Rules and Regulation Governing the

Establishment, Operation, and

Maintenance of an X-Ray Facility
in the Philippines
Requirements for the Control of Radiation Hazards
from Clinical Diagnostic X-ray Facilities
Manpower:
- Fellow Philippine College of Radiology
- Radiologic/ X-ray Technologist
- Radiation Safety Officer (attended training course in
RP conducted/recognized by the DOH)

Machine:
- at least 100mA
Requirements for the Control of Radiation Hazards
from X-ray Devices Used in Veterinary Medicine

Manpower:
- licensed veterinarian (completed training in RP in VM
conducted/ recognized by the DOH
- radiologic/x-ray technologist or any BS graduate w/ license
in any affiliated medical field (completed training in RP
in VM conducted/recognized by the DOH)
- RSO (completed training in RP in VM conducted/
recognized by the DOH)
Requirements for the Control of Radiation
Hazards from Dental X-ray Facility
Manpower Requirements:

- Staffed by a licensed dental x-ray practitioner

(authorized to interpret dental radiographs,
operate dental x-ray machines & process
dental x-ray films)

- Radiologic technologist ( in the absence of a

dental x-ray practitioner, shall be hired to
operate dental x-ray machines & process
dental x-ray films)

- RSO (dentist or Radiologic/X-ray technologist –

completed training conducted/recognized by DOH)
Requirements for the Control of Radiation Hazards
from Industrial and Anti-Crime X-ray Facilities.
 PURPOSE OF THE A.O.

To protect the health of the people by

preventing the operation of substandard
improperly managed & inadequately
shielded facilities using x-ray devices
used in industry & anti-crime work
Manpower Requirements:

- Operators who have completed training in radiation

protection for industrial & anti-crime work
conducted &/or recognized by the RHS
(CDRRHR)

- RSO/RPO has undergone training in radiation

protection for conducted &/or recognized
by the RHS (CDRRHR)
Basic Standards on Radiation Protection &
Safety Governing the Authorization for the
Introduction & Conduct of Practices Involving
X-ray Sources in the Philippines
Radiation Protection Officer (RSO)
An individual technically competent in RP matters
relevant for s given type of practice who is designated
by the registrant or licensee to oversee the application
of the requirements of the Standards
X-ray Machine Requirements

Requirements for Industrial Radiographic Equipment

- X-ray tube shall be enclosed in a housing that leakage

radiation at a distance of 1m from focus does not exceed
100mR in 1hr (100mSv/hr) at every rating specified by
the manufacturer in the tube housing

- Provided w/ diaphragms, cones or adjustable collimator

to limit area of useful beam
- Warning light & a warning sign to indicate
whether the tube is energized at a location
visible to the operator

- Provided w/ automatic timer w/c will terminate

the exposure by de-energizing the tube after
pre-set time has elapsed

- No radiation shall be detected when timer is set

at zero
Requirements for Industrial Fluoroscopic
Equipment
- Tube enclosed in a tube housing w/ aperture covered by a
shutter or completely shielded enclosure, all entrances are
interlocked so that opening one entrance immediately
de-energizes the tube

- Radiation level at any accessible point 5cm from the surface

of the tube housing & any enclosure attached to it shall not
exceed 25Sv (2.5mR) in 1hr when operated at any permissibl
ratings specified by the manufacturer
- Radiation level at 5cm from external surface of the equipment
shall not exceed 5Sv (2.5mR) in 1hr when averaged over an
area of 100sqm when tube is operated at any permissible
ratings specified by manufacturer

- Each tube shutter & enclosure shall be interlocked w/ tube

housing so that detachment of shutter or enclosure from
housing de- energizes the tube

- Fluoro, screens should be viewed indirectly by use of mirrors

or remotely by TV techniques
Requirements for Industrial X-ray Gauges

- Industrial x-ray thickness & level gauges & other similar devices
should be housed, shielded & installed to prevent unauthorized
access to these devices

- Relevant parts of requirements for industrial fluoro. eqpt.

Requirements for X-ray Analytical Equipment

- Fitted w/ an illuminated sign or combination of sign & a light

w/c is activated only if tube is operating.
Sign shall be eligible & readily discernible at a distance of 2m
on all accessible sides of the unit.

- High tension generator shall have an independent & easily

disconnectable cable connection or line switch.
- 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.

- X-ray camera or other recording device shall be

provided w/ a protective screen that effectively
absorbs radiation.

- Relevant parts of requirements for industrial fluoro. eqpt.

Requirements for Anti-crime Cabinet-type
X-ray Device

- Examination of carry-on baggage shall be arranged that

operator stays in a position where all ports & doors can
be readily observed during exposure

- Key operated control console shall be designed such that

x-rays cannot be produced when key is removed

- Exposure switch shall be dead man type

- X-ray indicator lights “X-RAYS ON” & only activated only
when x-ray tube is energized.
Words legible & readily discernible at least 2m from all
accessible sides of eqpt.
-

- Warning notice made of a solid yellow equilateral triangle

189mm long on each side. At center is a black tre-foil sign
for radiation.
Under triangle are words:
“CAUTION – X-RAY EMITTING APPARATUS.”
Warning notice on a 180mm x 270mm white background.

- Relevant parts of requirements for industrial fluoro. eqpt.

- Dose equivalent rate outside the boundary shall not
exceed 25Sv (2.5mR)/hr

- Continuous & competent supervision of the site shall be

carried on during the conduct of x-ray exposure

- Control console shall be located in an area where the dose

equivalent does not exceed 25mSv (2.5mR)/hr
Requirements for Anti-Crime X-ray Device

- May not be located in a separate room provided that access

to its location shall be limited to personnel to work in the areas
by the RSO/RPO.

- Visual warning signs shall be posted in the area.

The warning notice shall be made up of a solid yellow
equilateral triangle 180mm 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 180mm x 270mm
white background.
Working Procedures
Industrial Radiographic Equipment
- Used only if warning lights & interlocks are
operating properly

- Radiography shall be done such that primary beam is

directed either upward or downward.

- Safety devices, warning lights & interlocks shall be tested

periodically to ensure proper operation.

- RSO-RPO shall carry out regular radiation area &

equipment monitoring.
Keeps a record of the results of such activities &
report to RHS (CDRRHR) any significant levels
of radiation that may arise.
Fluoroscopic Equipment

- No industrial fluoro. eqpt. shall be operated if a person

occupying an area can be exposed to greater than
2.5(0.25mSv)/hr.

Relevant parts of Site Requirements for

Enclosed Installations
Use of X-ray Analytical Equipment &
X-ray Gauges

- When total enclosure of eqpt. is not practicable, shall be

located & supervised That no person can occupy an area
in w/c exposure rate is higher than 25Sv/hr

- No person shall expose any part of his body to a primary

beam

- Doors leading to the equipment shall be locked whenever

the unit remains energized & room is unsupervised
- Eqpt. Shall be periodically monitored for possible detection
of significant leakage radiation.

- Operators should use finger or wrist monitoring devices

- Neither repair nor cleaning involving removal of covers,

shielding material or tube housing, nor non-routine
exchange of filters, shutters, collimators, etc. hall be
performed unless it has been positively ascertained
that tube is de-energized.

- Relevant parts of site requirements for enclosed installations

shall apply.
Use of Anti-Crime X-ray Equipment

- Relevant parts of:

Site requirements for enclosed installation
Site requirements for open installations
Site requirements for anti-crime x-ray device
Administrative Requirements

- Owner shall appoint a RSO/RPO who shall manage the

conduct of Radiation Safety Program

- Owner shall provide personnel dose monitors for operators

& keep a record of occupational radiation doses received
by workers.

- Owner shall have or make available a radiation monitoring

instrument to carry out regular monitoring surveys of
industrial x-ray units.
Radiation monitoring instrument is calibrated at least
once a year.
Violations

- LTO may be revoked or suspended for any false statement

in the application or failure to observe by the licensee any
of the requirements & provisions of this standard

- No license shall be modified, suspended or revoked until

licensee shall have been allowed an opportunity to
demonstrate or achieve compliance w/ the standard
Penalties

- Punished by a fine or imprisonment or both

as provided in the penalty clause of PD480
 POLICY PLANNING DIRECTOR GENERAL LEGAL SERVICE
OFFICE SUPPORT CENTER
DIRECTOR DIRECTOR

DEPUTY DIRECTOR DEPUTY DIRECTOR

GENERAL GENERAL
ADMINSITRATION AND FIELD REGULATORY
FINANCE OFFICE OPERATIONS OFFICE

Center for Center for Center for Center for DEVICE

DRUGS FOODS COSMETICS DIRECTOR
DIRECTOR DIRECTOR DIRECTOR
 Center for Device Regulation, Radiation
Health, & Research
Engr. Bayani C. San Juan,MSCMNSA CESE

LRD PRSDD RRD PLSD

Engr, Ma. Cecilia Engr. Helen Ma. Gladys Elizabeth H.
Matienzo Ocampo Cabrera,MSc Mendoza

Central Service Laboratory

Regulation of the manufacture, import, export,
distribution, advertisement, and sale of medical
devices, radiation devices and other health related
devices

Regulation of the use of radiation devices

Health technology assessment of medical devices

Requirements for INITIAL/RENEWAL
of LTO a Industrial X-ray Facility

Duly accomplished dental X-ray application

form (2 copies)
- downloadable at www.fda.gov.doh or
www.doh.gov.ph

Photocopy of the OR of the personal dose

monitor from the service provider
(for renewal application only)
Photocopy of the personal dose evaluation reports
w/in the validity period of previous license
(for renewal application only)

Photocopy of the certificate of training of the

RSO/RPO conducted by an organization
recognized by the CDRRHR.
 Republic of the Philippines
The Philippine Society of Government
Radiologic Technologists, Inc.
in collaboration with the
Food and Drug Administration
Department of Health
Center for Device Regulation, Radiation
Health, and Research
(former name : Bureau of Health Devices and Technology)

This is to certify that

JEFFERSON M. ABRENICA
participated in and completed the

TRAINING COURSE FOR RADIATION SAFETY OFFICERS OF

INDUSTRIAL AND ANTI-CRIME X-RAY FACILITIES
held at
Tiera Oriental Hotel, Makati City
on
27 – 29 April 2017
The course programme included:
⬧Basic Concept of Radiation Physics
- X-ray Production & Properties
- Interactions of X-ray with Matter
⬧Radiation Quantities and Units
⬧Biological Effects of Ionizing Radiation
⬧Principles of Radiation Detection and Measurements
- Workplace Monitoring
- Personnel Monitoring
⬧Principles of Radiation Protection
- Basic Safety Requirements
 Duties & Responsibilities of Radiation Safety Officers
⬧A.O.No.40 s.1996 – Requirements for the Control of Radiation Hazards from
Industrial & Anti-crime X-ray Facilities
⬧Radiation Protection Program for the Safe Use of X-ray Producing Equipment
- Components of a Radiation Safety Program
- Preparation of an Industrial Radiation Safety Program

ENGR. BAYANI C. SAN JUAN,MSc,MNSA,CESE GREGORIO C. GALLARDO,RRT,MTM

Director IV, CDRRHR, FDA-DOH President, PSGRT,Inc.

Attested By:

JUANITO N. ESLAVA,RRT,PhD
Officer-In-Charge, PLSD
FDA-DOH
Not Valid w/o FDA Seal CDRRHR-FDA,DOH
RPInd 236 -17
License application fee.
For mailed application Manager’s cheque
shall be payable to the………
FOOD & DRUG ADMINISTRATION.
 PROCESS/ ACTIVITY MAX. TIME
Evaluate application form & documents 30mins
for completeness
Receives payment 5mins
Receives complete application forms, 5mins
documents photocopy of OR
 PROCESS/ ACTIVITY MAX.
Release of LTO TIME
Complex transaction 120days
(w/ RPSE, performance testing)
Simple transaction (e.g. renewal of LTO) 15days
Application/transactions:
- FDA Action Center (FDAC)
(FDA – PAIR)
 CENTER FOR DEVICE REGULATION,
RADIATION HEALTH & RESEARCH

Radiation Regulation Div. - 8159600

FDA Action Center (FDAC)

- 8211155