AERB, IAEA, Dose limits

1. RADIATION REGULATORY BODIES
PRESENTER : DR SIDDHARTH

2. WHAT IS A REGULATORY BODY?
• Regulatory body (Regulatory authority,Regulatory
agency) is a public authority or government agency
responsible for exercising autonomous authority
over some area of human activity in a regulatory or
supervisory capacity

3. FEATURES OF RADIATION REGULATORY
BODIES
• A regulatory authority be established by the
government to regulate the conduct and
introduction of any practice involving sources of
radiation.
• Regulatory authority must be independent of
registrants,licensees,designers and constructors
of radiation sources used in practices.

4. • The effective separation of responsibilities
between the junctions of 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.
• A single regulatory authority is responsible for all
aspects of radiation protection and safety in a
country.
• In some countries, regulatory responsibility for
different aspects of radiation protection and
safety may be divided between different
authorities

5. FUNCTIONS OF RADIATION
REGULATORY BODIES
• Assessment of applications for permission to
conduct practices pertaining to radiation exposure.
• Authorisation of practices involving radiation and
sources involved.
• Conduct of periodic inspections
• Quality assurance
• Assessing effectiveness of radiation protection and
safety measures for each authorized practice.

6. RADIATION REGULATORY BODIES

7. INTERNATIONAL ATOMIC ENERGY AGENCY

8. Autonomous organization
Established independent of United Nation through
its international treaty on 29 July 1957.
Total member countries =171 ( As of February 2019)
Director General : Mr.Yukiyo Amano (JAPAN)
Headquarters : Vienna,Austria
India joined in 1957 as a permanent member of
IAEA
“Safe,secure and peaceful uses of nuclear sciences
and technology”

9. INTERNATIONAL COMMISSION ON
RADIOLOGICAL PROTECTION (ICRP)
• An independent, international organization that
advances for the public benefit the science of
radiological protection, in particular by providing
recommendations and guidance on all aspects of
protection against ionising radiation
• A charity (not-for-profit organisation) registered
with the Charity Commission of England and Wales
• A community of more than 250 globally-recognised
experts in radiological protection science, policy,
and practice from more than 30 countries
• HEADQUARTERS : Ottawa, Canada.

10. • CHAIRPERSON : Dr.Claire Cousins (England)
• ICRP was established in 1928 at the second
International Congress of Radiology to respond to
growing concerns about the effects of ionizing
radiation being observed in the medical
community.
• At the time it was called the International X-ray
and Radium Protection Committee (IXRPC), but
was restructured to better take account of uses of
radiation outside the medical area and given its
present name in 1950.

11. ICRP WORKING
• Committee 1: RADIATION EFFECTS
- Stochastic effects
- Deterministic effects
• Committee 2: DOSES FROM RADIATION EXPOSURE
- Dose coefficients
- Reference biokinetic and
dosimetric models
- Reference data for workers &public

12. Committee 3 : PROTECTION IN MEDICINE
- Persons,unborn children
- Medical diagnosis , therapy or
for bio medical research
- Medical consequences of
accidental exposure
Committee 4 : APPLICATION OF COMMISSION’S
RECOMMENDATIONS
Committee 5 : PROTECTION OF ENVIRONMENT

13. INTERNATIONAL COMMISSION ON
RADIATION UNITS AND
MEASUREMENT(ICRU)
 Standardization body setup in 1925 by
International Congress of Radiology,originally as
X-ray unit committee until 1950.
 Objective: “Develop concepts,definitions and
recommendations for use of quantities and
their units for ionisation radiation and its
interaction with matter,in particular with
respect to biological effects induced by
radiation .“

14. • ICRU defines units and ICRP recommends,
develop and maintain international system of
Radiological Protection which uses these units.

15. FOOD AND DRUG ADMINISTRATION
(FDA)
• U.S FDA 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.
• 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.

16. FUNCTIONS OF FDA
• The FDA conducts an ongoing products radiation
control program, regulating the design and
manufacture of electronic products, including
diagnostic x-ray equipment.
• Conducts onsite inspections of x-ray equipment,
especially mammography units to determine the level
of compliance with standards in a given x-ray facility .
• Compliance with FDA standards ensures protection of
occupationally and non-occupationally exposed
persons from faulty manufacturing.

17. CDRH
• 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 devices

18. “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“.

19. NATIONAL COUNCIL ON RADIATION
PROTECTION AND MEASUREMENTS
(NRCP)
• 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 as follows: “
To: Collect, analyze, develop and disseminate in the
public interest information and recommendations
about

20. (a) protection against radiation
(referred to herein as radiation protection)
(b) radiation measurements, quantities and units,
particularly those concerned with radiation
protection
(c) 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 such organizations.

21. (d) Develop basic concepts about radiation
quantities, units and measurements, about the
application of these concepts, and about radiation
protection
(e) 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."

22. CE Mark

23. • The CE mark, or formerly EC mark, is a mandatory
conformity marking for certain products sold within
the European Economic Area(EEA) since 1985.
• CE an abbreviation of Conformité Européenne,
meaning "European Conformity“
• 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.

24. ATOMIC ENERGY REGULATORY BOARD
(AERB)

25. • 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
• Mission of the Board :
To ensure that the use of ionising
radiation and nuclear energy in India does not
cause undue risk to health and the environment.
Currently, the Board consists of a full-time Chairman, an ex
officio Member, three part-time Members and a Secretary.
CHAIRMAN : SHRI. G NAGESWARA RAO
HEADQUARTERS : ANUSHAKTINAGAR, MUMBAI

26. FUNCTIONS OF AERB
1. Develop safety policies in nuclear, radiation and
industrial safety areas for facilities under its
purview.
2. Develop Safety Codes, Guides and Standards for
siting, design, construction, commissioning,
operation and decommissioning of different types
of nuclear and radiation facilities.
3. Grant consents for siting, construction,
commissioning, operation and decommissioning,
after an appropriate safety review and assessment,
for establishment of nuclear and radiation facilities.

27. 4) Prescribe the acceptance limits of radiation
exposure to occupational workers and members of
the public and acceptable limits of environmental
releases of radioactive substances.
5) Review the emergency preparedness plans for
nuclear and radiation facilities and during transport
of large radioactive sources, irradiated fuel and
fissile material.
6) Review the training program, qualifications and
licensing policies for personnel of nuclear and
radiation facilities and prescribe the syllabi for
training of personnel in safety aspects at all levels.

28. 7) Take such steps as necessary to keep the public
informed on major issues of radiological safety
significance.
8) Maintain liaison with statutory bodies in the country as
well as abroad regarding safety matters.
9) Promote research and development efforts in the
areas of safety.
10) Review the nuclear and industrial safety aspects in
nuclear facilities under its purview.
11) Review the safety related nuclear security aspects in
nuclear facilities under its purview.
12) Notifying to the public, the 'nuclear incident', occurring
in the nuclear installations in India, as mandated by the
Civil Liability for Nuclear Damage Act, 2010.

29. • AERB of India recommends and lays down
guidelines regarding the Specifications of
 medical x-ray equipment
 room layout of x-ray installation
work practices in x-ray department
 protective devices
responsibilities of the radiation personnel,
employer and radiation safety officer (RSO).

30. REGULATORY CONTROL OF AERB
AERB is the regulatory control authority on
 Approval of new models of x-ray equipment
 and layout of any new proposed x-ray installation
 Registration and commissioning of new x-ray
equipment
 Inspection and decommissioning of x-ray
installation
 Certification of a RSO and of service engineers and
imposing penalties on any person contravening these
rules

31. eLORA(e-Licensing of Radiation
Applications)
• eLORA is a web-based I&CT (Information and
Communication Technology) application establishing
direct communication channel between AERB and its
stakeholders for exchange of information and
communication transaction.
• A state of art e-Governance system, through
automation of regulatory processes associated with
the use of ionising radiation in India

32. COMPONENTS OF eLORA
To achieve business solution with
Security
Performance
Availability
Manageability and Maintainability
Scalability

33. ALARA PRINCIPLE
• ALARA (As Low As Reasonably Achievable) is a
safety principle designed to minimize
radiation doses and releases of radioactive
materials.
• ALARA is predicated on legal dose limits for
regulatory compliance, and is a requirement
for all radiation safety programs.

34. • To maintain doses As Low As Reasonably
Achievable, make sure staff follow these three
major safety principles:
• 1. TIME
• 2. DISTANCE
• 3. SHIELDING

35. DOSE LIMITS
• As per Rule 15 of the Atomic Energy (Radiation Protection)
Rules, 2001
General Guidelines
I.
The limits on effective dose apply to the sum of effective doses
from external as well as internal sources.
II. The limits exclude the exposures due to natural background
radiation and medical exposures.
III. Calendar year shall be used for all prescribed dose limits.

36. APPLICATION RADIATION WORKER
(mSv/year)
PUBLIC
(mSv/year)
EFFECTIVE DOSE
(BASED ON STOCHASTIC
EFFECTS)
30mSv/year
Dose of 20 mSv/yr averaged
over five consecutive years
(calculated on a sliding scale
of five years);
1mSv/year
EQUIVALENT DOSE
(BASED ON DETERMINISTIC
EFFECTS)
-LENS
-SKIN
-HANDS AND FEET
150mSv/year
500mSv/year
500mSv/year
15mSv/year
50mSv/year
50mSv/year
PREGNANT WOMEN 2 mSV after declaration of pregnancy upto term
N.B : For Trainees,the effective dose in any year shall not exceed 6mSv

37. DOSE LIMITS (ICRP-60,1990))

38. RADIATION SYMBOL (AERB 2011)
I. RADIOACTIVE SOURCES

39. II. RADIATION GENERATING EQUIPMENTS

40. III. AT ENTRANCE OF X-RAY FACILITY

41. REGULATORY BODIES FOR EQUIPMENT
STANDARDS

42. INTERNATIONAL ELECTROTECHNICAL
COMMISSION (IEC)
• World’s leading organization that prepares and
publishes International Standards for all electrical,
electronic and related technologies Including
Medical electrical equipments.
• 83 members including India
• Serves world markets and society through its
"electro-technology".
• Promotes world trade and economic growth and
encourages the development of products, systems
and services that are safe, efficient and
environmentally friendly.

43. BUREAU OF INDIAN STANDARDS(BSI)
• 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.

45. The manufacturers of diagnostic x-ray
machines in the country are directed that
each make/model of X-ray unit manufactured
by them shall bear certification mark of the
BIS issued by BIS upon demonstration of
conformance with IS: 7620 (1&2&3) .

46. THANK YOU FOR PATIENT LISTENING