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News : Regulatory Affairs

30 April 2008

ISO/TC 34/ WG 10 Meeting London September 18 & 19

Romina Garay, Convenor of ISO/ TC 34/WG 10 is proceeding to organize a meeting of this working group to discuss ISO /CD 22008, Food irradiation – Good processing practices for the irradiation of foods intended for human consumption. The BSI British Standards has kindly offered to host this meeting at their headquarter offices in Chiswick[…]

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25 February 2008

Radiation Source Use and Replacement Report, Just Released

The “Radiation Source Use and Replacement” congressionally mandated report released February 20, 2008 by the National Research Council of the National Academies recommended the U.S. government should give high priority and take steps to promote the replacement of radioactive cesium chloride radiation sources, a potential “dirty bomb” ingredient used in some medical and research equipment,[…]

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4 February 2008

ISO/TC 34/ WG 10 Meeting

4 February 2008 | ISO/TC 34/WG 10 N 23 – Minutes of the Conference Call 31st January 2008, 11:00 (GMT -2:00) Not for distribution but internal use by iia Members. ISO/TC 34/WG 10 “Food irradiation” First Teleconference Meeting Minutes 31 January 2008, 11:00 (GMT -2:00) Welcome by Romina Garay, ISO/TC 34/WG 10 Convenor. Due to[…]

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29 November 2007

ASTM E10.01 New Online Standards Collection for Sterilization

Just released is the new ASTM online collection that gives users instant access to 14 ASTM Standards referenced in ISO 11137-3:2006. This collection provides guidance on the application of dose measurement during all stages of radiation processing. Subjects covered in this new online collection include: * Calibration of dosimetry systems used to measure absorbed does[…]

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27 September 2007

Finding of No Significant Impact, Pa’ina Irradiator Final Environmental Assessment

The US Nuclear Regulatory Commission (NRC) published the “Notice of Availability of Final Environmental Assessment and Finding of No Significant Impact for Proposed Pa’ina Hawaii, LLC Irradiator in Honolulu, HI”, on Friday August 17, 2007 in the Federal Register/ Vol. 72. No. 159 pages 46249- 46251. Typically the licensing of panoramic or underwater irradiators does[…]

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9 August 2007

A New Era for European Standardization

The European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) recently took action to strengthen the common values and principles of the European standardization system at their third annual meeting in Lemesos, Cyprus. The Cyprus decision seeks to create a more open, flexible, and dynamic system to anticipate and respond to[…]

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28 March 2007

Why the Changes and Additions to ISO 11137

Readers of iiA eNewsletter will be aware of the publication in 2006 of the two normative ‘radiation’ standards, (EN) ISO 11137-1 Requirements for development, validation and routine control of a sterilization process for medical devices and (EN) ISO 11137-2 Establishing the sterilization dose; these, with time, will replace the original standards, EN 552:1994 and ISO[…]

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28 March 2007

Irradiation of Wood Packaging Material- ISPM 15 under revision

Currently there is no internationally approved international standard for phytosanitary measure (ISPM) for the treatment of wood packaging (e.g. pallets, crates, boxes) that allows for the use of irradiation. In 2007, the International Plant Protection Convention Secretariat, Food and Agriculture Organization (FAO) of the United Nations will be calling for submissions of treatments of wood[…]

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22 February 2007

The Position of EN ISO 11137-2 in Europe

Following the joint CEN and ISO revision of EN 552:1994 and ISO 11137:1995 (with ISO lead) and the requisite CEN and ISO approvals of the resulting documents, ISO published the first edition of ISO 11137-2, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose on 15 April 2006. As is[…]

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26 January 2007

NRC Pai’ina Irradiator Public Meeting

The Nuclear Regulatory Commission (NRC) will hold a public meeting in Honolulu on Feb. 1 to seek public comment on a draft environmental assessment for a proposed irradiator to be built and operated adjacent to the Honolulu International Airport. Based on the draft assessment, the NRC concludes that there would be no significant environmental impact[…]

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