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. Scope of ASTM F ➢Provides information for developing accelerated aging protocols. ➢Information may be used to support shelf life and expiration date.
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ASTM F procedure for accelerated aging is comprised of the following: Refer to Practice D for standard conditions that may be used to challenge the sterile barrier f1980-7 to realistic extremes in temperature and humidity conditions. The sterile barrier system shall maintain sterility to the point of use or until the expiry date.
Accelerated Aging Test Results.
To receive an Official Detailed Quote, please fill-in the following fields. Link to Active This link will always route to the current Active version of the standard. Relative Humidity RH is not a factor in the Arrhenius equation. Please ship all samples with this form to: The expiry date of a medical product is commonly based on its manufacture date. In parallel, age samples at real-life aging conditions TRT.
Historical Version s – view previous versions of standard. UPS Ground, Account number. Fed-Ex 2 nd day, Account number. 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. If you have questions about our online quoting process or other questions or need assistance, call RMTS at Standards for Accelerated Aging The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are: Pricing includes monthly temperature graph reports.
The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are:. Ambient Temperature Warehouse Temperature Higher temp. Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements.
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. Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria.
Fed-Ex Overnight, Account number. Shelf Life Study Equivalent. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Therefore, some add an extra month to the aging study to allow for sterilization, etc. Extracted information from ASTM F testing may be used f9180-07 support expiration date claims for medical device sterile barrier systems.
Please fill out this form and return with your Product Submission. Fed-Ex Ground, Account number.
UPS Overnight, Account number. Age samples at TAA. 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.
Accelerated aging studies can provide an alternative means.
Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. Online Quote System – Accelerated Aging. If a different Temperature and or Temperature Humidity condition is required than listed above or more then 30 cubic feet of boxes, contact RMTS for Pricing at The resulting creation of an expiration date or shelf life is based on the use of a conservative estimate of the f198007 factor for example, Q 10 and is tentative until the results of real time aging studies are completed on the sterile barrier system.
Evaluate the package performance after accelerated aging relative to the initial package requirements. Work Item s – proposed revisions of this standard. Try out our Accelerated Aging Calculator! 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 ff1980-07 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. 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. Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion.
Define aging test time intervals including time zero. Accelerated Aging Temperature F1980-70 temp.
For example, a 12 month shelf life is simulated based on 13 months. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging.
Determining AAFs are beyond the scope of this guide.
For more information visit www. Please fill-in your Input Temperatures and select the Q10 value. The zstm 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.
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