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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Online Quote System – Accelerated Aging

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 you have questions about our online quoting process or other questions or need assistance, call RMTS at Pricing includes monthly temperature graph reports. Shelf Life Study Equivalent. Standards for Accelerated Aging The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are: 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.

Accelerated Aging Test Results. Fed-Ex Overnight, Account number.

Try out our Accelerated Aging Calculator! Evaluate the package performance after accelerated aging relative to the initial package requirements. ASTM F procedure for accelerated aging is comprised of the following: Historical Version s – view previous versions of standard.

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Ambient Temperature Warehouse Temperature Higher temp. Age samples at TAA.

ASTM-F – Accelerated Aging – Medical Package Testing

In parallel, age samples at real-life aging conditions TRT. Relative F9180 RH is not a factor in the Arrhenius equation. 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. UPS Ground, Account number.

ASTM F – 07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

The expiry date of a medical product is commonly based on its manufacture date. Evaluate package, or package performance, or both, after real time aging relative to asm initial package requirements. 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:.

ASTM-F1980

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. For more information visit www. 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.

Fed-Ex 2 nd day, Account number. Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion.

Please ship all samples with this form to: Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.

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UPS 2 nd day, Account number. Determining AAFs are beyond the scope of this guide. 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 t1980 that they can be stored for an extended period one year, two years, etc.

More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging. Therefore, some add an extra month to the aging study to allow for sterilization, etc. 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 Define package material properties, seal strength and f9180 tests, sample sizes, and acceptance criteria.

Please fill-in your Input Temperatures and select the Q10 value. Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems.

The sterile barrier system shall maintain sterility to the point of use or until the expiry date. For example, a 12 month shelf life is simulated based on 13 months.