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News : Regulatory Affairs

8 November 2017

Whitepaper – A Comparison of Gamma, E-beam, X-ray and Ethylene Oxide Technologies for the Industrial Sterilization of Medical Devices and Healthcare Products

The White Paper is being jointly published by GIPA and iia. The purpose of the White Paper is to describe the role and importance of the key industrial sterilization methods to the healthcare industry and the means by which each technology ensures that products are safe and ready for their intended use. This paper focusses […]

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7 November 2017

Sterigenics International LLC Changes Name to Sotera Health LLC

Sterigenics International LLC  announced today that it has changed its parent company name to Sotera Health LLC. Its three operating companies – Nelson Labs™, Nordion® and Sterigenics® – will continue to maintain their current names. The new parent company name signals a more integrated and holistic customer value proposition as it combines the offerings of […]

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6 November 2017

Groups urge update to EU irradiation rules

The International Irradiation Association is referenced in the linked article which reports that the European Commission has been urged to revise the legislation related to the irradiation of food and ingredients. Food Quality News  

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31 October 2017

Revision of AAMI TIR29:2012: Guide for process characterization and control in radiation sterilization of medical devices

This technical information report provides additional guidance for characterizing the irradiation process and for establishing requisite process controls to ensure the irradiation system remains in a validated state. This document is intended to complement qualification and routine control activities as defined in ANSI/AAMI/ISO 11137 for gamma, X-ray, and electron beam sterilization Reference : AAMI TIR29:2012/(R)2017 […]

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30 October 2017

White Paper – Comparison: Gamma, Eb, Xray and EO for Sterilisation

The International Irradiation Association (iia) has worked with the Gamma Industry Processing Alliance (GIPA) to publish the attached White Paper: “A Comparison of Gamma, E-beam, X-ray and Ethylene Oxide Technologies for the Industrial Sterilization of Medical Devices and Healthcare Products”. The purpose of the White Paper is to discuss the role and importance of major […]

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23 October 2017

iia and the Panel on Gamma & Electron Irradiation

The iia attended a meeting of the Panel on Gamma & Electron Irradiation (‘Panel’) on Wednesday 18th October. Martin Comben of iia presented an update of iia activities including details of: its activities to help address the issue of cobalt-60 shipment denial through the Transport Facilitation Working Group including the production of new literature and it […]

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16 October 2017

NUTECH 2017 – Report

The International Conference on Developments and Applications of Nuclear Technologies – NUTECH 2017 was held from September 10-13th in Krakow, Poland. Approximately 100 participants from 28 countries attended the conference that was as organized the Institute of Nuclear Chemistry and Technology in Warsaw and the GH University of Science and Technology. The main goal of […]

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5 October 2017

TFWG and Denial of Shipment

The iia is a member of the Transport Facilitation Working Group (TFWG) that is active in facilitating the safe and secure global transport of radioactive material. By joining this group, the iia is able to bring greater focus to issues that impact the radiation processing industry, particularly the denial and delay of Cobalt-60 shipments. Please […]

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3 October 2017

European Directives on food irradiation

The International Irradiation Association, the Joint FAO/IAEA Division of Nuclear Techniques in Food and Agriculture and 30 other people/organisations have submitted comments on the “Evaluation of the EU legal framework on food irradiation” ahead of the submission deadline today. The letter from iia and from the joint FAO/IAEA division can be accessed below. Other submissions […]

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