ANSTO's research capabilities, led by the OPAL nuclear research reactor and associated instruments provide access to users investigating areas as diverse as materials, life sciences, climate change and mining/engineering.
Medical Products (ISO 11137)
Manufacturers of disposable health care products and other medical devices are required by the Therapeutic Goods Administration (TGA) to substantiate the sterilising dose (typically 15 or 25 kGy) that their products receive during bulk irradiation at industrial irradiation plants.
The international standard followed, ISO 11137:2006 [1], specifies requirements for validation and control of these products to ensure microbiological contamination prior to use is minimised. This work requires regular testing of bioburden levels to determine the specific radiation dose (the verification dose) required to demonstrate a given sterility assurance level.
ANSTO’s irradiation facility consistently delivers verification doses for customers accurately and within a narrow range. Some examples of products undergoing this process include cotton tips, wound dressings, natural & synthetic bandages, eye pads, gauze swabs, metallic implants, frozen bones & tissues.
[1] ISO 11137:2006 (Parts 1-3) – Sterilisation of health care products.
Contact: Justin Davies