How to simulate shelf life for ageing trials.
Medical device manufacturers are compelled to validate the shelf-life claims of their products. If the materials used in the product and packaging can withstand elevated temperatures, accelerated ageing regimes may be used to simulate real-time ageing. If elevated temperatures are detrimental to the components involved, then real-time ageing is the only option. All testing should be carried out on sterile product when appropriate.
Turner
Mark
M
Medical Engineering Technologies Ltd, Hydra House, 26 North Street, Ashford TN24 8JR, UK. m.turner@met.uk.com
D004864:Equipment and Supplies / Q000592:standards*; D017408:Guidelines as Topic; D008422:Materials Testing / Q000379:methods*; D019064:Product Packaging / Q000592:standards*; D006113:United Kingdom