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Medical Product Shelf Life
Definition 1
The period during which a medical product retains its properties and stated performance within specified limits throughout its shelf life if stored under defined conditions. The stability period is determined from the date the product was manufactured. After the end of the product shelf life it is not to be used. The chemical, physical and microbiological aspects of stability are to be considered for a medical product according to 21 CFR Part 211 GMP. (NCI Thesaurus)
Definition 2
The period during which a medical product retains its properties and stated performance within specified limits if stored under defined conditions. The stability period is determined from the date the product was manufactured. (NCI Thesaurus/CDISC)
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