This Safety Report provides practical guidance on establishing the procedures to facilitate regulatory compliance on the use of radiation sources. It provides examples of processes to be followed, and the use of standard assessment plans for carrying out inspections. It contains examples of inspection procedures and checklists for the use of radiation sources in diagnostic radiology, nuclear medicine, radiotherapy, industrial radiography, research and industrial irradiators, gauges containing radioactive sources and well logging sources.
This Safety Guide provides recommendations on meeting the requirements of IAEA Safety Standards Series No. GSR Part 1 (Rev. 1), Governmental, Legal and Regulatory Framework for Safety, on the regulatory body's core functions and associated regulatory processes. This guidance is particularly important for regulatory bodies having responsibilities covering a range of facilities and activities that give rise to radiation risks and the important organizational interfaces between various regulatory authorities, which require effective coordination and cooperation. It promotes a consistent approach to regulation and specifically addresses the release of facilities and activities from regulatory control including sites, buildings, equipment and material. The publication is intended to be used mainly by regulatory bodies but will also be useful for governments that are developing a regulatory framework for safety. It will also assist authorized parties and others dealing with radiation sources in understanding regulatory procedures, processes and expectations.
This publication is the new edition of the International Basic Safety Standards. The edition is co-sponsored by seven other international organizations European Commission (EC/Euratom), FAO, ILO, OECD/NEA, PAHO, UNEP and WHO. It replaces the interim edition that was published in November 2011 and the previous edition of the International Basic Safety Standards which was published in 1996. It has been extensively revised and updated to take account of the latest finding of the United Nations Scientific Committee on the Effects of Atomic Radiation, and the latest recommendations of the International Commission on Radiological Protection. The publication details the requirements for the protection of people and the environment from harmful effects of ionizing radiation and for the safety of radiation sources. All circumstances of radiation exposure are considered.
Does radiation medicine need more regulation or simply better-coordinated regulation? This book addresses this and other questions of critical importance to public health and safety. The issues involved are high on the nation's agenda: the impact of radiation on public safety, the balance between federal and state authority, and the cost-benefit ratio of regulation. Although incidents of misadministration are rare, a case in Pennsylvania resulting in the death of a patient and the inadvertent exposure of others to a high dose of radiation drew attention to issues concerning the regulation of ionizing radiation in medicine and the need to examine current regulatory practices. Written at the request from the Nuclear Regulatory Commission (NRC), Radiation in Medicine reviews the regulation of ionizing radiation in medicine, focusing on the NRC's Medical Use Program, which governs the use of reactor-generated byproduct materials. The committee recommends immediate action on enforcement and provides longer term proposals for reform of the regulatory system. The volume covers: Sources of radiation and their use in medicine. Levels of risk to patients, workers, and the public. Current roles of the Nuclear Regulatory Commission, other federal agencies, and states. Criticisms from the regulated community. The committee explores alternative regulatory structures for radiation medicine and explains the rationale for the option it recommends in this volume. Based on extensive research, input from the regulated community, and the collaborative efforts of experts from a range of disciplines, Radiation in Medicine will be an important resource for federal and state policymakers and regulators, health professionals involved in radiation treatment, developers and producers of radiation equipment, insurance providers, and concerned laypersons.
This handbook is a practical aid to legislative drafting that brings together, for the first time, model texts of provisions covering all aspects of nuclear law in a consolidated form. Organized along the same lines as the Handbook on Nuclear Law, published by the IAEA in 2003, and containing updated material on new legal developments, this publication represents an important companion resource for the development of new or revised nuclear legislation, as well as for instruction in the fundamentals of nuclear law. It will be particularly useful for those Member States embarking on new or expanding existing nuclear programmes.
There are concerns that terrorist or criminal groups could gain access to high activity radioactive sources and use these sources maliciously. Based on extensive input from technical and legal experts, this implementation guide sets forth guidance on the security of sources.
The IAEA Safety Glossary defines and explains technical terms used in the IAEA Safety Standards and other safety related IAEA publications, and provides information on their usage. The 2018 Edition of the IAEA Safety Glossary is a new edition of the IAEA Safety Glossary, originally issued in 2007. It has been revised and updated to take into account new terminology and usage in safety standards issued between 2007 and 2018. The revisions and updates reflect developments in the technical areas of application of the safety standards and changes in regulatory approaches in Member States.
The objective of this Safety Guide is to provide guidance on the establishment of the national radiation safety infrastructure that meets the IAEA safety standards. It provides recommendations, in the form of actions, on meeting the relevant Safety Requirements in an effective and integrated manner while taking specific national circumstances into full consideration. This Safety Guide does not diminish the application of, or provide a synopsis of or a substitute for, the IAEA Safety Fundamentals and Safety Requirements publications or other associated Safety Guides. Rather it sets out a holistic approach to the establishment of the national radiation safety infrastructure and provides advice for the application of IAEA safety standards for both, States having essentially no elements of the radiation safety infrastructure in place, and those that already have some.
Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.
