The iia Information Hub aims to provide material which will be of value to iia members. Information sources will be categorised so as to collate data into recognisable and useful areas of interest. We aim to ensure that listed categories are dynamic so that they can be updated to reflect changing areas of interest and concern.
Following a unique collaboration between medical industry leaders, AAMI has published a collection of articles showcasing the best practices and alternative strategies for medical device and packaging sterilization. Shared as an 88-page free resource through AAMI’s Biomedical Instrumentation & Technology, the publication offers 11 articles...
Dr Bruno Tissier (Tissier Pharma Consulting) was a presenter at IMRP19 Strasbourg. His presentation can be viewed via the link below. Terminal Sterilisation of High Value Drugs - a success story Bruno Tissier IMRP19...
The International Irradiation Association estimate that 50% of single use medical devices are sterilised using ethylene oxide and that 45% are treated using gamma irradiation. The remaining 5% use a variety of technologies including moist heat, electron beam and x-ray. The availability of x-ray technology...
The International Irradiation Association estimate that 50% of single use medical devices are sterilised using ethylene oxide and that 45% are treated using gamma irradiation. The remaining 5% use a variety of technologies including moist heat, electron beam and x-ray. The availability of x-ray technology...
As part of the domestic Protect and Reduce mission, the Office of Radiological Security of the National Nuclear Security Administration (NNSA), requested the Illinois Accelerator Research Center (IARC) of Fermi National Accelerator Laboratory to prepare a a report on the opportunities and challenges to replace...
A new version of EN ISO 11737-2 on tests of sterility was published as BS EN ISO 11737-2:2020 in May. Some changes parallel those incorporated in EN ISO 11737-1. Others include adding requirements that: the interval between manufacturing the device and sterilizing it reflects routine...
This article and the embedded short video provides an information relating to the application of MDR Article 117. The sterilisation of drug device combination products has been a topic of interest for the past 10-15 years. A 2008 news article authored by iia can be...
