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. Scope of ASTM F • Significance and Use. • Understanding Accelerated Theory & Rationale. • Tolerances and Precision. • Cautions Using Accelerated.
|Published (Last):||4 September 2009|
|PDF File Size:||18.87 Mb|
|ePub File Size:||15.78 Mb|
|Price:||Free* [*Free Regsitration Required]|
Qstm testing using accelerated aging protocols shall be regarded as sufficient evidence for claimed expiry date until data from real time aging studies are available. Work Item s – proposed revisions of this standard.
Define aging test time intervals including time zero. Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion. 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.
Age samples at TAA. Evaluate the package performance after accelerated aging relative to the initial package requirements.
However, due to market conditions in which products become obsolete in a short time, and the need to get new products to market in wstm shortest possible time, real time aging studies do not meet this objective. 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 sterile barrier system shall maintain sterility to the point of use or until the expiry date. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. For more information visit www. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging.
Determining AAFs ast, beyond the scope of this guide. Historical Version s – view previous versions of standard. Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems.
ASTM F – 07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
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.
ASTM F procedure for accelerated aging is comprised of the following: Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.
Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc. In parallel, age samples at real-life aging conditions TRT.
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 f190 humidity conditions.
Link to Active This link will always route to the current Active version of the standard. 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.
Accelerated aging studies can provide an alternative means. Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies.