Applying radiation safety standards in radiotherapy

The International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources (BSS) cover the application of ionizing radiation for all practices and interventions and are, therefore, basic and general in nature. Users of radiation sources have to apply these basic requirements to their own particular practices. This requires a degree of 'interpretation' by the user, which can result in varying levels of regulatory compliance and inconsistencies between applications of the BSS to similar practices. In this context, the preamble of the BSS states that: The [regulatory body] may need to provide guidance on how certain regulatory requirements are to be fulfilled for various practices, for example in regulatory guideline documents. In order to guide the user to achieve a good standard of protection and to achieve a consistent national approach to licensing and inspection, some countries have developed practice specific regulatory guidance, while others have practice specific regulations. For obvious reasons, national regulatory guidance is tailored to a country's own legislation and regulations. This can lead to problems if the guidance is used in other States without appropriate modification to take local requirements into account. There would therefore appear to be scope for producing internationally harmonized guidance, while bearing in mind that the ultimate responsibility for the regulatory documents rests with the State. Some regions have taken the initiative of preparing guidance to facilitate the regional harmonization of regulatory control of certain common practices (e.g. radiotherapy). A number of draft regulatory guidance documents for the main practices involving the use of ionizing radiation have already been prepared. This initiative indicates that there is a global demand for such documents. In particular, it is felt that countries participating in the IAEA's technical cooperation model project on Upgrading Radiation and Waste Safety Infrastructure would benefit significantly from the availability of practice specific guidance. Member States could then more readily develop their own guidance tailored to their own requirements and needs. This idea led to the development of the present report. The Action Plan on the Radiological Protection of Patients, approved by the IAEA General Conference in September 2002, requires that the practice-specific documents under preparation should be finalized as guidance rather than regulations, and they should include input from professional bodies, from international organizations and from authorities with responsibility for radiation protection and medical care. Following this request, the only mandatory statements of this report are quotations from the BSS, including requirements. There are certain BSS requirements that, when applied to specific practices, can be fulfilled mainly through one practical solution. In these cases, the regulatory body may need to use a 'should' statement, which implies that licensees should choose this solution or, if another option is intended, an equivalent level of safety should be provided. In other cases, there may be more than one option. In these cases the regulatory body would just mention or describe them. This guidance is intended for both regulators and users of radiation sources in radiotherapy. Regulators may use it for reviewing applications for authorization and during the inspection of facilities. Registrants/licensees may wish to follow the guidance in order to comply with BSS requirements or equivalent national requirements. Experts recruited on IAEA missions to advise on the implementation of the BSS for the practice of radiotherapy are expected to use this regulatory guidance report rather than their own national guidance. Working safely, with a quality assurance programme, is important and contributes to gaining overall confidence and credibility in the practice of radiotherapy. This report has been prepared by the IAEA with the contributions of the Pan American Health Organization, the International Labour Office, the World Health Organization, the European Society for Therapeutic Radiology and Oncology and the International Organization for Medical Physics