Ionising radiation protection legal and regulatory basis Flashcards
(36 cards)
What is the definition of a sealed source?
A radioactive source whose structure is such as to prevent, under normal conditions of use, any dispersion of radioactive substances into the environment, but excludes RAS inside a nuclear reactor or any fuel element.
What is the definition of a High-activity Sealed Source (HASS)?
A sealed source for which the quantity of the radionuclide is equal to or exceeds the relevant quantity value set out in Part 4 of Schedule 7 of IRR17.
What is the definition of an open source?
Radioactive material which is not a sealed source and which is not waste.
What is the definition of radioactive waste and what are the differences between the IRR17 and EPR2016 defintions?
Essentially any open or sealed source which is no longer a source and for
IRR17: where activity cannot be disregarded for the purposes of radiation protection (column 2, Part 1 Table, Schedule 7)
EPR2016: meets the radioactivity concentration limits not to be exempt (column 2, Table 2, Part 3, Schedule 23) as amended in 2018
Is a 99Mo/99mTc generator an Open or Sealed source?
It is an open source as nothing is truly encapsulated.
Under which legislation are the Environmental Permitting Regulations 2016 made?
Pollution Prevention and Control Act 1999
Who enforces the Environmental Permitting Regulations 2016?
The Environment Agency through PIR/RSR Inspectors
What key areas are regulated for radioactive material under EPR 2016?
- Quantity of material held
- Purpose of use
- Storage and security
- Records and procedures
- Staff training
- Disposal of radioactive waste
When is a source no longer a source (i.e. part of permitted holding)?
- Following patient administration
- Any source moved to accumulating waste
- Liquid sources being discharged as waste to drains
- Open sources transferred ro another permitted holder
- Sealed sourced disposal or transfer
What would you expect the conditions for the keeping and use of a permit to include?
- Change of Name or registered office address or cessation of keeping or use of sources
- Management system
- Sources may be kept only for the permitted use(s)
- Total activity on the premises must not exceed the permitted holding for each specific radionuclide or group
- Prevent:
– Loss or escape of any source
– Unauthorised access to sources
– Premises access other than to authorised users - Escape of sources
- Records
- Offences
- Penalties
What is the definition of an orphan sources?
An open or sealed radioactive source which is neither exempted nor under regulatory control, e.g. because it has never been under regulatory control or because it has been abandoned, lost, misplaced, stolen or otherwise transferred without proper authorisation)
Whatare the additional permit conditions for HASS sources?
- Security in accordance with the NaCTSO RESTRICTED document “Security Requirements for Radioactive
Sources” - Security culture, awareness of the threat and need to Deter, Detect, Delay, Respond
– Site security plan
– Extendibility of security measures dependent upon the terrorist threat level
– Information security plan
– Specified number of physical security measures (delay source access)
– Timely detection of unauthorised access by monitored intruder alarm
– Timely police response to alarm
– Photographs of sources
– Interim reports to EA
– Evidence of financial provision for disposal costs
– Stringent personnel checks Re: security
– Written source specific emergency procedures (fire, loss, theft or unauthorised use)
Who is the Licensing Authority under the Ionising Radiation (Medical Exposure) Regulations 2017?
The Secretary of State, advised by ARSAC (Administration of Radioactive Substances Advisory Committee)
What are the two types of licences under the Ionising Radiation (Medical Exposure) Regulations 2017 and the key differences?
- Practitioner licence
- NOT site specific
- Free
- Employer licence
- One per site
- Fees apply
What aspects do the licences under IR(ME)R 2017 govern?
Licences govern:
- To whom,
- By whom,
- What,
- How,
- Why, and
- How much radioactive medicinal product is administered
What information is included in the ARSAC licenses?
Information relating to:
* organisational arrangements for protection & safety;
* staff competence;
* design features of the installation;
* anticipated occupational & public exposures;
* safety assessment of the activities
* emergency procedures;
* maintenance, testing, inspection & servicing
* management of waste
* quality assurance
What does ARSAC stand for
ARSAC stands for Administration of Radioactive Substances Advisory Committee
What are the eligibility requirements for an ARSAC practitioner licence?
Applicants must:
- Be medically qualified (Diagnostic, Therapeutic, or Research),
- Have theoretical and practical training (as per IRMER17 Schedule 3).
What must an employer have to obtain an ARSAC employer licence?
Employers must have:
- Suitable equipment, facilities, and support staff.
- Normally:
- MPE (Medical Physics Expert),
- A healthcare professional with responsibility for quality of RMPs or sealed RA source storage,
- Scientific support to maintain equipment and facilities,
- Medical Director or Chief Executive to sign
What activities require notification under the graded approach?
- Certain work with radioactive material (RAM)
- Work in a Radon atmosphere where the annual average concentration exceeds 300 Bq.m⁻³
What activities require registration?
- Use of radiation generators (e.g., most X-ray work),
- Some work with RAM (see Schedule 7 IRR17)
- Transport of RAM
What activities require consent to perform?
Separate consent is needed for each practice, such as:
- RAM administration to people,
- Radiopharmacy,
- HASS (High-Activity Sealed Sources),
- RAM waste management
What must an employer submit to obtain consent for specific practices?
A Safety Assessment which is inspected by the HSE and either grants or refuses consent.
What is the legislation for the transport of RAM?
The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009
