News : Regulatory Affairs

5June2012

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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5June2012

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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16April2012

US FDA Medical Device Establishment fees

A new fee structure will be introduced from 1 October 2012 which is the commencemet date for the Fiscal Year 2013. The fees have an impact on US and domestic and foreign contract manufactuers and contract sterilisers. Further information can be found via the following two FDA links US FDA and US FDA

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15October2011

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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20September2010

ISO TC34 / WG 10 – Results of vote on DIS 14470

20 September 2010 | The draft document ISO/DIS 14470 “Food irradiation – Requirements for the development, validation and routine control of the ionizing radiation process used for the treatment of food” is approved. It received a total of 30 affirmative and 3 negative votes from eligible P-members.  Countries that submitted a comment file included: Australia, […]

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12June2010

Internationalization of Guidelines and Standards on Food Irradiation

12 June 2010 | Shanghai, CHINA presentation by Yves Henon, iiA Asia representative Yves Henon gave a very nice presentation on the, “Internationalization of Guidelines and Standards on Food Irradiation” at the recent CIRE 2010/ iiA Forum in China 12 June 2010. As noted the ISO/DIS is consistent with the requirements for food irradiation. It […]

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30March2010

Sterilization Standards – Status Update

Early February at BSI in London the ISO TC 198 WG2- Radiation Sterilization met with twelve delegates representing seven countries (Austria, Belgium, Canada, Denmark, Japan, UK and USA). The working group reviewed and resolved 212 submitted on the text. Byron Lambert (USA), the convenor noted that many of the comments received sought consistency in the […]

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30March2010

Food Irradiation ISO TC34 WG 10

Memo 7 March 2010 to Members and Explanatory Report for ISO TC34 / WG 10 – Vote on DIS 14470, Food Irradiation – Requirements for the development, validation and routine control of the ionizing radiation process used for the treatment of food. The DIS 14470 vote is now open from the 5th of March to […]

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22March2010

FDA roasted over irradiation petition handling

22 March 2010 By Rory Harrington, FOODproductiondaily.com A US Congressional watchdog has slammed the Food and Drug Administration (FDA) for a catalogue of failings over its handling of petitions to use irradiation on food. The Government Accountability Office (GAO) said the food regulatory agency was too slow in reviewing six outstanding irradiation applications, and had […]

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7March2010

ISO TC34 / WG 10 – Upcoming vote on DIS 14470

7 March 2010 | Memo and Explanatory Report for ISO TC34 / WG 10 – Vote on DIS 14470, Food Irradiation – Requirements for the development, validation and routine control of the ionizing radiation process used for the treatment of food. The DIS 14470 vote is now open from the 5th of March 2010 to […]

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