Adopting X-Ray Sterilization for Medical Devices

The use of X-rays as an alternative modality to either gamma irradiation or electron beam irradiation for the sterilization of medical devices has become a topical subject over the last two or three years. The drivers are the improved capability of modern-day X-ray generation systems and a desire to develop a range of competitive and sustainable sterilization technologies. The Panel on Gamma and Electron Irradiation has compiled a short guidance document on the steps required when switching radiation sterilization technology, for example, from gamma or electron beam to X-ray. The guidance clarifies the requirements of ISO EN 11137-1 (Sterilization of health care products - Radiation: Requirements for development, validation, and routine control of a sterilization process for medical devices), the primary standard relevant to the radiation sterilization of medical devices. This standard addresses both the technological aspects of delivering the correct dose and the microbiological aspects of ensuring sterility of the treated product. When considering a switch to X-ray sterilization, the main challenge to be addressed is transferring the two key product-based irradiation parameters, namely the sterilization dose (required to achieve the desired sterility assurance level) and the maximum acceptable dose (that the product is qualified to withstand). The guidance document outlining the points to be considered and how to achieve them is available for free download from the Panel we...
Source: MDDI - Category: Medical Devices Authors: Tags: Sterilization Source Type: news