This publication has been superseded by SSG-46. Safety Reports Series No.38 Applying Radiation Safety Standards in Radiotherapy Jointly sponsored by This publication has been superseded by SSG-46. IAEA SAFETY RELATED PUBLICATIONS IAEA SAFETY STANDARDS Under the terms of Article III of its Statute, the IAEA is authorized to establish or adopt standards of safety for protection of health and minimization of danger to life and property, and to provide for the application of these standards. The publications by means of which the IAEA establishes standards are issued in the IAEA Safety Standards Series. This series covers nuclear safety, radiation safety, transport safety and waste safety, and also general safety (i.e. all these areas of safety). The publication categories in the series are Safety Fundamentals, Safety Requirements and Safety Guides. Safety standards are coded according to their coverage: nuclear safety (NS), radiation safety (RS), transport safety (TS), waste safety (WS) and general safety (GS). Information on the IAEA’s safety standards programme is available at the IAEA Internet site http://www-ns.iaea.org/standards/ The site provides the texts in English of published and draft safety standards. The texts of safety standards issued in Arabic, Chinese, French, Russian and Spanish, the IAEA Safety Glossary and a status report for safety standards under development are also available. For further information, please contact the IAEA at P.O. Box 100, A-1400 Vienna, Austria. All users of IAEA safety standards are invited to inform the IAEA of experience in their use (e.g. as a basis for national regulations, for safety reviews and for training courses) for the purpose of ensuring that they continue to meet users’ needs. Information may be provided via the IAEA Internet site or by post, as above, or by e-mail to [email protected]. OTHER SAFETY RELATED PUBLICATIONS The IAEA provides for the application of the standards and, under the terms of Articles III and VIII.C of its Statute, makes available and fosters the exchange of information relating to peaceful nuclear activities and serves as an intermediary among its Member States for this purpose. Reports on safety and protection in nuclear activities are issued in other publications series, in particular the Safety Reports Series. Safety Reports provide practical examples and detailed methods that can be used in support of the safety standards. Other IAEA series of safety related publications are the Provision for the Application of Safety Standards Series, the Radiological Assessment Reports Series and the International Nuclear Safety Group’s INSAG Series. The IAEA also issues reports on radiological accidents and other special publications. Safety related publications are also issued in the Technical Reports Series, the IAEA-TECDOC Series, the Training Course Series and the IAEA Services Series, and as Practical Radiation Safety Manuals and Practical Radiation Technical Manuals. Security related publications are issued in the IAEA Nuclear Security Series. This publication has been superseded by SSG-46. APPLYING RADIATION SAFETY STANDARDS IN RADIOTHERAPY This publication has been superseded by SSG-46. This publication has been superseded by SSG-46. SAFETY REPORTS SERIES No. 38 APPLYING RADIATION SAFETY STANDARDS IN RADIOTHERAPY JOINTLY SPONSORED BY THE EUROPEAN SOCIETY FOR THERAPEUTIC RADIOLOGY AND ONCOLOGY INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR OFFICE, INTERNATIONAL ORGANIZATION FOR MEDICAL PHYSICS, PAN AMERICAN HEALTH ORGANIZATION, AND WORLD HEALTH ORGANIZATION INTERNATIONAL ATOMIC ENERGY AGENCY VIENNA, 2006 This publication has been superseded by SSG-46. COPYRIGHT NOTICE All IAEA scientific and technical publications are protected by the terms of the Universal Copyright Convention as adopted in 1952 (Berne) and as revised in 1972 (Paris). The copyright has since been extended by the World Intellectual Property Organization (Geneva) to include electronic and virtual intellectual property. Permission to use whole or parts of texts contained in IAEA publications in printed or electronic form must be obtained and is usually subject to royalty agreements. Proposals for non-commercial reproductions and translations are welcomed and will be considered on a case by case basis. Enquiries should be addressed by email to the Publishing Section, IAEA, at [email protected] or by post to: Sales and Promotion Unit, Publishing Section International Atomic Energy Agency Wagramer Strasse 5 P.O. Box 100 A-1400 Vienna Austria fax: +43 1 2600 29302 tel.: +43 1 2600 22417 http://www.iaea.org/books © IAEA, 2006 Printed by the IAEA in Austria February 2006 STI/PUB/1205 IAEA Library Cataloguing in Publication Data Applying radiation safety standards in radiotherapy / jointly Sponsored by the International Atomic Energy Agency … [et al.]. — Vienna : International Atomic Energy Agency, 2006. p. ; 24 cm. — (Safety reports series, ISSN 1020-6450 ; no. 38) STI/PUB/1205 ISBN 92–0–110904–0 Includes bibliographical references. 1. Radiation — Safety measures — Standards. 2. Radiotherapy — Safety measures — Standards. I. International Atomic Energy Agency. II. Series. IAEAL 06–00417 This publication has been superseded by SSG-46. FOREWORD 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 This publication has been superseded by SSG-46. 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