A new revision of ISO 11137-1:2025 Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices has been released. The 2025 edition of ISO 11137-1, which specifies the requirements for radiation...
A new revision of ISO 11137-1:2025 Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices has been released. The 2025 edition of ISO 11137-1, which specifies the requirements for radiation...
The iia has confirmed that it will continue supporting the IAEA’s Denial of Shipment Working Group (DOS WG) in 2025. This support is a financial contribution to pay an expert consultant to manage the working group and its activities for a third year, following the...
The Society for Sterility Assurance Professionals (SfSAP), one of the iia's industry initiatives, has had a busy 2024. SfSAP was established with aims to enable the medical device and pharmaceutical industries to meet regulatory requirements by formulating a standard approach to defining and evaluating the...
Attendees of IMRP 2024 can now view Tech Theatre and Plenary presentations on the event web app. In order to revisit these presentations, you will need to log in to your IMRP 2024 account using the information used when registering for the conference. Tech Theatre Presentations...
The iia hosted a side event at the IAEA Ministerial Conference on Nuclear Science, Technology and Applications that was held on 26-28 November 2024 in Vienna, Austria. The conference brought together ministers and senior officials from IAEA Member States to discuss the role of nuclear...
The Phytosanitary Irradiation Platform (PsIP) held the 'Unlocking the Potential of Phytosanitary Irradiation' workshop in Costa Rica ahead of IMRP 2024. This brought together 35 participants from 13 countries to consider actions to advance the phytosanitary irradiation (PI) industry. Combining expert presentations and interactive discussions,...
‘The Importance of Irradiation to Global Wellbeing’ The iia will host a side event at the IAEA ‘Ministerial Conference on Nuclear Science, Technology and Applications and the Technical Cooperation Programme’ on 27 November 2024. The event titled ‘The Importance of Irradiation to Global Wellbeing’ will highlight...
AAMI recently published AAMI CR513:2024; Guidance on radiation sterilization validation and routine control of single-use systems used for pharmaceutical and biopharmaceutical manufacturing. The new guidance updates best practices and outlines acceptable alternative approaches to radiation sterilization validation and routine control for single-use systems in pharmaceutical and biopharmaceutical...
The iia and WINS (World Institute for Nuclear Security) has jointly published an update to their ‘Methodology for assessing the effectiveness of security arrangements at gamma irradiation facilities’. The original methodology was published in 2021 with industry input from members of the iia Gamma Working Group...
The iia has confirmed that it will continue its support of the IAEA’s Denial of Shipment Working Group (DOS WG) in 2024. This support is by way of a financial contribution to pay for an expert consultant to manage the working group and its activities...
The Canadian Nuclear Safety Commission (CNSC) is conducting a hearing on OPG's licence amendment application for the commercial production of cobalt-60 at their Darlington reactors. As part of this routine process, CNSC invites comments on the application. The iia has submitted comments in support of...
The IAEA 67th General Conference was held from 25-29th September 2023. During this conference, the IAEA Director General, Rafal Mariano Grossi, spoke of the role of the IAEA on addressing the important issue of denial and delay of radioactive shipments and highlighted the establishment of...
The Bio-Process Systems Alliance (BPSA) have published X-Ray Sterilisation of Single Use Bioprocess Equipment - Part II. Click here for more information. ...
On June 7, 2022, the FDA announced it was considering a master file pilot program for premarket approval (PMA) holders whose approved devices are sterilized using radiation, including gamma radiation. The FDA is considering this pilot program due to global supply chain constraints and to...
The iia is pleased to welcome Institute de Radioprotection et de Sûreté Nucléaire (IRSN) France as its latest new member. IRSN contributes to the safety of existing and future nuclear facilities, and to the radiological monitoring of French national territory and of workers exposed to...
The Government of Ontario in partnership with the Canadian Nuclear Isotope Council, Organization of Canadian Nuclear Industries and McMaster University is organizing virtual trade missions to Europe and the United States focused on medical isotopes. The iia is a member of the Canadian Nuclear Isotope Council...
