A method is described which supplements the AAMI B1 method for validating radiation
sterilization of medical devices. The method utilizes AAMI B1 experimental data in …

The validation and radiation sterilization process for biomaterials and medical devices
requires careful planning to ensure regulatory compliance followed by precise accuracy in …

An Overview of the Revised Radiation Sterilization Standards Page 1 Biomedical
Instrumentation &Technology 85 STANDARDS & REGULATORY WATCH An Overview of …

Radiation sterilization is one of the widely used sterilization methods, especially in the field
of medical device manufacturing. Radiation as a method of sterilization demands its proper …

A Technical Information Report, TIR 17, entitled,“Radiation Sterilization Material
Qualification” has been published by the Association for the Advancement of Medical …

Background ANSIIAAMI ST32 (1991), Guideline for Gamnta Radiario~ i Steriiizariotl,
provides three methods for determining the sterilization dose which are referred to as …

Potential solutions to some of the practical problems experienced when validating products
processed by radiation sterilization are discussed in this article. The standards for validation …

A method is described (Batch Release method) which allows the user to validate the sterility
of individual batches of gamma radiation-sterilized medical devices. The method has been …

This presentation provides an overview of the current status of the ISO radiation sterilization
standards. The ISO standards are voluntary standards which detail both the validation and …

The International and European standards for radiation sterilization require evidence of the
effectiveness of a minimum sterilization dose of 25kGy but do not provide detailed guidance …