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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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5 June 2012

Sterilisation Standards Update

Paris France: ISO TC 198 and CEN TC 204 meetings in Paris, April 2012. April 16 – 20 in Paris saw the 20th meeting of ISO TC 198 hosted by AFNOR, the French national standards organisation. Alongside and in parallel with this meeting a meeting of CEN TC 204 also took place. Specific to radiation […]

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5 June 2012

Serilisation Standards Update

Paris ISO TC 198 and CEN TC 204 meetings in Paris, April 2012 April 16 – 20 in Paris saw the 20th meeting of ISO TC 198 take place, hosted by AFNOR, the French national standards organisation. Alongside and in parallel with this meeting a meeting of CEN TC 204 also took place, there being […]

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15 October 2011

New ANSI/ AMMI Publication on Selecting a Sterility Assurance Level (SAL)

The 2011 ANSI/AAMI ST67:2011, Sterilization of health care products – Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled ‘sterile’ was published 2 August 2011. Originally published in 2003, this revised American standard now includes guidance on selecting an SAL other than 10-6 based on a risk assessment. There are many […]

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22 May 2009

CDC/AAMI WG 90 Meeting

revised DRAFT 4/22/09 rfm Notes from CDC/AAMI WG 90 Meeting of 3/16/09 David Liu and Bob Morrissey (representing AAMI WG 90) gave a presentation on sterility assurance of industry sterilized medical devices to Drs. Cliff McDonald, Arjun Srinivasan, Matthew Arduino, Lynne Sehulster and Elise Beltrami of the CDC Prevention & Response Branch. A summary of […]

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18 March 2009

ISO/ TC 198/WG 2 Radiation Sterilization

3-4 November 2008 | Hilton Financial District, San Francisco, CA USA The meeting was convened by Dr Byron Lambert (USA) and Ms S Balboni (AAMI, USA) was the secretary and attended by 17 delegates from 7 countries. Click here for the brief report. Below are unofficial comments provide by Dr. Alan Tallentire. The 200 submitted […]

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6 November 2008

London Workshop Radiation Sterilization of Combination Drug-Device Products

On Thursday the iiA sponsored the third workshop on the Radiation Sterilization of Advanced Combination Drug-Device Products. New generation combination products that contain a drug or another biological active component are demanding sterilization be considered earlier in the research and development process– this requires fresh thinking, scientific based approaches to deal with these complex, temperature […]

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4 August 2008

Sterility and Safety Assurance of Medical Devices, 1992

Here is the classic paper on “Sterility and Safety Assurance of Medical Devices” was published April 1992 in Medical Device and Diagnostic Industry. by Canon Communications and reprinted by the US Department and Health Services and CDC. Authors .F. Morrissey, PhD; C.W. Bruch, PhD; R.J. Sharbaugh, PhD; M.S. Favero, PhD; Jarvis and Masefield discuss the […]

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