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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 in gamma-ray or X-ray fields and electron beams used for radiation processing
* Different mathematical methods that may be used to calculate absorbed dose and criteria for their selection
* Materials description, dosimeter preparation, and procedures for using the alanine-EPR dosimetry system
* Procedures for handling, testing, and using a radiochromic film dosimetry system
* And much more!

This very useful collection of standards compliments: ISO 11137-1:2006 – Sterilization of health care products – Radiation Part 1: Requirements for the development, validation and routine control of a sterilization process of a sterilization process for medical devices. ISO 11137-2:2006 – Sterilization of health care products – Radiation Part 2: Establishing the sterilization dose. ISO 11137-3:2006 – Sterilization of health care products – Radiation Part 3: Guidance on dosimetric aspects

Also available on the ASTM website is the red book, Standards on Dosimetry for Radiation Processing published 2004. It contains 31 standards and is a valuable resource for operators of commercial radiation processing facilities, inspectors and researchers at university and government organizations, and dosimetry expert’s worldwide.

ASTM E10.01, chaired by John R. Logar (of Sterigenics) is the subcommittee dedicated to defining standards on dosimetry for radiation processing. ASTM International is one of the largest voluntary standards development organizations in the world with technical experts represent producers, users, consumers, government and academia. Participation in ASTM International is open to all with a material interest. This group typically meets twice a year in January and June.