ABSTRACT
DOSIMETRY, which is the method of measuring absorbed dose, is an important part of the radiation sterilization process. Knowledge of the min-
imum and maximum absorbed doses delivered to a medical device is necessary to confirm that the part received sufficient dose to make it sterile yet did not receive a dose that could compromise its intended function. In the chapter on processing with irradiators (Chapter 9) we will see that medical devices can be released for final distribution to the health care provider solely on the basis of knowledge of dose delivered to the product. This process is called dosimetric release. To satisfy this release process, knowledge of dose delivered to the product is critical. Another process, termed parametric release, also may be used as a method for postirradiation release of product. A detailed understanding of an irradiator's dose delivery characteristics as well as proper monitoring techniques and controls during the processing cycle are essential for implementation of a parametric release program. Dosimetry may not be required during routine processing when parametric release is invoked; however, dosimetry is expected to continue to play an important role in validation of the system and process and in periodic audits. General guidance on use of dosimetry in the radiation sterilization of health care products is given in an ANSI/ISO standard on radiation processing [ 13]. Standards on calibration and usc of several dosimetry systems also have been published by the American Society for Testing and Materials (ASTM) and approved as ISO Standards [35-41]. These standards guide the user in use of dosimetry systems to obtain quantitative measurements of absorbed dose.
