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.

RTI Queries & Responses


If you have any question unanswered even after going through the RTI queries, you are free to pass it to us. Please see the “contact us” page on this website for communicating your query to us.

Please note that for RTI queries are kept as received and hence correctness of language used is not ensured.

Q1.

Why is it essential to take regulatory consent from AERB for operating medical diagnostic X-ray equipment?

What is the mechanism to have supervisory eyes over the safe use of diagnosis instruments like CT Machine, C-Arm etc. in the larger interest of public health & safety from the adverse effect of this instrumental use?

Kindly provide details of steps taken by AERB to ensure adequate protection to public, patient & staff from operating radiation unit.

Ans

The mission of AERB is to ensure that the use of ionizing radiation and nuclear energy in India does not cause undue risk to the health of people and the environment. AERB enforces regulatory requirements to ensure safe operation of X-ray equipment such as Cath Lab equipment, Computed Tomography machines, C-Arm, Mammography machines, General purpose medical radiography machines etc. The primary mechanism of regulation is ensuring design safety of the machine by issuance of Type Approval (for the prototype model). The shielding adequacy around X-ray installation is ensured by providing appropriate structural shielding for walls, doors, ceiling and floor of the room so that radiation exposure received by workers and the members of public are kept to the minimum and shall not exceed the respective limits for annual effective doses as per Safety Directives issued by the Competent Authority. The operational safety of X-ray equipment is ensured by issuance of Licence/Registration to the utility after review of all aspects related to radiation safety and after ensuring that patient, staff and public are adequately protected. Moreover, continued safety is ensured by review of the periodic safety status reports submitted by the radiation facilities. AERB also carries out regulatory inspections on a sample basis to ensure safe operation of these X-ray equipment. Hence, a regulatory consent from AERB is essential to ensure radiation safety in operating the X-ray equipment.

AERB is seriously committed in its mission to ensure that the use of ionizing radiation does not cause undue harm to health of people and environment. To ensure maximum registration of medical diagnostic facilities, AERB has commissioned an easy and approachable interface for the user in the new web based system to enable easy filing of applications and issuance of Registration.(e-Licensing of Radiation Applications e-LORA for faster and on-line processing of licensing applications). Due to proactive approach of AERB, several institutions have come forward and initiated the process to acquire the registration/license for operating the medical diagnostic equipments. As on April 10, 2016, 36,755 X-ray equipments are declared and 25,211 equipments have been licensed through on-line mode. AERB has also put out the list of licensed X-ray installations on its website advising public to visit only licensed facilities for radiology services.

AERB is making diligent efforts to streamline and enhance the regulatory control over medical diagnostic X-ray facilities, with active co-ordination of several state agencies/regional regulatory centers. Considering the large number of wide spread X-ray facilities, AERB has initiated steps for decentralization of regulation of X-ray facilities. In this regard, AERB has initiated process for formation of Directorate of Radiation Safety (DRS) under Health and Family Welfare Department of every state, to carry out regulatory inspections of X-ray facilities (of the state) and support the utilities in obtaining licence/registration from AERB. Directorates of Radiation Safety (DRS) are made functional in six States (Kerala, Mizoram, Chhattisgarh, Arunachal Pradesh, Punjab and Tripura). The other six State Governments that signed a MoU with AERB are as follows: (1) Madhya Pradesh, (2) Tamil Nadu, (3) Gujarat, (4) Himachal Pradesh, (5) Maharashtra and (6) Odisha. Follow-up is in progress to enter in agreement with other States and make them functional.

Further, AERB has also established its own Regional Regulatory Centers (RRC) at Chennai, Kolkata and Delhi for catering to the southern, eastern and northern regions of the country respectively. AERB has also authorized around 79 Quality Assurance (QA) service providers to provide QA services to the utilities. This is to ensure that the quality of the equipment is robust with respect to radiation safety, to carry out patient diagnosis. The list of service providers is available on AERB website for ready reference by the utilities. AERB is already implementing actions for regulation of X-ray facilities in the country. In view of the above on-going actions, it is envisaged that in the near future, all the X-ray facilities will be effectively under regulatory control of AERB.

Q2.

What is maximum/permissible radiation exposure limit in India? Who is the deciding authority?

What is the limit of MPD (Maximum Permissible Dose) in India today? How it has been reduced?

Ans

Atomic Energy Regulatory Board (AERB), constituted on November 15, 1983 by exercising the powers conferred by the Atomic Energy Act, 1962 is the regulatory authority which stipulates the dose limits in India. The dose limits are revised based on recommendation of ICRP (International Commission on Radiological Protection) from time to time. Current Dose Limits are given in AERB Directive No. 01/2011 (Ref. No. No.CH/AERB/ITSD/125/2011/1507 dated April 27, 2011). As per the Directive, the effective dose received by a member of public shall not exceed 1 mSv in a year. The equivalent dose received by eye shall not exceed 15 mSv in a year. The equivalent dose received by skin, the extremities (hands and feet) shall not exceed 50 mSv in a year.

The effective dose received by a radiation worker shall not exceed 20 mSv in a year averaged over five consecutive years (calculated on a sliding scale of five years) and effective dose in any single year shall not exceed 30 mSv. The equivalent dose received by eye shall not exceed 150 mSv in a year. The equivalent dose received by skin, the extremities (hands and feet) shall not exceed 500 mSv in a year. The same dose limits shall be applicable to female workers also. However, once pregnancy is declared the equivalent dose limit to embryo/foetus shall be 1 mSv for the remainder of the pregnancy. For further details you may visit AERB website www.aerb.gov.in

Q3.

Is there any limit of X-ray exposure(s) done by a radiographer in one single day? Is there any limit of X-ray exposure(s) done by a radiographer fixed by any Authority, any State Govt./Central Govt. or by Atomic Energy Regulatory Board or by Radiological Safety Division?

How many X-ray exposures are permitted to be performed in a day as well as in a month by a Radiographer/X-ray technician?

What are the total permissible monthly duty hours of a Radiology Technician according to AERB rules and regulations?

How many X-rays, CT Scan, special procedures beside Mammography an individual radiographer can do in case of adult as well as paediatric patient in a single day? Please attach relevant document for the same.

How many working hours a day for nuclear medicine physician/technologist/radiological safety officer in nuclear medicine department as per AERB guidelines?

If a technologist is force to work for more than 8 hours a day, where the complaint should be lodge and what action would be taken against the person who is responsible for it? Is there any organization or body who monitor the working hours of radiotherapy technologist?

Ans

AERB has not stipulated any limit in respect of the maximum/mandatory working hours in a day/week/month and/or maximum no. of exposures permitted to be performed in a day/week/month in a radiation facility. AERB does not monitor the working hours of radiation workers, as there is no stipulation by AERB in this regard. However, the employer and the radiation worker shall ensure that the radiation dose received due to working in radiation area shall not exceed the occupational dose limits specified by AERB. The radiation dose limits specified by AERB for radiation workers are as follows:

The effective dose received by a radiation worker shall not exceed 20 mSv in a year averaged over five consecutive years (calculated on a sliding scale of five years) and effective dose in any single year shall not exceed 30 mSv.

The equivalent dose in any calendar year to the lens of the eye shall not exceed 150 mSv.

The equivalent dose in any calendar year to the skin, the hands and feet shall not exceed 500 mSv.

The same dose limits shall be applicable to female workers also. However, once pregnancy is declared the equivalent dose limit to embryo/foetus shall be 1 mSv for the remainder of the pregnancy.

Q4.

Why not radiation risk allowance should be recommended by AERB itself for radiographers, being the sole regulator for implementation of radiation protections rules and competent authority?

Is there any risk leave for the radiation worker in the hospital? Whether radiation risk allowances are being given to radiographers in other nation of the world?

Provisions for hazard and/or risk allowance for radiographers working at Central Government hospitals. Please furnish copy.

Ans

There is no risk leave and/or risk allowance prescribed by the Atomic Energy Regulatory Board (AERB) for radiation workers in India. As per Atomic Energy (Radiation Protection) Rules, 2004, there is no provision for any radiation/hazard leave, radiation allowance or any other type of allowances for employees working at radiation facilities such as hospitals, medical diagnostic centers etc.

Giving radiation risk allowance/risk leave to radiation workers is not recommended by IAEA (International Atomic Energy Agency). AERB has adopted the policies which are in line with IAEA recommendations.

Q5.

What kind of radiations are emitted from X-ray Machines? How dangerous they are?

How to detect radiations from X-ray Machines?

Ans

Ionizing radiations i.e. X-rays are generated from the X-ray machines, when they are in operation. X-rays are a form of electromagnetic radiation of high energy and very short wavelength and can pass through many materials. X-rays are produced within the machine by interaction of accelerated electrons with a metal target. No external radioactive material is involved.

Although Ionizing radiations such as X-rays are carcinogenic, they are safe when they are used properly. The chances of being harmed from X-rays are extremely small. Effects of ionising radiation are published in detail in standard literature such as UNSCEAR Reports.

Detection of X-rays is possible by using appropriate radiation measuring and monitoring instruments such as dosimeters, survey meters etc.

Q6.

Why radiation monitors and dosimetry devices should be available where radiation installations are operated? Where I can get information about radiation monitors, dosimetry devices etc.?

Kindly provide list of appropriate personnel monitoring devices to be provided to all radiation workers.

Do you recommend dosimeters to X-ray lab technicians? If an institute/hospital forced Radiographers to do duty of X-ray without TLD then what legal action can be taken against the institute/hospital?

Can a Radiology Technician be posted in Radiography room/portable radiography when he has not been provided a TLD badge or any other dose monitoring device?

Ans

Personal radiation monitoring devices or Dosimeters like Film badges, TLDs, Self Reading Pocket Dosimeters are used to measure the radiation dose received by radiation workers. All radiation workers should use appropriate personnel monitoring badges (TLD badges). TLD badges are mandatory for occupational workers to wear while working in a radiation area to ensure that the doses received by the radiation workers are within the AERB stipulated dose limits. The addresses of AERB accredited laboratories providing TLD services are available on AERB website www.aerb.gov.in .

It is the responsibility of the employer (Institute/Hospital) to provide TLD badges to radiation workers. As per Atomic Energy (Radiation Protection) Rules, 2004 and AERB Safety Codes, personnel monitoring services shall be provided to radiation workers and dose records shall be maintained. In case of any institution violating the prescribed regulatory requirements, AERB is empowered to suspend/modify/withdraw the licence/registration issued to that X-ray installation or seal the X-ray installation(s) in accordance with Rule 10 and 31 of the Atomic Energy (Radiation Protection) Rules, 2004 respectively.

Any violation in this regard can be complained to the authorities of facility concerned and to the Competent Authority i.e. Chairman, Atomic Energy Regulatory Board (AERB), under Atomic Energy (Radiation Protection) Rules, 2004.

Q7.

Kindly provide details about who should use TLD badges, where to wear TLD badges, where to store and how long can we use TLD badges.

Ans

TLD badge is used to measure the radiation dose to which a radiation worker is exposed while working in radiation area. TLD is a type of radiation dosimeter, which measures ionizing radiation exposure. It does not protect the user from the radiation. The TLD badges to be used only by persons directly working with radiation sources such as X-ray units, radioisotopes etc. The dark room technicians, sweepers helpers etc. need not normally be provided with TLD badges.

Whenever working in the radiation field, TLD badge should be always worn by the worker. A TLD badge allotted to one user should not be shared by any other person. There are two types of TLD badges, Chest badge & Wrist badge. One TLD badge i.e. Chest badge should be worn compulsorily at the chest level. If a lead rubber apron is used, TLD badge should be worn under the lead apron at the chest level. The dose recorded by the TLD badge worn at the chest level represents the whole body dose. In special cases, depending upon the nature of radiation work, if the doses to the hands and forearms are expected to be significantly higher than at the chest level, additional wrist badges may be procured and used. Examples of such categories are persons handling radioisotopes from close distances and radiologists/doctors doing the special investigations.

TLD badges should be stored in RADIATION FREE AREAS where there is no likelihood of any radiation exposure. Places such as X-ray rooms, rooms in which radioactive materials are stored, handled or used and areas in the immediate vicinity of such rooms are NOT RADIATION FREE AREAS and should be avoided for storing the TLD badges.

Depending upon the type of radiation facility, TLD service to an institution may be on monthly or quarterly basis. After one service period, the used TLD badges have to be replaced by the fresh badges supplied by accredited laboratories.

Q8.

What are the requirements to be met to establish Nuclear Medicine, Radiotherapy and Radiology department in a hospital?

Ans

The requirements to be complied for Nuclear Medicine facility are given in AERB Safety Code on “Nuclear Medicine Facilities”, AERB/RF-MED/SC-2 (Rev.2), 2011 and the AERB Safety Guide titled “Consenting Process for Radiation Facilities”, AERB/RF/SG/G-3, 2011. This AERB Safety Code stipulates the radiation safety requirements in handling radioactive materials for nuclear medicine applications.

The requirements for issuance of license for operation of Radiotherapy facility are given in AERB Safety Code on “Radiation Therapy Sources, Equipment and Installations”, AERB/RF-MED/SC-1 (Rev.1), 2011, and the AERB Safety Guide titled “Consenting Process for Radiation Facilities”, AERB/RF/SG/G-3,2011. This AERB Safety Code stipulates the radiation safety requirements in the design, installation and operation of radiation therapy sources, equipment and installations.

The requirements to obtain licence for X-ray equipment in Diagnostic Radiology Department are given in AERB Safety Code on “Radiation Safety in Manufacturer, Supply and Use of Medical Diagnostic X-ray equipment” AERB/RF-MED/SC-3 (Rev.2), 2016 and the AERB Safety Guide titled “Consenting Process for Radiation Facilities”, AERB/RF/SG/G-3, 2011.

This AERB Safety Code is intended to govern radiation safety in design, installation and operation of diagnostic X-ray equipment for medical diagnostic purposes.

Q9.

What action should be taken by AERB against those hospitals/clinics/diagnostic centres which are operating Nuclear Medicine, Radiotherapy and Radiology department without obtaining approval or license from AERB?

Ans

As per the records available with AERB, all Nuclear Medicine facilities, Radiotherapy facilities & Diagnostic Radiology centers operating in the country possessing radiation sources/radiation generating equipment are licensed by AERB. However, if any radiation sources/radiation generating equipment is found to be in operation without a licence from AERB, it may lead to seal or seize as per the Atomic Energy (Radiation Protection) Rules, 2004 and appropriate regulatory action as deemed fit will be initiated against such facility as per the provisions of the Atomic Energy Act & Rules. Section 24 of the Atomic Energy Act, 1962 and Rule 35 of the Atomic Energy (Radiation Protection) Rules, 2004 give the provision for the punishment and penalties to be imposed on radiation facilities in case of any violations.

Q10.

Which authority takes actions against those hospitals/clinics/diagnostic centers which are operating Nuclear Medicine, Radiotherapy and Radiology department without obtaining approval or license from AERB? Which authority/officer investigates these centres?

Ans

Chairman, AERB is the Competent Authority to initiate appropriate action against such facilities, in case of violation. Any person authorised by the Competent Authority is empowered to investigate the facilities found to be operating radiation sources/radiation generating equipment without license from AERB or he can delegate this responsibility to any official from AERB.

Q11.

Please provide the information regarding average and range of radiation dose to patients in following procedures 1) Interventional Procedure 2) CT Examinations 3) Nuclear Medicine Procedure. Which among these are associated with high radiation dose to staff?

Ans

Typical effective doses for patients in X-ray based Interventional Procedures are in the range of 10-100 mSv. Typical effective doses for patients in CT Examinations are in the range of 2- 10 mSv. The dose to the patient in Nuclear Medicine Procedures depends upon the activity administered and the stage of disease. The information is available on the standard literatures and journals published around the world.

Radiation dose to staff depends on the type of investigation and protocol followed in the institution. Interventional Radiology Procedures generally involve relatively higher potential

doses to staff compared to the other practices mentioned above. However, with safe design considerations, work practice and use of appropriate personal protective devices, radiation doses to occupational workers always remain well below the limit prescribed by AERB.

Q12.

Please provide the information that how the radiation dose to the patients and staff being monitored by AERB-RSD in CT Scan, Interventional Procedures and Nuclear Medicine Procedures over the past one decade?

Ans

Radiation exposure of staff working in radiation facilities is verified by AERB through personnel monitoring of individual radiation worker(s) at their work places. Individual patient dose(s) during Interventional Procedures and CT Scans are recorded (electronic formats) in the radiology centers/hospitals in the country, which are verifiable by AERB.

Q13.

Does AERB have any say regarding medical exposure to patients?

Ans

Primarily medical exposures mean exposures from either X-rays or radionuclides towards a) clinical diagnosis or b) towards treatment for medical conditions; mostly cancer. These exposures are prescribed by medical practitioners, as per the clinical requirement. Thus, medical exposures fall under the over-arching responsibility of patient welfare and is best decided upon by the medical practitioner. However, AERB’s oversight towards patient safety extends towards use of design approved equipment, their periodic Quality Assurance and operation of these equipments by qualified personnel.

Q14.

Please provide the information, whether the following approvals from Atomic Energy Regulatory Board are mandatory for (a) Type Approval (b) Layout Approval

(c) Submission of installation QC report of the scanner/machine (d) Obtaining regulatory consent (e) Appointment of RSO (f) Submission of annual report and renewal of license applicable to X-ray, CT Scan, Interventional Radiology and Cath Lab centers?

Ans

(a) Type Approval: Type Approval is issued by the Competent Authority based on evaluation of the device to ensure that it conforms to safety standards. Only type-approved and NOC-validated equipment shall be marketed and used in the country.

Regulatory Consent: No diagnostic X-ray equipment shall be operated for patient diagnosis unless licence for operation is obtained from the Competent Authority. Licence/Registration shall be obtained only after the installation of diagnostic X-ray equipment as per Layout and Shielding Guidelines prescribed by AERB .

X-ray Room Layout and Shielding Requirement : These requirements are specified in AERB Safety Code on “Radiation Safety in Manufacturer, Supply and Use of Medical Diagnostic X-ray equipment” AERB/RF-MED/SC-3 (Rev.2), 2016.

As per safety Code:

The room housing X-ray equipment shall have an appropriate area to facilitate easy movement of staff and proper patient positioning. Appropriate structural shielding shall be provided for walls, doors, ceiling and floor of the room housing the X-ray equipment so that radiation exposures received by workers and the members of the public are kept to the minimum and shall not exceed the respective limits for annual effective doses as per directives issued by the Competent Authority. Appropriate overlap of shielding materials shall be provided at the joints or discontinuities.

As per present policy, Pre-commissioning inspection is not carried out by AERB for diagnostic X-ray facilities. The Diagnostic X-ray installations shall be made available by the employer/owner for inspection, at all reasonable times, to the Competent Authority or its representative.

Layout Approval and QA Report Submission stages are merged with the stage of Regulatory Consents (Licence/Registration) of diagnostic X-ray Equipment.

Appointment of RSO: Every X-ray department shall have a RSO approved by the Competent Authority. The RSO may either be the employer himself/herself or an employee to whom the employer shall delegate the responsibility of ensuring compliance with appropriate radiation safety/regulatory requirements applicable to his X-ray installation. The minimum qualification and training shall be as prescribed by the Competent Authority

Submission of annual report and renewal of licence: Submission of annual report and renewal of licence of diagnostic X-ray equipment are mandatory.

Q15.

As per AERB rules, how long AERB should take to clear application for NOC, Type Approval, Approval of Layout and Registration/License of medical diagnostic X-ray equipment? Have you uploaded this time frame on your website? If AERB does not complete processing of an application within stipulated period who is liable for loss to manufacturer/supplier due to delay by AERB in application processing?

Ans

As per Rule 8 (Issuance of Licence) of Atomic Energy (Radiation Protection) Rules, 2004, licence shall be issued within a period of one hundred and eighty days from the date of receipt of the application subject to the condition that all the requirements for issuance of the licence have been duly fulfilled by the applicant.

However, the lead time(s) followed by AERB for review of applications is as per AERB Safety Guide for “Consenting Process for Radiation Facilities” [AERB/SG/G-3, 2011; which

is sixty days for licence facility (computed tomography and Interventional radiology equipment, commercial production of diagnostic X-ray equipment) and thirty days for general medical diagnostic X-ray equipment, subject to the condition that all the requirements for issuance of the licence have been duly fulfilled by the applicant.

AERB always issues the consents within the stipulated time period, provided that the submission of required documents is proper. In some cases, delay occurs, mainly due to non- submission of some requisite documents by the applicants. In such cases AERB communicates with the applicants through phone calls, emails or advisory letters for fulfilling the requirements for processing the application.

Q16.

Do you have any weekly/monthly vendor meeting stipulated time when vendors can come to AERB and speak to appointed AERB Officers to know status of their application pending with AERB?

Do you have any vendor grievance cell, any appointed Officer, public relation Officer, receptionist to whom vendors can contact for follow up regarding their application pending with AERB?

Ans

AERB has not established any weekly/monthly vendor meeting schedule with AERB officers to know the status of their applications. AERB has not established vendor grievance cell or Public Relation Officer to resolve the issues regarding pending applications. AERB Officers always communicate through phones/emails to applicants. In some cases, AERB Officers meet with representatives of the applicants depending upon the complexity of the issues(s). If any applicant wants to meet AERB officials, for valid reasons, he can meet with prior appointment at office.

Q17.

Will AERB provide Layout Approval/Registration or License to Diagnostic Centres/Hospitals purchased machines, not Type Approved by AERB from organization or individual not authorized supplier/dealer of manufacturer?

What action AERB will take against Hospitals/Diagnostic Centres purchased CT Scan machine from individual/organisations not authorized supplier/dealer of manufacturer?

Can any individual or any other private company other than principal manufacturer, supply and install CT Scan without manufacturer’s authorization? Will AERB provide License to such CT Scan?

Ans

As per AERB Safety Code on “Radiation Safety in Manufacturer, Supply and Use of Medical Diagnostic X-ray equipment” AERB/RF-MED/SC-3 (Rev.2), 2016; employer of diagnostic X-ray facility shall procure NOC validated/Type Approved X-ray equipment from authorized suppliers after obtaining procurement permission from the Competent Authority.

AERB issues Type Approval to X-ray equipment such as CT Machines, Fluoroscopy units, C-Arm, Mammography and Dental X-ray Machines etc. based on evaluation of the device to ensure that it conforms to the safety requirements of safety code and safety standards in force.

The detail of the supplier/manufacturer of the X-ray equipment is asked in the user application and verified at the time of review. It is the regulatory requirement for utilities to install only Type Approved equipment and operate it for patient diagnosis after obtaining AERB Registration/License for operation. AERB would initiate appropriate regulatory action in accordance with Atomic Energy (Radiation Protection) Rules, 2004 against the Hospitals/Diagnostic centres violating the regulatory requirements.

AERB authorised Suppliers and Service Agencies can supply and install diagnostic X-ray Equipment to the end-users. The details of authorised Service Agencies is available on AERB website

Type Approval for X-ray equipment issued by AERB to Manufacturer/Suppliers has validity for three years. The approval also gives details of the manufacturer/supplier supplying the X- ray equipment. The list of Type Approved X-ray equipment is available on AERB website

The operational safety of X-ray equipment is ensured by issuance of Licence/Registration by AERB to the utility after review of all aspects related to radiation safety and after ensuring that patient, staff and public are adequately protected.

Q18.

What are the rules to be followed by Manufacturer and Supplier for marketing X-ray equipment in India? Is regulatory authority, AERB prescribed this in any documents?

Kindly provide procedure to be followed by supplier to Import of X-ray equipment and to get Type Approval from Atomic Energy Regulatory Board.

Ans

AERB Safety Code on “Radiation Safety in Manufacturer, Supply and Use of Medical Diagnostic X-ray equipment” AERB/RF-MED/SC-3 (Rev.2), 2016; stipulate responsibilities of indigenous Manufacturer for production and marketing of their X-ray equipment and responsibilities of Supplier for marketing of X-ray equipment. This Safety Code also prescribes procedures for import of X-ray equipment and to get Type Approval from AERB. This AERB Safety Code is available on AERB website.

Q19.

Please provide a copy of order/instruction where in type approval certificate expired X- ray equipment are allowed to be used by CT Scan centres/Hospitals or allowed for import. If any such order/instruction was not issued, whether such approval expired X- ray equipment were directed to be withdrawn from usage by Scan centres/Hospitals throughout India, If so the copy of direction issued by AERB may be supplied to me.

Ans

Type Approval certificate is issued to supplier(s) of medical diagnostic X-ray equipment subject to meeting the design (built-in) safety criteria by diagnostic X-ray equipment. This certificate facilitates the supplier to import and supply diagnostic X-ray equipment at user- institutions. However, expiry of Type Approval certificate does not impact on the use of medical diagnostic X-ray equipment at user-institutions. For import of pre-owned (Used/Refurbished) medical diagnostic X-ray equipment, AERB recently revised the regulatory requirements and accordingly does not insist on validity period of Type Approval certificate on such import.

Q20.

If any customer purchased CT Scan from authorized seller and after that he took the services from unauthorized sources and that unauthorized person changes/replaces the parts/tubes with other than the original part/tube (Hybridization). In that case, does the AERB Type Approval number remains valid? If no, what action can be taken if any customer used not recommended parts/tubes.

Ans

Type Approval issued by AERB does not remain valid once the parts/tubes are replaced, unless the replacement is carried out by the original manufacturer/supplier. In case modifications are carried out on a Type Approved X-ray equipment, without prior approval of AERB, the applications from such users/customers would not be considered for issuance/renewal of regulatory consents for its use.

Q21.

We have statistical data that OEMs (GE, Siemens etc.) have sold several hundred pre-owned CT Scanners in India. Please elaborate whether these CT Scan Centers using second-hand CT Scanners have been given permission by AERB to operate.

Detail list of CT Scan models “Type Approved” by AERB is available on AERB website. Can I buy a pre-owned CT Scanner whose name appears in this list?

Ans

Pre-owned CT Scanners can be procured by end-users from authorised suppliers/service agencies subject to obtaining procurement permission from AERB. AERB issues consents for installation and use of pre-owned diagnostic X-ray equipment after review of all aspects related to radiation safety and after ensuring that patient, staff and public are adequately protected.

Q22.

Please mention all the acts related to import Pre-owned radiology equipment. Please provide me a copy of the list of service agency (authorized by AERB) for import of used/refurbished CT Scanner.

Ans

Import of pre-owned medical diagnostic X-ray equipments are regulated by “Regulatory requirements for supply and use of pre-owned (used/refurbished) medical diagnostic X-ray equipment ” dated February 25, 2015 issued by AERB, which is available on AERB website www.aerb.gov.in.

The list of authorised service agencies for supply of pre-owned (used/refurbished) diagnostic X-ray equipment is available on AERB website.

Q23.

How the pre-owned equipment supplier will get the Procurement Permission? Whether the Procurement Permission addresses the end user or Importer (Service/Supply Agency)? Does the equipment need to abide Pollution Control Board norms also?

Ans

For Procurement Permission, Applicant needs to apply to AERB through e-LORA (e- licensing for radiation applications) for Procurement of Pre-owned X-ray Equipment.

Permission for procurement of Pre-owned Medical Diagnostic X-ray equipment is issued to the end users with a copy to the authorised supplier/service agency.

AERB issues regulatory approvals from radiation safety view point only. For radiation safety requirement, ‘Permission for Procurement’ issued by AERB is to be submitted to Customs for clearance of imported Medical Diagnostic X-ray equipment (New/Pre-owned), X-ray tubes and X-ray tube inserts. Applicant has to obtain all other applicable clearances from other statutory State/National level authorities.

Q24.

If Atomic Energy Regulatory Board after inspection of X-ray machines of any hospitals and nursing homes instructs for not to use the X-ray machine for patient diagnosis due to unnecessary exposure of radiation, then can it be used further?

Ans

Diagnostic X-ray equipment can be used again in such a case, if diagnostic X-ray equipment satisfies the QA performance tests requirements as specified in AERB Acceptance Test Report for Diagnostic X-ray Equipment.

Q25.

Is Quality Assurance test mandatory for a X-ray equipment? Kindly state the periodicity, set for Quality Assurance test to be performed on all radiation equipment & accessories including X-Ray, CT Scan, C-Arm etc.

Ans

It is mandatory to get the Quality Assurance test done periodically of all the X-ray equipment. As of today, the routine Quality Assurance tests for diagnostic X-ray equipment units should be carried out once in two years.

Q26.

Is it ok to have the Radiological Diagnostics Lab in the area where there are more general public?

What is AERB’s stand on X-ray equipment installed at residential localities?

Ans

X-ray Room Layout and Shielding Requirement as per AERB Safety Code on “Radiation Safety in Manufacturer, Supply and Use of Medical Diagnostic X-ray equipment” AERB/RF- MED/SC-3 (Rev.2), 2016 are as follows:

The room housing X-ray equipment shall have an appropriate area to facilitate easy movement of staff and proper patient positioning. Appropriate structural shielding shall be provided for walls, doors, ceiling and floor of the room housing the X-ray equipment so that radiation exposures received by workers and the members of the public are kept to the minimum and shall not exceed the respective limits for annual effective doses as per directives issued by the Competent Authority. Appropriate overlap of shielding materials shall be provided at the joints or discontinuities.

It is the responsibility of the employer of the institution to demonstrate radiation safety infrastructure of the installation and ensure that the installation is safe for the workers and public at large.

AERB evaluates the X-ray installation room design from purely radiation safety standpoint and the requirements of Safety Code. Hence, a diagnostic X-ray facility designed as per the regulatory requirements is safe to operate without posing any radiological hazard to the residents of a building emplaced with medical diagnostic X-ray unit and related equipment.

Q27.

Kindly provide details of room layout requirements for X-ray equipment and installation as per AERB guideline.

For setting up X-ray lab in India by commercial health check up concerns, what are the prescribed norms for the following factors: (i) Location whether it can be set up in a residential locality (ii) Layout plan and Shielding thickness particularly about the walls of the room where X-ray machine is to be installed.

Ans

Pl. see Ans. of Q. 26.

Q28.

Are there any standard layout plans published for X-ray, CT Scanner, Interventional Radiology and Cath lab centers by AERB? If yes, please provide copies of such layouts.


Please provide the following documents, Layout plan in respect of erection of spiral CT- Scan, Digital X-ray and Format for submission of layout details of spiral CT Scan and Digital X-ray.

Ans

AERB has published Standard Layout of X-ray Installation, CT Installation, Interventional Radiology Installation, Mammography Installation etc. The

Standard Layouts and shielding Guidelines are published by AERB and available on AERB website.

For special cases, adequate shielding of the X-ray installation may be evaluated depending on the type of X-ray unit, patient workload, room dimensions, area of the room, wall construction materials, occupancy etc. as per the AERB Safety Codes.

AERB has been issuing License for Operation to X-ray equipment after verification of Layout Plan from radiation safety viewpoint. In current licensing process, AERB is not issuing separate Layout Approval to the institutes, now it is already a part of the Registration/License application.

Q29.

Please give information on whether shielding thickness of walls, ceilings and floors of X-ray, CT scanner room and Cath lab room varies depending on the type of scanner, slices of scanner, type of the CT scan and number of scans performed every day?

Please provide the information about the policy adopted by AERB in deciding permission to perform a given number of CT scans or interventional procedures based on the shielding thickness and type of the scanner/machine?

Ans

Shielding thickness of the walls of CT/Cath lab room are prescribed by AERB on the basis of maximum feasible workload of the facility and distance of wall(s) of Cath lab room from the centre of patient table or distance of wall(s) of CT room from isocentre of CT equipment.

Layout of Medical Diagnostic installations are designed taking into account the maximum workload (No. of patients/Procedure per day) of the facility.

The Standard Layouts and Shielding Guidelines published by AERB and are available on AERB website.

Q30.

Is it necessary to obtain License from AERB for the Operation of the Radiological equipment in the Radiology Department or Radiology Diagnostic Lab? Does such centre need to renew its Operation License every year?


Is it mandatory to obtain Registration from the Board to operate any kind of radiation equipments in any setup (small or large)? For what time such approval granted by your good self remains valid?

Ans

It is mandatory requirement that every user/utility of medical diagnostic X-ray equipment such as CT Machines, Fluoroscopes, C-Arm, Mammography and Dental X-ray Machines etc. in the country shall obtain licence/registration from AERB to operate the X-ray equipment. As per AERB Safety Code, No such Diagnostic X-ray equipment shall be operated unless licensee obtains license and/or registration from the Competent Authority, i.e. Chairman, AERB.

AERB issues licence/registration for the operation of such X-ray equipment, after verification of all aspects related to radiation safety for patient, operator and members of public.

The operational safety of X-ray equipment is ensured by issuance of Licence/Registration to the utility after review of all aspects related to radiation safety and after ensuring that patient, staff and public are adequately protected.

Validity period of the licence/registration for the operation of X-ray equipment is five years from the date of issuance. License for operation of X-ray equipment needs to be renewed after every five years.

Q31.

What criminal action is being taken against Medical Diagnostic X-ray installations which have not got Registration/Licence from AERB?

What action does AERB take against such Hospital(s) who have installed X-ray equipment without obtaining approval of AERB? Who is responsible for this?

Details of Penal Action which can be taken by AERB for running an X-ray testing labs/CT Scan without permission of AERB and the relevant section(s) of the relevant Act.

Ans

It is the statutory requirement of the hospitals/medical diagnostic X-ray centres to obtain Licence/Registration from AERB. Though the X-ray equipment are of low hazard potential, it is important that they are installed and operated in accordance with radiological safety requirements specified by AERB. AERB issues the requisite Licence/Registration after ensuring that they conform to the specified safety requirements. In case of any hospital/medical diagnostic X-ray centre violating the prescribed regulatory requirements, AERB is empowered to suspend/modify/withdraw the Licence/Registration issued to that institution or seal the X-ray installation(s).

As per Rule 3 of Atomic Energy (Radiation Protection) Rules, 2004, no person shall establish or operate a radiation facility without a Licence. It is the responsibility of the user to comply with the stipulations of the Atomic Energy Act, 1962 and Rules promulgated under this Act. As per section 24 of the Atomic Energy Act 1962, whoever contravenes any Rules made under section 17 of the Act shall be punishable with imprisonment for a term which may extend to five years, or with fine, or both. As per Rule 31 of Atomic Energy (Radiation Protection) Rules, 2004, the radiation installation may be sealed in case of contravention of any of the provisions of these rules. For further details please refer the relevant Act and Rule(s), which are available on AERB website www.aerb.gov.in.

Q32.

Is it required to get Licence from AERB for usage of MRI Scan unit for patient scanning in Diagnostic Centers?

What actions will be taken against Diagnostic Centers for use of MRI Scan units for patient scanning without permission from AERB?

Kindly furnish details of safety steps taken while doing functional MRI, MR tractography, MR mammography, 4D ultrasound with tomography etc.

Please provide approved diagnostic centers list in India for usage for MRI Scan for patients under the Atomic Energy (Radiation Protection) Rules.

Ans

MRI equipment, Ultrasound or Sonography machine etc. do not emit ionizing radiations. Since Atomic Energy Regulatory Board is responsible for regulating safe usage of ionizing radiations only, MRI equipment, Ultrasound or Sonography machines etc. do not come under regulatory purview of Atomic Energy Regulatory Board.

Q33.

If I use a mobile X-ray machine alone, will I get Licence from authorities? If no, why?

There are currently 3 vehicle Scanners operating in Mumbai which are used in public areas. Will a repeat of the Delhi incident occur (cobalt source found in Delhi scrap market) due to public being exposed to harmful X-Rays radiation? Corrective measures taken by AERB to ensure that public in general are not exposed to harmful radiation.

Ans

AERB issues Licence for every X-ray equipment including mobile X-ray machine after verifying compliance with regulatory requirements.

Incident like that happened at Delhi Scrap Market is unlikely to occur with the X-ray equipment if they are used properly. Because, X-rays can only be produced only when external electric power is supplied. Without external power supply, the X-ray tube is non hazardous in nature from radiological safety stand point.

During scanning in vehicles (e.g. scanning at RGSL), public is required to remain outside the cordoned off area as decided by AERB considering radiation safety. This ensures the safety of the public. Whenever a user deploys a vehicle scanner with due consent from AERB, it is mandatory to follow the radiation safety standards.

Q34.

What is the thickness required of lead sheet in mobile unit for mammography installation? How much mammography harmful for ladies? How many maximum number of mammography tests we can implement on patients in whole life?

Ans

Being self-shielded collimated beam and relatively low output of mammography equipment, protective barrier of 0.5 mm lead equivalence is sufficient for shielding purpose. Complete guidelines for shielding of X-ray installations including mammography equipment published by AERB and are available on AERB website.

There is no definite proof that mammograms increase the risk of cancer. Mammography is a justified diagnostic practice as the benefit outweighs the harmful effect associated with it. The decision on mammography scan depends on clinical judgement, which needs to be justified by the medical practitioner(s).

Q35.

Kindly give the minimum qualification for the appointment of Radiographers or X-ray technologist in any Government/Private hospitals in India. Is it that all Government hospital must follow AERB recruitment rule, in case of appointment of radiographers, otherwise it is a violation of AERB Act?

What are the criteria to fix the minimum qualification to Radiographer by AERB? What is the minimum educational qualification for a) Radiographer b) Jr. Radiographer c) X-ray technician or technologist?

What is the minimum qualification for a Radiographer to work in a Radio Diagnosis Department?

Ans

The basic educational qualification for X-ray technician/Radiographer in a Diagnostic Radiology department, as per Ref No.: AERB/RSD/MDX/Sp-order/2012/14316 dated Nov 26, 2012 is “Radiographer’s/X-ray Technologist’s course (including in-field training in diagnostic radiology) passed from recognized Institution/Board/University”.

All diagnostic radiology institutions/hospitals (private & government) should appoint the candidates for the post of Radiographer/X-ray Technologist as per qualifications specified by AERB.

Q36.

Provide the list of institutes recognised by AERB which are providing training to radiographers?

Ans

AERB has not conducted training programmes for X-ray technologists/Radiographers and not given recognition to any institute for providing training to X-ray technologists/Radiographers.

However, AERB conducts periodic awareness programmes in Radiation Safety for radiographers.

Q37.

Is it mandatory to an Institution/University to get approval from AERB to conduct Radio Diagnosis Technology/Medical Imaging Technology course?

Is there any list of AERB approved courses on Radio Diagnosis Technology/Medical Imaging Technology?

Ans

AERB does not approve any course. Any Institution/University conducting Radio Diagnosis Technology/Medical Imaging Technology course need not require approval from AERB.

Q38.

Recruitment Rule for X-ray technician or Radiographer of various Govt. Sector/Non- Govt. Sector is Matriculation ( 10thClass ) with Diploma or Certificate in Radiography, in this situation are they eligible for registration from AERB for running medical diagnostic radiology department.

Ans

It is mandatory requirement that all X-ray installations shall have a radiologist/related medical practitioner or a qualified X-ray technologist with adequate knowledge of radiation protection, to operate the X-ray unit.

For qualification and experience required for personnel in medical diagnostic X-ray installations, AERB issued an Order Ref. No. AERB/RSD/MDX/Sp-order/2012/14316 dated Nov 26, 2012, which is available on AERB website.

Q39.

What are the duties and responsibilities of a Radiologist, Non-radiologist, Radiographer, X-ray attendant in a Radiology Department?

What is the nature of work and responsibility of X-ray technician/Radiographer working in diagnostic radiology centre or hospital?

Duties and responsibilities, in detail of a) Radiographer b) Jr. Radiographer c) X-ray technician d) Radiologist.

Ans

The responsibilities of Operator, Medical Practitioner are mentioned in AERB Safety Code

“Radiation Safety in Manufacturer, Supply and Use of Medical Diagnostic X-ray Equipment” AERB/RF-MED/SC-3 (Rev.2), 2016 which is available on AERB website.

Q40.

Who is the authorised to apply the X-ray radiation on human patients, animals, and in other fields? Who is authorised/qualified to perform the positioning work in a radio- diagnostic facility meant for humans as well as for animals?

Who is qualified to consider the quantum of radiation doses to be delivered to the human/animal patients?

Ans

X-ray installations shall have a radiologist/related medical practitioner/X-ray Technologist with adequate knowledge of radiation protection, to operate the X-ray equipment.

It may be noted that the intent of radiation exposure to patient in diagnostic radiology is not to deliver radiation doses to the patient but to obtain radiographic image for improvements in the diagnosis and treatment. However, the radiation doses delivered shall be as low as reasonably achievable.

Q41.

Who will handle C-Arm, junior radiographer or radiographer? In few hospitals radiographers are forced to operate C-Arm machine, whether this is legal according to radiation safety rules?

Is it necessary that only an X-ray technician should go and operate the C-arm machine or any other person who has sufficient knowledge and experience in handing it can operate it? What protection measures should be taken by that person?

Who is authorized to operate C-Arm Machine (running X-Ray Fluoroscopic Unit) in Operation Theatre in hospital?

Ans

X-ray installations shall have a radiologist/related medical practitioner/X-ray Technologist with adequate knowledge of radiation protection, to operate the X-ray equipment.

Q42.

The Guidelines to open diagnostic centre in the country having all medical diagnostic facilities such as CT Scan, C-Arm etc. Can I open it in the area having flats for general public? What precautions should be taken for the general public?

Please provide the required information to install CT-Scan and X-ray Machines? What are the procedures to be followed? Please provide the list of currently running CT-Scan and X-ray centres in Faridabad, Haryana?

Ans

Regulatory Requirements/Guidelines to establish Medical Diagnostic centre having facilities such as general purpose X-rays, CT Scan and Mammography are stipulated in AERB Safety Code “Radiation Safety in Manufacturer, Supply and Use of Medical Diagnostic X-ray Equipment” AERB/RF-MED/SC-3 (Rev.2), 2016 which is available on AERB website.

In order to ease the procedures of filing of applications and obtaining regulatory consents, Registration/Licence, AERB has launched a state of the art online licensing system e-LORA (e-Licensing of Radiation Applications). Guidelines for Applying for Licence of Diagnostic Radiology X-ray Equipment through e-LORA System is available on AERB website

List of Licensed Medical Diagnostic X-ray facilities in the country are available on AERB website.

Q43.

What preventive measures are taken against exposure to harmful radiations in Radiotherapy establishments?

Ans

The preventive measures to minimise the effect of ionizing radiation from radiotherapy practises are ensuring built-in safety and operational safety of the equipment housing radioactive material and radiation generating equipment. It is ensured that the room housing such equipments are provided with adequate radiation shielding. AERB has published Safety Code for radiotherapy practices, i.e. Safety Code on “Radiation Therapy Sources, Equipment and Installations”, AERB/RF-MED/SC-1 (Rev.1), 2011. The objective of this code is to stipulate the radiation safety requirements in the design, installation and operation of radiation therapy sources, equipment and installations in order to ensure that radiation workers and members of the public do not receive radiation dose in excess of the limits specified by the Competent Authority.

AERB Safety Code on “Radiation Therapy Sources, Equipment and Installations”, AERB/RF-MED/SC-1 (Rev.1), 2011 is available on AERB website

Q44.

Please provide list of Radiation Therapy Centers in India to whom AERB has given Clearance as per Guidelines of AERB. Do all these centres have taken approval of layouts, have pre-commissioning inspection, approval of Licences, submission of annual reports and renewal of Licences by AERB?

Ans

This list of Radiation Therapy Centers in India is also available on AERB website

All these radiotherapy centres have obtained layout plan approval and Licence from AERB. They submit annual status report on yearly basis.

Q45.

What are the prescribed qualifications for the post of Radiotherapy Technologists as per AERB norms?

What is the minimum qualification required to be appointed as radiotherapist/radiotherapy technician/radiotherapy technologists to work in a Radiotherapy department?

Ans

The minimum qualification stipulated as per AERB Safety Code on “Radiation Therapy Sources, Equipment and Installations”, AERB/RF-MED/SC-1 (Rev.1), 2011 for Radiation Therapy Technologist is as follows:

10+2 or equivalent examination with science subject from a recognized university or board

2 years radiation therapy technologist course or equivalent based on the minimum course content prescribed by the competent authority-passed from a recognized institution with infield training in radiotherapy.

For further information, please refer AERB Safety Code AERB/RF-MED/SC-1 (Rev.1), 2011, which is available on AERB website.

Q46.

What is the educational qualification for the post of “Medical Physicist” in Radiotherapy department?

The minimum eligibility criteria (qualification) to be appointed as Physicist (Medical) in Radiotherapy Centre in India. Duties and responsibilities of a Medical Physicist in Radiotherapy department.

Ans

As per the AERB Safety Code on “Radiation Therapy sources, Equipment and Installations”, AERB/RF-MED/SC-1 (Rev.1), 2011, a Medical Physicist shall have:

A Post Graduate degree in Physics from a recognized university;

A Post M.Sc. diploma in radiological/medical physics from a recognized university; and

An internship of minimum 12 months in a recognized well-equipped radiation therapy department.

OR

A basic degree in science from a recognized university, with physics as one of the main subjects;

A post graduate degree in radiological/medical physics from a recognized university; and

An internship of minimum 12 months in a recognized well-equipped radiation therapy department.

The duties and responsibilities of Medical physicists in a Radiotherapy department are stipulated in this AERB Safety Code, AERB/RF-MED/SC-1 (Rev.1), which is available on AERB website

Q47.

I would like to know the Scope of practice for the Radiotherapy Technologist in India. Is there any organization or body who monitor the working hours of radiotherapy technologist? If Atomic Energy Regulatory Body (AERB) is a regulatory authority for radiotherapy technologist, then what steps have been taken for the educational development or maintenance of the professional competency for radiotherapy technologist?

Ans

As per AERB Safety Code on “Radiation Therapy Sources, Equipment and Installations”, AERB/RF-MED/SC-1 (Rev.1), 2011, a radiation therapy facility in the country shall have adequate number of qualified Radiation Therapy Technologists. The duties and responsibilities of Radiation Therapy Technologists are stipulated in this AERB Safety Code.

AERB does not monitor the working hours of radiation workers, as there is no stipulation for working hours by AERB. This does not come under the purview of AERB.

The role of AERB with respect to Radiation Therapy Technologist is limited to prescribing the minimum qualifications and radiation safety syllabus.

Q48.

What are the courses and institutions approved by AERB for Radiotherapy Technologists as of now? Is it mandatory to an Institution/University to get approval from AERB to conduct Radiotherapy Technology course? Please provide the copy of the list of AERB approved courses on Radiotherapy Technology.

I would like to know the list of the Institute, hospital or medical college conducting Radiotherapy Technologist course name year wise after Freedom in order from past to present (1960 to 2015). Please provide details, the syllabus of Radiotherapy technologist is standard for Diploma/PG Diploma/B.Sc. Radiotherapy or different.

Ans

AERB does not approve any course. However, AERB ensures that the courses are in line with requirements as stipulated by AERB i.e. with respect to entry level qualification, duration of course, incorporation of radiation safety syllabus, affiliation from any recognized Board/University and provision of in-house field training, so that after successful completion the candidates are recognized as suitably qualified to work as Radiation Therapy Technologist.

After publication of AERB Safety Code on “Radiation Therapy Sources, Equipment and Installations”, AERB/RF-MED/SC-1 (Rev.1), 2011, AERB intimated all the radiotherapy institutions in the country to approach AERB, in case they are conducting any Radiation Therapy Technologist course, so that AERB can assess whether they are in line with AERB requirements. Many institutions approached AERB thereafter.

AERB only prescribes radiation safety syllabus required for Radiation Therapy Technologist Course and the other part of the syllabus as deemed fit for the course is prerogative of the Board/University affiliating the course. The course details such as course commencement date, eligibility criteria, age limit etc. are as per rules of the particular Board/University and such information is not available with AERB.

The list of Radiotherapy Technologist courses in the country, which are in line with AERB requirements, is available on AERB website

Q49.

Can AERB allow or delegate the power to draft the course curriculum of ‘Radiation Therapy’ and regulate the ‘Radiation Therapy’ sector to MoHFW or any other body? Since when AERB is framing the course curriculum or regulating the ‘Radiation Therapy’ sector? Please provide the list of relevant notification/order/guidelines etc.

Ans

Drafting of course curriculum on ‘Radiation Therapy’ is not under the purview of AERB. In principle AERB started regulating Radiotherapy practice after formation of AERB in 1983. To strengthen the regulation in Radiotherapy practices, AERB has published Safety Code on “Radiation Therapy Sources, Equipment and Installations”, AERB/RF-MED/SC-1 (Rev.1), 2011.

Q50.

I want to know about the institutions, which are conducting Medical Physics courses for decades. Are all other institutions well equipped in line with the requirements? Please provide me the list of equipments and facilities associated with all institutions conducting Medical Physics course.

I want to know the course starting date, AERB inspection dates and AERB approval dates for M.Sc. Medical Physics/Diploma in Radiological Physics courses in India.

Whether the person holding B.Sc. degree in Physics from UGC recognized University and having percentage of marks less than 60% in aggregate degree is eligible to get admission in M.Sc. Medical Physics/Medical Radiation Physics in an institution whose course is in line with AERB requirements.

Ans

AERB does not approve any course. However, a committee constituted by Head, Radiological Physics & Advisory Division (RP&AD), BARC, Mumbai is assessing Medical Physics courses in line with AERB requirements since 2012. When course curriculum is found to be in line with the AERB requirements, AERB communicates the respective institution mentioning therein that candidates passing the course are eligible to work as Medical Physicist in the country. At present 18 Medical Physics courses are found to be in line with AERB requirements in the country.

The inspection of institutes conducting Medical Physics courses was started by this committee from 2012 onwards and therefore, AERB does not have information regarding equipments and associated facilities available for such courses which was started prior to 2012. However, it was decided in the relevant committee of AERB that all the institutes conducting Medical Physics course will be inspected by the above committee and their course will be reviewed to assess whether they are in-line with AERB requirements.

The course commencement date, eligibility criteria including percentage of marks, age limit etc. of Medical Physics/Diploma in Radiological Physics courses are as per rules of the particular university/institution and the information for the same is not available with AERB.

Q51.

I want to know the validity of my M.Sc. (Medical Physics) certificate from a University, which is not approved by AERB and they are conducting Medical Physics course.

I want to know whether my certificate is valid or not to work as Medial Physicist in India with a detailed explanation.

Ans

There are many institutions, irrespective to which university they are affiliated with, conducting M.Sc. (Medical Physics) course, which are not in-line with AERB requirements and your institution is one of them. Since the candidates having M.Sc. (Medical Physics) degree from the institutions for which syllabus is not in line with AERB requirements cannot be recognized to work as Medical Physicists in the country. AERB gave privilege to those candidates to appear a competency test, so that after passing the test they may be allowed to work as a Medical Physicist in the country.

Q52.

What are the requirements to be completed as per AERB guidelines to operate a Radiotherapy department in a Hospital?

Kindly provide details regarding setting up a Radiotherapy unit in a private institution in the country.

Ans

AERB Safety Code on “Radiation Therapy Sources, Equipment and Installations”, AERB/RF-MED/SC-1 (Rev.1), 2011 stipulates the radiation safety requirements in the design, installation and operation of radiation therapy sources, equipment and installations. This Safety Code elaborates the safety provisions as applicable to radiation therapy practices. AERB Safety Code, AERB/RF-MED/SC-1 (Rev.1), 2011 is available on AERB website.

AERB has launched a state of the art online licensing system e-LORA (e-Licensing of Radiation Applications) for obtaining requisite regulatory consents from AERB. Guidelines for obtaining requisite approvals for Radiotherapy Facilities through e-LORA System is available on AERB website

Q53.

What preventive measures are taken against exposure to harmful radiations in Nuclear Medicine department of hospitals?

Ans

As per Atomic Energy (Radiation Protection) Rules, 2004, Licence to operate any radiation facility depending on the practice, is accorded only after fulfilling the regulatory requirements in the respective AERB Safety Codes. The Licence for operation is issued to the facility only after review of all aspects related to radiation safety and after ensuring that patient, staff and public are adequately protected. Moreover, continued safety is ensured by review of the periodic safety status reports submitted by the radiation units.

AERB has published Safety Code on “Nuclear Medicine Facilities”, AERB/RF-MED/SC-2 (Rev.2), 2011. This code stipulates radiation safety requirements in handling radioactive materials for diagnostic and therapeutic operations in nuclear medicine practices in order to ensure that workers and members of the public are not exposed to radiation in excess of limits specified by the Competent Authority.

AERB Safety Code on “Nuclear Medicine Facilities”, AERB/RF-MED/SC-2 (Rev.2), 2011 is available on AERB website

Q54.

Please provide rules related to minimum number of Nuclear Medicine Technologists with number of equipment (Is one technologist enough to operate more than one equipment like Gamma Camera and PET-CT?).

How many qualified Nuclear Medicine Technologists, RSO and Nuclear Medicine Physician are required in order to set up a new nuclear medicine department as per AERB guidelines? What are their duties and responsibilities? Is the requirement same for already existing nuclear medicine department having the same kind of facility (Both PET-CT & Gamma Camera with SPECT-CT)?

Ans

The minimum staff requirement for a Nuclear Medicine Facility is specified in the AERB Safety Code on “Nuclear Medicine Facilities”, AERB/RF-MED/SC-2 (Rev.2), 2011. As per this Code, at least one nuclear medicine technologist with qualifications stipulated in the Safety Code is required for a Nuclear Medicine Facility. The requirement stipulated in this Safety Code is same for new as well as already operating facility.

The duties and responsibilities of Nuclear Medicine Physician, Nuclear Medicine Technologist and RSO in a Nuclear Medicine department are covered under Chapter 3 of Section 3.3, 3.4 & 3.5 of the AERB Safety Code, AERB/RF-MED/SC-2 (Rev.2), 2011. This code is available on AERB website

Q55.

Please provide rules and regulations related to minimum qualifications of Nuclear Medicine Technologist for Nuclear Medicine centre.

What are the educational qualifications for the post of “Medical Physicist” in Nuclear Medicine department?

If any student has passed B.Sc. (MT) Radiography, M.Sc. (Physics) and M.Sc. (Nuclear Medicine Technology), is he/she eligible for the post of “Medical Physicist” in Nuclear Medicine department?

Ans

As per AERB Safety Code on “Nuclear Medicine Facilities”, AERB/RF-MED/SC-2 (Rev.2), 2011, Nuclear Medicine Physician and Nuclear Medicine Technologist and RSO are mandatory staff requirements for a nuclear medicine facility and qualifications of these personnel should be as per the aforesaid AERB Safety Code. However, in some of the government institutions the Nuclear Medicine Technologists in nuclear medicine department are designated as Medial Physicists. The designation given by the institution is prerogative of the respective institution/employer and the same is not under the purview of AERB. AERB accepts only the minimum qualifications as laid down in the AERB Safety Code.

For further information, please refer AERB Safety Code AERB/RF-MED/SC-2 (Rev.2), 2011, which is available on AERB website.

Q56.

What is the difference between the Nuclear Medicine Technician and Nuclear Medicine Technologist in Nuclear Medicine department? What is the minimum qualification for the Nuclear Medicine Technician and Nuclear Medicine Technologist?

Ans

The qualification for Nuclear Medicine Technologist is given in the AERB Safety Code on “Nuclear Medicine Facilities”, AERB/RF-MED/SC-2 (Rev.2), 2011. As per this Safety Code, there is no requirement of a technician in Nuclear Medicine department and hence the qualification for Nuclear Medicine Technician is not defined.

Q57.

Is it mandatory to obtain authorization/approval/permission of AERB to start any educational course curriculum in the field of Nuclear Medicine (e.g. M.Sc. in Nuclear Medicine, Post Graduate Diploma in Nuclear Medicine etc.)? If yes, then what infrastructure, facility and faculty AERB has made mandatory to start such course work by any educational institute/university?

Ans

AERB does not approve any course. Only the radiological safety syllabus of any programme in Nuclear Medicine should be reviewed and approved by AERB.

As per AERB requirements, the institute conducting the programme in Nuclear Medicine shall submit a Memorandum of Understanding with the University of Affiliation and an undertaking that the Radiation safety module prescribed by AERB shall be included in the course curriculum.

Q58.

Provide list of AERB approved Institutes which are conducting the M.Sc. (Nuclear Medicine Technology)/DMRIT or PGDNMT (POST PG diploma) like programmes in all over India.

Ans

The following are the Institutes where the post graduate courses for Nuclear Medicine are conducted as per records available with AERB:

Radiation Medicine Centre, BARC.

School of Allied Health Sciences, Manipal University, Karnataka.

All India Institute of Medical Sciences (AIIMS), New Delhi.

Post Graduate Institute of Medical Education and Research (PGIMER) Chandigarh.

Ganesh Educational Institute & Research Centre, Delhi.

Sri Sathya Sai Institute, Andra Pradesh.

Sher-I-Kashmir Institute of Medical Sciences, Srinagar.

Tata Memorial Hospital, Mumbai.

Andhra University, Visakhapattanam.

Q59.

Kindly provide guidelines to establish Nuclear Medicine department in a well-equipped hospital in India.

Ans

AERB Safety Code on “Nuclear Medicine Facilities”, AERB/RF-MED/SC-2 (Rev.2), 2011 stipulates radiation safety requirements in handling radioactive materials for diagnostic and therapeutic operations in nuclear medicine practices. This Safety Code elaborates safety provisions applicable to nuclear medicine applications.

AERB Safety Code, AERB/RF-MED/SC-2 (Rev.2), 2011 is available on AERB website.

Guidelines for Applying for Licence of Nuclear Medicine Facility through e-LORA (e- Licensing of Radiation Applications), an online licensing System launched by AERB, is available on AERB website .

Q60.

Please provide rules and regulations for AERB registration for Radiography Service Organisations Companies/ Industries.

Ans

The industrial radiography agencies are governed by the following main regulations:

Atomic Energy Act, 1962

Atomic Energy (Radiation Protection) Rules, 2004

Atomic Energy (Safe disposal of radioactive wastes) Rules, 1987 and

AERB Safety Code on Industrial Radiography No. AERB/SC/IR-1, 2001.

AERB Safety Code on safe transport of radioactive material AERB/SC/TR/1, 1986

Q61.

Please give details of manpower or staff to be required in an Industrial Radiography unit as per AERB norms.

Ans

The minimum personnel requirements for an Industrial Radiography facility is prescribed in the AERB Safety Code on Industrial Radiography, AERB/SC/IR-1, 2001.

The qualifications and responsibilities of persons required in an Industrial Radiography Facility are covered under Chapter 4 of the AERB Safety Code, AERB/SC/IR-1, 2001.

AERB Safety Code for Industrial Radiography, AERB/SC/IR-1, 2001 is available on AERB website

Q62.

What are the guidelines prescribed by AERB for setting up a Radiographic unit for Industrial purposes?

Ans

AERB Safety Code for Industrial Radiography, AERB/SC/IR-1, 2001 stipulates the requirements for radiation safety in handling industrial gamma radiography exposure devices and X-ray generating equipment for industrial radiography. This Safety Code elaborates the safety provisions relevant to various industrial radiography operations. AERB Safety Code, AERB/SC/IR-1, 2001 is available on AERB website.

AERB has launched a state of the art online licensing system e-LORA (e-Licensing of Radiation Applications) for obtaining requisite regulatory consents from AERB. Guidelines for submission of application for various consents pertaining to Industrial Radiography practice through e-LORA System is available on AERB website

Q63.

Whether Radiology department can work without RSO? What are the Rules prescribed by AERB to authorize a person to function as RSO in Radiation unit?

Is Radiological Safety Officer mandatory for a radiation facility? Kindly state the competent authority’s name whose Approval is required before an employer can appoint a qualified Radiological Safety Officer.

Ans

Requirement of Radiological Safety Officer (RSO) is mandatory for operation of every radiation facility as stipulated in Rule 19 of Atomic Energy (Radiation Protection) Rules, 2004. Licence is not issued by AERB, without availability of RSO.

The person having appropriate qualifications as stipulated in the respective AERB Safety Code is to be nominated by the employer of the institution and has to be approved by the Competent Authority, AERB.

Rule 22 of Atomic Energy (Radiation Protection) Rules, 2004 prescribes responsibilities of the Radiological Safety Officer in a radiation facility.

Q64.

How many types of RSO Certificates are there? Please provide the full information about all certificates and also its eligibility criteria, duration, exam details.

What are the eligibility criteria to write RSO Level-I, II & III Certification examination as per AERB guidelines? Provide the list of Qualified RSOs (RSO-I, II & III) who have passed the certification of RSO from RS Division of AERB from the starting of certification.

Please specify & differentiate the Authority, Position/Rank with qualification of RSO Level-III, II & I approved by AERB across hospitals in India.

Ans

AERB does not conduct Radiological Safety Officer (RSO) course or certification examinations. AERB does not have the list of qualified RSOs. Radiological Physics & Advisory Division (RP&AD), BARC, Mumbai conducts RSO Certification programme. AERB only approves the candidates after successful completion of RSO Certificate

examination. The details regarding the eligibility criteria and other information may please be obtained from Head, RP&AD, BARC, CT&CRS Building, Anushaktinagar, Mumbai-400094.

It may be noted that presently there is no categorization of RSOs and the approval is issued for specific practices such as Radiotherapy, Diagnostic Radiology, Nuclear Medicine, Industrial Radiography etc. The earlier practice of RSO level III, II & I, which was based on risk associated with the radiation facilities has been abolished. However, minimum requirements of a candidate to be designated as RSO are stipulated in AERB Safety Codes for specific practices, which are available on AERB website.

Q65.

What are the duties and responsibilities of Radiological Safety Officer (RSO) Level I, II & III in a radiation facility?

Ans

It may be noted that presently there is no categorization of RSOs and the approval is issued for specific practices. AERB Safety Code, AERB/RF-MED/SC-1 (Rev.1) stipulates the requirements and responsibilities of Radiological Safety Officer (RSO) in Radiotherapy facility. The requirements and responsibilities of Radiological Safety Officer in Nuclear Medicine facility are covered under Chapter 3 of AERB Safety Code, AERB/RF-MED/SC-2 (Rev.2). The requirements and responsibilities of Radiological Safety Officer in Diagnostic Radiology facility are covered under Chapter 6 of AERB Safety Code, AERB/RF-MED/SC-3 (Rev.2), 2016. Chapter 4 of AERB Safety Code, AERB/SC/IR-1 covers the requirements and responsibilities of Radiological Safety Officer in Industrial Radiography facility. All these AERB Safety Codes are available on AERB website.

Q66.

Please confirm whether the regulatory inspection of the facility, which are Licenced by AERB has been carried out or not. If yes, indicate the time schedule for such inspections.

Does AERB have any mechanism to authenticate the information provided by Diagnostic centres/Hospitals to get AERB Licence?

Ans

AERB conducts regulatory inspections to verify compliance with the safety requirements as stipulated in the Atomic Energy Act and Rules and AERB Safety Codes. Regulatory Inspections of Radiation facilities are carried out on random basis across the country by AERB as per AERB Safety Manual on “Regulatory Inspection and Enforcement in Radiation Facilities”, AERB/RF/SM/G-3. The institutes to be inspected are selected for inspections periodically on random basis. The inspection frequency of an institution is once in three years.

Q67.

Please provide guidelines for disposal of radioactive waste from research laboratories/hospitals in India. Where are all the radioactive wastes disposed of?

Ans

Guidelines for disposal of radioactive waste from research laboratories and hospitals in India is governed by the AERB Safety Guide AERB/RF/SG/RW-6, titled “Management of Spent Radioactive Sources and Radioactive Waste Arising from the Use of Radionuclides in Medicine, Industry and Research, including Decommissioning of Such Facilities” and Atomic Energy (Safe Disposal of Radioactive Waste) Rules, 1987. These documents are available on AERB website.

The radioactive sources most commonly used are usually of low activity unsealed sources and disposed of using the principle of dilute and disperse. These sources after their useful life will be discharged through the main sewerage line connected to the Hospital.

Q68.

What are transportation rules and regulations concerned to safety and security of radioactive materials in India?

Ans

Transportation of radioactive material in India is governed by the Safety Code AERB/SC/TR- 1, issued by Atomic Energy Regulatory Board (AERB). This code is based on the International Atomic Energy Agency (IAEA) “Regulations for the Safe Transport of Radioactive Material”.

Q69.

Provide the list of Radiation accidents, associated with radiation facilities happened in India which is reported to AERB and the Investigation reports and further actions taken by AERB.

Ans

The list and details of incidents with radiation safety implication over the past years are available in AERB Annual Reports, which is available on AERB website. The radiation accident at Mayapuri scrap market, New Delhi, in April 2010 is the major radiation accident in India. No such disasters have taken place in any other state after Mayapuri. The regulatory mechanism on legacy sources has been improved thereafter.

The detail of Mayapuri accident is available in AERB Newsletter Vol. 23, Jan-Jun 2010, which gives details on outcomes of investigation and further actions taken by AERB. The newsletter is available on AERB website.

Q70.

Is AERB making any efforts to tackle radioactive emissions from different Diagnostic Radiology centres and apprising people in general about the harm caused thereby to human health? If yes, what are these efforts?

Ans

Atomic Energy Regulatory Board (AERB) makes all efforts to ensure that there is no undue risk because of the use of Ionizing Radiation as well as use of Nuclear energy in the Radiation & Nuclear establishments throughout the country.

AERB has structured procedures for safety reviews& regulatory inspections of all these Nuclear and Radiation facilities. AERB gives public information through its periodic Press Releases, Annual Reports, Newsletters, and direct Interviews with print and electronic media. AERB conducts public awareness programs periodically on various safety related issues for the benefit of various stakeholders and the public. AERB gives periodical advertisement in the newspapers for abiding by these statutory requirements with respect to radiation safety. AERB carries out safety reviews of the facilities at different stages of siting, construction, commissioning, operation and decommissioning. AERB also carries out periodic regulatory inspections of such facilities as per stipulations of AERB codes and recommendations made in AERB guides and manuals.

Further, AERB has also established its own Regional Regulatory Centers (RRC) at Chennai, Kolkata and Delhi for catering to the Southern, Eastern and Northern regions of the country respectively.

Q71.

What is the need of directorate of radiation safety agency in various states of India?

What is the status of directorate of radiation safety agency of various states?

Ans

There are a several thousands of medical diagnostic X-ray facilities dispersed in the country which need to be regulated by AERB. Decentralization of inspections of these facilities is one of the options considered for effective safety regulation of such installations. In this regard, AERB has initiated process for formation of Directorate of Radiation Safety (DRS) under Health and Family Welfare Department of every state, to carry out regulatory inspections of X-ray facilities (of the state) and support the utilities in obtaining Licence/registration from AERB.

Radiation Safety Agency is made functional in six States (Kerala, Mizoram, Chhattisgarh, Arunachal Pradesh, Punjab and Tripura). The other six State Governments that signed an MoU with AERB are as follows: (1) Madhya Pradesh, (2) Tamil Nadu, (3) Gujarat, (4) Himachal Pradesh, (5) Maharashtra and (6) Odisha. Follow-up is in progress to enter an agreement with other States and make them functional.

Q72.

Effect of ionizing radiation to general public and staff by the Medical Diagnostic Centres, Immunity/Disease/Infection or any side effects please give details.

Ans

Harmful effects of ionising radiation (X-rays) on human beings depend on the magnitude of absorbed dose. The magnitude of radiation absorbed dose must be very high for causing any detectable biological effects. It shall be noted that detectable chromosomes aberration reveals only on exposed individual for radiation absorbed dose greater than 100 mSv. Any side effect occurs at still higher doses. AERB prescribes annual dose limits for general public as 1mSv/year and for occupational worker as 30 mSv/year, which is much below the dose which could cause any biological/side effects.

Q.73

What are the Safety precautions to be followed by the user and instructor during the operation of dental X-ray equipment?

Ans

Dentist/Dental Surgeon/Dental Technicians, operating dental X-ray equipment should comply the following safety guidelines during its operation:

Dental X-ray equipment should be operated at least two meters away (by using cable length) from the dental X-ray equipment and patient. If this is not possible, the operator should wear a protective lead apron with minimum 0.25 mm lead equivalence.

The operator should ensure that there are no bystanders within a radius of two meter from the patient being examined with dental X-ray equipment.

Holding of patients or X-ray film cassettes during exposure should be done by persons accompanying the patient with wearing lead aprons.

No pregnant woman should assist in holding patients or X-ray film cassettes during radiography.

For dental (intra-oral) examinations, the X-ray beam should be directed such that the X-ray film completely intercepts the primary X-ray beam, and the patient’s eyes are not irradiated. When it is required to take multiple exposures (e.g., upper and lower jaw separately), it should be ensured that irradiated region will not be irradiated again during radiography of the other region.

Radiation workers use TLD badges at chest level while operating dental X-ray equipment.

TLD badge should be placed below the lead aprons.

Dentists/Dental Surgeons/Dental X-ray technicians should operate the dental X-ray equipment.

Q74.

Is it mandatory to have AERB Licence for the usage of dental X-ray unit?

Ans

Yes, it is mandatory to obtain Registration for operation of dental X-ray equipment from AERB.

Q75.

If the Dental X-ray room, operator and the user (patient) does not follow the necessary safety precautions like the room requirements including the space, room construction, safety gadgets then who is held responsible for liable action.

Ans

There is no requirement of room area for dental (intra-oral). The shielding requirements for dental OPG and dental CBCT is provided in shielding guidelines which is available in AERB website.

The Standard Layouts and Shielding Guidelines published by AERB which is available on AERB website.

Employer or licensee, as the case may be, of the dental facility is solely responsible for safe handling of dental X-ray equipment.

Q76.

What are the responsibilities of the manufacturers/suppliers of X-ray equipment, with respect to the end users. What actions are initiated by AERB against non-compliant manufacturers/suppliers?

Ans

Only licensed manufacturers/suppliers are permitted to supply X-ray equipment to end users. It is the responsibility of the supplier to supply to the end-user(s) only AERB Type approved models. Further, the supplier is also responsible for the following:

shall check for layout and shielding adequacy at the customer site before installation of X-ray equipment.

on installation of the equipment, shall carry out acceptance testing/quality assurance as part of commissioning of X-ray equipment;

shall ensure that the customer has the requisite radiation protection devices such as protective barrier, protective apron,

Layout guidelines for installation of dental X-ray equipment are prescribed by AERB. The above guidelines can be downloaded from AERB website. Users of dental X-ray equipment are advised to procure type approved dental X-ray equipment from authorized suppliers. Data of type approved X-ray equipment are available on AERB website.

AERB has initiated actions to bring unauthorized manufacturers/suppliers of diagnostic X-ray equipment under its regulatory control.

Q77.

Who is the watchdog for checking whether AERB guidelines are followed in all dental and medical X-ray units?

Ans

AERB routinely conducts regulatory inspections of X-ray installations all over the country on a sample basis. In addition, AERB is also taking diligent efforts to streamline and enhance regulatory control over medical diagnostic X-ray facilities, with active co-ordination of several state agencies/regional regulatory centers. Considering the large number of wide spread X-ray facilities, AERB has initiated steps for decentralization of regulation of X-ray facilities. In this regard, AERB has initiated process for formation of Directorate of Radiation Safety (DRS) under Health and Family Welfare Department of every state, to carry out regulatory inspections of X-ray facilities (of the state) and support the utilities in obtaining licence/registration from AERB. At present, DRS are functioning in Kerala, Mizoram, Chhattisgarh, Arunachal Pradesh, Tripura and Punjab.

Further, AERB has also established its own Regional Regulatory Centers (RRC) at Kalpakkam, Kolkata and Delhi for catering to the southern, eastern and northern regions of the country respectively.

Q78.

What is the penalty to be laid if the proper AERB guidelines are not followed in usage of both dental and medical X-ray units?

Ans

Employer/licensee, as the case may be, of the facility is responsible for abiding the rules and regulations governed by AERB.

In case any radiation generating equipment/radiation source is found to be in operation without a license from AERB or in contravention of the relevant Rules, AERB may seal or seize the same as per Atomic Energy (Radiation Protection) Rule, 2004 and such facility may be penalized as per provisions of Atomic Energy Act, 1962.

Visitor Count: 57984

Last updated date: