ASTM F1980 07 PDF
Buy ASTM F (R) GUIDE FOR ACCELERATED AGING OF STERILE BARRIER SYSTEMS FOR MEDICAL DEVICES from SAI. Time versus Temperature. – Relationship. – Affects on products. • Case Studies. • ASTM F – Changes to revision. • Real Time Aging. 1 This guide is under the jurisdiction of ASTM Committee F02 on Primary Last previous edition approved in as F – 07().
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Accelerated aging studies can provide an alternative means. The resulting f180 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 adtm the results of real time aging studies are completed on the sterile barrier system. 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, real time aging studies do not meet this objective.
If a different Temperature and or Temperature Humidity condition is required than f9180 above or more then 30 cubic feet of boxes, contact RMTS for Pricing at Therefore, some add an extra month to the aging study to allow for sterilization, etc.
Determining AAFs are beyond the scope of this guide. The sterile barrier system shall maintain sterility to the point of use or until the expiry date.
Online Quote System – Accelerated Aging
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. For example, a 12 month shelf life is simulated based on 13 months.
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.
The expiry date of a medical product is commonly based on its manufacture date.
ASTM-F – Accelerated Aging – Medical Package Testing
UPS Ground, Account number. Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria. UPS 2 nd day, Account number. Extracted information from ASTM F testing may be used to support expiration date claims asmt medical device sterile barrier systems. UPS Overnight, Account number.
Work Item s – proposed revisions of this standard. For more information visit www. Online Quote System – Accelerated Aging.
Evaluate the package performance after accelerated aging relative to the initial package requirements. Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements.
Please fill out this asym and return with your Product Submission. Fed-Ex Ground, Account number. In parallel, age samples at real-life aging conditions TRT. Try out our Accelerated Aging Calculator! Fed-Ex 2 nd day, Account number.
Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. Pricing includes monthly temperature graph reports.
Accelerated Aging Test Results. Stability testing using v1980 aging protocols shall be regarded as sufficient evidence for claimed expiry date until data from f1908 time aging studies are available. Relative Humidity RH is not a factor in the Arrhenius equation. If you have questions about our online quoting process or other questions or need assistance, call RMTS at Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion.
Accelerated Aging Temperature Higher temp. Link to Active This link will always route to the current Active version of the standard.
ASTM F – 07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.
Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc.
More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging. Please ship all samples with this form to: 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. ASTM F procedure for accelerated aging is comprised of the following: Please fill-in your Input Temperatures and select the Q10 value.
To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are:. To receive an Official Detailed Quote, please fill-in the following fields.
Shelf Life Study Equivalent. Standards for Accelerated Aging The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are: Historical Version s – view previous versions f11980 standard.