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. 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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The expiry date of a medical product is commonly based on its manufacture date. The resulting creation of an expiration date or aetm 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. Link to Active This link asttm always route to the current Active version of the standard. Accelerated aging studies can provide an alternative means.

Relative Humidity RH is not a factor in the Arrhenius equation. Please ship all samples with this form to: Define aging test time intervals including time zero. Shelf Life Study Equivalent. ASTM F procedure for accelerated aging is comprised of the following: Standards for Accelerated Aging The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are: UPS 2 nd day, Account number.

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

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

UPS Ground, Account number. Evaluate the package performance after accelerated aging relative to the initial package requirements. Work Item s – proposed revisions of this standard. To receive an Asgm Detailed Quote, please fill-in the following fields. Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems.

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Accelerated Aging Temperature Higher temp. If v1980-07 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 To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies.

Online Quote System – Accelerated Aging

f19800-7 UPS Overnight, Account number. Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc. For example, a 12 month shelf life is simulated based on 13 months.

Fed-Ex Ground, Account number. Fed-Ex Overnight, Account number. 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.

More aggressive AAFs may be used with documented evidence to show a f19880-07 between real time and accelerated aging. For more information visit www. Online Quote System – Accelerated Aging. Try out our Accelerated Aging Calculator!

Accelerated Aging Test Results. Historical Version s – view previous versions of standard. Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria.

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. Pricing includes monthly temperature graph reports. However, due g1980-07 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.

F1980–07 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. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.

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The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are:. Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements. If you have questions about our online quoting process or other questions or need assistance, call RMTS at In parallel, age samples at real-life aging conditions TRT.

ASTM-F – Accelerated Aging – Medical Package Testing

The sterile barrier astj material and device interaction compatibility that may be required for new product development or the resulting evaluation is not astmm in this guide. 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. Please fill out this form and return with your Product Submission.

Therefore, some add an extra month to the aging study to allow for sterilization, etc. The sterile barrier system shall maintain sterility to the point of use or until the expiry date. Please fill-in your Input Temperatures and select the Q10 value. Ambient Temperature Warehouse Temperature Higher temp. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part 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.

Determining AAFs are beyond the scope of this guide. Age samples at TAA.

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