News : Regulatory Affairs

1September2005

Irradiation of Shellfish Approved by USA FDA

August 16, 2005 the FDA announced in the US Federal Register (Volume 70, NO 197, 48057) they are amending the regulations to provide for the safe use of ionizing radiation for the control of Vibrio species and other foodborne pathogens in fresh and frozen molluscan shellfish (e.g. oysters, mussels, clams etc.) at a dose not […]

Read More »
10August2005

US NRC and States Regulatory Activities

Currently the US NRC is developing an implementation guide for the Financial Assurance for Materials Licensees published in the Federal Register/ Vol. 68, No. 192/ Friday, October 3, 2003/ Rules and Regulations 57327 Nuclear Regulatory Commission 10 CFR Parts 30, 40 and 70. Target date for the guide is 2005 December 2. At the heart […]

Read More »
5January2005

AAMI Meeting Highlights

2005 June 27 to 30th Lisa Foster, Sterigenics reports on the AAMI Sterilization meeting in Washington, USA. As expected the meetings were brief. Highlights: * Craig Herring, Ethicon EndoSurgery is leading a task group on to develop a TIR which expands VDmax 25 kGy to other sterilization doses with the goal to issue a draft […]

Read More »
1January2005

ISO TC 198 Meeting Highlights

Thank-you to Alan Tallentire for providing detailed notes of the ISO TC 198 Sterilization of Healthcare Products 2005 April 18-22 in Sydney Australia. This unofficial report is posted on the doubleia website. Highlights: Working Group 2 – Radiation Sterilization convened by Joyce Hansen (USA) had delegates from 9 countries. In total 388 comments were reviewed […]

Read More »
Page 9 of 9« First...56789