It offers multiple aging protocols to determine the effects of time on the sterile integrity of the packaging as well as the physical properties of the latter. While this guide does evaluate the sterile barrier system shelf life, it does not address the barrier system material and device interaction compatibility. The aging of products or materials refers to the variation of their properties over time. The properties of interest are those related to safety and efficacy. An aging study is a procedure that seeks the determination of the behavior of a device under normal-usage conditions over a relatively long time by exposing the material for a short period of time to an external stress, which is more severe or more frequently applied than normal environmental stresses. According to the latter, aging processes increase as a function of the ambient temperature.
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The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this guide.
Refer to Practice D for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. See Termninology F for a definition of "environmental challenging. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Your Alert Profile lists the documents that will be monitored. If the document is revised or amended, you will be notified by email.
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ASTM F1980-07 Accelerated Aging Test
Designation: F — Standard Guide for. A number in parentheses indicates the year of last reapproval. A superscript epsilon e indicates an editorial change since the last revision or reapproval.