1 FDA CIRCULAR  
No. ____________ 
S
UBJECT  :  Guidelines on the Conduct of Regulatory Inspections for 
Radiation Facilities  
I. B
ACKGROUND
T
he Department of Health (DOH), through the issuance of Administrative Order No. 2020 -
0035 or the Rules and Regulations on the Licensing and Registration of Radiation Facilities 
Involved in the Use of Radiation Devices and Issuance of Other Related Authori zations, 
provided an updated, re -engineered, and streamlined regulatory guideline in the 
authorization of radiation facilities, repealing DOH AO No. 124 s. 1992.  
A
mong the major changes introduced in the issuance of AO No. 2020- 0035, is the use of a 
graded or risk -based approach in the conduct of regulatory inspection of facilities 
commensurate with the radiation risks associated with the conduct of its activities. Such approach was utilized when the Food and Drug Administration (FDA) issued FDA Circular No. 2020- 035, entitled, “Interim Guidelines for the Conduct of Licensing Inspection for 
Radiation Facilities” adopting measures in tackling regulatory challenges faced during the 
COVID-19 pandemic. 
F
DA Circular No. 2020 -035 included provisions in the conduct of alternative arrangements 
and virtual inspections for continuous government service delivery while ensuring the safety of both its clients and regulatory officers. The conduct of on -line and virtual 
inspections are one of the risk -mitigating measures included in the FDA’s own Public 
Service Continuity Plan (PSCP)  line with the goals of Republic Act No. 10121 or the 
Philippine Disaster Risk Reduction and Management Act of 2010, the Sendai Framework for Disaster Risk Reduction 2015- 2030, and the ASEAN Agreement on Disaster 
Management and Emergency Response (AADMER), which requires the  implementation 
of policies, actions, and measures  to ensure the continuous performance any agency’s 
essential functions during an emergency.
1 
In
 view of the foregoing, the FDA aims to operationalize and supplement the provisions of 
DOH AO No. No. 2020 -0035 providing for a rationalized process for the conduct of 
regulatory inspections for radiation facilities. This FDA Circular is issued to revoke the FDA Circular No. 2020 -035 and provide uniform guidelines on the conduct of regulatory 
inspections for radiation facilities under the jurisdiction of the FDA.  
1 Section II. Legal & Policy Bases of Public Service Continuity Planning . The Public Service Continuity Planning (PSCP) Guidebook. PDRF, OCD, & NDRRMC, 2020
DRAFT FOR COMMENTS2 
 II. OBJECTIVES  
 
This Circular aims to outline guidelines on the conduct of regulatory inspections for radiation facilities with alternative modes and approaches  using digital means  to the 
conduct of such  in line with the graded approach established through DOH AO No. 2020-
0035.  
 
III. SCOPE  
 This Circular shall apply to  regulatory inspections  of radiation facilities to be  conducted as 
part of the authorization process  and continuous compliance  of radiation facilities under 
the jurisdiction of the FDA.  
 
IV. DEFINITION OF TERMS  
 
For the purpose of this Circular , the following terms shall mean and be understood as 
follows:  
 
A. Corrective Action / Preventive Action  (CAPA)  – refers to  the action done by 
radiation facility to comply to noted findings during the conduct of regulatory inspections and shall require subsequent compliance within a specified timeline.  
 
B. Regulatory Inspection  – refers to the regulatory enforcement and oversight 
activity to ensure that radiation facilities are meeting establis hed regulatory 
standards and policies.  Specifically, the types and modes of conducting 
regulatory inspections are:  
 
1. Modes of Conducting Regulatory Inspection 
 
a. On-Site Inspection  – refers to the mode of conducting regulatory 
inspections for radiation facilities through on- site physical evaluation, 
assessment, and/or verification of compliance.  
b. Virtual Inspection  – pertaining to  mode of conducting regulatory 
inspections through re al-time interactive online electronic 
communication devices or conferencing services.  
2. Types  of Regulatory Inspection ( DOH AO No. 2020-0035) 
 
a. Pre-Licensing Inspection / Radiation Protection Survey and 
Evaluation (RPSE)  – refers to a comprehensive and complete on- site 
inspection and evaluation of the radiation facility including, but not 
DRAFT FOR COMMENTS3 limited to the verification of submitted/compliance documents, 
evaluation of the qualification and number manpower  requirements, 
safety and quality of equipment, radiation safety programs, quality assurance programs, verification test and actual measurements to assess the performance of the machine, x- ray tube leakage radiation, checking 
adequacy of shielding barriers, accessories, and compliance with the 
appropriate requirements of this Order. 
b.Po
st-licensing Inspection (PLI) / Facility Compliance Monitoring
(FCM)  – refers to a post -approval inspection conducted to all radiation
facilitie s classified as high- risk facilities, as part of surveillance /
investigation activities to monitor continuous compliance with the
licensing requirements, accident/incident follow up, and specialinspection made because of reported violations of the relevant rules andregulations issued by the FDA.
c.Po
st-registration Inspection (PRI) / Facility Compliance
Monitoring (FCM)  – refers to a post -approval inspection conducted to
all radiation facilities classified as medium- risk facilities as part of
surveillance/investigation activities to monitor continuous compliancewith the facility registration requirements or because of reportedviolations of the relevant rules and regulations issued by the FDA.
C.S
elf-Assessment  Forms  (SAF) – refers to  guide documents  to be  accomplished
by applicants to check their  compliance to current regulatory standards.
V. G
ENERAL GUIDELINES
A.Th
e conduct of regulatory inspection for radiation facilities shall be  in
accordance with DOH A.O. No. 2020-0035, where a graded approach is applied
commensurate to the nature of hazard and level of risk associated with  radiation
facilities and activities .
B.S
elf-Assessment Forms (SAF)  (Annex  A to D) shall be accomplished by
applicants  and shall be submitted prior to the conduct of regulatory inspections
for initial and major variation application s.
C.V
irtual Inspection shall be done where circumstances will not allow for  the
conduct of On- site Inspection, such as but not limited to, a state of public health
emergency or state of calamity.
DRAFT FOR COMMENTS4 D. On -Site and Virtual Inspections shall follow an inspection process to provide
for comprehensive steps for the conduct of inspection and the timely completion
of the process.
E.I
f the conduct of Pre -licensing Inspection, whether on- site or virtual, was not
undertaken due to forc e majeure or any unforeseen event , appropriate
adjustments sh all be made as prescribed by  DOH A.O. No. 2020-0035.
F.D
irectives, findings, and violations noted by assigned inspectors shall be
reflected in the inspection report . Compliance of inspected facilities to noted
findings shall be done through the submission of Corrective Action / Preventive
Action (CAPA)  Form .
G.R
egulatory inspections for radiation facilities may be done motu propio in
adherence to FDA’s mandate in ensuring the compliance of regulated entities toestablished regulatory standards and polici es.
VI
. SPECIFIC GUIDELINES
A.C
onduct of Regulatory Inspection
1. Ra
diation facilities applying for a License to Operate (LTO) or  a Certificate
of Compliance (COC) for facilities under the DOH One -Stop Shop Licensing
System  shall undergo Pre- Licensing Inspection.
2.R
adiation  facilities applying for a Certificate of Facility Registration (CFR)
shall be subjected to Post- Registration Inspection .
3.R
adiation facilities applying for major variation shall undergo appropriate
regulatory inspection prior to the issuance of authorizat ion. For minor
variations , regulatory inspections shall be done after  the issuance of
authorization.
4.A
ll regulatory i nspection  done after the issuance of an authorization are
unannounced. Authorized radiation facilities shall allow FDA personnel to
perform  regulatory inspections anytime.
5.T
he conduct of Post- Licensing and Post -Registration Inspections for
radiation facilities shall be done by CDRRHR  in view of the limited
availability of technical personnel.
DRAFT FOR COMMENTS5 
 6. In consonance with DOH A.O. No. 2020- 0035 and its classif ication of  
radiation facilities and authorizations , the following schedule for the conduct 
of Post-Licensing and Post-Registration Inspections shall be observed: 
 
Classification of Radiati on Facility  Level of 
Risk  Schedule of 
Inspection  
MEDICAL    
Diagnostic X-ray Facilities    
1. General Radiography / Fluoroscopy  High  Once in  every  3 
years  2. Computed Tomography  High  
3. Mammography  High  
4. Bone Densitometry  Medium  Once in every 5 
years  
Interventional X-ray Facilities  High  Once every  year 
(Due to increased 
complexity and use of 
higher doses per 
procedure)  Therapeutic Radiation Facilities High  
DENTAL    
1. Periapical  Medium  Once in every 5 
years  
2. Panoramic / Cephalometric  High  Once in every 3 
years  3. CBCT  High  
NON -MEDICAL    
Anti-Crime    
1. Linear Accelerators for Anti -Crime 
Applications  High  Once in every 3 
years  
2. Security and Baggage Inspection System  Medium  Once in every 5 
years  
Education, Training, and Research  High  Once in every 3 
years  
Industrial    
1. Open -type Industrial Radiography  High  Once in every 3 
years  
2. Closed -type Industrial Radiography  Medium  Once in every 5 
years  
3. Linear Accelerators for Industrial 
Applications  High  
Once in every 3 
years  4. Computed Tomography for Industrial 
Applications  High  
5. Non-Destructive testing  High  
Veterinary  High  
 
DRAFT FOR COMMENTS6 
 7. The FDA reserves the right to conduct additional regulatory inspections as 
deemed necessary.  
 
B. Regulatory Inspection Process  
 
Process  Pre-Licensing Inspection  
On-site Virtual  
Preparatory 
Phase  Assigned inspectors shall send a formal notice of inspection to inform the applicant of the schedule of inspection. Assigned inspectors shall send the 
formal notice of inspection containing the online meeting link to be used throughout the conduct 
of the inspection.  
The facility to be inspected shall make available all relevant 
requirements such as but not limited to installed, calibrated, and functioning radiation device(s); administrative requirements; and 
operational requirements; among others.  
The facility to be inspected shall accomplish and prepare the SAF for the conduct of inspection. 
Survey and Evaluation Phase  An opening conference shall be 
conducted between the CDRRHR assigned inspectors and the facility . This shall include the 
introduction of parties, purpose and the scope of inspection, and 
flow of the inspection.  Same process with on -site but 
through the onl ine meeting link 
provided. 
Verification of the Self -Assessment Form (SAF) accomplished by the 
Facility  
Document review and  actual 
demonstration of regular clinical practice shall also be assessed.  Same process with on -site but 
through the online meeting platform, video recordings, or any other applicable mode of 
assessment.  
Physical manifestation of 
requirements and documentary 
evidence shall be required.  Scanned copies or photos of 
requirements shall be prepared 
and uploaded for assessment.  
Inspectors shall conduct Radiation 
Protection Survey and Evaluation (RPSE) and machine verification 
tests.  RPSE & verification tests shall be done after the issuance of authorization. 
Conduct of facility tour. Virtual facility tour subject to 
internet connectivity.  
Inspectors shall corroborate and prepare the final inspection report.  
DRAFT FOR COMMENTS7 
 Reporting 
Phase  An exit conference shall be 
conducted to discuss the findings , 
comments, and recommendations 
of the inspectors  to the facility . Same process with on -site but 
through the online meeting link provided. 
The inspection report shall be prepared and issued by the assigned inspector s to the facility.  
Where necessary, any findings noted shall merit the submission of CAP A by the facility pursuant 
to Section VI.D of this Circular.  Same process but t he inspection 
report  shall be transmitted online 
to the facility.  
 
Process  Post-Licensing / Registration Inspection  
On-site Virtual  
Preparatory Phase  Inspectors shall visit assigned facilities unannounced. Inspectors shall inform the 
facility of the inspection within the day through call and email. The inspectors shall provide an online meeting link to be used throughout the conduct of the 
inspection.  
If the facility did not acknowledge the notice for virtual inspection and  all efforts to 
contact the facility is exhausted and the facility remained unresponsive, CDRRHR will formally send a compliance letter through physical and electronic mail to seek explanati on 
regarding their unresponsiveness. 
Survey and Evaluation Phase  An opening conference shall be 
conducted between the CDRRHR assigned inspectors and the facility . This shall include the 
introduction of parties, purpose Same process with on -site but 
through the online meeting platform, video recordings, or any other applicable mode of 
assessment.  
DRAFT FOR COMMENTS8 
 and the scope of inspection, and 
flow of the inspection.  
Aside fro m document review, 
actual demonstration of regular 
clinical practice shall also be 
assessed.  
Physical manifestation of 
requirements and documentary 
evidence shall be required.  
Inspectors may conduct Radiation 
Protection Survey and Evaluation (RPSE) and machine verification 
tests.  
Conduct of facility tour.  
Reporting Phase  Inspectors shall corroborate and prepare the final inspection report.  
An exit conference shall be conducted to discuss the findings , 
comments, and recommendations of the inspectors  to the facility . 
The inspection report shall be 
issued by the assigned inspector s 
to the facility.  Where necessary, 
any findings noted shall me rit the 
submission of CAPA by the facility pursuant to Section VI.D 
of this Circular.  Same process but t he inspection 
report  shall be transmitted online 
to the facility.  
Any violation noted by inspectors, shall constitute appropriate 
regulatory action, remedy, or tool as specified in the inspection form to 
be given to the facility  pursuant to Section VI.D of this Circular .   
 
C. Self-Assessment Forms (SAF)  
 
1. Applicants shall accomplish and submit the SAF to CDRRHR assigned 
inspectors before the conduct of Pre -Licensing Inspections following the 
guidelines outlined in Annex A .  
 
2. The following Annexes shall be accomplished per specific type of radiation device being applied for: 
 
Annex  B SAF for Therapeutic X -ray Facilities utilizing Medical 
Linear Accelerators  
Annex  C General SAF for Diagnostic and Dental X -ray Facilities  
Annex C -1 Specific SAF for General Radiography and Fluoroscopic 
Machines  
DRAFT FOR COMMENTS9 
 Annex C -2 Specific SAF for Computed Tomography Machines  
Annex C -3 Specific SAF for Mammography Machines  
Annex C -4 Specific SAF for Dental X -ray Machines  
Annex C -5 Specific SAF for Bone Densitometers  
Annex D  General SAF for Industrial X -ray Facilities  
Annex D -1 Specific SAF for Industrial Radiographic Equipment  
Annex D -2 Specific SAF for Industrial Fluoroscopic Equipment  
Annex D -3 Specific SAF for Industrial X -ray Gauges  
Annex D -4 Specific SAF for Industrial X -ray Analytical Equipment  
Annex D -5 Specific SAF for Anti-Crime Cabinet -type X -ray Device  
Annex D -6 Specific SAF for Non -Medical Linear Accelerator 
(LINAC)  
 
D. Compliance to Noted Findings and Violation s 
 
1. Any of the following findings by the inspection team shall be  classified 
as a violation and shall be  noted in the inspection report  as basis  for 
further regulatory action: 
 
a. Operation of a radiation facility without a valid FD A 
authorization; 
 
b. Operation of a radiation facility without the required qualified 
personnel;  
c. Operation of radiation devices without a functioning collimator or appropriate beam -limiting  apparatus ; 
 
d. Operation of a radiation facility with no protective barrier; and, 
 
e. Non-compliance to a previous finding for compliance  or non-
submission of required CAPA. 
 
2. Aside from the enumerated above, any other findings  noted by the 
inspection team  during the conduct of regulatory inspections  shall merit 
the requirement of a CAPA . 
 
3. The applicant shall provide complete compliance documents or evidence on or before the deadline. Incomplete or late submissions shall be considered as grounds for legal action, or any other penalties 
prescribed by law. 
DRAFT FOR COMMENTS10 
  
4. For facilities with violations , CDRRHR shall forward a Report of 
Violation (ROV) to the Legal Services Support Center (LSSC) of FDA 
for appropriate action pursuant to the Implementing Rules and Regulations (IRR) of RA 9711. The radiation facility shall coordinate and comply with any administrative or legal proceedings following 
existing  FDA guidelines and processes. 
 
VII. PENALTY CLAUSE  
 
Any person, juridical or natural, found to violate any of the provisions set herein shall be imposed with administrative penalties/sanctions prescribed in Section 13 of Republic Act 9711 and Book III, Article XI of its Implementing Rules and Regulations. 
 
VIII.  SEPARABILITY CLAUSE  
 
In case any section or provision of this Circular or any part thereof, or the application of such section, provision or portion shall be declared invalid, the validity of the remaining 
provisions of this Circular shall not in any way be affected or impaired thereby. 
 
IX. REPEALING CLAUSE  
 The FDA Circular No. 2020-035 or the “Interim Guidelines for the Conduct of Licensing 
Inspection for Radiation Facilities ,” BHDT Bureau Order No. 46 s. 2003 entitled “Revision 
of Bureau Order No. 90 s. 2002,” and CDRRHR Center Order No. 2015- 071 or “Policies 
in Reporting the Violations Noted by the Health Physics Team in the Regular Conduct of 
RPSE and FCM”  are hereby repealed  and superseded. Any other FDA issuances that are 
inconsistent with the provisions of this Circular are hereby modified or repealed accordingly.  
 X. EFFECTIVITY  
 
This Circular shall take effect fifteen (15) days after its publication in the Official Gazette or in any newspaper of general circulation and upon filing with the University of the Philippines Law Center Office of the National Administrative Register.  
  
 
               DR. SAMUEL A. ZACATE  
                            Director General
 
Office  FDA-CDRRHR  FDA-PPS FDA-LSSC  
Initialed 
by  
 
 
 
MARIA CECILIA C. MATIENZO  
Director IV   
 
 
 
IRENE V. FLORENTINO -FARIÑAS, MD, RPh, MNSA  
Officer -in-Charge   
 
 
 
ATTY. EMILIO L. POLIG, JR.  
Director I II 
Date     
 
DRAFT FOR COMMENTS1 
 ANNEX A  
 
General Guidelines in Accomplishing the Self -Assessment Forms (SAF)  
 
1. Applicants shall download the SAFs at the FDA website - Downloadables  Section 
(https://www.fda.gov.ph/downloadables/ ) 
 
2. Documentary evidence, attachments , and supporting files  to the SAF shall be required 
for virtual pre -licensing inspections  only, applicants shall upload the SAF and its 
attachments to an  online cloud folder before the conduct of inspection. 
 
3. Applicants shall accomplish and submit the SAF through email before the conduct of 
on-site Pre -Licensing Inspection. 
 
4. The facility shall write/encode all necessary details in the SAF. Important details such as serial numbers and brand names shall reflect the same details provided in the applicant’s License Application Form (LAF).  
5. Use a check mark ( ✓) in filling out the checklist and provide necessary details in writing 
where applicable.  
 
6. Attach to the General SAF, all Specific SAF per machine being applied for as outlined in the machine list provided.  
7. The copy of accomplished SAF shall be kept by the  facility to be used for every conduct 
of regulatory inspection. 
DRAFT FOR COMMENTSPage 1 of 6 
   
 
  
THERAPEUTIC X- RAY FACILITY 
SELF ASSESSMENT CHECKLIST  
(Adapted from the current FDA -CDRRHR Radiation Protection Survey and Evaluation (RPSE) Checklists  for Regulatory Inspections ) 
(Based on A.O. 2020 -0035, A.O. 2022- 0022, and A.O. 31 s. 2013)  
 
 
Kindly put  in the appropriate column with the specific requirement as  stated below . Please provide evidence if necessary.  
 I. PERSONNEL REQUIREMENTS  
 
REQUIREMENTS  YES  NO 
1. One (1) radiation oncologist, w ho is an active member in good standing of the 
Philippine Radiation Oncology Society (PROS) and the Philippine College of 
Radi ology. (Refer to A.O. 31 s. 2013 Section 4.1.1)  
a. A chief radiation oncologist who is certified in the practice of radiation 
oncology by the Philippine Board of Radiology in Radiation Oncology shall be 
appointed. (Refer to A.O. 31 s. 2013 Section 4.1.2)  
b. Please provide notarized employment contract between the facility and the 
Radiation Oncologist.  
   
2. A Certified Medical Physicist in R adiation Oncology Medical Physics (CMP -
ROMP) who is certified by the Philippine Board of Medical Physics Section 
Radiation Oncology Medical Physics and is an active member in good standing of 
the Society of Medical Physicists in the Republic of the Philippines (SMPRP) shall 
be appointed. (Refer to A.O. 31 s. 2013 Section 4.2)  
a. The CMP -ROMP shall not be affiliated with not more than 3 facilities. (Refer 
to A.O. 31 s. 2013 Section 4.2.2)  
b. Please provide notarized employment contract between the facility and the  
CMP -ROMP.    
    
3. A full -time ROMP who is also an active member in good standing of SMPRP shall 
be hired. (Refer to A.O. 31 s.  2013 Section 4.2)  
   
4. The following documents and training certificates of ROMPs shall be provided:  
a. Notarized employment contract  between the facility and the in -house ROMP;  
b. Structured clinical training in ROMP under the close supervision of a CMP -
ROMP fo r a period of at least three (3) months (Refer to A.O. 31 s. 2013 
Section XV.C.2.b) ; 
c. One (1) week training on the facility’s treat ment  planning system under the 
supervision of the supplier’s application specialist; and 
d. One (1) week appropriate training in the equipment under the supervision of the supplier’s application specialist.    Nam e of Facility  
 Date Accomplished  
Facility Address  
 
 ANNEX B 
DRAFT FOR COMMENTSPage 2 of 6 
 5. A minimum of four (4) full -time radiotherapy tech nologists (RTTs) shall be 
employed for each medical linear accelerator operating for an 8 -hour shift.  (Refer to 
A.O. 31 s. 201 3 Section 4. 3.3) 
   
6. Among the four (4) RTTs, a chief radiotherapy technologist who is registered with 
the Professional Regulation Com mission (PRC) shall be appointed. (Refer to A.O. 
31 s. 2013 Section 4. 3.5) 
   
7. Refer to A.O. 31 s. 2013 Section 4.3.6 -8 for provisions for additional RTTs in the 
facility.  
   
8. The following documents and training certificates of RTTs shall be provided:  
a. Notarized employment contract between the facility and RTTs.  
b. The RTTs shall have undergone training in a therapeutic x- ray fa cility for at 
least (6) months under the supervision of a senior RTT and CMP -ROMP. 
(Refer to A.O. 31 s. 2013 Section 4. 3.1) 
   
9. RTTs s hall undergo at least one (1) week appropriate hand -on training on the 
equipment under the supervision of the supplier’s a pplication specialist. (Refer to 
A.O. 31 s. 2013 Section 4. 3) 
   
10. The Radiation Protection Officer (RPO) who is a medical physicis t and has a proper 
training in radiation protection and safety in radiation therapy shall be appointed. 
Please provide appoint ment letter authorizing the RPO to stop all unsafe activities 
involving the operation of therapeutic equipment. (Refer to A.O. 31 s. 2 013 Section 
4.4.1) 
   
11. The Assistant RPO who has the same qualifications with the RPO shall also be 
appointed. Please provide appointment letter authorizing the RPO to stop all unsafe 
activities involving the operation of therapeutic equipment. (Refer to A.O. 31 s. 
2013 Section 4. 4.3)   
 
II. MACHINE DETAILS  
A. Therapeutic X -ray Equipment  
Name of manufacturer  : _____________________ __________________________________________  
Address  : _______________________________________________________________  
Model name and number  : _______________________________________________________________  
Serial number  : ________________________________ _______________________________  
Country of manufacture  : _______________________________________________________________  
Year of  man ufacture  : _______________________________________________________________  
*Please provide a photo of sticker of the therapeutic x -ray equipment.  
 
B. Diagnostic and Specialized X -ray Equipment Used in Radiotherapy  
Manufacturer/Brand of Control Console  : ____ _________  Serial Number  : _______________  
Manufacturer /Brand of X -ray Tube  : _____________  Serial Number  : _____________ __ 
Maximum mA  : _____________  Maximum kVp  : _______________  
Shared with radiology department?  : _____________     
 C. Did the equipment  undergo and pass the compliance testing before using the equipment to patients? If yes, 
please provide the following details and submit a copy of the  conformance test results.  
 
Type of imaging equipment  : ______________________________________________ ____ ___________  
Date of Testing  : _____________________________________________________________  
Conducted by  : _____________ ________________________________________________  
Test Result  : ____________________________________________ _________________  
DRAFT FOR COMMENTSPage 3 of 6 
 III. RADIATION THERAPY SERVICES  
 
Level 1   Conventional Radiation Therapy  
Level 2   3D Conformal Radiation Therapy  
Level 3   Intens ity Modulated Radiation Therapy  
Level 4   Image Guided Radiation Therapy  
 Stereotactic Body Radiotherapy  
 Total Skin Electron I rradiation  
 Tomotherapy/Arc Therapy  
 Respiratory Gated Radiotherapy   Stereotactic Radiosurgery and Radiotherapy  
 Total Body Irradiation  
 Intra -operative Radiotherapy  
 Adaptive Radiotherapy  
 Others: ____________________________  
Specialized   Intraop erative Radiotherapy   Others: ____________________________  
 
IV. DESIGN OF THE FACILITY, THERAPEUTIC X- RAY MACHINE AND 
ANCILLARY EQUIPMENT  
 
REQUIREMENTS  YES  NO N/A 
1. The following documents shall be provided  
a. Commissioning results;  
b. Acceptance testing of therap eutic equipment; and  
c. Quality assurance program.  
    
2. Adequate ventilation shall be provided to protect the equipment from adve rse 
heat.     
3. A physical inventory of all equipment and accessories to confirm that they are 
present and secure in their assigned locations.  
    
4. A dehumidifier shall be provided in the treatment room to protect the 
equipment from adverse heat.  
    
5. Fire d etection and protection in the treatment room shall be provided.  
    
6. Mechanical door interlocks shall be provided and functioning . 
    
7. Standard warning sign and notice shall be installed on the door of the 
exposure room.  
    
8. Red warning light shall be i nstalled at the top of the door leading to the 
exposure room.  
    
9. An intercom shall be provided to allow two -way communication be twee n the 
patient being treated and the radiotherapy technologist at the control room.     
10. A CCTV cameral shall be provided to  monitor the patient.     
11. The radiotherapy facility shall be equipped with ancillary equipment 
(Appendix V). Please provide a scanned copy of calibration certification of 
the following equipment:  
a. An ionization chamber of farmer type  
Brand/Model: __________________  
Serial Number: _________________  
Due date of Calibration: __________  
 
b. A cylindrical ionization chamber (two sets per faci lity) 
Brand/Model: ________________  Brand/Model: _________________  
Serial Number: _______________ Serial Number: ________________  
Due date of Calibration: ________ Due date of Calibration: _________  ,   
DRAFT FOR COMMENTSPage 4 of 6 
 c. An appropriate radioactive source for checking the stabi lity of the 
ionization chamber.  
Radioactive Material:  _________ PNRI License No.: _______________  
 
d. A plane -parallel ionization  chamber for electrons. 
Brand/Model: __________________  
Serial Number: _________________  
Due date of Calibration: __________  
 
e. An e lectrometer compatible with the ionization chambers above and 
following the specifications of IAEA dosimetry publications.  
Brand/Model: __________________  
Serial Number: _________________  
Due date of Calibration: __________  
 
f. A water phantom for calibration (30cm x 40cm x 40cm)  
Brand/Model: __________________ Serial Number: _______________  
 
g. A radiation field analyzer/beam scanner to measure isodose distributions (50cm x 50cm x 40cm).  
Brand/Model: __________________ Serial Number: _______________  
 
h. Plastic sla b phantom  
Brand/Model: __________________ Serial Number: _______________  
 
i. An aneroid type or digital barometer calibrated at a  standards laboratory.  
Brand/Model: __________________  
Serial Number: _________________  
Due date of Calibration: __________  
 
j. A non- mercurial thermometer calibrated at a standards laboratory.  
Brand/Model: __________________  
Serial Number: _________________  
Due date of Calibration: __________  
 
k. In-house computerized treatment planning system 
 
l. An ionization chamber type radiation survey mete r calibrated at a 
standards laboratory.  
Brand/Model: __________________  
Serial Number: _________________  
Due date of Calib ration: __________  
 
m. Precision water level (bubble level) Brand/Model: __________________ Serial Number: _______________  
 
n. Graticule  
Brand/Model: __________________ Serial Number: _______________  
 
o. Portal verification device  
Brand/Model: __________________ Serial Number: _______________  
 
p. Patient specific QA tools (for level III and IV facilities)  
Brand/Model: __________________ Serial N umbe r: _______________  
 
q. Mechanical isocenter phantom  
Brand/Model: __________________ Serial Number: _______________  
DRAFT FOR COMMENTSPage 5 of 6 
 V. OPERATION AND MAINTENANCE  
 
REQUIREMENTS  YES  NO N/A 
1. Adequate preventive and corrective maintenance shall be performed as 
necessary to ensur e that design specifications for radiation protection and 
safety is retained throughout their useful life. Please provide the following 
documents:  
a. Preventive maintenance contract (or any document that supports the 
warranty of the therapeutic x -ray equi pmen t); 
b. Planned preventive maintenance schedule (indicate frequency of the 
maintenance)  
    
2. The preventive and corrective mai ntenance of the equipment is performed 
only by the equipment manufacturer. Please provide scanned copy of training 
certificate. 
    
3. Records of preventive and corrective maintenance program shall be kept for 
reference. 
    
 
VI. OCCUPATIONAL AND PUBLIC EXPOSURE 
 
REQUIREMENTS  YES  NO N/A 
1. Controlled and supervised a reas in therapeutic x -ray facility are properly 
delineated. Please provide pati ent flow of the facility.  
    
2. Signs and notices at access points of controlled and supervised areas shall be 
provided.  
    
3. All personnel working in controlled areas are provided with individual 
dosimeters.  
Service provider  : ________________________ ____ __________  
Subscription period  : ______________________________________  
Official Receipt No.  : _________________________ _____________  
No. of TLD/OSL  : ______________________________________  
 
    
4. Initial monitoring of radiation levels in the workpl ace shall be performed and 
documented. The area survey conducted by the facility shall indicate that the 
radiation room shield ing is adequate and the dose rates around the room meet 
authorized radiation levels. The facility shall provide a copy of area 
monitoring performed in the facility.  
    
5. Medical supervision intended to ensure initial and continuous fitness of 
workers for t heir intended tasks shall be provided.  
    
 
VII. MEDICAL EXPOSURE  
 
REQUIREMENTS  YES  NO N/A 
1. The facility shall provide a copy of patie nt chart with the following template:  
a. Pre-procedure assessment form (i.e. Radiation Oncologist’s order form)  
b. CT order form;  
c. Radiotherapy prescription form; and  
d. Consent forms (i.e. pregnant patient)     
2. A comprehensive quality assurance program for medical expo sures shall be 
developed and implemented in the facility . Please include this in the RPSP.     
DRAFT FOR COMMENTSPage 6 of 6 
  
VIII.  EMERGENCY PLAN 
 
REQUIREME NTS  YES  NO N/A 
1. The following emergency procedures shall be provided:  
a. In case of fire, flood and earthquake;  
b. In case the beam fail s to terminated;  
c. In case of power failure;  
d. In case LINAC door fails to open (for automatic door only);  
e. Accidental medical exposure of a patient;  
f. Accidental exposure of a Member of the Public; and  
g. Accidental exposure of workers.  
    
2. The plan must be rehear sed at suitable intervals. Please provide proper 
documentations (i.e. photos, attendance, etc.).  
    
 
IX. ROLES AND RESPONSIBILIT IES 
 
REQUIREMENTS  YES  NO N/A 
1. The management shall develop, implement, maintain and document a 
radiation protection and safety program  (RPSP) commensurate with the 
nature and extent of the risks associated with the practices in radiation 
oncology. Please refer to A.O. No. 31 s. 2013 Appendix IV “Radiation 
Protection and Safety Programme”  for reference. The RPSP shall be 
completely signed with the appropriate signatories (prepared by, reviewed by, 
and approved by).  
 
Date of last program review: _______________________________________  
    
2. The management shall provide adequate resources (time and money) for 
personnel training.  
    
3. The RPO shall conduct initial training of workers. Please provide complete 
documentations (i.e. photos, attendance, handouts, cert ificates, etc.) . 
    
 
X.  DECLARATION 
 
I hereby declare that this application has been accomplished by me, and that the 
foregoing inf ormation and attached documents required for the authorization are true and 
correct.  
 
  PREPARED AND ACCOMPLISHED BY:  
Name & Signature : 
 
 Designation/Position:  Date:  
 
  ATTESTED BY (FACILITY HEAD/MANAGER)  
Name  & Signature : 
 
 Designation/Position:  Date: 
 
DRAFT FOR COMMENTSGENERAL S ELF ASSESMENT FORM  (SAF) FOR  
DIAGNOSTIC, INTERVENTIONAL,  AND DENTAL X- RAY FACILITIES  
(Adapted from the current FDA -CDRRHR Radiation Protection Survey and Evaluation (RPSE) Checklists  for Regulatory Inspections ) 
Includes administrative and operational requirements for the whole facility. Every machine applied for will need its appropriate individual SAF as attachment.  
I. MACHINE LIST  (for those applied for initial authorization only ) 
(list all machines being applied for; please attach all individual machine SAF as attachment ) 
# Machine 
Type1 Manufacturer  Name / Brand  Serial Number  
Control Console  Tube  Control Console  Tube  
1      
2      
3      
4      
5      
6      
7      
8      
9      
10      
1Indicate if (1) Stationary/Mobile General X -ray (2) Stationary/Mobile Fluoroscopic X -ray (3) Mammography (4) Computed Tomography (5) Dental X -ray (Panoramic/Peri -apical) (6) 
Bone Densitometry (7) Positron Emission Tomography (PET) / Single Photon Emission Computed Tomography (SPECT)  
 
II. PERSONNEL REQUIREMENTS  
(please check  “yes” if complied, “no” if not complied, and N/A if not applicable ) 
REQUIREMENT  (Based on DOH AO No. 35 s. 1994, AO No. 2- A s. 1996, and AO 2022-0022)  YES  NO N/A 
1. The head of a diagnostic  x-ray facility who is the person -in-charge of the 
activities shall be a qualified physician as defined in DOH Administrative 
Order No. 35 s. 1994.  
a. Diplomate or fellow of the Philippine Board of Radiology or the Philippine College of Radiology.  
b. Refer to section 4.1.1.2 to 8 of AO 35 s. 1994 if no physician with the qualification above.  
c. For Dental x -ray facilities, a PRC licensed dental practitioner w ith 
appropriate training in dental x- ray work as per DOH AO no. 2 -A 
s. 1996.     
2. A fulltime x -ray/radiologic technologist who is registered with the 
Professional Regulation Commission (PRC) shall be hired for each machine.  
a. Required only for dental x- ray machines in lieu of an available duly 
qualified dental x -ray practitioner.     
3. The facility shall have a Radiation Protection Officer (RPO) who is one of 
the following:  
a. Head of the facility  (Refer to number 1) 
b. Medical Physicist  
c. Chief Radiologic Technologist of x- ray technologist with at least 
ten years working experience and attended a course on radiation 
protection conducted by an organization recognized by the 
CDRRHR.   
d. For dental facilities, a dental practitioner with appropriate training  
for dental x -ray facilities.     Name of Facility  
 
 Date Accomplished  
Facility Ad dress 
 X-ray Facility Level  ANNEX C 
Page 1 of 3  
DRAFT FOR COMMENTS 
 III. OPERATIONAL AND ADMINISTRATIVE REQUIREMENTS  
(please check “yes” if complied, “no” if not complied, and N/A if not applicable)  
REQUIREMENT  (Based on DOH AO No. 35 s. 1994, AO No. 2- A s. 1996, and AO 2022-0022)  YES  NO N/A 
1. The facility shall establish a quality assurance program to ensure continuous 
compliance with the requirements set forth by the Department of Health under 
which the following policies should be included:     
a. The head of the facility shall establish a Quality Control (QC) 
Program/Manual for the x- ray facility under which the following minimum  
provisions  should be included:  (provide a scanned copy )    
i. List of individuals responsible for monitoring and maintenance.     
ii. List of parameters to be monitored and frequency of monitoring.  (e.g. 
button checks, daily output checks if applicable, etc.)     
iii. Description of standards, criteria of quality, limits of acceptability for 
every machine to be monitored.      
iv. Description of procedures to be done for every machine to be monitored.     
v. Records of preventive and corrective maintenance done per machine 
including records of daily quality checks.     
vi. Records of frequency of changing solutions for  darkroom  image 
processing.  (if applicable)     
vii. Operation manuals and circuit diagrams including tube rating charts and 
cooling diagrams.     
2. The Radiation Protection Officer (RPO) shall establish and be responsible for 
the conduct of a Radiation Protection/Safety Program under which the 
following minimum  provisions should be included:   
(provide a scanned copy )    
a. Provision s on dose monitoring  policies  for radiology personnel (including 
interns, OJTs), patients, carers, pregnant personnel, etc.      
b. Policy on radiation protection/safety for pregnant women. (e.g.  posting of 
notices, risk communication, etc.)     
c. Records and analysis of personnel dose monitoring.  (provide a scanned 
copy of receipt/proof of purchase ) 
Service Provider: ____________________________________  
Subscription period: __________________________________  
Official Receipt No. __________________________________  
No. of TLD/OSL: __________________________________ __    
d. Provision for r ecords and policy on request and referral of x -ray 
examinations.      
e. Classification of areas as to controlled and supervised areas for occupational 
dose monitoring.     
f. Provision for p rocedures and practices to reduce dose of patients, workers, 
and the public  applicable to the facility     
g. Guidelines of appropriate action for personnel/patient that exceeded dose 
limits. ( action plan, corrective measures, risk communication, etc. )     
h. Process of reporting and notification in cases of exceeded doses.     
3. All x -ray examinations should be justified by a qualified physician in which a 
proper request and referral policy should be established.     
4. Radiographic technique charts per x -ray machine  posted near the control 
console . (provide a scanned copy )    
5. Records and analysis of image reject/spoilage.  (if applicable, provide picture 
of dedicated logbook/software to be used to record  image reject )    
6. Cleanliness and orderliness of the whole x -ray facility.  (provide photo)     
7. File of written results signed by qualified physician.  (provide photo of a 
sample , data privacy policy applies )    
 
 
Page 2 of 3 
DRAFT FOR COMMENTS 
 IV. GENERAL PHYSICAL PLANT REQUIREMENTS  
(please check “yes” if complied, “no” if not complied, and N/A if not applicable)  refer to individual machine checklist for 
physical plant requirements specific to an x -ray machine  
REQUIREMENT  (Based on DOH AO No. 35 s. 1994, AO No. 2- A s. 1996, and AO 2022-0022)  
(PROVIDE DIGITAL/SCANNED COPY OF FACILITY  AS-BUILT  FLOOR PLAN /LAYOUT  
INCLUDING PICTURES OF THE ACTUAL FACILITY  AND REQUIRED EQUIPMENT ) YES  NO N/A 
1. For automatic/manual processing (Dark room processing)     
a. Adequate space (2.0 m x 1.5m)     
b. Processing tanks ( for manual processing only )    
c. Separate paddles for processing tanks (for manual processing 
only)     
d. Light tight      
e. Well ventilated  (with exhaust fan)      
f. Tinted standard safelight (>1.3 m from working table)      
g. Proper storage of unprocessed films      
h. Well -maintained intensifying screens      
i. Luminous timer/digital timer ( for manual processing only )     
j. Non-mercurial thermometer ( for manual processing only )    
2. For digital/computed radiography processing (DR/CR)     
a. Designated area for processing/viewing machine     
3. Waiting area  for patients  (provision/designated area)     
4. Film storage and/or reading area  (where applicable)   
a. 1 m x 2 m for level one (1) x- ray facility  
b. 3 m x 3.5 m for level two (2) and three  (3) x -ray facility     
 
V. SPECIFIC  MACHINE REQUIREMENTS  
Accomplish and attach applicable individual machine  checklist as per machine list  
(Annex C-1 to 5) 
I hereby declare that this application has been accomplished by me, and that the 
foregoing information and attached documents required for the authorization are true and 
corre ct.
  PREPARED AND ACCOMPLISHED BY:  
Name  & Signature : 
 
 
 Designation/Position:  Date:  
  ATTESTED BY (FACILITY HEAD/MANAGER) : 
Name  & Signature : 
 
 Designation/Position:  Date:  
Page 3 of 3 
DRAFT FOR COMMENTS 
 SPECIFIC  SELF ASSESMENT FORM FOR GENERAL RADIOGRAPHY AND FLUOROSCOPY  
X-RAY MACHINE REQUIREMENTS  
(use additional sheets if necessary)  
Machine #    Applicable Type of Machines  
Stationary X -ray Machine  Radio/Fluoroscopic X -ray Machine (RF)  
Mobile X -ray Machine  Mobile C -arm Fluoroscopy Machine  
Transportable X -ray Machine  Cardiac Catherization Fluoroscopic Machine  
(Accomplished per machine as an attachment to the DIAGNOSTIC, INTERVENTIONAL, AND DENTAL X -RAY FACILITIES)  Name of Facility  
Facility Ad dress 
REQUIREMENT  (please check “yes” if complied, “no” if not complied, and N/A if not applicable ) YES  NO N/A 
1. X-ray machine properly installed, operational, and duly accepted by the licensee with appropriate 
documents signed by installer/supplier and received by licensee representative/owner . (provide 
pictures/proof of installation AND signed calibration report bearing the same serial numbers indicated in the 
application form for tube & console with values for kVp, mA, time, and constancy checks by the service engineer or a 
medical physicist;  with details of test tools/ radiation monitoring instruments used )    
2. Audible and/or visible indication of x -ray production  (AO 35 s. 1994 sec. 5.1.14)     
3. Means to set exposure factors  (provide pictures of control console) (AO 35 s. 1994 sec. 5.1.9)     
4. Mechanically stable  (AO 2022 -0022, Annex B, Part 7 )     
5. All moving parts move smoothly without obstructions to motion  (AO 2022 -0022, Annex B,Part 7 )    
6. Adequate x -ray room size (for stationary x -ray & RF machines)  (provide digital/scanned copy of 
detailed facility floor plan /layout ) (AO 35 s. 1994  sec. 6.1)  
a. X-ray w/o table: 2.5 x 3 m  
b. X-ray w table: 3.5 x 4 m  
c. X-ray w titling table: 4.5 x 4.5 m  
d. Transportable x -ray: 2 .0 m width  (provide pictures  with proof of measurement)     
7. Adequate shielding for the x -ray room (doors, walls, etc.)  (AO 35 s. 1994  sec. 6.2)  
a. At least 6 inches thick poured concrete with a density of 2.35 g/cm3  
(Provide picture/scanned copy of signed facility layout showing wall thickness; shielding to be 
confirmed during inspection)  
b. At least 1/6 in (1.5 mm) thick lead sheet glued onto and sandwich between wooden panels without any punctures during installation.  
(Provide picture/proof of purchase of lead sheets; shielding to be confirmed during inspection)     
8. Dressing Area  (provide pictures)  (AO 35 s. 1994  sec. 6.18)     
9. Fixed/Movable Protective barrier with means of viewing patient (glass/acrylic with 1.5 mm lead 
equivalence) and with adequate shielding from x -rays similar to room shielding requirements.  
(provide pictures ; shielding to be confirmed during inspection ) (AO 35 s. 1994  sec. 6.4)     
10. If windows are present, it should be elevated to height of at least 2 m from ground.  (provide 
pictures)  (AO 35 s. 1994  sec. 6.6)     
11. With red warning light bulb  (provide pictures)  (AO 35 s. 1994  sec. 6.7)     
12. With appropriate warning notice  (provide pictures)  (AO 35 s. 1994  sec. 6.8)     
13. With adequate ventilation  (provide pictures)  (AO 35 s. 1994  sec. 6.1)     
14. Toilet with door opening directly to x -ray room  if examinations using contrast media will be 
performed  (provide pictures)  (AO 35 s. 1994  sec. 6.19)     
15. Radiological accessories  (provide pictures  or proof of purchase)  (AO 35 s. 1994  sec. 6.20)     
a. Caliper      
b. Contact gonadal shields all sizes (>1.5 mm Pb equivalent)  (not needed for x -ray 
facilities for chest, heart, and lung s imaging only)     
c. Upright gonadal shield ( >1.5 mm Pb equivalent)     
d. Lead equivalent gloves (>0.25 mm Pb equivalent)  (not needed for x -ray facilities for 
chest, heart, and lung s imaging only)     
e. Lead equivalent apron (>0.25 mm Pb equivalent)     
f. Lead equivalent goggles ( for fluoroscopic machines only)  (not needed for x -ray 
facilities for chest, heart, and lung s imaging only)     
g. Lead equivalent thyroid shields ( for fluoroscopic machines only)  (not needed for x -ray 
facilities for chest, heart, and lung s imaging only)      
(Based  on 
MACHINE LIST  
of Annex C) ANNEX C - 1 
DRAFT FOR COMMENTS 
  
SPECIFIC  SELF ASSESMENT FORM  FOR COMPUTED TOMOGRAPHY 
 
X-RAY MACHINE REQUIREMENTS  
(use additional sheets if necessary)  
 
Machine #    Applicable Type of Machines  
Computed Tomography Machines  CT Simulator Machine for Radiation Therapy  
PET CT Machines   
SPECT Machines   
(Accomplished per machine as an attachment to the DIAGNOSTIC, INTERVENTIONAL, AND DENTAL X- RAY FACILITIES)  Name of Facility  
Facility Ad dress 
REQUIREMENT  (please check “yes” if complied, “no” if not complied, and N/A if not applicable ) YES  NO N/A 
1. CT unit assembly properly installed, operational, and duly accepted by the licensee 
with appropriate documents signed by installer/supplier and received by licensee 
representative/owner.  (provide pictures /proof of installation)      
2. Undergone and passed performance testing conducted by PLSD -CSL or by DTI -PAB 
accredited testing laboratory (attach  SIGNED report of service provider)   
(BO 220 s. 2002)     
3. Adequate x -ray room size ( manufacturers specifications ) (AO 35 s. 1994 sec. 6.1 .4)    
4. Adequate shielding for the x -ray room (doors, walls, etc.)  (AO 35 s. 1994  sec. 6.2)  
a. At least 6 inches thick poured concrete with a density of 2.35 g/cm3(Provide 
picture/scanned copy of signed facility layout showing wall thickness; 
shielding to be confirmed during inspection)  
b. At least 1/6 in (1.5 mm) thick lead sheet glued onto and sandwich between 
wooden panels without any punctures during installation.  (Provide 
picture/proof of purchase of lead sheets; shielding to be confirmed during 
inspection)     
5. Fixed/ Movable Protective barrier with means of viewing patient (glass/ac rylic with 1.5 
mm lead equivalence) and with adequate shielding from x -rays similar to room 
shielding requirements.  (AO 35 s. 1994 sec. 6.4)  
(provide  pictures; shielding to be confirmed during inspection)     
6. If windows are present, it should be elevated to height of at least 2 m from ground.  
(provide pictures)  (AO 35 s. 1994  sec. 6.6)     
7. With red warning light bulb (provide pictures)  (AO 35 s. 1994  sec. 6.7)     
8. Dressing Area  (provide pictures)  (AO 35 s. 1994  sec. 6.18)     
9. With appropriate warning notice outside x -ray examination room door. It shall be 
made up of a solid yellow equilateral triangle 180 mm long on each side. At the center of the triangle is a black tre -foil sign for radiation. Under the triangle are the words  
“X-RAY ROOM: DO NOT ENTER WHEN THE RED LIGHT IS ON”. The 
Warning notice shall be on a 180 mm x 270 mm white background.  (provide pictures)  
(AO 35 s. 1994  sec. 6.8)     
10. With adequate ventilation  (provide pictures)  (AO 35 s. 1994 sec. 6.1)     
11. Toilet with d oor opening directly to x -ray room if examinations using contrast media 
will be performed  (provide pictures)  (AO 35 s. 1994  sec. 6.19)     
12. Radiological accessories  (provide pictures  or proof of purchase)   
(AO 35 s. 1994  sec. 6.20)     
a. Lead equivalent gloves (>0.25 mm Pb equivalent)     
b. Lead equivalent apron (>0.25 mm Pb equivalent)     
c. Quality control phantom  (AO 35 s. 1994  sec. 5.7.9)      
(Based on 
MACHINE LIST 
of Annex C)  ANNEX C - 2 
DRAFT FOR COMMENTS 
  
SPECIFIC  SELF ASSESMENT FORM  FOR MAMMOGRAPHY  
 
X-RAY MACHINE REQUIREMENTS  
(use additional sheets if necessary)  
 
Machine #    Applicable Type of Machines  
Analog Mammography Machines  
Digital Mammography Machines  
3D Mammography Machines  
 
(Accomplished per machine as an attachment to the DIAGNOSTIC, INTERVENTIONAL, AND DENTAL X -RAY FACILITIES)  
 Name of Facility  
Facility Ad dress 
REQUIREMENT  (please check “yes” if complied, “no” if not complied, and N/A if not applicable ) YES  NO N/A 
1. Mammographic unit assembly  properly installed, operational, and duly 
accepted by the licensee with appropriate documents signed by 
installer/supplier and received by licensee representative/owner.  
(provide pictures/proof of installation)     
2. Undergone and passed performance testing  conducted by PLSD -CSL 
or by DTI -PAB accredited testing laboratory  (attach  SIGNED report 
of service provider)  (BO 220  s. 2002 )    
3. Adequate x -ray room size  (manufacturers specifications )  
(AO 35 s. 1994  sec. 6.1.4 )    
4. Adequate shielding for the x -ray room (doors, walls, etc.)   
(AO 35 s. 1994 sec. 6.2) 
a. At least 6 inches thick poured concrete with a density of 2.35 
g/cm3 (Provide picture/scanned copy of signed facility layout showing wall 
thickness; shielding to be confirmed during inspection)  
b. At least 1 /6 in (1.5 mm) thick lead sheet glued onto and 
sandwich between wooden panels without any punctures during installation. 
(Provide picture/proof of purchase of lead sheets; 
shielding to be confirmed during inspection)     
5. Fixed/ Movable Protective barrier w ith means of viewing patient  
(glass/acrylic with 1.5 mm lead equivalence) and with adequate shielding from x -rays similar to room shielding requirements.  
(provide pictures; shielding to be confirmed during inspection) (AO 35 s. 1994  sec. 6.4)    
6. With r ed warning light bulb  (provide pictures)  (AO 35 s. 1994  sec. 6.7)    
7. With appropriate w arning notice  outside x -ray examination room door. 
It shall be made up of a solid yellow equilateral triangle 180 mm long 
on each side. At the center of the triangle is a black tre- foil sign for 
radiation. Under the triangle are the words “ X-RAY ROOM: DO NOT 
ENTER WHEN THE RED LIGHT IS ON ”. The Warning notice shall 
be on a 180 mm x 270 mm white background.  
(provide pictures)  (AO 35 s. 1994  sec. 6.8)    
8. With a dequate ventilation (provide pictures)  (AO 35 s. 1994  sec. 6.1)    
9. Dressing Area (provide pictures)  (AO 35 s. 1994  sec. 6.18)     
(Based on 
MACHINE LIST 
of Annex C)  ANNEX C - 3 
DRAFT FOR COMMENTS 
  
SPECIFIC  SELF ASSESMENT FORM  FOR DENTAL X- RAY  
 
X-RAY MACHINE REQUIREMENTS  
(use additional sheets if necessary)  
Machine #    Applicable Type of Machines  
Panoramic/Cephalometric  
Dental CT/CBCT  
Dental Intraoral/Periapical  
 
(Accomplished per machine as an attachment to the DIAGNOSTIC, INTERVENTIONAL, AND DENTAL X -RAY FACILITIES)  
 Name of Facility  
Facility Ad dress 
REQUIREMENT  (please check “yes” if complied, “no” if not complied, and N/A if not applicable ) YES  NO N/A 
1. Dental x -ray unit assembly properly installed, operational, and duly accepted by the licensee 
with appropriate documents signed by installer/supplier and received by licensee 
representative/owner.  
(provide pictures/proof of installation AND signed machine calibration report with values for kVp, 
mA, time, and constancy checks from the service engineer ; with details of test tools/radiation 
monitoring devices used ) (AO 2 -A s. 1996  sec. 5)     
2. With effective electrical grounding (provide pictures)  (AO 2 -A s. 1996 sec. 5.3)     
3. Stability and quality of mechanical parts (AO 2 -A s. 1996 sec. 5.14)     
4. Adequate x -ray room size ( manufacturer’s specifications , not required for ) (AO 2 -A s. 
1996 sec. 6)     
5. Adequate shielding for the x -ray room (doors, walls, etc.) (AO 2 -A s. 1996 sec. 6)  
a. Homogeneous concrete with a density of 2.35 g/cm3 (Provide picture/scanned 
copy of signed facility layout showing wall thickness; shielding to be confirmed 
during inspection)  
b. Lead sheet glued onto and sandwich between wooden panels without any punctures during installation. (Provide picture/proof of purchase of lead sheets; 
shielding to be confirmed during inspection)     
6. Fixed/ Movable Protective barrier with means of viewing patient (glass/acrylic with 1.5 
mm lead equivalence) and with adequate shielding from x -rays similar to room shielding 
requirements for panoramic dental x -ray units (provide pictures; shielding to be confirmed 
during inspection) (AO 2 -A s. 1996 sec. 6.9 and 10)     
7. With red warning light bulb (provide pictures)     
8. With appropriate warning notice outside x -ray examination room door. It shall be made up 
of a solid yellow equilateral triangle 180 mm long on each side. At the center of the triangle is a black tre-foil sign for radiation. Under the triangle are the words “ X-RAY ROOM: 
DO NOT ENTER WHEN THE RED LIGHT IS ON ”. The Warning notice shall be on a 
180 mm x 270 mm white background. (provide pictures) (AO 2 -A s. 1996 sec. 7.3.1)     
9. With adequate ventilation (provide pictures) (AO 2 -A s. 1996 sec. 6.2)     
10. Radiologi cal accessories (provide pictures/proof of purchase)     
a. Thyroid shields (1/8 in lead equivalent) (AO 2 -A s. 1996 sec. 7.1.8)     
b. Lead rubber apron, with lead equivalence of 0.25 mm (AO 2 -A s. 1996 sec. 7.1.8)     
c. Film holders for periapical & bitewing examinations (if applicable)      
(Based on 
MACHINE LIST 
of Annex C)  ANNEX C - 4 
DRAFT FOR COMMENTS 
  
SPECIFIC  SELF ASSESMENT FORM  FOR BONE DENSITOMET ERS   
 
X-RAY MACHINE REQUIREMENTS  
(use additional sheets if necessary)  
 
Machine #    Applicable Type of Machines  
Bone Densitometer / DEXA  
 
 
 
(Accomplished  per machine  as an attachment to the  
DIAGNOSTIC , INTERVENTIONAL, AND DENTAL X -RAY FACILITIES ) Name of Facility  
Facility Ad dress 
REQUIREMENT  (please check “yes” if complied, “no” if not complied, and N/A if not applicable ) YES  NO N/A 
1. X-ray machine properly installed, operational, and duly accepted by the licensee 
with appropriate documents signed by installer/supplier and received by licensee 
representative/owner. (provide pictures/proof of installation AND signed 
calibration report be aring the same serial numbers indicated in the application 
form for tube & console with values for kVp, mA, time, and constancy checks by 
the service engineer)  (AO 35 s. 1994 sec. 5. 8.10)    
2. Audible and/or visible indication of x- ray production (AO 35 s. 1994 sec. 5. 8.8)    
3. Means to set exposure factors (provide pictures of control console) (AO 35 s. 1994 
sec. 5. 8.3)    
4. Mechanically stable ( AO 2022 -0022, Annex B, Part 7)     
5. All moving parts move smoothly without obstructions to motion (AO 2022 -0022, 
Annex B, Part 7 )    
6. With red warning light bulb (provide pictures) (AO 35 s. 1994 sec. 6.7)     
7. With appropriate warning notice (provide pictures) (AO 35 s. 1994 sec. 6.8)     
8. With adequate ventilation (provide pictures) (AO 35 s. 1994 sec. 6.1)      
(Based on 
MACHINE LIST 
of Annex C)  ANNEX C - 5 
DRAFT FOR COMMENTSGENERAL S ELF ASSESMENT FORM  (SAF) FOR  
INDUSTRIAL /ANTI -CRIME  X-RAY FACILITY  
(Adopted from the current FDA -CDRRHR Radiation Protection Survey and Evaluation (RPSE) Checklists;  
Based from DOH AO 40 s.1996, DOH AO 2022-0022, DOH AO 2020 -0035) 
1Indicate whether: Industrial (choose: Irradiation facility / Food production / Semiconductor, etc.) or Anti -Crime ( choose: Baggage / Packages / Freight / Cargo Inspection) . 
I. MACHINE LIST  (list all machines being applied for; please attach all individual machine SAF as attachment)  
a Indicate whether: Open Installation or Enclosed Installation  
b Indicate whether: Cabinet -type, Handheld, or Portable  
c Indicate whether: LINAC, X -ray Gauge (choose: Thickness Gauge / Level Gauge), Radiography, Computed Tomography or Fluoroscopy (choose: Analytical / 
Scanning Electron Microscopy / Spectrometry / Diffractometry / Photo- ionizer / Fat Analyzer)  
 
II. PERSONNEL REQUIREMENTS  
(please check  “yes” if complied, “no” if not complied, and N/A if not applicable ) 
REQUIREMENT  (Based on DOH AO No. 40 s. 1996 and AO 149 s. 2004)  YES  NO N/A 
1. The facility shall have and appoint a Radiation Protection Officer (RPO) who 
is an individual that undergone training in radiation protection for industrial 
and anti -crime facilities conducted by institutions  recognized by CDRRHR. 
(Attach Certificate of Co mpletion conducted by a recognized third-party service 
provider)     
2. The facility shall have operators who have completed training in radiation 
protection for industrial and anti -crime work conducted and/or recognized by 
the CDRRHR. (Attach proof of radiation protection training )    
 
III. OPERATIONAL AND ADMINISTRATIVE REQUIREM ENTS  
(please check  “yes” if complied, “no” if not complied, and N/A if not applicable)  
REQUIREMENT  (Based on DOH AO No. 40 s. 1996 and AO 149 s. 2004)  YES  NO N/A 
1. The facility shall have or make available a radiation monitoring instrument for 
the purpose of carrying out regular radiation monitoring surveys of x -ray units. 
The radiation monitoring instrument shall be calibrated at least once a year. 
(Attach proof of provision of radiation monitoring instrument and its Certificate of 
Calibration)     Name of Facility  
 
 Date Accomplished  
Facility Ad dress 
 X-ray Facility Type1 
Machine 
No. Type of 
Installationa Type of X -ray 
Machineb Manufacturer / 
Model  Max. mA 
(or MeV)  Max. 
kVp Machine Serial 
Number   Application / 
Usec Location  
1         
2         
3         
4         
5         
6         
7         
8         
9         
10         ANNEX D 
Page 1 of 3 
DRAFT FOR COMMENTS 
 Brand / Model: _______________________  
Serial Number: _______________________  
Calibration factor: _____________________ 
Due date of Calibration: ________________  
    
2. The Radiation Protection Officer (RPO) shall establish and be responsible 
for the conduct of a Radiation Protection/Safety Program under which the 
following policies  should be included: (PROVIDE A DULY SIGNED & 
APPROVED SCANNED COPY)     
a. Policy on dose mon itoring for operators  (including interns, OJTs),  
pregnant personnel, etc.     
b. Policy on radiation protection/safety of pregnant women. (e.g. posting of 
notices, risk communication, etc.)     
c. Records and analysis of personnel dose monitoring.  
Service Provider:          ____________________________________  
Subscription period:     ____________________________________  
Official Receipt No.     ____________________________________  
No. of TLD/OSL:         ____________________________________         
____________________________________     
d. Guidelines of appropriate action for operators/ personnel that exceeded 
dose limits. (action plan, corrective measures, risk communication, etc.)     
e. Process of reporting and notification in cases of exceeded doses  and 
radiation accidents .    
f. Quarterly  Area Survey Monitoring for scattered radiation. (Floor plan / 
machine diagram showing points for measurements)     
g. Policy on the access of operators, other personnel, and non -personnel 
(i.e., interns, t rainees, visitors) to the site/location of the x -ray machine.     
h. Policy on monitoring of equipment for possible detection of significant 
leakage radiation.     
i. Policy on working procedures and protocols when operating the x -ray 
machine. (Refer to Section VI of the DOH AO No. 40 s.1996 for 
guidance)     
j. For open installations, policy on continuous and competent supervision of 
the site during the conduct of x-ray exposure.     
 
IV. SITE REQUIREMENTS (Attach detailed floorplan indicating the wall thickness, distances, and 
points of measurements for scattered radiation)  
(please check  “yes” if complied, “no” if not complied, and N/A if not applicable)  
REQUIREMENT  (Based on DOH AO No. 40 s. 1996 and AO 149 s. 2004)  YES  NO N/A 
1. Enclosed Installations     
a. All walls and doors shall be made of materials which will 
reduce radiation level to 2.5 μSv per hour (0.25 mR/hr).     
b. There shall be functioning interlocks installed either in the 
machine or on the door leading to the room. (Upload a video 
as proof of fun ctioning interlocks)     
c. There shall be a warning visual boundary (floor markings) at 
least 1.0 m perimeter from the machine. (Upload photo/s)     
2. Open Installation     
a. The boundaries of an open field shall be clearly defined by 
some appropriate means such as ropes, perimeter cords, or 
fences. (Attach photo of the actual field/area)     
b. Dose equivalent rate outside the boundary shall not exceed 
25 μSv per hour (2.5 mR/hr)     
Page 2 of 3 
DRAFT FOR COMMENTS 
 c. For industrial radiographic equipment using manual 
image acquisition (x -ray film) , there shall be a darkroom 
designed and equipped with following: (Attach photos)     
i. Light tight room (no light leaks)     
ii. Well ventilated (installed light-tight exhaust fan)     
iii. Processing tanks (with two insert tanks)     
iv. Separate paddles for the developer and fixer 
solutions     
v. Adequate supply of fresh water     
vi. Amber or red -tinted safelight installed not lower 
than 4 feet from the working table     
vii. Proper storage for unprocessed films     
 
V. SPECIFIC  MACHINE REQUIREMENTS  
Accomplish and attach applicable individual machine  checklist as per machine list  
(Annex D- I to VI) 
I hereby declare that this application has been accomplished by me, and that the 
foregoing information and attached documents required for the authorization are true and 
corre ct.
  PREPARED AND ACCOMPLISHED BY:  
Name  & Signature : 
 
 
 Designation/Position:  Date:  
  ATTESTED BY (FACILITY HEAD/MANAGER) : 
Name  & Signature : 
 
 Designation/Position:  Date:  
Page 3 of 3 
DRAFT FOR COMMENTS 
 SPECIFIC  SAF  FOR INDUSTRIAL RADIOGRAPHIC EQUIPMENT  
 
X-RAY MACHINE REQUIREMENTS  
(use additional sheets if necessary)  
 
Machine No.   Applicable Type of Machines  
Industrial Radiographic 
Equipment  X-ray equipment used in taking radiographs of test items 
and specimens  
 
 
 
(Accomplished  per machine  as an attachment to the GENERAL SELF ASSESMENT FORM (SAF) FOR  
INDUSTRIAL /ANTI- CRIME X- RAY FACILITY )  Name of Facility  
Facility Ad dress 
REQUIREMENT  (please check “yes” if complied, “no” if not complied, and N/A if not applicable ) YES  NO N/A 
1. Audible and visual warning signs shall be provided within the perimeter where 
the machine is installed or will be operated. The audible and visual warning 
signs shall be actuated before the irradiation and shall remain actuated until 
completion of the irra diation. (Upload a video as proof of functioning audible and 
visual warning signs)     
2. Warning notices shall be posted along defined boundaries and shall be made up 
of a solid yellow equilateral triangle 180 mm long on each side. At the center of the triangle is a black tre -foil sign for radiation. Under the triangle are the 
words “ CAUTION – X- RAY EMITTING APPARATUS.” The warning 
notice shall be on a 180 mm x 270 mm white background. (Attach a photo of 
the posted standard warning notice)     
3. The radiographic equipment shall be enclosed in a housing such that the leakage 
radiation measured at a distance of 1.0 m from the focus does not exceed 1 mSv/hr. (attach a duly signed leakage radiation survey report using the 
facility’s survey meter)     
4. The radiographic equipment shall be provided with diaphragms, cones, or 
adjustable collimator to limit the area of the useful beam.     
5. The radiographic equipment shall be provided with an automatic timer which 
will terminate the exposure by de -energizing the x -ray tube after the pre- set 
time has elapsed.     
6. Safety devices such as warning lights and interlocks shall be tested periodically 
to ensure their proper operation. (Attach proof of provision of preventive 
maintenance service/s).      
(Based  on 
MACHINE LIST  
of Annex D) ANNEX D - 1 
DRAFT FOR COMMENTS 
  
  
SPECIFIC  SELF ASSESMENT FORM FOR INDUSTRIAL FLUOROSCOPIC EQUIPMENT  
 
 
X-RAY MACHINE REQUIREMENTS  
(use additional sheets if necessary)  
 
Machine No.   Applicable Type of Machines  
Industrial Fluoroscopic 
Equipment  X-ray equipment used for test items or specimens for 
fluoroscopic inspection.  
 
 
 
 
(Accomplished  per machine  as an attachment to the GENERAL SELF ASSESMENT FORM (SAF) FOR  
INDUSTRIAL /ANTI- CRIME X- RAY FACILITY )  Name of Facility  
Facility Ad dress 
REQUIREMENT  (please check “yes” if complied, “no” if not complied, and N/A if not applicable ) YES  NO N/A 
1. Audible and visual warning signs shall be provided within the perimeter where 
the machine is installed or will be operated. The audible and visual warning 
signs shall be actuated before the irradiation and shall remain actuated until completion of the irra diation. 
(Upload a video as proof of functioning audible and 
visual warning signs)     
2. Warning notices shall be posted along defined boundaries and shall be made up 
of a solid yellow equilateral triangle 180 mm long on each side. At the center of the triangle is a black tre -foil sign for radiation. Under the triangle are the 
words “ CAUTION – X- RAY EMITTING APPARATUS.” The warning 
notice shall be on a 180 mm x 270 mm white background. (Attach a photo of 
the posted standard warning notice)     
3. The x -ray tube shall be enclosed in a tube housing with an aperture that is 
covered by a shutter or a completely shielded enclosure which include 
interlock s so that opening one entrance automatically deenergizes the x -ray 
tube.     
4. Radiation level at any a ccessible point 5 cm from the surface of the x -ray tube 
housing and any enclosure attached to it shall not exceed 25 µSv (2.5 mR) per  
hour when the x- ray tube is operated at any of the permissible ratings specified 
by the manufacturer of the equipment.      
5. Radiation level at any accessible point 5 cm from the external surface of the 
equipment shall not exceed 5 µSv (0.5 mR) per hour when averaged over an area of 100 cm
2 when the tube is operated at any of the permissible rating 
specified by the manufacturer.     
6. Fluoroscopic scree ns should be viewed indirectly by the use of  mirrors or 
remotely by TV/Digital screens/monitors.  (Attach a photo )    ANNEX D - 2 
 
(Based on 
MACHINE LIST  
of Annex D ) 
DRAFT FOR COMMENTS 
  
 
SPECIFIC  SELF ASSESMENT FORM  FOR INDUSTRIAL X- RAY GAUGES  
 
 
X-RAY MACHINE REQUIREMENTS  
(use additional sheets if necessary)  
 
Machine No.   Applicable Type of Machines  
Industrial X-ray Gauges  X-ray device that uses the detection of an x -ray beam 
transmitted through or scattered by a material of interest to 
measure a parameter associated with the material.  
 
 
 
(Accomplished  per machine  as an attachment to the GENERAL SELF ASSESMENT FORM (SAF) FOR  
INDUSTRIAL /ANTI- CRIME X- RAY FACILITY ) 
  Name of Facility  
Facility Ad dress 
REQUIREMENT  (please check “yes” if complied, “no” if not complied, and N/A if not applica ble) YES  NO N/A 
1. Audible and visual warning signs shall be provided within the perimeter 
where the machine is installed or will be operated. The audible and visual 
warning signs shall be actuated before the irradiation and shall remain 
actuated until completion of the irra diation. (Upload a video as proof of 
functioning audible and visual warning signs)     
2. Warning notices shall be posted along defined boundaries and shall be made 
up of a solid yellow equilateral triangle 180 mm long on each side. At the center of the triangle is a black tre- foil sign for radiation. Under the triangle 
are the words “CAUTION – X-RAY EMITTING APPARATUS.” The 
warning notice shall be on a 180 mm x 270 mm white background. (Attach a 
photo of the posted standard warning notice)     
3. The x -ray tube shall be enclosed in a tube housing with an aperture that is 
covered by a shutter or a completely shielded enclosure which include 
interlocked so that opening one entrance automatically deenergizes the x- ray 
tube.     
4. Radiation level at any accessible point 5 cm from the external surface of the 
equipment shall not exceed 5 µSv (0.5 mR) per hour when averaged over an 
area of 100 cm2 when the tube is operated at any of the permissible rating 
specified by the manufacturer.     
5. The equipment shall be housed, shielded, and installed so as to prevent 
unauthorized access to these devices.      ANNEX D - 3 
 
(Based on 
MACHINE LIST  
of Annex D ) 
DRAFT FOR COMMENTS 
  
 
 
SPECIFIC SELF ASSESMENT FORM FOR INDUSTRIAL X- RAY ANALYTICAL EQUIPMENT  
 
 
X-RAY MACHINE REQUIREMENTS  
(use additional sheets if necessary)  
 
Machine No.    Applicable Type of Machines  
Industrial X-ray Analytical 
Equipment  X-ray device which is used to determine properties and 
composition of materials using x -ray fluorescence or x -ray 
diffraction techniques.  
 
 
(Accomplished  per machine  as an attachment to the GENERAL SELF ASSESMENT FORM (SAF) FOR  
INDUSTRIAL /ANTI- CRIME X- RAY FACILITY )  Name of Facility  
Facility Ad dress 
REQUIREMENT  (please check “yes” if complied, “no” i f not complied, and N/A if not applicable ) YES  NO N/A 
1. Audible and visual warning signs shall be provided within the perimeter 
where the machine is installed or will be operated. The audible and visual 
warning signs shall be actuated before the irradiation and shall remain actuated until completion of the irra diation. 
(Upload a video as proof of 
functioning audible and visual warning signs)     
2. Warning notices shall be posted along defined boundaries and shall be made 
up of a solid yellow equilateral triangle 180 mm long on each side. At the center of the trian gle is a black tre -foil sign for radiation. Under the triangle 
are the words “CAUTION – X-RAY EMITTING APPARATUS.” The 
warning notice shall be on a 180 mm x 270 mm white background. (Attach a 
photo of the posted standard warning notice)     
3. The high -tension generator supplying the x -ray tube shall have an independent 
and easily detachable  cable connection or line switch.     
4. An interlocking device should prevent entry of any part of the body into the 
beam path or cause the beam to be shut off upon such entry into its path.     
5. The x -ray camera or other recording devices shall be provided with a 
protective screen that effectively absorbs radiation.     ANNEX D - 4 
 
(Based on 
MACHINE LIST  
of Annex D ) 
DRAFT FOR COMMENTS 
  
 
SPECIFIC SELF ASSESMENT FORM FOR ANTI -CRIME CABINET- TYPE X -RAY DEVICE  
 
 
X-RAY MACHINE REQUIREMENTS  
(use additional sheets if necessary)  
 
Machine No.    Applicable Type of Machines  
Anti-Crime Cabinet -Type X -
ray Devices   X-ray unit used for inspection of mails, packages, baggage, 
freight, and other articles for security purposes.  
 
 
 
(Accomplished  per machine  as an attachment to the GENERAL SELF ASSESMENT FORM (SAF) FOR  
INDUSTRIAL /ANTI- CRIME X- RAY FACILITY ) 
  Name of Facility  
Facility Ad dress 
REQUIREMENT  (please check “yes” if complied, “no” if not complied, and N/A if not applicable ) YES  NO N/A 
1. Audible and visual warning signs shall be provided within the perimeter 
where the machine is installed or will be operated. The audible and visual 
warning signs shall be actuated before the irradiation and shall remain 
actuated until completion of the irra diation. (Upload a video as proof of 
functioning audible and visual warning signs)     
2. Warning notices shall be posted along defined boundaries and shall be made 
up of a solid yellow equilateral triangle 180 mm long on each side. At the center of the trian gle is a black tre -foil sign for radiation. Under the triangle 
are the words “CAUTION – X-RAY EMITTING APPARATUS.” The 
warning notice shall be on a 180 mm x 270 mm white background. (Attach a 
photo of the posted standard warning notice)     
3. Devices used for baggage inspection shall be arranged that the operator stays 
in a position where all ports and doors can be readily observed during 
exposure.     
4. A key operated control console shall be designed such that x -rays cannot be 
produced when the key is removed.     
5. Exposure switch shall be of a dead man type.     
6. Radiation level at any accessible point 5 cm from the external surface of the 
equipment shall not exceed 5 µSv (0.5 mR) per hour when averaged over an area of 100 cm
2 when the tube is operated at any of the permissible rating 
specified by the manufacturer.      
7. Anti-crime x -ray device may not be located in a separate room , provided that 
access shall be limited to personnel authorized to work in the area .    ANNEX D - 5 
 
(Based on 
MACHINE LIST  
of Annex D ) 
DRAFT FOR COMMENTS 
  
 
SPECIFIC SELF ASSESMENT FORM FOR NON- MEDICAL LINEAR ACCELERATOR (LINAC)  
 
 
REQUIREMENTS  
(use additional sheets if necessary)  
 
Machine No.    Applicable Type of Machines  
Non-Medical LINAC  X-ray equipment used either for irradiation to treat an 
object for variety of purposes or inspection of cargo 
shipments for security purposes.  
 
1. ADDITIONAL OPERATIONAL REQUIREMENTS  
 
2. MACHINE REQUIREMENTS  
 
(Accomplished  per machine  as an attachment to the GENERAL SELF ASSESMENT FORM (SAF) FOR  
INDUSTRIAL /ANTI- CRIME X- RAY FACILITY ) Name of Facility  
Facility Address  
REQUIREMENT (please check “yes” if complied and “no” if not complied)  YES  NO 
1. Machine commissioning report duly signed by the authorized Service Engineer of 
the manufacturer (Attach document)    
2. Installation report duly signed by the authorized service engineer of the 
manufacturer (Attach document)    
REQUIREMENT (Please check “yes” if complied, “no” if not complied, and N/A if not applicable.)   YES  NO 
1. Audible and visual warning signs shall be provided within the perimeter where the 
machine is installed or will be operated. The audible and visual warning signs shall 
be actuated before the irradiation and shall remain actuated until completion of the 
irradiation. (Upload a video as proof of functioning audible and visual warning signs)    
2. Warning notices shall be posted along defined boundaries and shall be made up of 
a solid yellow equilateral triangle 180 mm long on each side. At the center of the triangle is a black tre -foil sign for radiation. Under the triangle are the words 
“CAUTION – X-RAY EMITTING APPARATUS.” The warning notice shall be 
on a 180 mm x 270 mm white background. (Attach a photo of the posted standard 
warning notice)    
3. Safety devices such as warning lights and mechanical door interlocks shall be 
provided and tested periodically to ensure their proper operation. (Attach proof of 
provision of preventive maintenance service).    
4. The equipment shall be provided with an automatic timer which will terminate the 
exposure by de -energizing the x -ray tube after the pre -set time has elapsed.    ANNEX D - 6 
 
(Based on 
MACHINE LIST 
of Annex D)  
DRAFT FOR COMMENTS