Standards Development

Scope

This document establishes security requirements of me equipment using high activity sealed sources, directly or indirectly, for medical treatment and other clinical procedures. me equipment containing sealed sources that are defined as Category 1, 2 and 3 radioactive sources by IAEA[2] are subject to this standard.The object of this standard is to specify requirements for the security of me equipment containing high activity sealed sources(s) with the aim to minimize the risk of unauthorized access to the contained sources, and to serve as the basis for particular standards. This standard contains requirements for the manufacturer of the me equipment and, separately, for the responsible organization regarding security at the location during use and storage.The requirements of this standard apply when the radioactive source(s) are contained in the me equipment, i.e. from the time when the radioactive sources are inserted into the me equipment, during the intended medical use and when the me equipment is not being used for its intended purpose or taken out of regular use, until the equipment is being decommissioned, i.e. until all radioactive sources are permanently removed. The following ISO/IEC standards are related to the safety of me equipment containing radioactive sources.IEC 60601-1-8: Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in ME equipment and medical electrical systems IEC 60601-2-11: ME equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment. IEC 60601-2-17: ME equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically controlled brachytherapy afterloading equipment. PD   IEC/TR   80001-2-5:   Application   of   risk   management   for   IT-networks   incorporating medical devices – Part 2-5: Application guidance – Guidance on distributed alarm systems. ISO 14971:2019: Medical devices – Application of risk management to medical devices ISO/TR 14971: Medical devices - Guidance on the application of ISO 14971. The following Nuclear Safety Standards and Nuclear Security Guidance published by the International Atomic Energy Agency (IAEA) are related to this standard:The IAEA Code of Conduct on the Safety and Security of Radioactive Sources IAEA, Vienna, 2004 © IAEA. Nuclear security recommendations on radioactive material and associated facilities: recommendations. — Vienna: 2011. - ISSN 1816–9317; no. 14, STI/PUB/1487 ISBN 987–92–    0–112110–3 Categorization of radioactive sources. — Vienna, International Atomic Energy Agency, 2005., ISSN 1020–525X; STI/PUB/1227 ISBN 92–0–103905–0 Security of radioactive sources: implementing guide. — IAEA nuclear security series, ISSN 1816-9317; no. 11 STI/PUB/1387, ISBN 978-92-0-102609-5 Nuclear security culture: implementing guide. — Vienna: International Atomic Energy Agency, 2008. ISSN 1816– 317; no. 7 STI/PUB/1347 ISBN 978–92–0–107808–7.