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[…]Read More »
News : Healthcare
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[…]Read More »
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[…]Read More »
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[…]Read More »
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.Â The 200 submitted[…]Read More »
Members of ISO TC 198,WG 2 – Radiation Sterilization met in San Francisco 3-7 November 2008 and will issue a Corrigendum.
Members of ISO TC 198, including WG 2 – Radiation Sterilization met in San Francisco during the week 3-7 November 2008. ISO/TC 198 thanked Ms. Joyce Hansen for her long and dedicated service as convener of WG 2 and welcomed the new convenor Dr. Byron Lambert (USA). Dr. Lambert conducted the meeting with Ms S[…]Read More »
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[…]Read More »
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[…]Read More »
11:30 – 11:50 Tuesday 23 September | Heathcare 2: Process Stephen Ward: Onyvax Limited, London, United Kingdom E-Mail: email@example.com Abstract Therapeutic vaccine strategies can be used to harness the selective power of the immune system to treat life-threatening cancer. The use of whole tumour cells as a vaccine strategy is advantageous as the resulting formulation[…]Read More »
210 Combination products – What effects might processing conditions and product composition have on microbial radiation response?
11:00 – 11:30 Tuesday 23 September | Heathcare 2: Process Alan Tallentire: Air Dispersions Ltd, Manchester, UK E-Mail: Abstract The sterilization of drug-device combination products can necessitate the use of radiation processing conditions significantly different from those normally employed for the sterilization of medical devices. To minimise the detrimental effect that exposure to radiation can[…]Read More »