REGULATORY BODIES , GENERAL SAFETY RULES

Akshay singh B.Sc Med. Tech. Final year Department of Radio-diagnosis and imaging

PGIMER Chandigarh

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 with them, 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 practices,

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.

Functions

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 INDIA

International atomic energy agency(IAEA)

Atomic energy regulatory board (AERB)

International Commission on Radi-olo-gical Protection (ICRP)

National council on radiation protec-tion and mesurements

U.S FDA (Food and drug adminstra-tion)

REGULATORY BODIES FOR EQUIPMENT STANDARDS

INTERNATIONAL INDIAInternational electro-technical commission (IEC)

Bureau of indian standards (BIS)

International Organization for Standardization (ISO)

The International Atomic Energy Agency (IAEA) is an international organization that seeks to promote the peaceful use of nuclear energyThe IAEA was established as an autonomous organization on 29 July 1957. Established independently of the United Nations through its own international treaty.

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 Committee(IXRPC).

The work of the Commission centres on the operation of five main committees:Committee 1 Radiation effects CommitteeThe 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 (deterministic effects).

Committee 2 Doses from radiation exposureDevelopment 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.

ICRP WORKING

Committee 3 Protection in medicineConcerned 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 recommendationsConcerned 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 ionising radiation.

Committee 5 Protection of the environmentConcerned with radiological protection of the environment. It

aims to ensure that the development and application of ap-proaches to environmental protection are compatible with those for radiological protection of man, and with those for protection of the environment from other potential hazards.[2]

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 radiation".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.

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

Food and drug administration , a United States federal regulatory body. 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 devices

"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 organizationThe 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 (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 such organizations;

Develop basic concepts about radiation quantities, units and measurements, about the application of these concepts, and about radiation protection;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 "European Conformity"

 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.

FUNCTIONS

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 and consultants

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 demonsration of conformance with IS: 7620 (1&2&3) .

GENERAL SAFETY RULES

TUBE HOUSINGLeakage radiation through the protective tube housingin 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 DevicesTube 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

Beam Filtration(a) The minimum total filtration in useful beam for maximum rated operating tube potential shall be as given in the following table:

(b) Total filtration shall be indicated on the tube housing. The total permanent filtration in the tube shall be not less than 1.5 mm Al.

Tube PositioningX-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.Bucky AlignmentX-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.Cable LengthX-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 PanelControl 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.TabletopTabletop 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 weightCarbon fibres are commonly used .

This sign should be present on the doors of x-ray room

Thank you