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News : Healthcare

15 July 2015

EN/ISO 11137 parts 1,2 and 3 – Microbiological and Dosimetric issues.

There is a very important initiative being undertaken by EMPIR (European Metrology Programme for Innovation and Research).   Refer to the attached document.   This initiative has significant consequences for the industry in terms of how product is currently processed. “Recent revisions of the medical device radiation sterilization standards (EN/ISO 11137-1,2&3 have highlighted the lack of a[…]

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26 April 2014

Medtronic and Coviden almost one year after the $50 Billion merger.

A number of meetings have taken place during the past few weeks.    ISO TC198 meeting in Sydney (Australia) –  The Sterility Assurance Task Group had its first face to face meeting. The meeting was well attended and the draft New Work Item Proposal (NWIP) was thoroughly reviewed, had broad support, and was finalized for submission[…]

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27 March 2014

Nordion & Adesto Technologies present CBRAM data storage. The product will enable medical devices with embedded electronics to be sterilised using gamma irradiation.

Nordion recently collaborated with Adesto Technologies, a leading developer of non-volatile memory solutions. Together they confirmed that Adesto CBRAM® data storage technology is gamma radiation compatible. This will enable medical devices with embedded electronics to be sterilized using gamma. The research results were presented at MD&M West.

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26 November 2013

Assurance of Sterility

Action from AAMI WG90 via representation to ISO TC 198 recently resulted in the establishment of the AAMI WG90 Sterility Assurance Study Group. iia has been working with the Study Group to formulate ways in which it can support the initiative. Two papers are presented: (1) The Sterility Assurance Discussion and (2) iia Role in[…]

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22 February 2013

TC 198

The agreed Terms of Reference are To identify Regional and National standards that specify requirements for Assurance of Sterility To ascertain the interest in developing standards on Assurance of Sterility at an International level To review the potential role of international standards on Assurance of Sterility in relation to meeting regulatory requirements To make recommendations[…]

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7 January 2013

ISO TC 198 WG2

The summary is reproduced by courtesy of Alan Tallentire and the Panel on Gamma and Electron Irradiation.  The meeting was held on 5 and 6 December 2012 in Daytona Beach, Florida, USA Meeting Notes

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