ASTM F offers multiple aging protocols to determine the effects of time on the sterile integrity and the physical properties of medical packaging. 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. Scope of ASTM F • Significance and Use. • Understanding Accelerated Theory & Rationale. • Tolerances and Precision. • Cautions Using Accelerated.
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ASTM-F – Accelerated Aging – Medical Package Testing
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 using accelerated aging protocols shall be regarded as sufficient evidence for claimed expiry date until data from real time aging studies are available.
However, due to market conditions in which products become obsolete in a short qstm, and the need to get new products to market in the shortest possible time, real time aging studies do not meet this objective. Accelerated aging studies can provide an alternative means. Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems. Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion.
Stability f190 shall demonstrate that the sterile barrier system maintains integrity over time. Link to Active This link will always route to the current Active version of the standard. The introduction of new or modified products to the marketplace requires the assurance that they ast, be stored for an extended period one year, two years, etc.
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.
ASTM F – 02 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
Historical Version s – view previous versions of standard. In parallel, age samples at real-life aging conditions TRT. 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. The resulting creation of an expiration date or shelf life is based on the use of a conservative estimate of the aging factor for example, Q 10 and is tentative until the results of real time aging studies are completed on the sterile barrier system.
To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies.
ASTM F procedure for accelerated aging is comprised of the following: Try out our Accelerated Aging Calculator! Refer to Practice D for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and asttm conditions. Evaluate the package performance after accelerated aging relative to the initial package requirements.
Determining AAFs are beyond the scope of this guide. Age samples at TAA. For more information visit www.
Work Item s – proposed revisions of this standard. Define aging test time intervals including time zero. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging. Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements.
The sterile barrier system shall maintain sterility to the point of use v1980 until the expiry date. 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, astn.
Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc. Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria.