified 
activities relating to a facility or activity. Authorization may take other forms, such as 
registration.  
 
Licensee  - is the person or organization having overall responsibility for a facili ty or 
activity and the holder of a current license.  
 
Medical exposure  - Exposure incurred by patients for the purposes of medical or dental 
diagnosis or treatment; by carers and comforters; and by volunteers subject to exposure as 
part of a program of biom edical research  
 
Medical Physicist  – A health professional, with specialist education and training in the 
concepts and techniques of applying physics in medicine, and competent to practise 
independently in one or more of the subfields (specialties) of medi cal physics.  
 
Medical radiation facility  - The medical radiation facility may be a ‘stand alone’ entity, 
such as a medical clinic or imaging clinic/center or it may be part of a larger organization, 
such as a hospital  
 
Member of the public  - For purposes o f protection and safety, in a general sense, any 
individual in the population except when subject to occupational exposure or medical 
exposure. For the purpose of verifying compliance with the annual dose limit for public 
exposure, this is the representati ve person.  
 
Monitoring  - The measurement of dose, dose rate or activity for reasons relating to the 
assessment or control of exposure to radiation, and the interpretation of the results.  
 
Notification  - A document submitted to the FDA by a person or organi zation to notify an 
intention to carry out a practice or other use of a radiation devices.  Occupational exposure  - Exposure of workers incurred in the course of their work.  
 
Optimization of protection and safety  - The process of determining what level of 
protection and safety would result in the magnitude of individual doses, the number of 
individuals (workers and members of the public) subject to exposure and the likelihood of 
exposure being “as low as reasonabl y achievable, economic and social factors being taken 
into account” (ALARA). For medical exposures of patients, the optimization of protection 
and safety is the management of the radiation dose to the patient commensurate with the 
medical purpose.  
 
Planned exposure situation  – For purposes of this regulation, it is a situation of exposure 
that arises from the planned operation of an ionizing radiation devices or from a planned 
activity that results in an exposure due to the use of an ionizing radiati on device.  
 
Potential exposure - Prospectively considered exposure that is not expected to be delivered 
with certainty but that may result from an anticipated operational occurrence or accident at 
a radiation devices or owing to an event or sequence of eve nts of a probabilistic nature, 
including equipment failures and operating errors.  
 
Practice - Any human activity that introduces additional sources of radiation or additional 
exposure pathways, so as to increase the exposure or the likelihood of exposure o f people 
or the number of people exposed.  
 
Principal parties – The persons having the main responsibilities for the application of these 
regulations. These are: (a) registrants or licensees; (b) employers of workers and (c) 
radiological medical practitione rs. 
 
Protection and safety - The protection of people against exposure to ionizing radiation and 
the safety on the use of radiation devices, including the means for achieving this, and the 
means for preventing accidents and for mitigating the consequences of accidents if they do 
occur.  
 
Public exposure - Exposure incurred by members of the public due to radiation devices in 
planned exposure situations, emergency exposure situations and existing exposure 
situations, excluding any occupational exposure or med ical exposure.  
 
Qualified expert - An individual who, by virtue of certification by appropriate boards or 
societies, professional license or academic qualifications and experience, is duly 
recognized as having expertise in a relevant field of specializatio n, e.g. medical physics, 
radiation protection, occupational health, fire safety, quality management or any relevant 
engineering or safety specialty.  
 Radiation  
 
ionizing radiation . For the purposes of radiation protection, radiation capable of 
producing i on pairs in biological material(s).  
 
Radiation protection officer  - A person technically competent in radiation protection 
matters relevant for a given type of practice who is designated by the registrant, licensee or 
employer to oversee the application of regulatory requirements.  
 
Radiation device  - A device capable of  generating ionizing radiation, such as X rays, 
neutrons, electrons or other charged particles, that may be used for medical and non -
medical application.  
 
Radiological procedures  - A medical imaging procedure or therapeutic procedure that 
involves ionizing  radiation — such as a procedure in diagnostic radiology, or radiation 
therapy, a planning procedure involving radiation, or an image guided interventional 
procedure or other interventional procedure involving radiation — delivered by a radiation 
device to  a patient.  
 
Radiological medical practitioner  - A health professional with specialist education and 
training in the medical uses of radiation, who is responsible for administering a radiation 
dose to a patient and competent to perform independently or to oversee radiological 
procedures involving medical exposure in diagnostic radiology, interventional radiology 
(image -guided procedures), radiation oncology and nuclear medicine.  
 
Radiologic/x -ray technologists  - A health professional, with specialist education and 
training  in medical radiation technology, competent to carry out radiological procedures, 
on delegation from the radiological medical practitioner, in one or more of the specialties 
of medical radiati on technology.  
 
Referring medical practitioner  - A health professional who, in accordance with national 
requirements, may refer individuals to a radiological medical practitioner for medical 
exposure.  
 
Regulatory Body  - An authority, designated by the Phil ippine government having legal 
authority or mandate for the development of requirements, regulations and regulatory 
guides, review and assessment of facilities and activities, and of information relevant to 
safety; conducting the regulatory process, includ ing inspection, issuing authorizations and 
enforcement, and thereby regulating the use of radiation devices  
 Regulatory Control  - Any form of control or regulation applied to facilities or activities 
by the FDA for reasons related to radiation protection o r to the safety on the use of radiation 
devices  
 
Registrant - The holder of a current registration.  
 
Registration - A form of authorization for practices of low or moderate risks whereby the 
person or organization responsible for the practice has, as appro priate, prepared and 
submitted a safety assessment of the facilities and equipment to the regulatory body. The 
practice or use is authorized with conditions or limitations as appropriate.  
 
Representative person  - An individual receiving a dose that is repr esentative of the doses 
to the more highly exposed individuals in the population  
 
Safety assessment  - Assessment of all aspects of a practice that are relevant to protection 
and safety; for an authorized facility, this includes siting, design and operation  of the 
facility.  
 
Safety Culture  - The assembly of characteristics and attitudes in organizations and 
individuals which establishes that, as an overriding priority, protection and safety issues 
receive the attention warranted by their significance.  
 
Super vised areas  - A defined area not designated as a controlled area but for which 
occupational exposure conditions are kept under review, even though no specific protection 
measures or safety provisions are not normally needed.  
 
Supplier (of radiation devices /device)  - Any person or organization to whom a registrant 
or licensee assigns duties, totally or partially, in relation to the design, manufacture, 
production or construction of a radiation devices.  
 
Worker  - Any person who works, whether full time, part time or temporarily, for an 
employer and who has recognized rights and duties in relation to occupational radiation 
protection. A self -employed person is regarded as having the duties of both an employer 
and a worker.  
 
 
 
 
 
 
 
 Annex B  
 
DOSE LIMITS FOR PLANNED EXPOSURE SITUATIONS  
(Reference: IAEA GSR Part 3 Schedule III)  
 
OCCUPATIONAL EXPOSURE  
 
1. For occupational exposure of workers over the age of 18 years, the dose limits are:  
 
a. An effective dose of 20 mSv per year averaged over five consecutive years1 
(100 mSv in 5 years) and of 50 mSv in any single year;  
 
b. An equivalent dose to the lens of the eye of 20 mSv per year averaged over five 
consecutive years (100 mSv in 5 years) and of 50 mSv in any single year;  
 
c. An equivalent dose to the extremities (hands and feet) or to the skin2 of 500 
mSv in a year.  
 
Additional restrictions apply to occupational exposure for a female worker who has 
notified pregnancy or is breast -feeding.  
 
PUBLIC EXPOSURE  
 
2. For public exposure, the dose limits are:  
 
a. An effective do se of 1 mSv in a year;  
 
b. In special circumstances, a higher value of effective dose in a single year could 
apply, provided that the average effective dose over five consecutive years does 
not exceed 1 mSv per year;  
 
c. An equivalent dose to the lens of the eye  of 15 mSv in a year;  
 
d. An equivalent dose to the skin of 50 mSv in a year.  
 
 
 
1 The start of the averaging period shall be coincident with the first day of the relevant annual period after the date of entr y into force of these Standards, with no 
retrospective averaging.  
2 The equivalent dose limits for the skin apply to the average dose over 1 cm2 of the most highly irradiated area of the skin. The dose to the skin also contributes 
to the effective dose, this contribution being the average dose to the entire skin multiplied by the tissue weighting factor for the skin.  
 
 
 Part 1  
REQUIREMENTS FOR RADIATION PROTECTION  
 
1. Justification of Practices  
 
1.1 No practice shall be authorized unless it is likely to produce sufficient benefit 
to the exposed  individuals or to  the society to offset the radiation harm that it 
might cause, considering  social, economic,  and other relevant factors. If 
requested by the FDA, the applicant for an authorization shall provide sufficient 
information and evidence on the benefits and the harm to support the 
justification of the use of radiation devices and operation of x -ray faci lities. The 
FDA may deny authorization of the proposal in the application on the basis that 
it is not justified.  
 
1.2 The following practices using radiation devices are deemed to be not justified:  
 
a. Human imaging using radiation devices that is performed as a form of art or 
for publicity purposes.  
 
b. Human imaging using radiation devices that is performed for occupational, 
legal or health insurance purposes, and is undertaken without reference to 
clinical indication shall normally be deemed to be not justified. If, in 
exceptional circumstances, the FDA decides that the justification of such 
human imaging for specific practices is to be considered, the requirements 
of this AO shall apply.  
 
c. Human imaging using radiation devices for theft detection purpos es.  
 
d. Human imaging using radiation devices for the detection of concealed 
objects for anti -smuggling purposes.  
 
e. Human imaging using radiation devices for the detection of concealed 
objects that can be used for criminal acts that pose a national security threat 
shall be justified only by the government. If the government decides that the 
justification of such human imaging is to be considered, the requirements of 
this AO shall apply.  
 
2. Optimization of Protection and Safety  
 
2.1 Registrants and  License es shall ensure that protection and safety is optimized  
 
2.2 For occupational exposure and public exposure, registrants and licensees shall 
ensure that all relevant factors are taken into account in a coherent way in the optimization of protection and safety t o contribute to achieving the following 
objectives:  
 
a. To determine measures  for protection and safety that are optimized for the 
prevailing circumstances, with account taken of the available options for 
protection and safety as well as the nature, likelihoo d and magnitude of 
exposures;  
 
b. To establish criteria, on the basis of the results of the optimization, for the 
restriction of the likelihood and magnitudes of exposures by means of 
measures for preventing accidents and for mitigating the consequences of 
those that do occur.  
 
3. Dose Constraints  
 
For occupational exposure and public exposure, registrants and licensees shall 
ensure, as appropriate, that relevant dose constraints are used in the optimization of 
protection and safety for a radia tion device within a practice.  
 
4. Dose Limits  
 
Registrants and licensees shall ensure that the exposures of individuals due to the 
practices using radiation devices for which the registrants and licensees are authorized 
are restricted, so that neither the effective dose nor the equivalent dose to tissues or 
organs exceeds any relevant dose limit specified in Annex B of this AO.  
 
5. Management Requirements  
 
5.1 The principal parties shall ensure that protection and safety is effectively 
integrated into the overall management system of the organizations for which 
they are responsible.  
 
5.2 The principal parties shall demonstrate commitment to protection and safety at 
the highest levels within the organizations for which they are responsible.  
 
5.3 Licensees shall establish a management system, commensurate with the size 
and nature of the authorized activity, which ensures that:  
 
a. Policies and procedures are established that identify safety as being of the 
highest priority;  
 
b. Problems affecting protect ion and safety are promptly identified and 
corrected in a manner commensurate with their importance;  
 c. The responsibilities of each individual for safety are clearly identified and 
each individual is suitably trained and qualified;  
 
d. Clear lines of authority  for decisions on safety are defined;  
 
e. Organizational arrangements and lines of communications are established 
that result in an appropriate flow of information on safety at and between 
the various levels in the entire organization of the licensee.  
5.4 The principal parties shall ensure that the management system is designed and 
implemented to enhance protection and safety by:  
 
a. Applying the requirements for protection and safety coherently with other 
requirements including requirements for oper ational performance, and 
coherently with guidelines for security;  
 
b. Describing the planned and systematic actions necessary to provide 
adequate confidence that the requirements for protection and safety are 
fulfilled;  
 
c. Ensuring that protection and safety is  not compromised by other 
requirements;  
 
d. Providing for the regular assessment of performance for protection and 
safety and the application of lessons learned from experience;  
 
e. Promoting safety culture.  
 
5.5 The principal parties shall ensure that the protectio n and safety elements of the 
management system are commensurate with the complexity of and the radiation 
risks associated with the activity.  
 
6. SAFETY CULTURE  
 
6.1 The principal parties shall promote and maintain a safety culture by:  
 
a. Promoting individual and collective commitment to protection and safety at 
all levels of the organization;  
 
b. Ensuring a common understanding of the key aspects of safety culture 
within the organization;  
 
c. Providing the means by which the organization supports individu als and 
teams in carrying out their tasks safely and successfully, with account taken 
of the interactions between individuals, technology and the organization;   
d. Encouraging the participation of workers and their representatives and other 
relevant persons i n the development and implementation of policies, rules 
and procedures dealing with protection and safety;  
 
e. Ensuring accountability of the organization and of individuals at all levels 
for protection and safety;  
 
f. Encouraging open communication with regard to protection and safety 
within the organization and with relevant parties, as appropriate;  
 
g. Encouraging a questioning and learning attitude and discouraging 
complacency with regard to protection and safety;  
 
h. Providing means by which the organizatio n continually seeks to develop and 
strengthen its safety culture.  
 
7. Human Factors  
 
7.1 The principal parties and other parties having specified responsibilities in 
relation to protection and safety, as appropriate, shall take into account human 
factors and shal l support good performance and good practices to prevent 
human and organizational failures, by ensuring that:  
 
a. Sound ergonomic principles are followed in the design of equipment and the 
development of operating procedures, so as to facilitate the safe oper ation 
and use of equipment, to minimize the possibility that operator errors will 
lead to accidents, and to reduce the possibility that indications of normal 
conditions and abnormal conditions will be misinterpreted;  
 
b. Appropriate equipment, safety systems and procedural requirements are 
provided and other necessary provisions are made:  
 
i. To reduce, as far as practicable, the possibility that human error or 
inadvertent action could give rise to accidents or other incidents 
leading to the exposure of a ny person;  
 
ii. To provide means for detecting human errors and for correcting 
them or compensating for them;  
 
iii. To facilitate protective actions and corrective actions in the event of 
failures of safety systems or failures of measures for protection and 
safety.  
 7.2 All employees shall be informed at least annually of the   importance of effective 
measures for protection and safety and be trained in their implementation as 
appropriate.  
 
7.3 Training programs shall be routinely evaluated and updated as necessary.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Part 2  
 
VERIFICATION OF SAFETY  
 
1. Safety Assessment  
 
1.1 When so required by the FDA, or to meet management system requirements, the 
licensee shall prepare safety assessments in accordance with the graded approach 
for which they are responsible so as to:  
 
a. To identify the ways in which exposures could be incurred, account being taken 
of the effects of external events as well as of events directly involving the 
radiation devices and associated equipment;  
 
b. To determine the expected magnitudes and likelihood of exposures in normal 
operation and, to the extent reasonable and practicable, make an assessment of 
potential exposures;  
 
c. To assess the adequacy of the provisions for protection and safety.  
 
1.2 The safety assessment shall include, as appropriate, systematic critical review of:  
 
a. The operational limits and conditions for the operation of a facility;  
 
b. The ways in which structures, systems and components, including software, 
and procedures relating to protection and safety might fail, singly or in 
combination, or might otherwise give rise to exposures, and the consequences 
of such events;  
 
c. The ways in which external factors could affect protection and safety;  
 
d. The ways in which operating procedures relating to protect ion and safety might 
be erroneous, and the consequences of such errors;  
 
e. The implications for protection and safety of any modifications;  
 
f. The implications for protection and safety of security measures or of any 
modifications to security measures;  
 
g. Any uncertainties or assumptions and their implications for protection and 
safety.  
 
1.3 The licensee shall take into account in the safety assessment:  
 a. Factors that could give rise to unintended operation of any radiation devices or 
a loss of shielding, and the measures available to detect and to prevent or 
control such occurrences;  
 
b. The extent to which the use of redundant and diverse safety features, that are 
independent of each other so that failure of one does not result in failure of any 
other, is appropriate to restrict the likelihood and magnitude of potential 
exposure.  
 
1.4 Licensees shall ensure that the safety assessment is documented and, where 
appropriate, that it is independently reviewed under the relevant management 
system.  
 
1.5 Licensees  shall perform additional reviews of the safety assessment as necessary 
to ensure that the technical specifications or conditions of use continue to be met 
when:  
 
a. Significant modifications to the facility or to its operating procedures or 
maintenance proce dures are envisaged;  
 
b. Significant changes occur on the site that could affect the safety of the facility 
or of activities on the site;  
 
c. Information on operating experience, or information about accidents and other 
incidents that could result in exposures, indicates that the current assessment 
might be invalid;  
 
d. Any significant changes in activities are envisaged;  
 
e. Any relevant changes in guidelines or standards have been made or are 
envisaged.  
 
1.6 If as a result of a safety assessment, or for any ot her reason, opportunities to 
improve protection and safety appear to be available and improvement seems 
desirable, any consequential modifications shall be made cautiously and only after 
favorable assessment of all the implications for protection and safet y. The 
implementation of all improvements shall be prioritized so as to optimize 
protection and safety.  
 
2. Monitoring, Testing and Verification of Compliance  
 
 Licensees and employers shall ensure that:  
 a. Monitoring and measurements of parameters are perform as necessary for 
verification of compliance with the requirements of regulations and license 
conditions;  
 
b. Suitable equipment is provided and procedures for verification are 
implemented;  
 
c. Equipment is properly maintained, tested and calibrated at ap propriate intervals 
with reference to standards traceable to national or international standards;  
 
d. Records are maintained of the results of monitoring and verification of 
compliance, as required by the FDA, including records of the tests and 
calibrations c arried out in accordance with regulations and license conditions;  
 
e. The results of monitoring and verification of compliance are shared with the 
FDA as required.  
 
 
3. Prevention and Mitigation of A ccidents  
 
Registrants and licensees shall apply good engineering practices and shall take all 
practicable measure to prevent accidents and to mitigate the consequences of those 
accidents that do occur.  
 
Good engineering practice  
 
3.1 The registrant or licensee, in cooperation with other responsible parties, shall ensure 
that the siting, location, design, manufacture, construction, assembly, 
commissioning, operation, maintenance and decommissioning (or closure) of 
facilities or parts thereof are based on good enginee ring practice which shall, as 
appropriate:  
 
a. Take account of international and national standards;  
 
b. Be supported by managerial and organizational features, with the purpose of 
ensuring protection and safety throughout the lifetime of the facility;  
 
c. Include adequate safety margins in the design and construction of the facility, 
and in operations involving the facility, so as to ensure reliable performance in 
normal operation, and take account of the necessary quality, redundancy and 
capability for ins pection, with emphasis on preventing accidents, mitigating the 
consequences of those accidents that do occur and restricting any possible future 
exposures;  
 d. Take account of relevant developments concerning technical criteria, as well as 
the results of any relevant research on protection and safety and feedback of 
information on lessons learned from experience.  
 
Defence in depth  
 
3.2 Registrants and licensees shall ensure that a multilevel (defence in depth) system of 
sequential, independent provisions for prote ction and safety that is commensurate 
with the likelihood and magnitude of potential exposures is applied to sources for 
which the registrants and licensees are authorized.  
 
3.3 Registrants and licensees shall ensure that if one level of protection were to fail, the 
subsequent independent level of protection would be available. Such defence in 
depth shall be applied for the purposes of:  
 
a. Preventing accidents;  
 
b. Mitigating the conse quences of any accidents that do occur;  
 
c. Restoring the sources to safe conditions after any such accidents.  
 
Accident Prevention  
 
3.4 Registrants and licensees shall ensure that structures, systems and components, 
including software, that are related to protec tion and safety for facilities and 
activities are designed, constructed, commissioned, operated and maintained so as 
to prevent accidents as far as reasonably practicable.  
 
3.5 The registrant or licensee for any facility or activity shall make suitable 
arrange ments:  
 
a. To prevent reasonably foreseeable accidents in the facility;  
 
b. To mitigate the consequences of those accidents that do occur;  
 
c. To provide workers with the information, instruction, training and equipment 
necessary to restrict potential exposures;  
 
d. To ensure that there are adequate procedures for the control of the facility and 
for the management of any reasonably foreseeable accidents;  
 
e. To ensure that safety significant structures, systems and components, including 
software, and other eq uipment can be inspected and tested regularly for any 
degradation that could lead to abnormal conditions or inadequate performance;   
f. To ensure that maintenance, inspection and testing appropriate to the 
preservation of the provisions for protection and saf ety can be carried out 
without undue occupational exposure;  
 
g. To ensure that abnormal operating conditions that could significantly affect 
protection and safety are detected by systems that respond quickly enough to 
allow for corrective action to be taken i n a timely manner;  
 
h. To ensure that all relevant safety documentation is available in the appropriate 
languages understandable to users.  
 
4. Investigations and Feedback of Information on Operating E xperience  
 
4.1 Licensees shall ensure that information on normal operation performance as well 
as abnormal conditions and events significant to radiation safety is disseminated 
or made available, as appropriate, to the FDA and other relevant parties, including 
other users, as specified in relevant guidelines issued by the FDA.  
 
4.2 In addition, and where applicable, licensees shall make suitable arrangements with 
suppliers of radiation devices to establish and maintain mechanisms for transfer 
from licensees to suppliers of any information on the use, ma intenance, disposal 
and malfunctioning that may be relevant for future improvements in the design and 
fabrication of the radiation devices they have supplied.  
 
4.3 Licensees shall conduct an investigation in the event that:  
 
a. A quantity or operating parameter r elating to protection and safety on the use 
of radiation devices  exceeds an investigation level or is outside the stipulated 
range of operating conditions; or  
 
b. Any equipment failure, accident, error, mishap or other unusual event or 
condition occurs that h as the potential for causing a quantity to exceed any 
relevant limit or operating restriction.  
 
 
4.4 The licensee shall conduct an investigation as soon as possible after an event and 
shall prepare a written record of its causes, or suspected causes, including a 
verification or determination of any doses received or committed and 
recommendations for preventing the recurrence of the event and the occurrence of 
similar events.  
 
4.5 The licensee shall communicate to the FDA and to any other relevant parties, as 
appropriate, a written report of any formal investigation relating to events 
prescribed by the FDA, including exposures giving rise to doses exceeding a dose limit. The licensee also shall immediately report to the FDA any event in which a 
dose limit is  exceeded.  
 
5. Requirements for Reporting to the FDA  
 
Licensees shall:  
 
5.1 Notify the FDA by FDA telephone or facsimile immediately of any event in which 
a dose limit is exceeded;  
 
5.2 Notify the by telephone or facsimile as soon as practicable, but not later than 24 
hours after discovery, of any significant unintended or accidental medical exposures  
 
5.3 Submit to the FDA, within 30 days after discovery of any significant unintended or 
accidental medical exposures, a written report which states the cause of any 
significant unintended or accidental medical exposures and includes information on 
the doses, corrective measures and any other relevant information;  
 
5.4 Report a summary of the public exposure monitoring results to the FDA at approved 
intervals and promp tly inform the FDA of any abnormal results which lead or could 
lead to an increase of public exposure  
 
6. Non -Compliance and Accidents  
 
6.1 In the event of a breach of any applicable requirement of these AO, principal parties 
shall, as appropriate:  
 
a. Investiga te the breach and its causes, circumstances and consequences;  
 
b. Take appropriate action to remedy the circumstances and to prevent a recurrence 
of similar situations;  
 
c. Report to the FDA within 24 hours, or as required, on the causes of the breach, 
its circumstances and consequences, and on the corrective or preventi ve actions 
taken or to be taken ; 
 
d. Take whatever other actions are necessary as required by these AO.  
 
6.2 Failure to take corrective or preventive actions  within a reasonable time in 
accordance with these AO shall be grounds for enforcement in accordance with the 
relevant regulations issued by the FDA.  
 
       7.  Inventory and Records  
 
7.1 Licensees shall establish, maintain and be able to retrieve records relating to:   
a. Inventory of radiation devices;  
 
b. Records of doses from occupational exposures;  
 
c. Records relating to x -ray facilities and activities using radiation devices;  
 
d. The testing of instruments and safety systems, and calibrations carried out in 
accordance with the requirements  of this AO.  
 
7.2 Licensees shall provide the FDA as required with appropriate information from 
their inventory records of radiation devices. Licensees shall check inventory 
periodically to confirm that radiation devices are in their assigned locations and are  
under control.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Part 3  
 
HUMAN IMAGING FOR PURPOSES OTHER THAN MEDICAL 
DIAGNOSIS, MEDICAL TREATMENT OR BIOMEDICAL RESEARCH  
 
1. Justification of Practices of Any Type of Human Imaging Using R adiation  
 
1.1 The justification process applied to the practice of any type of human imaging 
procedure in which radiation is used for purposes other than for medical diagnosis 
or medical treatment or as part of a program of biomedical research shall include 
the consideration of:  
 
a. The ben efits and detriments of implementing the type of human imaging 
procedure;  
 
b. The benefits and detriments of not implementing the type of human imaging 
procedure;  
 
c. Any legal or ethical issues associated with the introduction of the type of human 
imaging procedure;  
 
d. The effectiveness and suitability of the type of human imaging procedure, 
including the appropriateness of the radiation equipment for the intended use;  
 
e. The availability of sufficient radiation devices to conduct the human imaging 
procedure safely throughout the intended period of the practice  
 
1.2 If it has been determined through the process specified in (1.1) that a particular 
practice of human imaging using radiation is justified, then, such a practice shall be 
subject to the requiremen ts of this AO.  
 
2. Optimization of Protection and Safety  
 
2.1 For human imaging using radiation conducted by medical personnel using medical 
radiological equipment, which exposes humans to radiation for employment 
related, legal or health insurance  purposes without reference to clinical indications, 
the licensee shall ensure that the appropriate optimization requirements for medical 
exposure specified in this AO are applied, with dose constraints used instead of 
diagnostic reference levels.  
 
2.2 Procedur e with inspection imaging  devices in which radiation is used to expose 
persons for the purpose of detection of concealed weapons, contraband or other 
objects on or within the body shall be considered to give rise to public exposure. 
Licensees shall apply t he requirements for public exposure as required in this AO. 
In particular, licensees shall ensure that optimization of protection and safety is subject to any dose constraints for public exposure set by the government or the 
FDA.  
 
2.3 Licensees shall ensure th at all persons who are to undergo procedures with 
inspection imaging devices in which ionizing radiation is used are informed of the 
possibility of requesting the use of an alternative inspection technique that does not 
use ionizing radiation, where availa ble. 
 
2.4 The licensee shall ensure that any inspection imaging device used for the detection 
of concealed objects on or within the body, whether it is manufactured in or 
imported into the country in which it is used, conforms to applicable standards of 
the In ternational Electrotechnical Commission (IEC) or the International 
Organization for Standardization (ISO) or to equivalent national standards.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Part 4  
OCCUPATIONAL EXPOSURE  
 
1. General Responsibilities  
 
1.1 For workers who are engaged in activities in which they are or could be subject to 
occupational exposure in planned exposure situations, licensees and employers 
shall be responsible for:  
 
a. Protection of workers against occupational exposure;  
 
b. Compliance with relevant requireme nts of this AO and license conditions.  
 
1.2 Licensees and employers shall ensure, for all workers engaged in activities in which 
they are or could be subject to occupational exposure, that:  
 
a. Occupational exposure is controlled so that the relevant dose limits for 
occupational exposure specified in Annex B of this AO are not exceeded;  
 
b. Protection and safety is optimized in accordance with the requirements specified 
in this AO;  
 
c. Decisions with regard to measures for protection and safety are recorded and 
made available to relevant parties, through their representatives where 
appropriate, as specified by the FDA;  
 
d. Policies, procedures and organizational arrangements for occupational 
protectio n and safety are established to implement the relevant requirements  of 
these AO, with priority given to design measures and technical measures for 
controlling occupational exposure;  
 
e. Suitable and adequate facilities, equipment and services for protection and 
safety are provided, the type and extent of which are commensurate with the 
expected likelihood and magnitude of the occupational exposure;  
 
f. Necessary workers’ health surveillance and health services for workers are 
provided;  
 
g. Appropriate monitoring equipment and personal protective equipment are 
provided and  arrangements are made for its proper use, calibration, testing and 
maintenance;  
 h. Suitable and adequate human resources and appropriate training in protection 
and safety are provided, as well as periodic retraining as required to ensure the 
necessary level  of competence;  
 
i. Adequate records are maintained in accordance with the requirements of these 
AO and license conditions;  
 
j. Arrangements are made to facilitate consultation and cooperation with workers, 
with regard to protection and safety, through their rep resentatives where 
appropriate, on all measures to achieve effective application of these AO;  
 
k. Necessary conditions for promoting a safety culture are provided.  
 
1.3 Licensees and employers shall:  
 
a. Involve workers, through their representatives where appropriate, in 
optimization of protection and safety;  
 
b. Establish and use, as appropriate, constraints as part of optimization of 
protection and safety.  
 
1.4 Licensees and employers shall ensure that workers exposed to radiation from 
radiation devices  within a  practice that are not required by or directly related to their 
work have the same level of protection against such exposure as members of the 
public.  
 
1.5 Licensees and employers shall take such administrative actions as are necessary to 
ensure that workers a re informed that ensuring protection and safety is an integral 
part of a general occupational health and safety program in which they have specific 
obligations and responsibilities for their own protection and the protection of others 
against radiation exp osure and for the safety of radiation devices.  
 
1.6 Licensees and employers shall record any report received from a worker that 
identifies any circumstances that could affect safety conditions or compliance with 
the requirements of these AO, and shall take app ropriate remedial actions.  
 
1.7 Employers and licensees shall facilitate compliance by workers with the 
requirements of these AO.  
 
2. Cooperation b etween Employers and Licensees  
 
2.1 Employers and licensees shall cooperate to the extent necessary for compliance by 
all responsible parties with the requirements of the Regulations.  
 2.2 If workers are engaged in work that involves or that could involve from the use of 
radiation devices that is not under the control of their employer, the licensee 
responsible for the radiation devices and the employer shall cooperate to the extent 
necessary for compliance by both parties with the requirements of these AO.  
 
2.3 Cooperation between the employer and the licensee shall include, where 
appropriate:  
 
a. The development and u se of specific restrictions on exposure and other means 
of ensuring that the measures for protection and safety for workers who are 
engaged in work that involves or could involve the use of a radiation devices 
that is not under the control of their employe r are at least as good as those for 
employees of the licensee;  
 
b. Specific assessments of the doses received by workers as specified in (a);  
 
c. A clear allocation and documentation of the responsibilities of the employer and 
those of the licensee for protectio n and safety.  
 
2.4 As part of the cooperation between parties, the licensee responsible for the radiation 
devices or for the exposure shall, as appropriate:  
 
a. Obtain from the employers, including self -employed individuals, the previous 
occupational exposure history of workers as specified in Part 4. 1.1, and any 
other necessary information;  
 
b. Provide appropriate information to the employer, including any available 
information relevant for compliance with the requirements of these Standards 
that the em ployer requests;  
 
c. Provide both the worker and the employer with the relevant exposure records  
 
3. Classification of Areas  
 
3.1 Controlled Areas:  
 
3.1.1 Registrants and licensees shall designate as a controlled area any area in which 
specific measures for protection and safety are or could be required for:  
 
a. Controlling x -ray exposures in normal operation;  
 
b. Preventing or limiting the likelihood and magnitud e of exposures in anticipated 
operational occurrences and accident conditions.  
 3.1.2 In defining the boundaries of any controlled area registrants and licensees shall 
take account of the magnitude of the exposures expected in normal operation, 
the likelihood and magnitude of exposures in anticipated operational 
occurrences and in accident conditions, and the type and extent of the 
procedures required for protection and safety.  
 
3.1.3 Registrants and licensees:  
 
a. Shall delineate controlled areas by physical means or, where this is not 
reasonably practicable, by some other suitable means.  
b. Shall, where a radiation device is only intermittently brought into operation or 
energized, or is moved from place to place, delineate an appropriate controlled 
area by means that are appropriate under the prevailing circumstances and shall 
specify exposure times.  
 
c. Shall display the symbol recommended by the International Organization for 
Standardization and shall display instructions at access points to and at 
approp riate locations within controlled areas.  
 
d. Shall establish measures for protection and safety, and local rules and 
procedures for controlled areas.  
e. Shall restrict access to controlled areas by means of administrative procedures 
such as the use of work permi ts, and by physical barriers, which could include 
locks or interlocks, the degree of restriction being commensurate with the 
likelihood and magnitude of exposures.  
 
f. Shall provide, as appropriate, at entrances to controlled areas:  
 
i. Personal protective equip ment;  
 
ii. Equipment for individual monitoring and workplace monitoring;  
 
iii. Suitable storage for personal clothing.  
 
g. Shall periodically review conditions to assess whether there is any need to 
modify the measures for protection and safety or the boundaries of controlled 
areas;  
 
h. Shall provide appropriate information, instruction and training for persons 
working in controlled areas.  
 
3.2 Supervised A reas 
 3.2.1 Registrants and licensees shall designate as a supervised area any area not 
already designated as a  controlled area but for which occupational exposure 
conditions need to be kept under review, even though specific measures for 
protection and safety are not normally needed.  
 
3.2.2 Registrants and licensees, taking into account the nature, likelihood and 
 magni tude of exposures in the supervised areas:  
 
a. Shall delineate the supervised areas by appropriate means;  
 
b. Shall display approved signs, as appropriate, at access points to supervised 
areas;  
 
c. Shall periodically review conditions to assess whether there is any need for 
further measures for protection and safety or any need for changes to the 
boundaries of supervised areas.  
 
4. Local Rules and Procedures and Personal Protective E quipment  
 
4.1 Employers and registrants and licensees shall minimize the need to rely on  
administrative controls and personal protective  equipment for protection and 
safety by providing well engineered controls and satisfactory working conditions, 
in accordance with the following hierarchy of preventive measures:  
 
a. Engineered controls;  
 
b. Administrative controls;  
 
c. Personal protective equipment.  
 
4.2 Employers, registrants and licensees, in consultation with workers, or through their 
representatives where appropriate:  
 
a. Shall establish in writing local rules and procedures that are necessary for 
protection and safety for workers and other persons;  
 
b. Shall include in the local rules and procedures any relevant investigation level 
or authorized level, and the procedures to be followed in the event that any such 
level is exceeded;  
 
c. Shall  make the local rules and procedures and the measures for protection and 
safety known to those workers to whom they apply and to other persons who 
may be affected by them;  
 d. Shall ensure that any work in which workers are or could be subject to 
occupational exposure is adequately supervised and shall take all reasonable 
steps to ensure that the rules, procedures, and measures for protection and safety 
are observed;  
 
e. Shall designate, as appropriate, a radiation protection officer in accordance wit h 
criteria to be established by the FDA.  
4.3 Employers, registrants and licensees shall ensure that:  
 
a. Workers are provided with suitable and adequate personal protective equipment 
that meets relevant standards or specifications, such as protective aprons, 
protective gloves, thyroid and organ shields.  
 
b. Tasks requiring the use of certain personal protective equipment are assigned 
only to workers who on the basis of medical advice are capable of safely 
sustaining the extra effort necessary.  
 
c. All personal protectiv e equipment, including equipment for use in an 
emergency, is maintained in proper condition and, if appropriate, is tested at 
regular intervals.  
d. If the use of personal protective equipment is considered for any given task, 
account is taken of any additiona l exposure that could result owing to the 
additional time taken or the inconvenience, and of any non -radiological risks 
that might be associated with using personal protective equipment while 
performing the task.  
 
5. Monitoring of the W orkplace  
 
5.1 Licensees, in cooperation with employers if appropriate, shall establish, maintain 
and keep under review a program for the monitoring at the workplace under the 
supervision of a radiation protection officer or qualified expert, commensurate with 
the graded  approach.  
 
5.2 The type and frequency of monitoring of workplaces shall:  
 
a. Be sufficient to enable:  
 
i. Evaluation of the radiological conditions in all workplaces;  
 
ii. Assessment of the exposure of workers in controlled areas and supervised 
areas;  
 
iii. Review of the classification of controlled and supervised areas;   
5.3 Licensees, in cooperation with employers where appropriate, shall maintain records 
of the findings of the workplace monitoring program. The findings of the workplace 
monitoring program shall be made avail able to workers, where appropriate through 
their representatives.  
 
5.4 The program for monitoring of the workplace shall specify:  
a. The quantities to be measured;  
 
b. Where and when the measurements are to be made and at what frequency;  
 
c. The most appropriate measur ement methods and procedures;  
d. Investigation levels and the actions to be taken if they are exceeded.  
 
6. Occupational Exposure Assessment  
 
6.1 Licensees and employers shall be responsible for making arrangements for the 
assessment of the occupational exposure of workers, on the basis of individual 
monitoring where appropriate, and shall ensure that arrangements are made with 
appropriate or approved dosimetry service providers that operate under a quality 
management system.  
 
6.2 For any worker who regularly  works in a supervised area or who enters a controlled 
area only occasionally, the occupational exposure shall be assessed on the basis of 
the results or workplace monitoring or of individual monitoring, as appropriate.  
7. Records of Worker Exposure  
 
7.1 Employers and licensees shall maintain records of occupational exposure for each 
worker for whom assessment of occupational exposure is required under Part 4.6.  
 
7.2 Records of occupational exposure for each worker shall be maintained during and 
after the work er’s working life, at least until the worker attains or would have 
attained the age of 75 years, and for not less than 30 yea rs after cessation of the 
work in which the worker was subject to occupational exposure.  
 
7.3 Records of occupational exposure shall in clude:  
 
a. Information on the general nature of the work in which the worker was subject 
to occupational exposure;  
 
b. Information on dose assessments, exposures and intakes at or above the relevant 
recording levels and the data upon which the dose assessments w ere based;  
 c. When a worker is or has been exposed while in the employ of more than one 
employer, information on the dates of employment with each employer and on 
the doses, and  exposures in each such employment;  
 
d. Records of any assessment of doses, exposur es and intakes due to actions taken 
in an emergency or due to accidents or other incidents, which shall be 
distinguished from doses, exposures and intakes due to normal conditions of 
work and which shall include references to reports of any relevant 
invest igations.  
7.4 Employers and licensees shall:  
 
a. Provide workers with access to records of their own occupational exposure;  
 
b. Provide the supervisor of the program for workers’ health surveillance, the FDA  
and the re levant employer with access to workers’ records of occupational 
exposure;  
c. Facilitate the provision of copies of workers’ exposure records to new 
employers when workers change employment;  
d. Make arrangements for the retention of exposure records for former workers by 
the employer or licensee, as appropriate;  
 
e. In complying with (a) –(d) above, give due care and attention to maintaining the 
confidentiality of records.  
 
7.5 If employers and licensees cease to conduct activities in which workers are subject 
to occupational exposure, they shall make arrangements for the retention of 
workers’ records of  occupational exposure by the FDA ( or other designated 
organization ) or by relevant employer or licensee.  
 
8. Workers’ Health Surveillance  
 
8.1 Employers and licensees, in accordance with the rules established by the FDA, shall 
make arrangements for appropriate health surveillance based on the general 
principles of occupational health and designed to assess the initial fitness and 
continuing fitness of workers for their i ntended tasks  
 
8.2 If one or more workers are to be engaged in work in which they are or could be 
exposed to radiation from a radiation device that is not under the control of their 
employer, the licensee responsible for the radiation device shall, as a precon dition 
for the engagement of such workers, make with the employer any special 
arrangements for workers’ health surveillance that are needed to comply with the 
rules established by the FDA or other relevant authority.  
 9. Information, Instructions and Training  
Employers, in cooperation with licensees:  
a. Shall provide all workers with adequate information on health risks due to their 
occupational exposure i n normal operation, anticipated operational occurrences 
and accident conditions, adequate instruction  and training and periodic 
retraining in protection and safety, and adequate information on the significance 
of their actions for protection and safety;  
 
b. Shall provide those workers who could be involved in or affected by the 
response to an emergency with appropriate information, and adequate 
instruction and training and periodic retraining, for protection and safety;  
c. Shall maintain records of the training provided to individual workers.  
 
10. Conditions of Service  
 
10.1 The conditions of service of workers shall be independent of whether they are or 
could be su bject to occupational exposure. Special compensatory arrangements or 
preferential consideration with respect to salary, special insurance coverage, 
working hours, length of vacation, additional holiday s or retirement benefits shall 
neither be granted nor be used as substitutes for measures for protection and safety 
in accordance with the requirements of these AO.  
 
10.2 Employers shall make all reasonable efforts to provide workers with suitable 
alternative employment in circumstances for which it has been determined, either 
by the FDA or in the framework of the program for workers’ health surveillance in 
accordance with the requirements of these AO, that workers, for health reasons, 
may no longer  continue in employment in which they are or could be subject to 
occupational exposure.  
 
11. Special Arrangements for Female Workers and for Persons U nder 18 years o f age 
Undergoing T raining  
 
11.1 Employers, in cooperation with licensees, shall provide female worke rs who are 
liable to enter controlled areas or supervised areas or who may undertake 
emergency duties with appropriate information on:  
 
a. The risk to the embryo or fetus due to exposure of a pregnant woman;  
 
b. The importance for a female worker of notifying he r employer as soon as 
possible if she suspects that she is pregnant.  
 
11.2 Notification of the employer by a female worker if she suspects that she is pregnant 
shall not be considered a reason to exclude a female worker from work. The employer of a female worke r, who has been notified of her suspected pregnancy 
shall adapt the working conditions in respect of occupational exposure so as to 
ensure that the embryo or fetus or the infant is afforded the same broad level of 
protection as is required for members of t he public.  
 
11.3 Employers and licensees shall ensure that no person under the age of 16 years is or 
could be subject to occupational exposure.  
 
11.4 Employers and licensees shall ensure that persons under the age of 18 years are 
allowed access to a controlled area only under supervision and only for the purpose 
of training for employment in which they are or could be subject to occupational 
exposure or for the purpose of studies in which radiation devices are used.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Part 5  
MEDICAL EXPOSURE  
 
1. General Responsibilities of Licensees  
 
1.1 Licensees shall ensure that no patient, whether symptomatic or asymptomatic, 
undergoes a medical exposure unless:  
 
a. It is radiological procedure that has been requested by a referring medical 
practitioner and information on the clinical context has been provided, or it is 
part of an approved health screening program;  
 
b. The medical exposure has been justified by means of consultation between the 
radiological medical practitioner and the r eferring medical practitioner, as 
appropriate, or it is part of an approved health screening program;  
 
c. A radiological medical practitioner has assumed responsibility for protection 
and safety in the planning and delivery of the medical exposure as specifie d in 
Section Part 5.1.4 (a) of this AO.  
 
d. The patient or the patient’s legal authorized representative has been informed, 
as appropriate, of the expected diagnostic or therapeutic benefits of the 
radiological procedure as well as the radiation risks.  
 
1.2 Licen sees shall ensure that no individual incurs a medical exposure as part of a 
program of biomedical research unless the exposure has been approved by an ethics 
committee (or other institutional body that has been assigned functions similar to 
those of an eth ics committee by the relevant authority) as required in paragraph 5 
of this Part and a radiological medical practitioner has assumed responsibility as 
specified in Part 5.1.4 (a) of this AO. Licensees shall ensure that the requirements 
are met for the opti mization of protection and safety for person subject to exposure 
as part of a program of biomedical research.  
 
1.3 Licensees shall ensure that no individual incurs a medical exposure as a carer or 
comforter unless he or she has received, and has indicated an u nderstanding of, 
relevant information on radiation protection and information on the radiation risks 
prior to providing care and comfort to an individual undergoing a radiological 
procedure. Licensees shall ensure that the requirements specified in Part 5. 8.1 are 
fulfilled for the optimization of protection and safety for any radiological procedure 
in which an individual acts as a carer or comforter.  
 
1.4 Licensees shall ensure that:  a. The radiological medical practitioner performing or overseeing the radiological 
procedure has assumed responsibility for ensuring overall protection and safety 
for patients in the planning and delivery of the medical exposure, including the 
justification of t he radiological procedure as required in Section Part 5.2 and the 
optimization of protection and safety, in cooperation with the medical physicist 
and the medical radiologic technologist;  
 
b. Radiological medical practitioners, medical physicists, radiologic/ x-ray 
technologists and other health professionals with specific duties in relation to 
protection and safety for patients in a given radiological procedure are 
specialized in the appropriate area;  
 
c. Sufficient medical personnel and paramedical personnel are available as 
required by DOH / FDA;  
d. Medical personnel and paramedical personnel are specialized in the appropriate 
area and meet the respective requirements for education, training and 
competence in radiation protection ( as specified by the F DA); 
 
e. The names of all medical and paramedical personnel are named in a list 
maintained up to - date;  
 
f. For therapeutic radiological procedures, the requirements of these AO for 
calibration, dosimetry and quality assurance, including the acceptance and 
commi ssioning of medical radiological equipment, as specified in Sections P art 
5.4, Part.5.1 (a), Part 5.6 , are conducted by or under the Supervision of a medical 
physicist;  
 
g. For diagnostic radiological procedures and image guided interventional 
procedures, the  requirements of these Standards for medical imaging, 
calibration, dosimetry and quality assurance, including the acceptance and 
commissioning of medical radiological equi pment, as specified in Part 5. 1 (a), 
5.1 (b), Part 5.8, Part 5.7.1 and 7.2,  are fulf illed by or under the oversight of or 
with the documented advice of a medical physicist, whose degree of 
involvement is determined by the complexity of the radiological procedures and 
the associated radiation risks;  
 
h. Any delegation of responsibilities by a  principal party is documented.  
 
2. Justification of Medical Exposure  
 
2.1 Medical exposures shall be justified by weighing the diagnostic or therapeutic 
benefits that they are expected to yield against the radiation detriment that they 
might cause, with account taken of the benefits and the risks of available alternative 
techniques that do not involve medical exposure.  
 2.2 The justification of medical exposure for an individual patient shall be carried out 
by means of consultation between the radiological me dical practitioner and the 
referring medical   practitioner, as appropriate, with account taken, in particular for 
patients who are pregnant or pediatric, of:  
 
a. The appropriateness of the request;  
 
b. The urgency of the radiological procedure;  
 
c. The characteristics of the medical exposure;  
 
d. The characteristics of the individual patient;  
 
e. Relevant information from the patient’s previous radiological procedures.  
 
2.3 Relevant national or international referral guidelines shall be taken into account for 
the justification of the medical exposure of an individual patient in a radiological 
procedure.  
 
2.4 Justification for radiological  procedures to be performed as part of a health 
screening program for asymptomatic populations shall be carried out by the health 
authority in conjunction with appropriate professional bodies.  
 
2.5 Any radiological procedure on an asymptomatic individual that is intended to be 
performed for the early detection of disease, but not as part of an approved health 
screening program, shall requir e specific justification for that individual by the 
radiological medical practitioner and the referring medical practitioner, in 
accordance with the guidelines of relevant professional bodies or the health 
authority. As part of this process, the individual  shall be informed in advance of the 
expected benefits, risks and limitations of the radiological procedure.  
 
2.6 The exposure of volunteers as part of a program of biomedical research is deemed 
to be not justified unless:  
 
a. It is in accordance with the provis ions of the World Medical Association 
Declaration of Helsinki, Ethical Principles for Medical Research Involving 
Human Subjects and follows the guidelines for its application prepared by the 
Council for International Organizations of Medical Sciences (CIOM S) in 
collaboration with the WHO, International Ethical Guidelines for Biomedical 
Research Involving Human Subjects ; and  
 
b. It is subject to approval by an ethics committee (or other institutional body that 
has been assigned functions similar to those of an ethics committee by the 
relevant authority), subj ect to any dose constraints that may be specified (as required in Part 5.8.2), and subject to applicable national regulations and local 
regulations.  
 
3. Optimization of Protection for Medical Exposures  
 
3.1 Licensees and radiological medical practitioners shall ensure that protection and 
safety is optimized for each medical exposure.  
 
Design considerations  
 
3.2 In addition to ensuring that the responsibilities stated in Part 7.1 are discharged, as 
applicable, licensees, in cooperation with suppliers, shall ensure that medical 
radiological equipment, and software that could influence the delivery of medical 
exposure are used only if they conforms to the applicable standards of the 
International Electrote chnical Commission (IEC) and the International 
Organization for Standardization (ISO) or to national standards adopted by the 
FDA.  
 
Operational considerations  
 
3.3 For diagnostic radiological procedures and image guided interventional procedures, 
the radiological medical practitioner, in cooperation with the medical radiologic 
technologist and the medical physicist, shall ensure that the following are used:  
 
a. Appropriate medical radiological equipment and software  
 
b. Appropriate techniques and parameters  to deliver a medical exposure of the 
patient that is the minimum necessary to fulfil the clinical purpose of the 
radiological procedure, with account taken of relevant norms of acceptable 
image quality established by relevant professional bodies and of re levant 
diagnostic reference levels established in accordance with Part 5.6.  
 
3.4 For therapeutic radiological procedures, the radiological medical practitioner, in 
cooperation with the medical physicist and the medical radiologic technologist, 
shall ensure tha t for each patient the exposure of volumes other than the planning 
target volume is kept as low as reasonably achievable consistent with delivery of 
the prescribed dose to the planning target volume within the required tolerances.  
 
3.5 Licensees shall ensure t hat the aspects  of medical exposures are considered in the 
optimization process for:  
 
a. Pediatric patients subject to medical exposure;  
 
b. Individuals subject to medical exposure as part of a health screening program;  
 c. Volunteers subject to medical exposure as part of a program of biomedical 
research;  
 
d. Relatively high doses to the patient;  
 
e. Exposure of the embryo or fetus, in particular for radiological procedures in 
which the abdomen or pelvis of the pregnant female patient is exposed to the 
useful radiation beam or could otherwise receive a significant dose;  
 
4. Calibration  
 
In accordance with Part 5.1.4 (f) and (g), the medical physicist shall ensure that:  
 
a. All radiation devices giving rise to medical exposure are calibrated in terms of 
appropriate q uantities using internationally accepted or nationally accepted 
protocols;  
 
b. Calibrations are carried out at the time of commissioning a unit prior to clinical 
use, after any maintenance procedure that could affect the dosimetry and at 
interval s required by the FDA in other regulations;  
 
c. Calibrations of radiotherapy units are subject to independent verification prior 
to clinical use;  
 
d. Calibration of all dosimeters used for dosimetry of patients and for the 
calibration of radiation devices is traceable to a standards dosimetry laboratory.  
 
5. Dosimetry of Patients  
 
5.1 Licensees shall ensure that dosimetry of patients is performed  and documented 
by or under the supervision of a medical physicist, using calibrated dosimeters  and 
following  internation ally accepted or nationally accepted protocols, including 
dosimetry to determine the following:  
 
a. For diagnostic radiological procedures, typical doses to patients for common 
procedures;  
 
b. For image guided interventional procedures, typical doses to patients;  
 
c. For therapeutic radiological procedures, absorbed doses to the planning target 
volume for each patient treated with external beam therapy and absorbed doses 
to relevant tissues or org ans as determined by the radiological medical 
practitioner;  
 
6. Diagnostic Reference Levels   
6.1 Licensees shall ensure that:  
 
a. Local assessments, on the basis of the measurements required in Part 5. 1.a, are 
made at approved intervals for those radiological procedures for which 
diagnostic reference levels have been established by FDA , through consultation 
with relevant professional bodies.  
 
b. A review is conducted to determine whether the optimization of protection and 
safety for patients is adequa te, or whether corrective action is required if, for a 
given radiological procedure:  
 
i. Typical doses or activities exceed the relevant diagnostic reference level; or  
 
ii. Typical doses or activities fall substantially below the relevant diagnostic 
reference lev el and the exposures do not provide useful diagnostic 
information or do not yield the expected medical benefit to the patient.  
 
7. Quality Assurance for Medical Exposure  
 
7.1 Licensees shall establish a comprehensive program of quality assurance for medical 
exposures with the active participation of medical physicists, radiological medical 
practitioners, medical radiologic technologists and in conjunction with other health 
professionals as appropriate.  
 
7.2 Licensees shall ensure that programs of quality assurance for medical exposures 
include, as appropriate to the medical radiation facility:  
 
a. Measurements of the physical parameters of medical radiological equipment 
made by or under the supervision of, a medical physicist:  
 
i. At the time of acceptance and c ommissioning of the equipment prior to its 
clinical use on patients;  
 
ii. Periodically thereafter;  
 
iii. After any major maintenance procedure that could affect protection and 
safety of patients;  
 
iv. After any installation of new software or modification of existing software 
that could affect protection and safety of patients;  
 
b. Implementation of corrective actions if measured values of the physical 
parameters mentioned in (a) are outside established tolerance limits;  
 c. Verification of the appropriate physical and clinical factors used in radiological 
procedures;  
 
d. Maintaining records of relevant procedures and results;  
 
e. Periodic checks of the calibration and conditions of operation of dosimetry 
equipment and monitoring equipment.  
 
7.3 Licensees shall ensure that reg ular and independent audits are made of the program 
of quality assurance for medical exposures, and that their frequency is in accordance 
with the complexity of the radiological procedures being performed and the 
associated risks.  
 
8. Dose Constraints  
 
8.1 Licensees shall ensure that relevant dose constraints are used in the optimization of 
protection and safety in any radiological procedure in which an individual acts as a 
carer or comforter.  
 
8.2 Licensees shall ensure that dose constraints specif ied or approved by the ethics 
committee, or by another institutional body that has been assigned functions similar 
to those of an ethics committee by the relevant authority, on a case by case basis as 
part of a proposal for bi omedical research (Part  5.2.6 ) are used in the optimization 
of protection and safety for person subject to exposure as part of a program of 
biomedical research.  
 
9. Pregnant Patients  
 
9.1 Licensees shall ensure that there are arrangements in place for appropriate radiation 
protection in case s where a female patient is or might be pregnant.  
 
9.2 Licensees shall ensure that signs in appropriate languages are placed in public 
places, waiting rooms for patients, cubicles and other appropriate places, and that 
other means of communication are also use d as appropriate, to request female 
patients who are to undergo a radiological procedure to notify the radiological 
medical practitioner, medical radiologic technologist or other personnel in the event 
that she is or might be pregnant;  
 
9.3 Licensees shall ens ure that there are procedures in place for ascertaining the 
pregnancy status of a female patient of  reproductive capacity before the 
performance of any radiological procedure that could result in a significant dose to 
the embryo or fetus, so that this inf ormation can be considered in the justification 
for the  radiological procedure ( Part 5.2.1) and in the optimization of protection and 
safety.  
 10. Unintended and Accidental Medical Exposures  
 
Licensees, in accordance with the relevant requirements of Section VI.B.8, Part 1.6 and 
Part 7, shall ensure that all practicable measures are taken to minimize the likelihood of 
unintended or accidental medical exposures arising from flaws in design and operational 
failures of medical radiological equipment, from  failures of and errors in software, or as a 
result of human error.  
 
11. Investigation of Unintended and Accidental Medical Exposures  
 
11.1 Licensees shall promptly investigate any of the following unintended or accidental 
medical exposure:  
 
a. Any medical treatment d elivered to the wrong individual or to the wrong 
tissue or organ of the patient or dose fractionation differing substantially 
from (over or under) the values prescribed by the radiological medical 
practitioner, or that could lead to unduly severe secondary  effects;  
 
b. Any diagnostic radiological procedure or image guided interventional 
procedure in which the wrong individual or the wrong tissue or organ of 
the patient is subject to exposure  
 
c. Any exposure for diagnostic purposes that is substantially greater than was 
intended;  
 
d. Any exposure arising from an image guided interventional procedure that 
is substantially greater than was intended;  
 
e. Any inadvertent exposure of the embryo or fetus in the course of 
performing a radiological proced ure; 
 
f. Any failure of medical radiological equipment, failure of software or 
system failure, accident, error, mishap or other unusual occurrence with the 
potential for subjecting the patient to a medical exposure that is 
substantially different from what wa s intended.  
 
11.2 Licensees shall, with regard to any unintended or accidental medical exposures 
investigated as required above:  
 
a. Calculate or estimate the doses received and the dose distribution within the 
patient;  
 
b. Indicate the corrective actions required to prevent recurrence of such an 
unintended or accidental exposure;  
 c. Implement all the corrective actions that are under their own responsibility;  
 
d. Produce and keep, as soon as possible after the investigation or as otherwise 
required by the regul atory body, a written record that states the cause of the 
unintended or accidental medical exposure and includes the information 
specified in (a) to (c) above, as relevant, and any other information as required 
by the FDA; and for significant unintended or  accidental medical exposures or 
as otherwise required by the FDA, submit this written record, as soon as 
possible, to the FDA, and to the relevant health authority if appropriate;  
 
e. Ensure that the appropriate radiological medical practitioner informs the 
referring medical practitioner and the patient or the patient’s legal authorized 
representative of the unintended or accidental medical exposure.  
 
12. Radiological Reviews  
 
Licensees shall ensure that radiological reviews are performed periodically by the 
radiological medical practitioners at the medical radiation facility, in cooperation with the 
medical radiologic technologists and the medical physicists. The radiological review shall 
include an investigation and critical review of the current practical appli cation of the 
radiation protection principles of justification and optimization for the radiological 
procedures that are performed in the medical radiation facility.  
 
13. Records Related to Medical Exposures  
 
13.1 Licensees shall maintain for a period as specified by the regulatory body and shall 
make available, as required, the following personnel records:  
 
a. Records of any delegation of responsibilities by principal parties (as required in 
Part 5.1.4 (h));  
 
b. Records of training of personnel in radiation pro tection.  
 
13.2 Licensees shall maintain for a period as specified by the FDA and shall make 
available, as required, the following records of calibration, dosimetry and quality 
assurance:  
 
a. Records of the results of the calibrations and periodic checks of the relevant 
physical and clinical parameters selected during treatment of patients;  
 
b. Records of dosimetry of patients, as required in Part 5.5;  
 
c. Records of local assessments and reviews made with regard to diagnostic 
reference levels, as required in Part 5.6 ; 
 d. Records associated with the quality assurance program, as required in Part 5.7.2 
(d). 
 
13.3 Licensees shall maintain for a period as specified by the regulatory body and shall 
make available, as required, the following records for medical exposure:  
 
a. For diagnostic radiology, information necessary for retrospective assessment 
of doses, including the number of exposures and the duration of fluoroscopic 
radiological procedures;  
 
b. For image guided interventional procedures, information necessary for 
retrospective assessment of doses, including the duration of the fluoroscopic 
component and the number of images acquired;  
 
c. For external beam radiation therapy, a description of the planning target 
volume, the absorbed dose to the centre of the planning ta rget volume, and the 
maximum and minimum absorbed doses delivered to the planning target 
volume, or equivalent alternative information on absorbed doses to the 
planning target volume, and the absorbed doses to relevant tissues or organs as 
determined by th e radiological medical practitioner; and in addition, for 
external beam radiation therapy, the dose fractionation and the overall 
treatment time;  
 
d. Exposure records for volunteers subject to medical exposure as part of a 
programme of biomedical research;  
 
e. Reports on investigations of unintended and accidental medical exposures (as 
required in Part 5. 11.2 (d).  
 
 
 
 
 
 
 
 
 
 
 
 Part 6  
PUBLIC EXPOSURE  
 
1. General Responsibilities  
 
1.1 Licensees in cooperation with suppliers, in applying the principle of optimization 
of protection and safety in the design, planning, operation of an radiation devices, 
shall take into account :  
 
a. Good design and construction of the facility  
 
b. Good practice in the operation of the f acility using radiation devices  
 
1.2 Licensees, using radiation devices under their responsibility, shall establish, 
implement and maintain:  
 
a. Policies, procedures and organizational arrangements for protection and safety 
in relation to public exposure, and in accordance with the requirements of these 
AO; 
 
b. Measures for ensuring:  
 
i. Optimization of protection and safety;  
 
ii. Limitation of exposure of members of the public from such radiation 
devices, in order that the total exposure is not higher than the dose limits for 
members of the public as specified in Annex B of this AO;  
 
c. Measures for ensuring the safety of such radiation devices;  
 
d. Provision for suitable and adequate radiation devices (including facilities, 
equipment and services) for the protection and safety of members of the public, 
comm ensurate with the likelihood and magnitude of the exposures;  
 
e. Programmes for appropriate training of personnel having functions relevant to 
the protection and safety of the public, as well as periodic retraining as required, 
to ensure the necessary level o f competence;  
 
f. Provision for appropriate monitoring equipment, monitoring programmes and 
methods for assessing public exposure  
 
g. Emergency plans, emergency procedures and emergency response 
arrangements, in accordance with the nature and magnitude of the radiation 
risks associated with the radiation devices;   
h. Adequate records of monitoring programmes.  
 
2. Control of Visitors  
 
Licensee s, in cooperation with employers where appropriate, shall:  
 
a. Apply the relevant requirements of these AO in respect of public exposure for 
visitors to a controlled area or a supervised area;  
 
b. Ensure that visitors are accompanied in any controlled area by a  person who 
knows the measures for protection and safety for the controlled area;  
 
c. Provide adequate information and instructions to visitors before they enter a 
controlled area or a supervised area so as to provide protection and safety for 
visitors and ot her individuals who could be affected by their actions;  
 
d. Ensure that adequate control is maintained over the entry of visitors to a 
controlled area or a supervised area, including the use of signs for such areas.  
 
3. Radiation Devices of External Irradiation  
 
Licensees shall ensure that if a radiation device can give rise to external exposure of 
members of the public:  
 
a. The floor plans and arrangements of equipment for all new installations utilizing 
such radiation devices, as well as all significant modifications to existing 
installations, are subject, as appropriate, to review and approval by the FDA 
prior to commissioning;  
 
b. Shielding and other measures for protection and safety, including access 
controls, are provided as appropriate for restricting public exposure, in 
particular at open sites such as for some applications of industrial radiography.  
 
4. Monitoring of Public Exposure  
 
Licensees shall, as appropriate:  
 
a. Establish and implement monitoring programs to ensure that public exposure 
due to radiat ion devices under their responsibility is adequately assessed and 
that the assessment is sufficient to verify and demonstrate compliance with the 
authorization. These programs shall include monitoring of the external exposure 
from radiation devices; and ot her parameters for the assessment of public 
exposure;  
 b. Maintain appropriate records of the results of the monitoring programs and 
estimated doses to members of the public;  
 
c. Report promptly to the FDA any levels exceeding the operational limits and 
conditions relating to public exposure, in accordance with reporting criteria 
established by the FDA;  
 
d. Report promptly to the FDA any significant increase in dose rate in accordance 
with reporting criteria established by the FDA in specific regulations;  
 
e. Establish and maintain a capability to carry out monitoring in an emergency, in 
the event of unexpected increases in radiation levels due to accidents or other 
unusual events attributed to the authorized use of radiation devices or operation 
of the x -ray fa cility;  
 
f. Verify the adequacy of the assumptions made for the assessment of public 
exposure;  
 
g. Publish or make available on request by the FDA, results from radiation devices 
monitoring and assessments made of doses from public exposure.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Part 7 
RADIATION DEVICES  
 
 
1. General Responsibilities  
 
1.1 The licensee, in cooperation with other responsible parties, shall ensure that the 
siting, location, design, construction, assembly, commissioning, operation, 
maintenance and closure of facilities using radiation devices are based on good 
engineering practice which shall, as appropriate:  
 
a. Take account of international and national standards;  
 
b. Be supported by managerial and organizational features, with the purpose of 
ensuring protection and safety throughout the lifetime of the facility;  
 
c. Include adequate safety margins in the design and construction of the facility, 
and in operations involving the facility using radiation devices, so as to ensure 
reliable performance in normal  operation, and take account of the necessary 
quality, redundancy and capability for inspection, with emphasis on preventing 
accidents, mitigating the consequences of those accidents that do occur and 
restricting any possible future exposures;  
 
d. Take account of relevant developments concerning technical criteria, as well as 
the results of any relevant research on protection and safety and feedback of 
information on lessons learned from experience.  
 
1.2 Where applicable, licensees shall make suitable arrang ements with suppliers of 
radiation devices and radiation devices, the FDA and relevant parties for the 
purposes of:  
 
a. obtaining information on conditions of use and operating experience that may 
be important for protection and safety;  
 
b. providing feedback an d information that may have implications for protection 
and safety for other users, or that may have implications for the possibility for 
improvements in protection and safety for radiation devices  
 
2. Design of Radiation Devices  
 
2.1 Licensees who are manufactur ers and suppliers of ionizing radiation devices shall:  
 
a. supply well -designed, well -manufactured and well - constructed radiation 
devices;  
 b. demonstrate radiation devices meets specifications in conformance to 
applicable technical standards (such as IEC and ISO – equivalent standards or 
where applicable Philippine National Standards ; 
 
c. provide instructions on installation, operating and maintenance;  
 
d. ensure that the radiation device meets quality standards commensurate with the 
significance for protection and safety of systems and components, including 
software;  
 
e. ensure protective devices (e.g. shielding) are optimized;  
 
f. provides clear displays, gauges and instructions on operating consoles in a 
language understandable to the users) (local langua ge or in English);  
 
g. ensure that radiation devices are tested to demonstrate compliance with the 
relevant specifications; Ensuring that the protection provided by shielding and 
by other protective devices is optimized  
 
2.2 Licensees shall ensure that arrangemen ts are made promptly for the safe 
management of and control over radiation devices, including appropriate financial 
provision, once it has been decided to take them out of use.