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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Shelf Life Study Equivalent. Determining AAFs are beyond the scope of this guide.

In parallel, age samples at real-life aging conditions TRT. 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: Refer to Practice D for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and f180-07 conditions. Ambient Temperature Warehouse Temperature Higher temp. Link to Active This link will always route to the current Active version of the standard. Please fill-in your Input Temperatures and select the Q10 value.

The introduction of f180-07 or modified products to the marketplace requires the assurance that they can be stored for an extended period one year, two years, etc.

Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc. Please fill out this form and return with your Product Submission. Define aging test time intervals including time zero. Fed-Ex Overnight, Account number.

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More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging. For more information visit www.

Work Item s – proposed revisions of this standard. Accelerated Aging Test Results. Fed-Ex 2 nd day, Account number. Try out our Accelerated Aging Calculator! Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems. 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.

The expiry date of a medical product is commonly based on its manufacture date. Accelerated Aging Temperature Higher temp. Online Quote System – Accelerated Aging.

Pricing includes monthly temperature graph reports. 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 axtm completed on the sterile barrier system. If you have questions about our online quoting process or other questions or need assistance, call RMTS at The sterile barrier system shall maintain sterility to the point of use or until the expiry date.

Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria. Relative Humidity RH is not a factor in the Arrhenius equation.

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Online Quote System – Accelerated Aging

To receive an Official Detailed Quote, please fill-in the following fields. Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion. Age samples at TAA. Evaluate the package performance after accelerated aging relative to the initial package requirements.

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.

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. 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.

Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements.