ASTM F1980 02 PDF
This standard is issued under the fixed designation F ; the 1 This guide is under the jurisdiction of ASTM Committee F02 on Flexible. The ASTM F guide provides documentation for developing accelerated aging protocols to promptly determine the effects, if any at all, due to the passage of. Designation: F – Standard Guide for. Accelerated Aging of Sterile Medical Device Packages1 This standard is issued under the fixed designation F .
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Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.
Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria. Evaluate the package performance after accelerated aging relative to the initial package requirements. Are you sure you want to empty the cart?
ASTM F – 02 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
The following editions for this book are also available To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Land Use and Development. Remember me for one month. 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.
Copyright Compu-tecture, Inc. Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc. The sterile barrier system shall maintain sterility to the point of use or until the expiry date. No items in cart. If you like to setup a quick demo, let us know at support madcad. Register for a trial account. ASTM-F Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices The introduction of new or modified products to the marketplace requires the assurance that they can be stored for an extended period one year, two years, etc.
Package and product compatibility and interactions should be addressed as a material analysis process before package design. Define aging test time intervals including time zero.
Stability testing using accelerated aging protocols shall be regarded as sufficient evidence for claimed expiry date until data from real time aging studies are available. For more information visit www. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER.
However, due to market conditions in which products become obsolete in a short time, and the need to get new products to market in the shortest possible time, atsm time aging studies do not meet this objective.
ASTM F procedure for accelerated aging is comprised of the following: Historical Version s – view previous versions of standard.
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. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging.
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. Try xstm our Accelerated Aging Calculator! Today, some 12, ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence.
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. Extracted information from ASTM F testing may be used to f980 expiration date claims for medical device sterile barrier systems. There were no books found for the applied search filters.
In parallel, age samples at real-life aging conditions TRT.
Click here to download full list of books. Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion. Please login to your authorized staff account to use this feature.