ASTM F1980 PDF
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. 1 Mar Time versus Temperature. – Relationship. – Affects on products. • Case Studies. • ASTM F – Changes to revision. • Real Time Aging.
|Country:||Antigua & Barbuda|
|Published (Last):||13 June 2015|
|PDF File Size:||7.57 Mb|
|ePub File Size:||13.48 Mb|
|Price:||Free* [*Free Regsitration Required]|
Historical Version s – view previous versions of standard.
Select the Q10 value Define f9180 desired shelf life of the package marketing and product needs, etc. Link to Active This link will always route to the current Active version of the standard. 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.
Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems. 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 wstm possible time, real time aging studies do not meet this objective.
More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging. Accelerated aging studies can provide an alternative means.
Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion. Define package material properties, seal strength and f190 tests, sample sizes, and acceptance criteria. Determining AAFs are beyond the scope of this guide.
To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Stability testing shall demonstrate that the sterile barrier system maintains integrity over aatm. Evaluate the package performance after accelerated aging relative to the initial package requirements. ASTM F procedure for accelerated aging is comprised of the following: The introduction of new or modified products to the marketplace requires f180 assurance that they can be stored for an extended period one year, two years, etc.
ASTM F – 02 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
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.
Define aging test time intervals including time zero. Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements.
In parallel, age samples at real-life aging conditions TRT. Referenced Documents purchase separately The documents listed below are astn within the subject standard but are not provided as part of the standard.
Work Item s – proposed revisions of this standard.
ASTM-F – Accelerated Aging – Medical Package Testing
The sterile barrier system shall maintain sterility to the point of use or until the expiry date. The sterile barrier system material and device interaction compatibility f19800 may be required for new product development or the resulting evaluation is not addressed in this guide. Age samples at TAA.
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. 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. 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.
Try out our Accelerated Aging Calculator! For more information visit www.