radiation regulatory bodies. ( international + indian )
REGULATORY BODIES ,
GENERAL SAFETY RULES
B.Sc Med. Tech. Final year
Department of Radio-diagnosis and imaging
8 July 2015
What is regulatory body ?
Regulatory body ( Regulatory authority , Regulatory agency )
is a public authority or government agency responsible for
excercising autonomous authority over some area of human
activity in a regulatory or supervisory capacity .
Full and proper implementation of the Standards requires that
a Regulatory Authority be established by the Government to
regulate the introduction and conduct of any practice
involving sources of radiation
The Regulatory Authority must also be independent of
registrants, licensees and the designers and constructors of the
radiation sources used in practices
The effective separation of responsibilities between the
Junctions of the Regulatory Authority and those of any other
party is to be made clear so that the regulators retain their
independence of judgement and decision as safety authorities.
Features of radiation regulatory bodies
A single Regulatory Authority is responsible for all aspects of
radiation protection and safety in a country.
In some countries, however, regulatory responsibility for different
practices or different aspects of radiation protection and safety
may be divided between different authorities.
The assessment of applications for permission to conduct
practices that entail or could entail exposure to radiation; the
authorization of such practices and of the sources associated
The conduct of periodic inspections to verify compliance with
the conditions; and the enforcement of any necessary actions
to ensure compliance with the regulations and standards.
notification, registration and licensing of the sources within
The surveillance, monitoring, review, verification and
inspection of sources (QA) and for ensuring that adequate
plans exist for dealing with radiation accidents and carrying
out emergency interventions.
The effectiveness of radiation protection and safety measures
for each authorized practice and the total potential impact of
authorized practices need to be assessed.
RADIATION REGULATORY BODIES
International atomic energy agency
Atomic energy regulatory board
International Commission on Radiolo
-gical Protection (ICRP)
National council on radiation protecti
on and mesurements
U.S FDA (Food and drug adminstrati
REGULATORY BODIES FOR EQUIPMENT
Bureau of indian standards
International Organization for
The International Atomic Energy Agency (IAEA) is an
international organization that seeks to promote the peaceful use
of nuclear energy
The IAEA was established as an autonomous organization on 29
Established independently of the United Nations through its own
International Atomic Energy Agency (IAEA)
The IAEA exists to pursue the "safe, secure and peaceful uses
of nuclear sciences and technology" (Pillars 2005).
The IAEA executes this mission with three main functions: the
inspection of existing nuclear facilities to ensure their peaceful
use, providing information and developing standards to ensure
the safety and security of nuclear facilities, and as a hub for
the various fields of science involved in the peaceful
applications of nuclear technology.
Total member countries - 164
The International Commission on Radiological Protection (ICRP)
is an independent, international non-governmental organization
providing recommendations and guidance on radiation protection.
It was founded in 1928 by at the second International Congress of
Radiology in Stockholm, Sweden (later these were organized by
the International Society of Radiology (ISR)) and was then called
the International X-ray and Radium Protection
The work of the Commission centres on the operation of five
Committee 1 Radiation effects Committee
The risk of induction of cancer and heritable disease (stochastic
effects) together with the underlying mechanisms of
radiation action; also, the risks,severity, and mechanisms of
induction of tissue/organ damage and developmental defects
Committee 2 Doses from radiation exposure
Development of dose coefficients for the assessment of internal
and external radiation exposure, development of reference
biokinetic and dosimetric models, and reference data for
workers and members of the public.
Committee 3 Protection in medicine
Concerned with protection of persons and unborn children
when ionising radiation is used for medical diagnosis,
therapy, or for biomedical research; also, assessment of the
medical consequences of accidental exposures.
Committee 4 Application of the Commission’s
Concerned with providing advice on the application of the
recommended system of protection in all its facets for
occupational and public exposure. It also acts as the major
point of contact with other international organisations and
professional societies concerned with protection against
Committee 5 Protection of the environment
Concerned with radiological protection of the environment. It
aims to ensure that the development and application of
approaches to environmental protection are compatible with
those for radiological protection of man, and with those for
protection of the environment from other potential hazards.
The International Commission on Radiation Units and
Measurements (ICRU) is a standardization body set up in 1925 by
the International Congress of Radiology, originally as the X-Ray
Unit Committee until 1950. Its objective "is to develop concepts,
definitions and recommendations for the use of quantities and
their units for ionizing radiation and its interaction with matter, in
particular with respect to the biological effects induced by
The ICRP is a sister organisation to the International Commission
on Radiation Units and Measurements (ICRU). In general terms
ICRU defines the units, and ICRP recommends, develops and
maintains the International System of Radiological Protection
which uses these units.
The Food and Drug Administration (FDA or USFDA) is a federal
agency of the United States Department of Health and Human
Services, one of the United States federal executive departments
Food and drug administration , a United States federal regulatory
Individual states and other federal agencies regulate the use of the x-
ray imaging devices through recommendations and requirements for
personnel qualifications , quality assurance and quality control
programs and facility accreditation.
The FDA conducts an ongoing products radiation control
program, regulating the design and manufacture of electronic
products, including diagnostic x-ray equipment. To determine the
level of compliance with standards in a given x-ray facility, the
FDA conducts onsite inspections of x-ray equipment, especially
mammography units. Compliance with FDA standards ensures
protection of occupationally and non-occupationally exposed
persons from faulty manufacturing.
The Center for Devices and Radiological Health (CDRH) is
the branch of the United States Food and Drug
Administration (FDA) responsible for the premarket approval
of all medical devices, as well as overseeing the manufacturing
performance and safety of these devices. The CDRH also
oversees the radiation safety performance of non-medical
"FDA-Cleared" vs "FDA-Approved"
Clearance requests are for medical devices that prove
they are "substantially equivalent" to the predicate
devices already on the market. Approved requests are for
items that are new or substantially different and need to
demonstrate "safety and efficacy“.
The National Council on Radiation Protection and
Measurements (NCRP. is a non government U.S organization
The Charter of the Council (Public Law 88-376) states its objectives
Collect, analyze, develop and disseminate in the public interest
information and recommendations about (a) protection against
radiation (referred to herein as radiation protection) and (b) radiation
measurements, quantities and units, particularly those concerned
with radiation protection;
Provide a means by which organizations concerned with the
scientific and related aspects of radiation protection and of radiation
quantities, units and measurements may cooperate for effective
utilization of their combined resources, and to stimulate the work of
Develop basic concepts about radiation quantities, units and
measurements, about the application of these concepts, and about
Cooperate with the international commission on radiological
protection, the federal radiation council, the international
commission on radiation units and measurements, and other national
and international organizations, governmental and private,
concerned with radiation quantities, units and measurements and
with radiation protection."
The CE mark, or formerly EC mark, is a mandatory conformity
marking for certain products sold within the European Economic
Area(EEA) since 1985. The CE marking is also found on products
sold outside the EEA that are manufactured in, or designed to be
sold in, the EEA. This makes the CE marking recognizable
worldwide even to people who are not familiar with the
European Economic Area.
CE an abbreviation of Conformité Européenne, meaning
The CE marking indicates the compliance with EU legislation of a
product, wherever in the world manufactured, and enables its free
movement within the European market
Atomic energy regulatory board.
The Mission of the AERB is to ensure the use of ionising
radiation and nuclear energy in India does not cause undue risk
to the health of people and the environment.
The Atomic Energy Regulatory Board (AERB) was constituted
on November 15, 1983 by the President of India by exercising the
powers conferred by Section 27 of the Atomic Energy Act, 1962
AERB of india recommends and lays down guidelines regarding
the Specifications of medical x-ray equipment
For the room layout of x-ray installation,
Regarding the work practices in x-ray department , the protective
devices and also the responsibilities of the radiation personnel,
employer and radiation safety officer (RSO).
AERB is the authority in India which exercises a regulatory control
on the approval of new models of x-ray equipment and the layout
of any new proposed x-ray installation.
It also is the regulatory authority for registration and commissioning
of new x-ray equipment, inspection and decommissioning of x-ray
installation, certification of a RSO and of service engineers and also
for imposing penalties on any person contravening these rules .
The International Electro-technical Commission(IEC) is the
world’s leading organization that prepares and publishes
International Standards for all electrical, electronic and related
technologies Including Medical electrical equipments.
It has 83 members including India
The International Electro-technical Commission serves world
markets and society through its standardization and conformity
assessment work for all electrical, electronic and related
technologies – collectively known as "electro-technology".
The IEC promotes world trade and economic growth and
encourages the development of products, systems and services
that are safe, efficient and environmentally friendly.
The Standardization Management Board is responsible for the
overall management of the technical work.
The standards work of the Commission is carried out through
technical committees and subcommittees, composed of
representatives of the Full Member National Committees, each
dealing with a particular subject.
IEC 60601-1-3:2008+A1:2013 applies to X-ray equipment and
to subassemblies of such equipment
The Bureau of Indian Standards (BIS) is the national Standards
Body of India working under the aegis of Ministry of Consumer
Affairs, Food & Public Distribution , Government of India.
For formulation of Indian Standards, BIS functions through
the Technical Committee structure comprising of Division
Councils, Sectional Committees, Subcommittees and Panels.
Division Councils are set up by Standards Advisory Committee
(SAC) in defined areas of industries and technologies for
formulation of standards. These include representatives of various
interests such as consumers, regulatory and other Government
bodies, industry, scientists, technologists, testing organizations
BUREAU OF INDIAN STANDARDS.
The manufacturers of diagnostic x-ray machines in the country are
directed that each make/model of xray unit manufactured by them
shall bear certification mark of the BIS issued by BIS upon demon
sration of conformance with IS: 7620 (1&2&3) .
Leakage radiation through the protective tube housing
in any direction, shall not exceed an air kerma of 1 mGy in
one hour at a distance of 1.0 m from the X-ray target when
the tube is operating at the maximum rated kVp and for the
maximum rated current at that kVp. There shall be a
distinctly visible mark on the tube housing to indicate the
plane of focus.
Beam Limiting Devices
Tube housing for stationary and mobile diagnostic X-ray
units shall be provided with light beam collimators. These
collimators shall comply with the leakage radiation level
prescribed for tube housing
(a) The minimum total filtration in useful beam for maximum
rated operating tube potential shall be as given in the following
(b) Total filtration shall be indicated on the tube housing. The
total permanent filtration in the tube shall be not less than 1.5
X-ray unit shall have facilities for tube positioning, target-to-film
distance selection, useful beam centring and angulation, positioning
of the patient and the X-ray film for exposure in the desired manner,
and appropriate features to display the same.
X-ray table shall have provisions for correct positioning of the grid,
the bucky tray and the film cassette in proper alignment with the
useful beam and for their locking in the desired position.
X-ray unit shall be provided with electrical cables of sufficient length
so that the control panel/operation switch can be located and operated
from a minimum distance of 3 m from the nearest position of the X-
ray tube. For mobile/portable X-ray equipment the cable length shall
be not less than 2 m.
Control panel shall be provided with means to indicate and control
exposure parameters, including tube potential, time of exposure,
tube current, and integral exposure in milliampere-seconds (mAs).
It shall also provide facilities for technique selection and the
engagement of the bucky mechanism. A clearly marked and
identifiable indicator shall be provided at the control panel to show
whether the X-ray beam is 'ON' or 'OFF'. For portable/mobile units
appropriate indication of exposure parameters shall be provided.
Tabletop should be made of radioparent substances which allow
to pass radiation without much attenuation. But as well as they
should be strong enough to carry patient weight
Carbon fibres are commonly used .
This sign should be present on the doors of x-ray room